News | EATG http://www.eatg.org European AIDS Treatment Group Thu, 16 Nov 2017 19:34:07 +0000 en-US hourly 1 https://wordpress.org/?v=4.8 Open letter to the Romanian MoH to focus on TB http://www.eatg.org/news/open-letter-to-the-romanian-moh-to-focus-on-tb/ Thu, 16 Nov 2017 19:34:07 +0000 http://www.eatg.org/?post_type=news&p=6776 The Romanian Health Observatory, supported by the Romanian Angel Appeal Foundation (RAA) under the Global Fund programme, has published “The Crisis of Anti-TB Medicines in Romania”, a comprehensive and evidence-based report and long-term sustainable solutions for the TB drugs situation in our country. The report is endorsed by the Romanian Stop TB Partnership.

The Report states that “Out of the 28 investigated TB medicines mentioned as essential or necessary for the treatment of Tuberculosis and drug-resistant tuberculosis by the World Health Organization or by the Methodological Guidelines for Implementing the National Program for the Prevention and Control of Tuberculosis in Romania, 15 essential drugs are reported to be unavailable or have disruptions in supply caused by existing legislative barriers in Romania. Other 3 drugs recommended in international guidelines, but considered to have alternatives, are missing from Romania.”

Despite the slight fall in TB incidence, Romania still has the highest number of new TB cases every year in the EU. It also is an upper-middle income country, which will make it ineligible for international donors in the near future.

Since 2007, full-course drug regiments for the treatment of MDR/XDR-TB have been procured by RAA through GDF mechanism, with funding from the Global Fund and Norway Grants. These drugs supported the NTP to provide adequate non-interrupted treatment to over 2,000 MDR/XDR TB patients. In addition, with the support of the Global Fund, a WHO Technical Assistance Mission was organized by RAA in 2016 to assess the situation and formulate recommendations for resolving the crisis. Until now, the Romanian State has made no significant progress in this regard.

We urge the Romanian Government to take immediate action in order to be able to procure the full regimens for both TB and MDR/XDR-TB patients, from domestic funds.

We have designed an open letter for the Romanian Prime Minister and the Minister of Health we want to send and publish this week. Please find attached the open letter, the Executive Summary and the full report, in English.

This letter has also been endorsed by EATG: TB Romania Open Letter_with signatures

]]> Join MSF and Stop TB Partnership in asking countries to #StepUpforTB http://www.eatg.org/news/join-msf-and-stop-tb-partnership-in-asking-countries-to-stepupfortb/ Sat, 11 Nov 2017 22:59:32 +0000 http://www.eatg.org/?post_type=news&p=6743 Join Médecins Sans Frontières (MSF) and the Stop TB Partnership in a call to action to #StepUpforTB by signing and sharing a petition by 14 November 2017. The petition will be delivered at the Global Ministerial Conference on Ending TB to be held on 16-17 November 2017 in Moscow, Russia. Sign the petition here!      

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Vital microbicides may soon be out of reach http://www.eatg.org/news/vital-microbicides-may-soon-be-out-of-reach/ Sat, 11 Nov 2017 22:55:34 +0000 http://www.eatg.org/?post_type=news&p=6762 Whether, when, and how microbicide development proceeds depends on the U.S government, and the federal Division of AIDS has suggested this development may no longer be a priority. It’s wrong.

The first proven microbicide to prevent HIV may be ready for market by the end of the decade. That’s the good news. The bad news: Although there are numerous candidate microbicides in the research pipeline, this first one could end up being the only one to become publicly available. That’s because of a push to eliminate funding for research of these vital tools. The public has until November 30 to comment on such a move. More on that later.

For over 25 years, women have been calling for an HIV prevention tool that is woman-initiated, easy to use, undetectable during sex and, ideally, comes in both contraceptive and non-contraceptive forms. Research to develop such products, called microbicides, started in 1992.

Twenty-five years later, a vaginal ring, replaced monthly, is now undergoing regulatory review by the European Medicines Agency, the first microbicide to make it to this point. The International Partnership for Microbicides plans to submit it to the South African Health Products Regulatory Authority (South Africa’s equivalent of the FDA) in early 2018, followed later by submissions to other national regulatory authorities in sub-Saharan Africa. If the ring is approved, the soonest it is currently projected to be available in some countries is late 2019. It will be the realization of a dream almost three decades in the making.

Like the contraceptive NuvaRing, this microbicidal ring is a hollow silicone device—but loaded with dapivirine, an anti-HIV drug, that is released gradually over the course of a month. In clinical trials, the ring reduced new HIV infections by 56 percent among women who used it consistently as instructed.

The chance to cut one’s HIV risk in half is big news, indeed, in areas where most of the 25- to 29-year-olds with HIV (two-thirds) are women, and where only about half of all adults between 25-49 years old report using condoms regularly. Researchers estimate that this vaginal ring, alone, could “avert at least a million HIV infections [globally] over the next 20 years.”

Oral pre-exposure prophylaxis (PrEP), a pill to prevent HIV, is a new prevention strategy that offers much higher levels (over 90 percent) of protection if taken daily. A recent demonstration project among young women in South Africa, however, showed that even while getting reminders to take a pill daily, only 57 percent of participants had detectable levels of the prevention drug in their blood at week 12, and 38 percent by week 24. This suggests that the higher efficacy of the pills can be offset by inconsistent use when daily adherence is required.

The dapivirine ring is just the first of several microbicide candidates under development. Researchers are now testing the feasibility of longer-lasting, multi-purpose rings loaded with both an anti-HIV drug and a contraceptive, thus preventing both HIV and pregnancy simultaneously for up to three months. One-time use, fast-dissolving vaginal films and tablet inserts (to be inserted before sex) are also being tested.

Several “behaviorally congruent” rectal microbicide products are also in development. These products are formulated to look and feel like the douches and lubricants that people often use before or during anal sex—but have the advantage of containing anti-HIV drugs. Thus, they should fit comfortably into common sexual behaviors while also providing protection to the user and her/his partner. 

Why Would Microbicide Development Stop Now?

Whether, when, and how microbicide development proceeds depends on the U.S government simply because it has provided almost all the funding so far to develop HIV prevention tools, including PrEP, microbicides, and the (still elusive) HIV vaccine. This funding has been allocated by the Division of AIDS (DAIDS) at the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH).

Between 2000-2016, for example, over $3 billion was spent globally on microbicides research and four times that amount—more than $12 billion—on vaccine development. Almost all of this money (93 percent of the vaccines funding and 84 percent of the microbicides funding in 2016, for example) came from DAIDS.

Now, however, the government is looking to reduce funding for all kinds of important public health research, including for HIV and AIDS. DAIDS Director Carl Dieffenbach announced earlier this year that he will be leading the NIH’s effort to “refine the HIV research enterprise” by prioritizing funding for HIV prevention products that are both long-acting (work in the body for six months or longer) and systemic (affecting the whole body). Vaccines, long-term injectable PrEP, and implants meet this definition. But microbicides do not.

Microbicides are instead localized, only affecting the part of the body that needs protection; reversible, because drug levels do not remain in the body long after use; short-acting, designed to be used only at the time of sex (the vaginal ring is an exception to this); and user-controlled, meaning not injected or inserted by a medical provider.

One of DAIDS’ arguments against microbicides is that “it has not been demonstrated that the most vulnerable users would choose or adhere to these products.” This is based on the results of a few microbicide gel trials and two ring trials, in which ring use among some participants was lower than expected. Additional research is pending to see if the low rates of ring use among younger women were motivated by physical, social, or behavioral factors.

Two “open-label” studies are also underway to assess ongoing interest in the product. Once the effectiveness of a new product has been proven, an open label trial is done to see how participants feel about using it. Typically, uptake and adherence is significantly greater in open-label trials because participants know they are all getting the real product and not being randomly assigned to either the real drug or the placebo (or fake drug), as occurs in the effectiveness trial.

The question of ring acceptability among younger women, in particular, is also a matter of ongoing study. Between 2014-2016, a U.S. study enrolled 96 sexually active girls (ages 15-17) in six cities and found that almost all (95 percent) participants described the ring as easy to use. Blood tests done to confirm product use among the study participants found the preventive drug in 87 percent of the participants blood samples. Another trial in Africa is also planned to look specifically at how African adolescent girls and young women (16-21) feel about the ring.

Despite the mixed data on young women’s willingness to use the microbicidal ring, Dr. Dieffenbach, a biophysicist, maintains that DAIDS funding should only be allocated to developing prevention tools that are both long-lasting and systemic. Advocates see this decision as resulting in the defunding of microbicide research altogether. The only other potential funder for the field would be private, corporate interests. Unfortunately, the available evidence demonstrates that that this expectation is not at all realistic.

At its highest level (in 2006-07), commercial investment comprised 2 percent of all funding for microbicide research, and development and came from small biotech companies, not pharmaceutical corporations. By 2016, commercial interests were providing 0.2 percent of all resources for microbicide development. Without public support, and specifically without DAIDS funding, microbicide research and development will likely stall. This will waste 25 years of labor, amassed expertise, and investment that have brought the field to this present cusp of success, as well as the opportunity to put HIV prevention into women’s hands.

DAIDS’ focus on long-lasting methods overlooks the fact that effective microbicides are right around the corner and no injectable PrEP (which would likely require six clinic visits per year) or HIV vaccines have proven levels of effectiveness. Further, it ignores the great lesson of contraception: that different people want different methods. When people have a range of birth control choices (pills, implants, rings, injections, intrauterine devices, and so on) available to them, the number of unintended pregnancies goes down. One size does not fit all, especially in terms of personal protection. We can’t end AIDS by ignoring that lesson.

Between Now and November 30: Take Action

DAIDS has provided an opportunity for the public (in the United States and internationally) to submit comments between now and November 30. These comments go straight to DAIDS and they make a difference!

To enter your comments to DAIDS about microbicide funding, go to: https://www.niaid.nih.gov/forms/refining-hiv-research-enterprise-response-form

Here are some points to keep in mind:

  1. The United States has been, by far, the world’s strongest funder for microbicides research to date. If that stops in the next funding cycle, the chance to finish development of microbicides that could save millions of lives will be lost.
  2. Men who have sex with men in a wide range of countries and young women, especially those in southern Africa, are two key populations at very high risk of HIV contraction. If we can reduce their vulnerability to HIV, we may be able to turn the tide of AIDS. Both populations have expressed the desire for microbicides and a willingness to use them. Their needs are immediate, urgent, and ongoing.
  3. A multi-purpose vaginal ring is already in development that would provide women with contraception and HIV protection—an enormous benefit, especially for young women. The United States must not stop now and miss the chance to put these kinds of tools into women’s hands!
  4. Several rectal microbicide products are now being tested for their feasibility and safety. With so much money and time already invested, it would be financially wasteful not to finish testing these candidates to find out if one or more of them works for rectal protection.

You can also sign on to an international community letter to DAIDS on this issue by clicking on this link. Signers (organizations and individuals) from all nations are welcome!

The level of alarm about this change in direction has even roused Congress members’ attention. Rep. Jan Schakowsky (D-IL) has initiated a “Dear Colleague” letter inviting her colleagues to join her in signing to, “Support Microbicides as an NIH and NIAID Research Priority.” Please speak out with us on this urgent issue. Together, we can be heard.

For more information on this issue, please visit http://rectalmicrobicides.org/save-microbicide-research-and-development/.

By Anna Forbes

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Russia’s methadone ban is fueling an HIV epidemic in Crimea http://www.eatg.org/news/russias-methadone-ban-is-fueling-an-hiv-epidemic-in-crimea/ Sat, 11 Nov 2017 22:50:20 +0000 http://www.eatg.org/?post_type=news&p=6755 Georgy’s drug addiction started when he was just 15.

It began with the painkillers doctors gave him after he fractured his hip. But tension at home made it difficult to stop and the habit spiraled beyond his control.

“When my prescription ran out,” he says, “I started to buy soft drugs on the street. By the time I was 21, I was hooked on heroin.” Soon, he was making his own heroin at home.

In 2008, eight years into his addiction, doctors told him he had one year left to live and Georgy realized he needed help. He began a drug substitution therapy called OAT to safely wean himself off drugs.

At that point, Crimea, where Georgy lived, was still part of Ukraine and substitution therapy (OAT) was legal. But when Russia annexed Crimea in March 2014, the peninsula’s new leadership announced the therapy would be banned.

By May that year, more than 800 drug users who had been receiving OAT, including Georgy, found themselves cut off from treatment. Now local and international rights groups say the ban is fueling a resurgent HIV epidemic with fatal consequences.

“When I started OAT, my life became manageable,” Georgy, now 33, says. “I could work, I gained self-confidence and I stopped associating with criminals. If it weren’t for OAT, I wouldn’t be alive.”

‘Painful situation’

Backed by the World Health Organization (WHO) and used in over 60 countries, OAT replaces street narcotics with methadone or buprenorphine, which are less potent and longer lasting. It is widely considered to be one of the most effective methods of reducing opioid misuse and preventing HIV.

Centers where patients received daily treatment and had access to social and counseling services operated in cities across Crimea for nine years before the annexation.

The impact of the ban on Crimeans has been dramatic, local and international rights groups say. According to United Nations statistics, up to 120 patients have died from suicide, overdoses, or complications related to HIV and tuberculosis, as a result of being cut off from medication to suppress the viruses.

Another 14,000 Crimeans, who were covered by HIV prevention services, like needle exchanges, have also been cut off from treatment, according to the International HIV/AIDS Alliance in Ukraine, an NGO dedicated to issues around HIV and AIDS.

“Most OAT patients have reverted to street drugs like ‘krokodil’ and some have been put in prison,” Pavlo Skala, Associate Director at International HIV/AIDS Alliance in Ukraine, told The Moscow Times.

“Many HIV-positive patients lost touch with the health care system and came back to hospitals in a terminal phase,” he says. “The situation is painful.”

Western consensus

Ajay Manhapara, a research scientist at Yale University, argues that quitting heroin without OAT is “dangerous.”

Krokodil, the cheap heroin substitute that rights groups say is sweeping Crimea, is a deadly black-market drug. Poorly made, it can cause giant abscesses in the skin, exposing the flesh to viruses and paralyzing muscles. According to HIV/AIDS Alliance in Ukraine, its use is now rapidly increasing.

“Dependent drug users in an OAT program decrease their risk of mortality by two-thirds compared with those who try to give it up by themselves,” Manhapara said.

Russian officials, however, remain opposed, and Health Ministry officials have denied the deaths are related to the methadone ban.

In 2011, Viktor Ivanov, the head of Russia’s Federal Anti-Narcotics Agency, said “there have been no clinical trials to prove the effectiveness of the method.”

He claimed that OAT “helped to kill drug users” and that people who participated in the program were 10 times more likely to die compared to those who did not engage in the “inhumane scheme.”

In a 2014 speech in Crimea, Ivanov derided OAT as serving the interests of Western pharmaceutical companies.

“This is an incredible line of propaganda,” says Michel Kazatchkine, UN Special Envoy for AIDS in Eastern Europe and Central Asia. “The evidence is compelling, overwhelming and comprehensive.”

“The discontinuation of OAT in Crimea is a blatant example of health policy being hijacked for political ends rather than being led by evidence.”

Growing epidemic

Moreover, Kazatchkine says, the OAT ban is fueling Russia and Ukraine’s growing HIV epidemic.

Over the past decade HIV infections in Russia have soared from 170,000 in 2004 to 1.5 million last year, according to a joint European Center for Disease Prevention and Control (ECDP) and WHO report. Drug users are most at risk.

Russia accounts for nearly two-thirds of all new HIV infections in the European region, the report found. After Russia, Ukraine has the second largest HIV epidemic, with 240,000 people living with HIV.

Research by International HIV/AIDS Alliance in Ukraine shows that infection rates among younger drug users had decreased more than fivefold between 2007 and 2013 after OAT was introduced.

“OAT and other harm-reduction measures had begun to reverse Ukraine’s HIV/AIDS epidemic, which was mainly the result of injection drug users,” Skala says.

According to Chief Doctor of the Crimean State Center for Prevention and Control of AIDS Alexander Nemkin, 1,417 newly diagnosed cases of HIV were recorded in Crimea in the first nine months of 2016 — and 25 percent of those cases were the result of drug injection.

The figures mark an overall increase of 10 to 12 percent in HIV cases compared with the previous year.

Independent NGOs are working to counter the increased risk of HIV in Ukraine and Russia. But the Russian government has added some of the groups to its list of “foreign agents,” a stigma which can lead to fines and is leading groups to drop foreign funding.

That list includes ARF, the only HIV-focused organization offering free needle exchange in Moscow. “We do carry out our work using foreign funding, but this is not because we want to work this way,” ARF says in online statement in June 2016.

“Over the last few years, we applied for presidential grants four times so that our work could be funded from Russian sources, but our projects were never financed,” the statement says.

“Russia has never supported HIV prevention services among people who inject drugs, which is why the number of new infections both among this group as well as the general population is dramatically increasing,” says Andrei Klepikov, the Executive Director of the International HIV/AIDS Alliance in Ukraine in March 2014.

“We should not let 14,000 Ukrainian drug users be taken hostage in this way, cutting them off from life-saving medical services,” he says.

About 60 patients, including Georgy, were able to leave Crimea for treatment in the Ukrainian capital Kiev. With the support of the International HIV/AIDS Alliance they received housing, food and social support too. But leaving Crimea isn’t an option for most patients who either can’t afford to travel costs or have family commitments.

Georgy says he knows he was one of the lucky OAT patients. One of his friends, he says, died from an overdose when he couldn’t access treatment.

“I don’t know what happened to the rest. I haven’t heard from them since I left.”

By Madeline Roache

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A modest increase in U.S. investment to fight HIV/AIDS in sub-Saharan Africa could prevent 22 million new HIV infections by 2032 http://www.eatg.org/news/a-modest-increase-in-u-s-investment-to-fight-hivaids-in-sub-saharan-africa-could-prevent-22-million-new-hiv-infections-by-2032/ Sat, 11 Nov 2017 22:48:43 +0000 http://www.eatg.org/?post_type=news&p=6758 Analysis examines historical and potential impact of U.S. global health funding in region bearing heavy HIV/AIDS burden

NEW YORK, Nov. 10, 2017 – A new analysis shows that nearly 5 million lives in sub-Saharan Africa have been saved since 2003 as a result of U.S. investments in the global HIV/AIDS response. According to the analysis, if investment in global AIDS programs is increased by 10 percent, up to 22 million new HIV infections and 2.3 million deaths could be averted in the region by 2032.

Researchers at Imperial College London, amfAR, The Foundation for AIDS Research, and Friends of the Global Fight Against AIDS, Tuberculosis and Malaria examined the historical impact of U.S. global health investments and the implications of budget cuts in sub-Saharan Africa, the region that is home to 70 percent of all people living with HIV. Their findings are published online in the November 28 edition of the journal AIDS.

“As the leader in the global HIV/AIDS response, the United States has been instrumental in significantly reducing millions of AIDS-related deaths and preventing millions of HIV infections in Africa,” said Jessica B. McGillen, a research associate from the Department of Infectious Disease Epidemiology at Imperial College London and the lead author. “This analysis underscores the dramatic consequences of the U.S. not funding or reducing its commitment to fighting the epidemic.”

While U.S. investment in global health programs constitutes a tiny proportion of the nation’s federal spending budget — just a quarter of one percent – the U.S. is the largest donor to the global fight against HIV/AIDS through the President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund). PEPFAR is among the most successful global health programs in history and is currently supporting 11.5 million people on lifesaving antiretroviral treatment (ART). The Global Fund is the world’s largest public-private funder for HIV, tuberculosis and malaria, and along with PEPFAR has been vital in funding treatment delivery, supporting HIV testing services, and scaling up HIV prevention services. Global Fund-supported programs have saved more than 22 million lives to date.

The Administration proposed cuts that would have decreased global AIDS funding for PEPFAR by $800 million and for the Global Fund by $225 million in Fiscal Year 2018, representing reductions of 18 and 17 percent, respectively.

A World Without PEPFAR and the Global Fund

The authors used a mathematical model of HIV transmission to evaluate the impact of U.S. support for HIV programs across sub-Saharan Africa. They sought to determine how the HIV epidemic might have progressed if the U.S. had failed to invest and how the epidemic is likely to evolve under several future U.S. funding scenarios, and to explore the impact of a shift away from key at-risk populations.

Using financial data to assess the impact of lost PEPFAR and the Global Fund contributions if the programs had never been established, the authors found that AIDS mortality rates would have continued to increase instead of dropping in the mid-2000s, resulting in 3.7 million more HIV infections by the end of 2016 and nearly 5 million more lives lost to the epidemic.

From 2017 onward, if current numbers of people on treatment are maintained without any program expansion, as has been proposed by the Administration, the model indicated that 25.7 million new HIV infections and nearly 4.4 million AIDS deaths could occur by 2032.

A stepped-up response with a 10 percent increase in U.S. funding for PEPFAR and the Global Fund, coupled with more ambitious domestic HIV spending by African countries, and a focus on optimizing resource allocation, including targeting key at-risk populations, would enable 83 percent of adults with HIV to be virally suppressed on treatment, and avert more than 22 million new HIV infections and 2.3 million AIDS-related deaths over a 15-year period, relative to no expansion of the programs.

“Deaths from HIV-related causes have been halved since 2005, and more than half of all people living with HIV are on life-saving treatment, but the epidemic is far from over,” said Alana Sharp, a policy associate with amfAR and one of the authors. “We hope this informs funding and allocation decisions for global health, because without the political will and appropriate investments, we won’t be able to do what is needed to end the epidemic.”

“PEPFAR and the Global Fund work together at the country level to drive down HIV mortality and incidence, and their exceptional results deserve continued U.S. investment,” said Chris Collins, President of Friends of the Global Fight. “Yet the fight against HIV remains underfinanced. Building on the impact we’ve seen, it’s time to accelerate the effort to save lives and end the AIDS epidemic.”

Click here for more information on the impact of U.S. investments on PEPFAR.

# # #

About amfAR
amfAR, The Foundation for AIDS Research, is one of the world’s leading nonprofit organizations dedicated to the support of AIDS research, HIV prevention, treatment education, and the advocacy of sound AIDS-related public policy. Since 1985, amfAR has invested more than $480 million in its programs and has awarded grants to more than 3,300 research teams worldwide.

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World Antibiotic Awareness Week 13-19 November to draw attention to global AMR threat http://www.eatg.org/news/world-antibiotic-awareness-week-13-19-november-to-draw-attention-to-global-amr-threat/ Sat, 11 Nov 2017 22:45:10 +0000 http://www.eatg.org/?post_type=news&p=6764 World Antibiotic Awareness Week will take place next week from 13-19 November, shining a spotlight on the growing crisis of antimicrobial resistance (AMR). The first descriptions of infectious diseases becoming resistant to the antimicrobial treatments available were in 1948 and were for drugs used to treat tuberculosis (TB).

Although major gains have been made in medical R&D, the problem of drug-resistant TB (DR-TB) has only worsened. In 2016, there were an estimated 600,000 new cases of DR-TB. It is predicted that by 2050, DR-TB will lead to 2.5 million deaths annually, which would be a quarter of antimicrobial resistance (AMR) deaths.

“AMR is one of the most critical challenges the world faces. Strengthening the response to TB is a cornerstone in the fight against AMR.” said José Luis Castro, Executive Director of The Union.

World Antibiotic Awareness Week coincides with the World Health Organization’s (WHO) global political meeting of ministers in Moscow, Russia, on “Ending TB in the Sustainable Development Era: A Multisectoral Response”. The meeting aims to accelerate implementation of the WHO End TB Strategy, with immediate action addressing the DR-TB crisis, and will then inform the UN General Assembly High-Level Meeting (HLM) on TB in 2018.

The Russian Federation is one of the three countries in the world with the highest number of DR-TB cases, with those three countries (India, China and Russia) bearing more than half of the global burden. The incidence of DR-TB in Russia continues to increase, meaning it is crucial to the success of the international effort to end TB.

The WHO describes antibiotic resistance as one of the biggest threats to global health, food security, and development today. Earlier this year, the WHO’s Priority Pathogen Report, highlighted DR-TB as a priority for research and development in the battle against AMR. The report went on to highlight five key reasons why TB is a global priority for research and development.

Echoing this concern, the WHO Director General, Dr. Tedros, has said, “We cannot underestimate this crisis and we must do better to identify, track and manage these drug-resistant TB cases as part of our AMR efforts.”

Dr Paula I Fujiwara, Scientific Director of The Union said: “We need new and innovative approaches to research and development if we’re to solve the crisis of antimicrobial resistance. We look forward to working further with global leaders to accelerate progress against TB and AMR.”

As part of our work to combat this growing threat, The Union is working with partners on The Life Prize, a new way to unite researchers and incentivise new TB research and development funding.

Grania Brigden, Project Lead for The Life Prize said: “The Life Prize (formerly known as the 3P Project) aims to overcome the barriers to TB treatment development to ensure a healthy TB drug pipeline and ensuring that promising candidates are developed as combination regimens and are affordable and accessible to all those in need.”

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Eliminating viral hepatitis: time to match visions with action http://www.eatg.org/news/eliminating-viral-hepatitis-time-to-match-visions-with-action/ Sat, 11 Nov 2017 22:43:28 +0000 http://www.eatg.org/?post_type=news&p=6750 Viral hepatitis caused an estimated 1·4 million deaths in 2015—similar to tuberculosis and more than either HIV or malaria, yet historically these diseases have received insufficient attention from donors and policy makers. In May, 2016, the World Health Assembly adopted the Global Health Sector Strategy on Viral Hepatitis, 2016–20, which aims to eliminate viral hepatitis as a major public health threat by 2030. The strategy set global targets to reduce new viral hepatitis infections by 90% and to reduce deaths due to viral hepatitis by 65%, focusing mainly on hepatitis B virus (HBV) and hepatitis C virus (HCV), which are responsible for most of the global burden. Last week, politicians, policy makers, researchers, and members of civil society met in São Paulo, Brazil, at the World Hepatitis Summit to take stock, with new data indicating that only a handful of countries are set to meet the 2030 targets.

Practices associated with increased risks of contracting HBV and HCV have contributed to stigma and discrimination against patients, especially prisoners and people who inject drugs. Prevention of both diseases involves reducing the risks of exposure to the viruses, and, for hepatitis B, vaccination. Acute HBV and HCV infection tend to be asymptomatic; however, chronic infections can lead to cirrhosis and hepatocellular carcinoma. Antiviral treatment for hepatitis B is not curative, but can slow disease progression and improve survival, whereas direct-acting antiviral (DAA) therapy for hepatitis C can cure around 95% of cases.

New data from WHO, released at the summit, showed the number of people who were newly treated for hepatitis C increased from 1·1 million in 2015 to 1·76 million in 2016. Likewise, 2·8 million people began treatment for hepatitis B in 2016, up from 1·7 million in 2015. Despite these improvements, data from the Polaris Observatory indicated that although 82 countries now have viral hepatitis plans, only nine (Australia, Brazil, Egypt, Georgia, Germany, Iceland, Japan, the Netherlands, and Qatar) are on track to reach their 2030 elimination goals for hepatitis C. Globally, a major challenge is diagnosis, with many countries “running out” of patients with hepatitis C to treat, according to the World Hepatitis Alliance. Indeed, new Polaris data indicate that just 20% of people with HCV have been diagnosed, ranging from around 44% in high-income countries to 9% in low-income countries.

The price of DAAs, especially in high-income countries, is a barrier to providing effective treatment, with the list price of a 12-week course of sofosbuvir and daclatasvir ranging from US$78 in India to $77 000 in the UK and around $96 000 in the USA. Like many high-income countries, Australia initially restricted access to DAAs. But in March, 2016, following the implementation of a risk-sharing agreement with pharmaceutical companies, Australia initiated universal access. On a background of high diagnosis rates, this led to the treatment of over 30 000 patients in 2016. Challenges for the USA include the opioid crisis, which has caused some states to see steep increases in new HCV infections through injection drug use. Stretched prison budgets mean that although an estimated one in six prisoners has hepatitis C, few are treated.

Children represent a particular challenge. The Polaris Observatory estimates that 52 million children were living with viral hepatitis in 2016—4 million with HCV and 48 million with HBV. Whereas new HBV infections are declining in children owing to vaccine use, new HCV infections are on the rise. Mother-to-child transmission was the main source of paediatric HCV infection, pointing to the need for comprehensive prevention programmes for women of childbearing age. Worryingly, treatment options are limited, with DAAs not recommended for pregnant women or children younger than 12 years. Writing in a recent Series paper for The Lancet Gastroenterology & Hepatology, Wendy Spearman and colleagues argue that prevention of mother-to-child transmission through screening and treatment is a key priority for HBV elimination in sub-Saharan Africa.

Several innovations could accelerate progress towards 2030 targets, including improved point-of-care diagnostics, establishing better treatment options for young children and pregnant women with hepatitis C, developing a functional cure for hepatitis B, improving access to generic DAAs, raising awareness and combating stigma, and developing sustainable financing models as part of progress towards universal health coverage. Yet, fundamentally, the tools needed to move towards elimination targets already exist—an effective vaccine for hepatitis B and a curative treatment for hepatitis C. What is needed now more than anything else is the political will to scale up prevention, diagnosis, and treatment programmes.

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Dynavax announces FDA approval of HEPLISAV-B(TM) for prevention of hepatitis B in adults http://www.eatg.org/news/dynavax-announces-fda-approval-of-heplisav-btm-for-prevention-of-hepatitis-b-in-adults/ Sat, 11 Nov 2017 22:07:14 +0000 http://www.eatg.org/?post_type=news&p=6752 First and only two-dose vaccine in United States for prevention of hepatitis B in adults
First new hepatitis B vaccine in United States in more than 25 years

BERKELEY, CA — 11/09/17 — Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the U.S. Food and Drug Administration (FDA) has approved HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. HEPLISAV-B is the first new hepatitis B vaccine in the United States in more than 25 years and the only two-dose hepatitis B vaccine for adults.

Hepatitis B is an extremely infectious and potentially deadly virus affecting a wide range of adults in the United States. There is no cure for hepatitis B, and infections are on the rise. In 2015, new cases of acute hepatitis B increased by more than 20 percent nationally.(i) Hepatitis B can be prevented through effective vaccination. Current hepatitis B vaccines require three shots over a six-month period, however, almost half of adults fail to complete the series within one year.(ii)

“Prevention of hepatitis B in adults through vaccination is more important than ever given the increase in the rate of infections,” said William Schaffner, M.D., professor of Preventive Medicine, Vanderbilt University Medical Center. “Too many at-risk adults remain unprotected against this virus. A two-dose schedule with higher rates of protection, along with other strategies, may help us move closer to the goal of eliminating hepatitis B as a public health problem in the United States.”

The approval of HEPLISAV-B was based on data from three Phase 3 non-inferiority trials of nearly 10,000 adult participants who received HEPLISAV-B. The pivotal studies compared HEPLISAV-B administered in two doses over one month to Engerix-B administered in three doses over a six-month schedule. Results from the largest Phase 3 trial, which included 6,665 participants, showed that HEPLISAV-B demonstrated a statistically significantly higher rate of protection of 95% compared with 81% for Engerix-B. In a subgroup analysis of 961 participants with Type 2 diabetes, HEPLISAV-B demonstrated a statistically significantly higher rate of protection of 90% compared to 65% for Engerix-B. Across the three clinical trials, the most common local reaction was injection site pain (23% to 39%). The most common systemic reactions were fatigue (11% to 17%) and headache (8% to 17%).

“HEPLISAV-B is the first FDA-approved product for Dynavax and demonstrates our ability to develop innovative products and progress them from discovery to commercialization,” said Eddie Gray, chief executive officer of Dynavax. “We would like to thank the many study participants and clinical trial investigators who contributed to the development of HEPLISAV-B. We expect that it will become an essential tool in the public health community’s fight to prevent hepatitis B, and we look forward to making HEPLISAV-B available to clinicians and their adult patients.”

Dynavax expects to commercially launch HEPLISAV-B in the United States in the first quarter of 2018. In preparation for launch, Dynavax has been building commercial infrastructure and optimizing manufacturing processes to meet anticipated demand.

About Hepatitis B

Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,(iii) and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease. In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The CDC recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.(iv) Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician’s discretion.(v) Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.(vi)

About HEPLISAV-B

HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

Indication and Use
HEPLISAV-B is indicated for active immunization against infection caused by all known subtypes of hepatitis B virus. HEPLISAV-B is approved for use in adults 18 years of age and older.

Important Safety Information (ISI)
Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.

Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).

For full Prescribing Information for HEPLISAV-B, click here.

About Dynavax

Dynavax is a commercial-stage biopharmaceutical company focused on leveraging the power of the body’s innate and adaptive immune responses through toll-like receptor (TLR) stimulation. Dynavax discovers and develops novel vaccines and immuno-oncology therapeutics. The Company’s first commercial product, HEPLISAV-B, a hepatitis B vaccine for adults, is approved in the United States. Dynavax’s lead immunotherapy product, SD-101, is an investigational cancer immunotherapeutic currently being evaluated in Phase 1/2 studies and its second cancer immunotherapeutic, DV281, is in Phase 1 development. For more information, visit www.dynavax.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the commercial launch and manufacturing of HEPLISAV-B. These statements are subject to a number of risks and uncertainties that could cause actual results to differ materially, including whether the company will be able to build the commercial infrastructure required to launch HEPLISAV-B; whether we will launch HEPLISAV-B in the first quarter of 2018; whether we will be able to ramp up manufacturing activities to meet demand for HEPLISAV-B; whether the CDC’s Advisory Committee on Immunization Practices (ACIP) will add HEPLISAV-B to its adult vaccination schedule during its February 2018 meeting, or at all; whether potential claims against us, including those based on patent rights of others, will result in an injunction against sales or otherwise impact commercialization and sales; and the results of clinical studies of Dynavax’s product candidates, such as SD-101, and the impact of those results on the initiation or continuation of subsequent studies for those product candidates, and issues arising in the regulatory process; and other risks detailed in the “Risk Factors” section of our most recent current periodic report filed with the SEC. These statements represent our estimates and assumptions only as of the date of this press release. We do not undertake any obligation to update publicly any such forward-looking statements, even if new information becomes available. Information on Dynavax’s website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.

(i) CDC. https://www.cdc.gov/hepatitis/statistics/2015surveillance/index.htm#tabs-5-8. Fig 3.2

(ii) Nelson J, et al. Compliance with multiple-dose vaccine schedules among older children, adolescents and adults: results from a Vaccine Safety Datalink Study. American Journal of Public Health. 2009;99:S2.

(iii) CDC. https://www.cdc.gov/hepatitis/hbv/bfaq.htm.

(iv) CDC. https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm.

(v) CDC. https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf.

(vi) CDC. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf.

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Highlights from the CHMP November meeting http://www.eatg.org/news/highlights-from-the-chmp-november-meeting/ Sat, 11 Nov 2017 21:56:49 +0000 http://www.eatg.org/?post_type=news&p=6751 At its November meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended for approval two generic versions of darunavir – Darunavir Krka and Darunavir Krka d.d. for the treatment of HIV infection.

Summary of opinion for Darunavir Krka is available here.
Summary of opinion for Darunavir Krka d.d. is available here.

CHMP also recommended an extension of therapeutic indications for Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) with marketing authorisation holder Gilead Sciences International Limited.

Summary of opinion for Genvoya is available here.

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Understanding the Berlin patient’s unexpected cure of HIV http://www.eatg.org/news/understanding-the-berlin-patients-unexpected-cure-of-hiv/ Sat, 11 Nov 2017 21:54:30 +0000 http://www.eatg.org/?post_type=news&p=6757 New tool developed to study stem cell transplants as a potential way to treat HIV

A decade ago, the medical world was shocked when a patient in Berlin, Germany, had been declared free of HIV after receiving a stem cell transplant to treat cancer. Doctors have repeatedly tried to replicate the result, but this HIV cure has evaded other patients so far.

Dr. Jonah Sacha and colleagues at OHSU’s Vaccine & Gene Therapy Institute are among the many scientists who are seeking to understand why the much-studied “Berlin patient” was so fortunate. Now, they’ve developed a new way to understand his cure. Sacha’s team has shown a species of monkey called Mauritian cynomolgus macaques can successfully receive stem cell transplants.

Researchers have long used a different monkey species to research stem cell transplants, but that species’ biological characteristics means it can’t be reliably used to find good donor matches to mimic human stem transplants.

In a paper published Nov. 10 in the journal Nature Communications, Sacha and colleagues report they successfully performed stem transplants on two monkeys more than a year ago that continue to lead healthy lives today. The recipients did not suffer from the many common adverse effects of stem transplants, including the grueling graft-versus-host disease, which can cause severe liver damage, rashes, diarrhea and even death.

The finding provides Sacha a critical tool needed to explore how the Berlin patient was cured. As a result of the finding, researchers can also use Mauritian cynomolgus macaques to improve stem cell transplant outcomes for human patients with other blood-related conditions such as leukemia and sickle-cell disease.

Journal Reference:

  1. Benjamin J. Burwitz, Helen L. Wu, Shaheed Abdulhaqq, Christine Shriver-Munsch, Tonya Swanson, Alfred W. Legasse, Katherine B. Hammond, Stephanie L. Junell, Jason S. Reed, Benjamin N. Bimber, Justin M. Greene, Gabriela M. Webb, Mina Northrup, Wolfram Laub, Paul Kievit, Rhonda MacAllister, Michael K. Axthelm, Rebecca Ducore, Anne Lewis, Lois M. A. Colgin, Theodore Hobbs, Lauren D. Martin, Betsy Ferguson, Charles R. Thomas, Angela Panoskaltsis-Mortari, Gabrielle Meyers, Jeffrey J. Stanton, Richard T. Maziarz, Jonah B. Sacha. Allogeneic stem cell transplantation in fully MHC-matched Mauritian cynomolgus macaques recapitulates diverse human clinical outcomes. Nature Communications, 2017; 8 (1) DOI: 10.1038/s41467-017-01631-z
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Traditional interventions can prevent cardiovascular disease in patients with HIV http://www.eatg.org/news/traditional-interventions-can-prevent-cardiovascular-disease-in-patients-with-hiv/ Sat, 11 Nov 2017 21:52:16 +0000 http://www.eatg.org/?post_type=news&p=6759 Traditional methods for preventing cardiovascular disease can maximize the cardiovascular health of patients with HIV and defray future health care costs, according to findings published in Clinical Infectious Diseases.

“Although cardiovascular pathophysiology in the HIV context is not yet fully understood, likely mechanisms include complex interactions between traditional and HIV-related risk factors,” Mikaela Smit, PhD, research associate in the department of infectious disease epidemiology, Imperial College London, and colleagues wrote. “Prevention interventions will need to be firmly integrated into HIV care and supported by evidence-based studies in order to effectively mitigate the emerging [cardiovascular disease] burden, mortality risk and impact on quality of life of [people living with HIV].”

The researchers created an individual-based model of cardiovascular disease in 8,791 patients with HIV who were receiving ART, all of whom were included in the Dutch national AIDS Therapy Evaluation in the Netherlands, or ATHENA, cohort. The model followed patients as they aged and developed and then began treatment forcardiovascular disease. Smit and colleagues evaluated four different prevention interventions: earlier diagnosis and treatment of HIV, avoiding combination ART in the presence of increased cardiovascular risk, smoking cessation and more intensive monitoring and treatment of dyslipidemia and hypertension.

Most patients (77.9%) were male, and slightly more than half (52.5%) were MSM. Median age was 43.8 years. The model predicted a 55% increase of cardiovascular disease among patients with HIV between 2015 and 2030, Smith and colleagues reported, while costs were predicted to rise by 36%. Smoking cessation averted 13.1% of cases of cardiovascular disease in the model, whereas intensified monitoring and treatment of hypertension averted 20%. These traditional methods were significantly more effective than earlier HIV diagnosis and treatment, which averted a projected 0.8% of cases, and avoiding combination ART with increased cardiovascular risk, which avoided 3.7% of cases, the researchers wrote.

Smit and colleagues added that targeting high-risk patients “could avert the majority of events and costs.

“Intensified monitoring and successful treatment of hypertension and dyslipidemia in [people living with HIV] is expected to be the most feasible intervention accompanied by the largest cardiovascular health benefit and could safeguard quality of life of HIV-positive people,” the researchers wrote.

Smit M, et al. Clin Infect Dis. 2017;doi:10.1093/cid/cix858.

By Andy Polhamus

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CVD, CKD should be assessed together in HIV-positive patients http://www.eatg.org/news/cvd-ckd-should-be-assessed-together-in-hiv-positive-patients/ Sat, 11 Nov 2017 21:50:18 +0000 http://www.eatg.org/?post_type=news&p=6760 HIV-positive patients at predicted risk for cardiovascular disease (CVD) and chronic kidney disease (CKD) are at an even greater risk for CVD and CKD events, according to new research published in PLOS Medicine.

First author Mark A. Boyd, MD, and a team confirmed their hypothesis that predicted risk scores would translate to a higher risk of disease after evaluating a large-scale cohort of 27,215 HIV-positive individuals. Boyd and colleagues drew their pool of participants from the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) study, which has its own specialized predictive risk models for CVD and CKD in the HIV-positive population.

Nearly 50,000 patients are enrolled in the D:A:D study, which stretches across countries worldwide and aims to establish whether the use of combination antiretroviral therapy is associated with increased risks of conditions like CVD, end-stage renal disease, liver disease, cancer and death. These combination antiretroviral therapies have “transformed the lives of HIV-positive people” in high-income countries, Boyd et al. wrote, but though the drugs have been linked to decreased disease rates and increased life expectancy, evidence also exists that the medication can lead to greater and earlier onset comorbidities.

CVD and CKD are diseases that feed one another, the authors explained—CKD is an established independent risk factor for CVD and the two conditions share a handful of risk factors.

“It is well recognized that the effects of comorbidity may be greater than the effects of the sum of risk of each disease, and that their coexistence may lead to more severe illness, poorer prognosis and premature death,” they wrote.

For their study, the researchers pulled D:A:D participants who had recorded predicted risk scores for CVD and CKD higher than the general HIV-positive population. The risk equations predicted 13.1 percent of those patients at high CVD risk, 18.4 percent at high CKD risk and 5.8 percent at high risk for both diseases. CVD and CKD event rates were calculated by predicted five-year CVD and CKD risk groups and were multiplicative, Boyd and colleagues reported. The strongest finding was that CVD and CKD are especially dangerous when they come hand-in-hand.

The authors said these findings suggest a possible need to monitor HIV-positive patients more closely when it comes to CVD and CKD risk factors.

“We found that people at high predicted risk for both CVD and CKD have substantially greater risks for both CVD and CKD events compared with those at low predicted risk for both outcomes, and compared to those at high predicted risk for only CVD or CKD events,” Boyd et al. wrote. “This suggests that CVD and CKD risk in HIV-positive persons should be assessed together.”

By Anicka Slachta

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Ireland’s first clinic monitoring anti-HIV drug PrEP opens http://www.eatg.org/news/irelands-first-clinic-monitoring-anti-hiv-drug-prep-opens/ Sat, 11 Nov 2017 21:29:05 +0000 http://www.eatg.org/?post_type=news&p=6748 Clinic will be open to users of PrEP and will provide HIV tests and STI screening

9 November 2017: Ireland’s first clinic for monitoring users of anti-HIV drug PrEP will open in Dublin on Thursday.

Pre-Exposure Prophylaxis (PrEP) is a once-daily medication that has been proven to reduce the risk of HIV infection, particularly among members of the gay community, by up to 90 per cent.

The clinic will be open to users of the drug and will provide HIV tests and STI screening; it will not supply the drug.

The clinic will be open on Baggott street in Dublin every Thursday from 10-12am.

PrEP may not be available under the HSE payment scheme until 2019, a delay that could see up to 800 new infections, health groups have warned.

The cost of PrEP is not covered by the HSE, although it can be obtained privately with a doctor’s prescription at a cost of € 400 a month.

Gay rights activists say most people can’t afford this, leading many to import it from abroad, a practice which is illegal in Ireland.

The HSE said an assessment was taking place on whether it would be cost effective for it to cover the cost of the drug.

The assessment is being carried out by the National Centre for Pharmacoeconomics (NCPE).

In June the NCPE conducted a “rapid review” which is an initial assessment of the drug.

This was completed in late July and a full assessment was recommended.

However, this assessment cannot progress until the manufacturers of the PrEP, Gilead Sciences, make a formal application to the HSE.

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Danish court invalidates Gilead SPC http://www.eatg.org/news/danish-court-invalidates-gilead-spc/ Sat, 11 Nov 2017 21:23:29 +0000 http://www.eatg.org/?post_type=news&p=6747 The Danish Maritime and Commercial High Court has invalidated a supplementary protection certificate (SPC) owned by Gilead.

On October 26, the court rejected Gilead’s motion for an injunction against generics maker Accord.

Gilead’s SPC, number CR 2005 00032, covers the combination of emtricitabine and tenofovir disoproxil.

It was issued for Danish patent EP 0,915,894, called “Nucleotide analogs”, which expired in July this year.

Gilead sells emtricitabine/tenofovir under the brand name Truvada, to treat and prevent HIV/AIDS.

According to the court, Gilead was informed in May 2017 that Accord had obtained a marketing authorisation (MA) for the drug “emtricitabine/tenofovir disoproxil Accord”.

Gilead then contacted Accord, asking the generics maker not to market these products until the SPC was no longer in force.

In June, Gilead sent a follow-up letter to Accord, as Accord had not responded.

This time, Accord responded, claiming that its product didn’t infringe because the tenofovir disoproxil contained in its drug was not present in its fumarate acid state (which was protected under the certificate), and that the SPC was invalid.

Gilead claimed that the SPC covers tenofovir disoproxil in its various forms, in combination with other therapeutic components such as emtricitabine.

The court backed Gilead, finding that company had made it probable that the SPC covered the active ingredients listed in the MA, namely emtricitabine and tenofovir disoproxil, in all pharmaceutical forms.

Turning to the validity of the SPC, the court discussed claim 27 of the patent, on which the SPC was based.

The claim covers a compound (as described in claims 1-25), together with a pharmaceutically acceptable carrier and, optionally, other therapeutic ingredients.

According to Gilead, the SPC had been issued in accordance with article 3(a) of the SPC regulation, and the combination was protected.

The Danish court, citing the Court of Justice of the European Union (CJEU) in Medeva (case C-322/10), noted that article 3(a) must be interpreted as precluding the issuance of an SPC which contains active ingredients that do not appear in the wording of the requirements of the basic patent relied on.

Eli Lilly (C-493/12), a judgment by the CJEU in 2013, was also quoted as stating that an active ingredient not mentioned in the basic patent requirement is not protected under article 3(a).

The court also mentioned guidelines from the Danish Patent and Trademark Office on SPCs, which note that “a combination product consisting of the two active ingredients A and B is considered to be protected by a basic patent when combinations A and B appear from the wording of the requirements”.

According to the court, emtricitabine is not apparent from the wording of claim 27, so Accord had established that the contested SPC was invalid.

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Healthcare workers living with HIV have different motivations for disclosing or concealing their HIV status http://www.eatg.org/news/healthcare-workers-living-with-hiv-have-different-motivations-for-disclosing-or-concealing-their-hiv-status/ Sat, 11 Nov 2017 21:16:44 +0000 http://www.eatg.org/?post_type=news&p=6746

Nurses and other healthcare workers who are living with HIV have mixed reactions when they mention their HIV status to colleagues, according to a small Dutch study reported in the November/December issue of the Journal of the Association of Nurses in AIDS Care. Some healthcare workers disclosed because they expected a positive reaction or they felt the need to share a secret. Others concealed their HIV status because they feared a negative reaction or did not believe that disclosure was relevant or necessary.

Many people with HIV discuss their HIV status with partners, friends and family, but conceal it with employers and colleagues. Moreover, there can be particular difficulties for people working in healthcare, because of anxieties about infection control. Nonetheless, Sarah Stutterheim found that all previous studies investigating the experiences of healthcare providers with HIV were conducted in sub-Saharan Africa, with none from a European context.

She recruited ten healthcare workers living with HIV by placing an advertisement on the Dutch HIV Association’s website and through snowball sampling. The participants took part in face-to-face interviews in 2011 and 2012.

Six were nurses, three were nursing assistants and one was a pharmacist. Workplace settings were varied – general hospitals, a psychiatric hospital, nursing homes for the elderly, a group home for people with disabilities and a pharmacy.

Nine participants were gay men and one was a heterosexual woman. All were Dutch. Their mean age was 46 and they had been diagnosed for a mean of nine years.

Disclosing or concealing

Three participants reported making a conscious choice to be open about their HIV at work. Two others said they did not explicitly hide their HIV status, but were not particularly open about it either. As one of them said:

‘‘I would never deny it if people were to ask but I wouldn’t go up to my new colleagues and say, ‘I have to tell you something: I have HIV.’’’

Two interviewees had made a conscious decision to conceal their HIV status. A further three had previously been open at work, but were not anymore.

The motivations of those who chose to disclose at work varied. Some felt that it would be cathartic.

‘‘It felt like the more open I was about it, the more I felt set free, and I became happier by, by just sharing it.’’

Others expected the reaction to be positive.

‘‘I don’t feel like hiding it at work… We have lots of clients with HIV so it’s pretty normal.’’

‘‘There was another guy in my department who was also HIV positive and he was open about it so I knew that it was a safe environment for me to talk about it.’’

Others felt that by being proactive, they could prevent future problems:

‘‘So that all my colleagues would hear it from me, to prevent it from spreading through the hospital as gossip.’’

In contrast, half the participants were concealing their HIV status at work at the time of the interview. A key motivation for this was that they expected negative reactions or stigma, often because they had previously experienced this themselves or had seen it occur in relation to other people.

“I’m not going to tell them anymore because I’m, yeah, I’m scared of how my colleagues will react. And where does this come from? It comes from, for example, the fact that whenever a patient is admitted and he has HIV, then they immediately say, ‘You need to be careful, eh? He has HIV so be extra careful’.”

One nurse said that he no longer discussed his status because of a “horribly disastrous” experience with a former employer.

“I was basically removed from my position there. I was allowed to stay in the department but I wasn’t allowed to do any patient treatment or activities anymore, so basically it became an administrative job.”

A very different reason not to disclose HIV status relates to the normalisation of HIV – participants did not see the relevance or necessity of discussing HIV with colleagues.

“Who am I accountable to? Accountability: what a word, eh? I mean do I really have to automatically tell them everything about me? If I have something, do I immediately have to tell my colleagues, I have this or that? No, I don’t.”

“I haven’t told anyone there. I’ve gotten to the point where, it’s part and parcel and, I don’t need – I don’t feel the need to talk about, to tell people. I no longer have that need to talk about it with everyone.”

Those who hid their status said that concealment could sometimes be difficult. They reported fears of being discovered, for example when colleagues saw them taking medication or if they had periods of sickness.

“You only realize after the fact just how much energy it costs to live with a secret and that’s especially the case when things start to shift and they get complicated because there comes a point when you can’t remember who you’ve told and who you haven’t told.”

Reactions to disclosure

Many participants had had positive reactions to disclosure. Some colleagues and managers responded with interest, support and empathy. Very often, those disclosed to saw the participant’s HIV status as a non-issue.

“Basically, it was like there was a peak but that peak came and went really fast. So, what it comes down to is that, in the beginning, it was talked about and thought about a lot but that was, at a given moment, gone and nobody gave it anymore thought.”

Other interviewees noted with satisfaction that their confidentiality had been maintained.

A few participants had experienced negative reactions, including management wanting to reassign duties or inform colleagues about the person’s status.

“She [team leader] wanted to inform human resources and the management about my HIV status because I was a risk to the department for both patients and my colleagues. And I tried to explain that HIV can’t be transmitted in normal social contact, but she wasn’t so sure of that. And I told her that she couldn’t do that, that she couldn’t simply decide to tell others that I’m HIV-positive because it violates privacy laws. And she just got really angry. She said to me, ‘Well, I believe, in this situation, you are in no position to make demands’.”

Some said they were gossiped about or found it difficult to find new work. Experiences like these had a substantial negative impact.

“It hit me like a bomb. I was totally floored… I was very emotional and I couldn’t put it in perspective.”

“I felt down. I felt really small.”

Some confronted colleagues with accurate information (for example about infection risks), some distanced themselves by attributing the reaction to ignorance, others sought support from colleagues – and two of the ten respondents decided to find work elsewhere.

Recommendations

Sarah Stutterheim and colleagues suggest the development of specialised counselling services for employees with HIV which could help with disclosure decisions. Such services should emphasise that disclosure is a choice. They should help employees to explore their motivations for disclosure (or concealment) and the potential reactions if they do disclose. The authors comment that while disclosure can be beneficial if it results in social support or reduces psychological stress, it may sometimes be more advantageous to conceal at work, especially when the risks are great and social support is available elsewhere.

This kind of counselling should include role-play, to help people prepare for disclosure and dealing with negative reactions. It should also focus on developing coping skills and building resilience.

Meanwhile, health care organisations should make workplaces safe for people living with HIV through inclusive workplace policies and structures, initiatives that increase HIV knowledge, and efforts to enhance contact between people living with HIV and others.

By Roger Pebody

Reference

Stutterheim SE et al. HIV status disclosure in the workplace: Positive and stigmatizing experiences of health care workers living with HIV. Journal of the Association of Nurses in AIDS Care 28: 923-937, 2017.

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Fighting TB stigma: we need to apply lessons learnt from HIV activism http://www.eatg.org/news/fighting-tb-stigma-we-need-to-apply-lessons-learnt-from-hiv-activism/ Sat, 11 Nov 2017 21:10:58 +0000 http://www.eatg.org/?post_type=news&p=6745 BMJ Global Health published an article on TB stigma and how lessons learnt from HIV activism can be successfully applied to confront the TB-related stigma.

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TAG releases new report on TB research funding http://www.eatg.org/news/tag-releases-new-report-on-tb-research-funding/ Thu, 09 Nov 2017 20:27:37 +0000 http://www.eatg.org/?post_type=news&p=6738 Higher funding for TB research signals hope, but governments must dramatically increase spending to end TB.

Before the World Health Organization Global Ministerial Conference on Ending TB in the Sustainable Development Era, advocates call on all countries to increase support for TB research to reach global targets.

NEW YORK, NOVEMBER 8, 2017—Global funding for tuberculosis (TB) research reached a previously unreported high of $726 million in 2016, according to a report released today by Treatment Action Group (TAG) and the United Nations–hosted Stop TB Partnership. This represents a $100 million increase over 2015 levels and marks the first time annual funding for TB research and development (R&D) has exceeded $700 million since TAG began tracking spending in 2005. Although higher than in previous years, this amount remains woefully inadequate when judged against the innovation gaps holding back the response to TB, which is the world’s leading cause of death from a single infectious agent.

In October, the World Health Organization (WHO) announced that TB killed 1.7 million people in 2016 and caused 10.4 million new cases of TB disease. “WHO’s new TB burden estimates highlight the persistent lethality of the TB epidemic in the face of chronic underfunding and limited scientific progress,” said Mark Harrington, TAG executive director. “Exceeding $700 million in funding for TB R&D in 2016 is a hopeful sign, but with at least $2 billion needed annually, this must be the preliminary ascent, not the peak. We have to make up for decades of underinvestment and scientific neglect.” The Stop TB Partnership estimates that the world needs to spend $9 billion on TB R&D from 2016 to 2020 to stay on track with the global goal of ending TB by 2030.

TAG released the report, The Ascent Begins: Tuberculosis Research Funding Trends, 2005–2016, a week before ministers of health and high-ranking officials from over 90 countries will meet in Moscow at the first Global Ministerial Conference on Ending TB in the Sustainable Development Era, convened by the WHO and hosted by the government of the Russian Federation. The Ministerial Conference will culminate in a signed political declaration committing ministers of health and other agencies to work with each other and within their governments to end the TB epidemic by 2030, as called for by the United Nations Sustainable Development Goals (SDGs) and the WHO End TB Strategy. That strategy indicates that universal access to currently existing technologies will not be enough to reduce TB incidence and mortality to the desired near-elimination levels; instead, ending TB by 2030 will require introducing new tools to prevent, diagnose, and treat TB no later than 2025.

“Ministerial engagement on TB R&D is important, but unless we have heads of state committing to fill the TB research funding gap, we will go nowhere,” said Dr. Lucica Ditiu, executive director of the Stop TB Partnership. “We must raise the TB R&D topic on the political agenda, through our continuous advocacy, and the first-ever United Nations High-Level Meeting on Tuberculosis in 2018. And political commitments and discussions must translate into concrete actions. Governments must increase their spending on TB research to develop the innovations we need to end TB.”

The TAG/Stop TB Partnership report cautions that the spending increase observed in 2016 is mostly attributable to existing major donors such as the U.S. National Institutes of Health and the Bill & Melinda Gates Foundation, which together have contributed over half of all reported funding for TB research since 2005. Pharmaceutical industry expenditures on TB R&D declined for the fifth straight year.

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Download the report The Ascent Begins: Tuberculosis Research Funding Trends, 2005–2016

More information:

  1. Country-Specific TB Research Funding Targets
  2. WHO Global Ministerial Conference on Ending Tuberculosis
  3. G20 Leaders Declaration (para. 22 mentions TB R&D)
  4. BRICS Leaders Xiamen Declaration (para. 64 mentions TB R&D)

About TAG

Treatment Action Group is an independent, activist, and community-based research and policy think tank fighting for better treatment and prevention, a vaccine, and a cure for HIV, TB, and hepatitis C virus (HCV). TAG works to ensure that all people with HIV, TB, and HCV receive lifesaving treatment, care, and information. We are science-based treatment activists working to expand and accelerate vital research and effective community engagement with research and policy institutions.

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WHO compendium of TB guidelines and associated standards http://www.eatg.org/news/compendium-of-who-guidelines-and-associated-standards/ Thu, 09 Nov 2017 20:25:58 +0000 http://www.eatg.org/?post_type=news&p=6736 Compendium of WHO guidelines and associated standards: ensuring optimum delivery of the cascade of care for patients with tuberculosis

3 November 2017 | Geneva: The Global Tuberculosis Programme of the World Health Organization (WHO) has released the “Compendium of WHO guidelines and associated standards” to support the delivery of care for all persons affected by tuberculosis (TB).

The Compendium has been developed as a clear and concise instrument to facilitate the understanding and planning of delivery of high-quality care for everybody affected by TB. It incorporates all recent policy guidance from WHO; follows the care pathway of persons with signs or symptoms of TB in seeking diagnosis, treatment and care; and includes key algorithms and cross-cutting elements that are essential to a patient-centered approach in the cascade of TB care.

The Compendium is structured into 33 WHO standards and consolidates all current WHO TB policy recommendations into a single resource, with electronic links to the individual, comprehensive WHO policy guidelines.

Background

Ending the TB epidemic requires speedy adoption and implementation of the WHO End TB Strategy [1] to reach its the ambitious targets, within the framework of the United Nations Sustainable Development Goals. This in turn requires implementation and scale-up of the most modern standards for TB  prevention, diagnosis and treatment, supported by cross-cutting elements such as ethics and human rights and with significantly enhanced human and financial resources.

Beyond accelerated implementation of existing tools, an effective TB response must embrace innovation through the rapid uptake of new interventions such as diagnostics, medicines, and digital platforms to modernize care provision. Working with communities, civil society and any partners, governments need to assume full responsibility for ensuring access to person-centered, modern, high-quality TB services, regardless of whether care is sought from public, voluntary, private or corporate care providers. Securing comprehensive care along with essential support for each person with TB also calls for collaboration within and beyond the health sector.

“After decades of stagnation, finally new diagnostics, drugs and regimens have become available through intensified research efforts and increased field experiences,” said Dr Mario Raviglione, Director of the WHO Global TB Programme. “Implementing the standards of TB care outlined in this Compendium will ensure that these innovations rapidly translate into optimal care for all affected by TB.”

The Compendium will be updated annually, including in its digital format, to allow incorporation of new evidence emerging from the rapidly evolving TB diagnostic and treatment landscape.

[1] Implementing the End TB Strategy: the essentials (WHO/HTM/TB/2015.31). Geneva, World Health Organization. 2015. (http://www.who.int/tb/publications/2015/end_tb_essential.pdf; accessed 2 November 2017).

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FDA guidance for industry on DAA development for hepatitis C http://www.eatg.org/news/fda-guidance-for-industry-on-daa-development-for-hepatitis-c/ Thu, 09 Nov 2017 20:20:12 +0000 http://www.eatg.org/?post_type=news&p=6742 FDA published a final guidance on Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment. The guidance can be found at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm225333.pdf

This guidance assists sponsors in the clinical development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C (CHC) from the pre-investigational new drug application stage through the new drug application and post-marketing stages.  This guidance finalizes the draft guidance of the same name issued in May 2016.  Major changes from the draft include the following:

  • Modification of several sections to focus on interferon-free DAA regimens.
  • Additional clarification on trial designs for combinations of investigational DAAs with or without ribavirin.
  • Additional clarification on the recommended trial population to include patients with clinical or laboratory evidence of CHC disease.
  • Additional details on DAA drug development in patients with decompensated cirrhosis.
  • Additional clarification on efficacy endpoints.
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Fact sheets on global health R&D http://www.eatg.org/news/fact-sheets-on-global-health-rd/ Thu, 09 Nov 2017 20:15:30 +0000 http://www.eatg.org/?post_type=news&p=6735 The Global Health Technologies Coalition (GHTC) released a six-part fact sheet series examining the contributions of the US government agencies to advancing global health R&D, including USAID, NIH, CDC, FDA, DoD, and BARDA.

The fact sheets can be downloaded here.

 

The Kaiser Family Foundation released an updated fact sheet explaining the US government’s role in addressing global TB, including the history of the US involvement and funding trends.

The fact sheet can be downloaded here.

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Gilead loss of generic HIV drug battle a boost for gay community in Ireland http://www.eatg.org/news/gilead-loss-of-generic-hiv-drug-battle-a-boost-for-gay-community-in-ireland/ Thu, 09 Nov 2017 20:09:42 +0000 http://www.eatg.org/?post_type=news&p=6741 Generic versions of Truvada that are 60 per cent cheaper are about to hit Irish market

A campaign by Ireland’s gay and transgender community for access to cheaper drugs to treat and prevent HIV has received a major boost, after pharma giant Gilead lost a court action in Dublin against generics manufacturers.

Gilead has generated almost $14 billion globally in recent years from sales of its blockbuster HIV drug, Truvada. It came off patent in July, but its Irish exclusivity is extended until 2020 by a supplementary protection certificate (SPC).

In July, Gilead initiated High Court action against generics manufacturers Mylan and Teva, who planned to launch generic versions in Ireland upon patent expiry. Gilead sought an injunction blocking them due to the SCP.

This week, however, the court rejected its application for an interlocutory [provisional] injunction, which would have blocked Mylan and Teva until a full trial.

Sources say that the launch of generic versions of Truvada by Mylan and Teva in Ireland is now imminent. They will be up to 60 per cent cheaper.

Access to Truvada and its generic equivalents is at the heart of a passionate campaign in Ireland and abroad. Primarily for men who have sex with other men, the drug has three uses: to treat HIV once contracted; as part of a preventative cocktail taken immediately after possible exposure; and, taken routinely to help reduce the risk of contracting HIV.

The Health Service Executive (HSE) spends about €24 million on Truvada as a treatment and also for immediate post-exposure prophylaxis (PEP) treatment. The State does not, however, fund Truvada for pre-exposure (PrEP) use, which is at the heart of the campaign by advocates for the gay community.

Some studies have shown that taking a PrEP drug as a preventative measure reduces contraction rates among men who have sex with men by 90 per cent.

In its High Court action, Gilead sought the injunction and also for Mylan and Teva to “deliver up” their plans for their products. Mylan responded that it already has “pricing approval” from the State for its generic version, while Teva also said it would not wait on the expiration of the SPC.

SPCs for Truvada are being challenged in several countries across Europe by Mylan and Teva, including the UK, Spain and Germany. They have not sought to revoke the SPC in Ireland. Meanwhile, Gilead failed to get an interim injunction in France, but its SPC was upheld in Portugal.

Mr Justice Brian McGovern rejected Gilead’s injunction application, partly on the basis that if it is found at full trial that the SPC stood and its rights were breached, Gilead could seek monetary damages.

Andrew Leavitt, a member of campaign group Act Up Dublin, welcomed this week’s “significant” decision, which he said could “accelerate the timeline” for State-funded PrEP because the generics are 60 per cent cheaper.

He said many gay men order the drug online themselves at a cost of €100 for a three-month preventative supply, but customs often seize it on importation in the post.

“We don’t care who the HSE acquires PrEP from, we just want it available in Ireland,” said Mr Leavitt.

Gilead did not make any comment about the judgment.

By Mark Paul

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Scientists find missing clue to how HIV hacks cells to propagate itself http://www.eatg.org/news/scientists-find-missing-clue-to-how-hiv-hacks-cells-to-propagate-itself/ Thu, 09 Nov 2017 19:58:57 +0000 http://www.eatg.org/?post_type=news&p=6740

Computer modeling has helped a team of scientists, including several scholars from the University of Chicago, to decode previously unknown details about the process by which HIV forces cells to spread the virus to other cells. The findings, published Nov. 7 in Proceedings of the National Academy of Sciences, may offer a new avenue for drugs to combat the virus.

A key part of HIV’s success is a nasty little trick to propagate itself inside the body. Once HIV has infected a cell, it forces the cell to make a little capsule out of its own membrane, filled with the virus. The capsule pinches off—a process called “budding”—and floats away to infect more cells. Once inside another unsuspecting cell, the capsule coating falls apart, and the HIV RNA gets to work.

Scientists knew that budding involves an HIV protein complex called Gag protein, but the details of the molecular process were murky. “For a while now we have had an idea of what the final assembled structure looks like, but all the details in between remained largely unknown,” said Gregory Voth, the Haig P. Papazian Distinguished Service Professor of Chemistry and corresponding author on the paper.

Since it’s been difficult to get a good molecular-level snapshot of the protein complex with imaging techniques, Voth and his team built a computer model to simulate Gag in action. Simulations allowed them to tweak the model until they arrived at the most likely configurations for the molecular process, which was then validated by experiments in the laboratory of Jennifer Lippincott-Schwartz at the National Institutes of Health and the Howard Hughes Medical Institute Janelia Research Campus.

They built a model of missing parts of the Gag protein complex, and tweaked it until they could see how the proteins assemble by taking advantage of cellular infrastructure in preparation for the budding process.

“It really demonstrates the power of modern computing for simulating viruses,” Voth said.

“The hope is that once you have an Achilles’ heel, you can make a drug to stop Gag accumulation and hopefully arrest the virus’s progression.”

The team plans next to study the structures of the Gag proteins in the HIV virus capsule after budding, he said.

Other UChicago authors on the paper were postdoctoral researcher Alexander Pak, researcher John Grime and graduate student Aleksander Durumeric.


Citation: “Immature HIV-1 Lattice Assembly Dynamics are Regulated by Scaffolding from Nucleic Acid and the Plasma Membrane,” Pak et. al., Proceedings of the National Academy of Sciences, Nov. 7, 2017. doi: 10.1073/pnas.1706600114

Funding: National Institutes of Health, Howard Hughes Medical Institute, European Molecular Biology Laboratory, Chica un Heinz Schaller Siftung, Deutsche Forschungsgemeinschaft, National Science Foundation, State of Illinois.

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Undetectable = Untransmittable: a community brief http://www.eatg.org/news/undetectable-untransmittable-a-community-brief/ Wed, 08 Nov 2017 22:44:58 +0000 http://www.eatg.org/?post_type=news&p=6726 The International Council of AIDS Service Organizations (ICASO) developed a brief to provide the HIV community with current information and analysis of new and updated clinical data on the effectiveness of antiretroviral therapy (ART) in preventing HIV transmission to sexual partners of people living with HIV. While the health benefits of treatment will always be the primary purpose of ART, it is vital that the secondary benefits to people living with HIV and their sexual partners be fully understood and communicated. The brief is organized as follows:

  1. Introduction
  • Overview of the rationale for this brief as well as a glossary of key terms
  1. HIV Basics: Prevention, Sexual Transmission and the Dual Role of Anti-retrovirals
  • Overview of current global information on sexual transmission, combination HIV prevention packages and the dual role of ART in improving the health of people living with HIV and preventing sexual transmission to sexual partners
  1. The Science of HIV Transmission: What’s New?
  • Summary of clinical findings released in 2016 and early 2017 on the role of ART in preventing transmission to sexual partners of people living with HIV
  • Brief review of the clinical evidence regarding the use of ARVs as oral pre-exposure prophylaxis (PrEP) by HIV-negative people to prevent HIV acquisition
  1. Advocacy for Access to ART and HIV diagnostics
  • Analysis of implications of new and updated clinical findings in developing advocacy strategies to address disparities in access to HIV diagnostics including viral load testing and ART.
  1. Advocacy for Accurate, Rights-based HIV Education: Challenging HIV Stigma
  • Analysis of implications of new and updated clinical findings in developing rights-based HIV education for people living with HIV
  1. The Population Potential of ARVs as Prevention
  • Analysis of the population potential of ARVs in reducing or eliminating sexual transmission of HIV
  1. Law Reform on Criminalization of HIV Non-Disclosure
  • Implications for advocacy for law reform efforts aimed at ending the unjust, overly-broad application of general and HIV-specific laws which criminalize people living with HIV
  • ICASO’s position is consistent with international guidance on restricting the use of criminal law to exceptional circumstances of intentional, actual transmission.

 

Download the community brief here.

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Advances in HIV prevention, treatment and cure: a special issue of PLOS Medicine http://www.eatg.org/news/advances-in-hiv-prevention-treatment-and-cure-a-special-issue-of-plos-medicine/ Wed, 08 Nov 2017 22:41:59 +0000 http://www.eatg.org/?post_type=news&p=6733 Senior Editor Richard Turner discusses the content published in week 1 of the PLOS Medicine Special Issue on HIV/AIDS.

This week, PLOS Medicine begins publication of a Special Issue on Advances in HIV Prevention, Treatment and Cure, advised by Guest Editors Linda-Gail Bekker, Steven Deeks and Sharon Lewin of the Desmond Tutu HIV Centre, University of Cape Town, South Africa; the University of California, San Francisco, USA; and the Peter Doherty Institute of Infection and Immunity, University of Melbourne and Royal Melbourne Hospital, Australia, respectively. The issue will feature research and discussion content addressing one of the world’s most critical health challenges.

Developing scientific and societal solutions to control the spread of the HIV epidemic has been a long struggle, drawing on commitment and advocacy from many quarters, including researchers, donors, activists and patients, including many in low- and middle-income countries. Today, potent methods for prevention and treatment of HIV infection are widely available, but the wide geographic spread of the virus and its prevalence within vulnerable population groups mean that the scale of the epidemic remains a serious problem—in 2016, there were an estimated 1.8 million new HIV infections and 1 million deaths from AIDS-related illnesses, a large proportion in low- and middle-income countries.

In a Research Article in PLOS Medicine, Tonia Poteat and colleagues address the situation of a key population at risk of HIV/AIDS—transgender women and men who have sex with men (MSM) in Africa. In an analysis of survey data on more than 4,500 participants from 8 countries, Poteat and colleagues document a greater risk of HIV infection for transgender women as compared with other MSM, and report on behavioural risk factors associated with HIV infection and on participants’ experiences of stigma and violence. Such findings should be valuable in guiding the design of programmes to engage with, and address the challenges around provision of prevention and care for, this at-risk group.

With the goal of ending the HIV epidemic in mind, the Joint United Nations Programme on HIV/AIDS (UNAIDS) has set demanding targets for achieving high coverage of HIV testing, as well as effective and sustained treatment of people who are infected, across all countries. As an example of the issues of engaging and retaining patients in care, Samantha Kaplan and colleagues report in their Research Article on a longstanding programme for provision of HIV therapy in Khayelitsha township in South Africa. The authors estimate that around 25% of patients disengaged from care over 2 years, although a proportion of these patients were found to have subsequently re-engaged in care. These findings indicate the difficulties of providing effective therapy for a mobile population in such settings.

In a further Research Article, Margaret McNairy and colleagues report the findings of Link4Health, a cluster-randomized trial carried out in Swaziland. With an aim of improving the engagement of and retention in care of people with HIV, the authors tested a combination intervention including prompt HIV testing and initiation of antiretroviral therapy, together with other approaches to support provision of care. Substantial benefits in engagement and retention in care up to 1 year are reported, indicating the promise of combined approaches to increase population coverage with effective treatment. In a Perspective entitled “Reaching global HIV/AIDS goals: What got us here, won’t get us there”, Wafaa El-Sadr and coauthors discuss the importance of tailoring HIV therapy and care to specific settings and population groups.

The ultimate solution to the HIV/AIDS epidemic would be to develop a reliable method to cure HIV infection, but to date this has been achieved very rarely. Timothy Henrich and colleagues address this topic in a Research Article, in which they describe detailed studies carried out on two people participating in pre-exposure prophylaxis programmes. These individuals started antiretroviral treatment a few days after HIV infection, and one patient subsequently underwent an analytical treatment interruption; Henrich and colleagues studied the characteristics and distribution of the viral reservoir for more than two years. Although cure was not achieved in either of these patients, such analyses should be able to inform future strategies intended to eradicate HIV from people with the infection.

Effective antiretroviral therapy means that people are now living with HIV for many years, and large population studies such as D:A:D (Data collection on Adverse events of Anti-HIV Drugs) are important to monitor the long-term effects of HIV infection on the immune system and associated disease sequelae, and on the adverse effects of antiretroviral drugs. Mark Boyd and colleagues, in their Research Article, study patients at elevated risk of cardiovascular and renal disease among more than 27,000 participants in the D:A:D study, and report a multiplicative increase in the risk of events in those patients judged to be at risk of both types of disease.

The issue will continue for the next several weeks with further research and commentary papers—to view the papers, visit the Special Issue Collection.

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Aidspan publishes new issue of ‘Global Fund Observer’ http://www.eatg.org/news/aidspan-publishes-new-issue-of-global-fund-observer-32/ Wed, 08 Nov 2017 22:36:43 +0000 http://www.eatg.org/?post_type=news&p=6732 Aidspan: Global Fund Observer

Aidspan, an independent watchdog of the Global Fund to Fight AIDS, Tuberculosis and Malaria, published Issue 323 of the “Global Fund Observer.” The newsletter includes articles on various topics, including an announcement of a new fund to support the engagement of adolescent girls and young women in Global Fund-related and national processes; a commentary on the Global Fund and PEPFAR’s complementary approaches and collaborations; and a primer on transitioning from Global Fund support.

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HIV remission: the quest to turn lessons from exceptional cases into solutions http://www.eatg.org/news/hiv-remission-the-quest-to-turn-lessons-from-exceptional-cases-into-solutions/ Wed, 08 Nov 2017 22:33:47 +0000 http://www.eatg.org/?post_type=news&p=6731 The case of an HIV-infected child in South Africa who has been in remission for nearly nine years without taking any antiretroviral drugs has provided further proof that HIV remission is possible.

Remission (also known as functional cure) is a term that describes the body’s ability to control HIV to undetectable levels without the use of antiretroviral therapy. Remission refers to a state following treatment that is then stopped. Less than 1% of people who are infected with HIV are naturally able to do this without any treatment.

The South African case – the first reported instance of HIV remission in an African child, and only the third case in the world – has raised many questions: what makes this child so unique? Is it the virus? Is it the host? Were the drugs essential to this outcome?

I am part of a team of researchers that’s investigating this unusual case, an endeavour that’s intensified this year. What we found were signs that HIV can be suppressed naturally for a long time after someone has been on a short spell of treatment. We presented our findings at the 9th International Aids Society conference on HIV science in Paris in July.

The discovery is only the first bit of a puzzle we are piecing together – on an ongoing basis – into what exactly causes suppression. It opens the door for researchers to establish how to make long-term remission possible for other people. This is a critical part of making HIV a manageable disease.

A remarkable outcome

The child – whose gender has not been disclosed – was born in 2007 to an HIV-infected mother. The child was diagnosed as HIV-positive at one month of age and then enrolled in a clinical trial called CHER (Children with HIV Early Antiretroviral Therapy). The trial ran from 2005 to 2011.

The child – randomly selected in the trial to receive early treatment – started anti-retrovirals just after turning two months old. The child was one of 143 babies who received early treatment for 40 weeks.

The virus rebounds within weeks in most people who stop taking the drugs. HIV attacks the T-cells, forcing the person’s CD4 count to drop significantly. But in this instance the child’s CD4 count remained at the level of a healthy child’s after the drugs were stopped. And has remained so ever since.

More than eight and half years later the child has no symptoms of infection. The virus has not rebounded and it cannot be detected with standard methods.

To establish what led to this outcome the child’s blood samples have been subjected to detailed virological, immunological and genetic studies to understand the state of the virus in the body.

The child had high levels of the virus in the blood before starting treatment at two and a half months. This suggested that the child had an actively replicating virus at the time.

But by the time the child was nine and a half years old, there were only small traces of virus in the cells and the virus was no longer actively replicating.

In addition, we saw signs that the child’s immune system had identified the virus before. At this stage we don’t know which parts of the immune system were active close to the time of infection and treatment. Understanding both the response now – and which immune responses were initially involved – is critical to help us develop a vaccine, or other strategies, that could solicit a similar immune response in other people.

What the three rare finds tell us

The three remission cases have provided researchers with different lessons. The first case was a baby born in Mississippi in 2010 who was HIV infected at birth. The baby started treatment 30 hours after she was diagnosed and continued treatment until she was 18-months-old. The virus remained under control – that is below detectable levels – for the next 27 months. But then it rebounded.

This case highlighted that remission was possible for a period of time.

The second case involved a child born in France in 1996. Treatment was started at three-months-old but then stopped when the child was about six years old. The virus remains under control. This case showed that long-term remission is possible.

Our case further confirms that long term remission is possible, even with a short period of treatment.

Since the first remission case, several trials are trying to establish whether starting babies identified with HIV at birth with treatment within 48 hours of the discovery could help.

The thinking is that intercepting HIV as close to the time of infection as possible can result in a smaller reservoir of virus in the cells. This in turn could increase the chances of remission for sustained periods of time or maybe even permanently.

Take home messages

There is no doubt that early treatment is desirable. It reduces chances of transmission, protects the immune system from damage caused by the virus, keeps virus reservoirs small and improves general health and the chances of survival.

But we know that, if treatment is stopped, early treatment isn’t enough for most people to achieve remission. Other interventions need to be sought.

For most infected patients, treatment starts long after they are infected. This presents an even greater challenge to achieve remission.

The South African child tells us that other factors, unique to an individual or to very rare groups of individuals, are important. The clues are there. We need to find what these factors are from the few and turn them into solutions for the many.

And, more important than anything, is that patients don’t stop their treatment until we have all the pieces of the puzzle in place.

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HIV patients at greater risk of both heart and kidney disease http://www.eatg.org/news/hiv-patients-at-greater-risk-of-both-heart-and-kidney-disease/ Wed, 08 Nov 2017 22:31:21 +0000 http://www.eatg.org/?post_type=news&p=6728 HIV patients and their doctors are urged to be more aware of the additional health risks associated with treated HIV infection. This follows new research that shows HIV patients at high risk for a heart attack or stroke are also at substantially greater risk for chronic kidney disease and vice versa.

The research, led by the University of Adelaide’s Professor Mark Boyd, will be published today in a special issue of the journal PLOS Medicine, which focuses on worldwide advances in HIV prevention, treatment and cure in the lead up to World AIDS Day on 1 December.

Professor Boyd, an infectious diseases expert with the Adelaide Medical School, University of Adelaide, led an international team to investigate additional diseases associated with HIV infection and its treatment.

Drawing on data from the international D:A:D (Data collection on Adverse events of Anti-HIV Drugs) study, Professor Boyd and colleagues assessed the risks of cardiovascular disease and chronic kidney disease in people with HIV infection. They found elevated risks of each disease occurring simultaneously.

More than 1400 people in the study being treated for HIV had been diagnosed with chronic kidney disease, and more than 900 had experienced a cardiovascular disease event. Almost 11% of these patients had experienced both chronic kidney disease and cardiovascular disease, with many of these events occurring just one year apart.

“Our research found that people with HIV at high risk of cardiovascular disease had a corresponding 5.63-fold increase in risk of chronic kidney disease — a finding not consistent with the general community,” Professor Boyd says.

“This study adds to the international body of research that shows we need to pay close attention to the broader, general healthcare of people living with HIV.

“It’s wonderful that anti-HIV medication has been able to save the lives of so many with HIV; what we need to do now is to help people with HIV realise the full potential of their much-extended life expectancy.

“Despite much effort over the past decade to focus attention on reducing cardiovascular risk in HIV-positive people, there has been a lack of attention to the management of this disease in people living with HIV. Unfortunately, this has implications for other diseases, and the interaction between diseases creates substantial risks for future life-threatening events,” he says.

Professor Boyd says the research shows that the risks for cardiovascular and chronic kidney disease in people with HIV should be assessed together.

“We strongly urge both people with HIV and their doctors to be aware of these risks, and to treat them as a combined healthcare issue, not separately,” he says.

“Primary prevention and effective management of these diseases, prioritising interventions that have been repeatedly shown in the general community, will convey the same if not greater benefits for the population of HIV-positive people.

“This approach should be incorporated in to the development of guidelines and defining future research priorities for HIV-positive people,” he says.

Professor Boyd has also been invited to participate in the upcoming Clinton Foundation convened Third Conference on Antiretroviral Drug Optimization, 29 November to 1 December, in Johannesburg, South Africa. The event brings together international experts to discuss and debate what is required over the next five years to support the global access to HIV care initiative.

Journal Reference:

  1. Mark A. Boyd, Amanda Mocroft, Lene Ryom, Antonella d’Arminio Monforte, Caroline Sabin, Wafaa M. El-Sadr, Camilla Ingrid Hatleberg, Stephane De Wit, Rainer Weber, Eric Fontas, Andrew Phillips, Fabrice Bonnet, Peter Reiss, Jens Lundgren, Matthew Law. Cardiovascular disease (CVD) and chronic kidney disease (CKD) event rates in HIV-positive persons at high predicted CVD and CKD risk: A prospective analysis of the D:A:D observational study. PLOS Medicine, 2017; 14 (11): e1002424 DOI: 10.1371/journal.pmed.1002424
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Study finds no evidence raltegravir-based ART regimen leads to cancer or death http://www.eatg.org/news/study-finds-no-evidence-raltegravir-based-art-regimen-leads-to-cancer-or-death/ Wed, 08 Nov 2017 22:17:18 +0000 http://www.eatg.org/?post_type=news&p=6730 A crucial step in the propagation of the HIV is the integration of viral nucleic acids into the host genome. This process occurs with the help of the HIV-1 integrase enzyme. Raltegravir is the first approved antiretroviral (ART) drug that works by inhibiting the HIV-1 integrase enzyme, thereby preventing strand transfer. Although raltegravir exhibited satisfactory safety profiles and was approved for use in 2010, increased incidence of cancers was observed in patients who were given a raltegravir-based drug regimen. Recent in vitro data demonstrated that small doses of raltegravir could lead to large rearrangements in the host genome, including insertions and deletions, which would be conducive to developing malignancies.

However, these observations and the in vitro data have yet to be substantiated. A recent study published in HIV Medicine sought to address this question, to determine if raltegravir indeed increases the risk of developing cancer. Co-investigators, Amanda Mocroft, PhD, and Ole Kirk, PhD, led the study.

The authors utilized the EuroSIDA cohort, an on-going prospective study that consists of 18,931 individuals from 111 hospitals in 34 countries currently living with HIV. The cohort was divided into 3 groups: those that started raltegravir-based therapy on or after December 2007, those that added a new antiretroviral drug (not raltegravir) to their regimen between January 2005 and December 2007 (termed HIST), and those that added a new antiretroviral drug (not raltegravir) to their regimen after December 2007 (termed CONC). The raltegravir cohort consisted of 1470 patients, with 4058 person-years of follow-up (PYFU). The other 2 cohorts, HIST and CONC, consisted of 3787 (4472 PYFU) and 4467 (10,691 PYFU) respectively. The authors assessed 4 outcomes: newly diagnosed cancers, both AIDS and non-AIDS related, liver-related events, lipodystrophy, and mortality.

The majority of the patients, across the 3 cohorts, were white males. In addition, the mode of HIV transmission was similar in the 3 cohorts, with 40% of patients being men who have sex with men (MSM). A total of 20% acquired HIV through heterosexual contact, and the remaining patients were persons who inject drugs (PWID).

In the raltegravir cohort, 24% of patients discontinued the drug, with 11% discontinuing the drug within 3 months. These early discontinuations were generally due to raltegravir-related gastrointestinal toxicity or patient choice. The later discontinuations seemed to be mostly due to decisions made by the monitoring physician, with 71 out of the 312 longer-term discontinuations due to this reason.

Overall, the authors found that there was no evidence that the patients in the raltegravir cohort were at increased risk of cancer or death in comparison to those given alternative ART regimens. The study confirms that raltegravir is a safe as a therapeutic option for HIV, particularly for patients who have a history of failed therapy or in patients intolerant towards other ART drugs. However, the authors caution the reader against drawing firm conclusions from the study as it was an observational cohort study and not a randomized clinical trial. In other words, this study is unable to exclude confounding variables, such as lifestyle choices like smoking.

By Samar Mahmoud

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People with HIV more likely to adhere to their antiretroviral therapy than treatment for other chronic health problems http://www.eatg.org/news/people-with-hiv-more-likely-to-adhere-to-their-antiretroviral-therapy-than-treatment-for-other-chronic-health-problems/ Wed, 08 Nov 2017 21:34:20 +0000 http://www.eatg.org/?post_type=news&p=6725

Ageing HIV-positive people have significantly higher levels of adherence to their antiretroviral therapy than to medication taken for other chronic health problems, Swiss investigators report in HIV Medicine. The research also revealed that people living with HIV rated the necessity of their HIV treatment more highly than therapy for other illness and also had lower levels of concern about their antiretroviral treatment compared to therapy for co-morbid conditions.

“This is the first study on HIV-infected patients’ beliefs about all their co-treatment in comparison with their cART [combination antiretroviral therapy],” comment the investigators. “It is essential to explore the different beliefs about medicines of comorbid HIV-infected patients which may influence their medication management strategies and decisions to adhere to prescribed regimens.”

The success of antiretroviral therapy means that most HIV-positive people now have an excellent life expectancy. People living with HIV can expect to survive well into old age and therefore require treatment for chronic health problems such as cardiovascular disease, osteoporosis and depression.

Investigators from the Swiss HIV Cohort hypothesised that people would have differing attitudes towards their HIV treatment and therapy taken for other conditions.

They therefore designed a prospective, observational cross-sectional study involving antiretroviral-treated people taking long-term therapy for at least one other chronic health problem. After a routine clinic visit, individuals were asked to complete two standardised questionnaires assessing beliefs about the necessity of their treatment and their concerns about such therapy. The first questionnaire explored beliefs about antiretroviral treatment, the second beliefs about therapy taken for other chronic conditions.

Concerns were rated on a scale from 1 (low) to 5 (high).

Adherence to HIV therapy and treatment was also measured. Adherence was defined as not missing any doses in the previous four weeks.

The survey took place between 2015 and 2016.

The final study sample consisted of 105 people. Three-quarters were men and the median age was 56 years. Half the participants were employed and 26% had a bachelor’s degree or higher. Almost all (97%) had an undetectable viral load and median CD4 cell count was 707 cells/mm3. The major prescribed co-therapies were for cardiovascular disease (79%) and depression (44%).

A significantly higher proportion of people reported being adherent to their HIV treatment compared to therapy for co-morbidities (87 vs 75%, p = 0.0001).

The necessity of antiretroviral therapy was rated much higher than treatment for other chronic health problems (mean scores: 4.46 vs 2.86, p < 0.0001). Individuals without a university degree gave higher scores for co-treatment necessity than those with a degree.

“This counterintuitive result might be a consequence of patients with more education possibly being more likely to question their doctors’ decisions regarding co-treatment choices and believing that they know their disease and treatment options well, and are capable of making educated decisions about their therapy,” suggest the authors.

Overall, patients were more likely to be concerned about their co-medications than their HIV therapy (mean scores: 4.09 vs 2.9, p < 0.001).

Taking two or more co-medications was associated with higher necessity scores (p = 0.041) and increased concerns (p = 0.036). A higher CD4 cell count was associated with a higher co-treatment necessity score (p = 0.016).

“Further research is needed to explore the association between adherence and patients’ perceptions,” conclude the authors. “Although our findings need confirmation, they suggest that it could be important to focus on patient beliefs to improve adherence to co-treatments.”

By Michael Carter

Reference

Kamal S et al. HIV-infected patients’ beliefs about their chronic co-treatments in comparison with their combined antiretroviral therapy. HIV Med, online edition. DOI: 10.1111/hiv.12542 (2017).

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HIV diagnoses in English gay men have been falling since 2014 http://www.eatg.org/news/hiv-diagnoses-in-english-gay-men-have-been-falling-since-2014/ Wed, 08 Nov 2017 21:31:02 +0000 http://www.eatg.org/?post_type=news&p=6723

A new analysis by Public Health England of testing rates and HIV diagnoses from all of England’s sexual health clinics shows that the decline in diagnoses is England-wide, started at least a year before the decline was first noticed at London’s 56 Dean Street clinic, and is not restricted to gay men who test frequently.

One of the big stories in HIV prevention this year has been the dramatic drop in HIV diagnoses being seen among gay men in HIV clinics in London. This started when, less than a year ago, Dean Street clinic announced a 40% drop in infections in 2016. This trend, there and at other inner London clinics, has been maintained to the extent that there were only four HIV diagnoses at Dean Street in October 2017 compared with 60 in October 2015 – a drop of 93%.

However Noel Gill of Public Health England, presenting data from English sexually transmitted infection (STI) clinics at the recent 16th European AIDS Conference (EACS 2017) in Milan, said that there was evidence that the falls in HIV diagnoses had started earlier and were national.

In summary, HIV diagnoses have fallen by 65% in London and by 48% outside London from their peak in 2014. In the third quarter of 2014 there were approximately 370 HIV diagnoses in gay men in London and 250 outside. They then started to fall, and in the second quarter of 2017 the total of new HIV diagnoses both in and outside London was 130. The decline was already well underway in London by mid-2016, which is when Dean Street noticed it. London HIV diagnoses in the second quarter of 2016 had already fallen by 46% relative to their peak in 2014.

What has caused the decline in diagnoses? Noel Gill did not ascribe it to any one cause, but said that the “lower threshold of access to HIV testing” with results available within an hour and the use of self-sampling and, increasingly, self-testing as options were all helping. He also said it was important that STI clinics in the UK were generally “held in high regard” by their users.

An increase in attendances and in the frequency of HIV testing among gay men are associated with the declines in diagnosis.

Starting in 2014, there was a large increase in the number of attendances at STI clinics by gay men and in the frequency of HIV testing. There were 14,500 attendances by gay men at high risk of HIV in London clinics in the first quarter of 2014. This expanded, within 18 months, to about 19,000 attendances and has stayed at that level since. Out of London, the increase took longer, but there were over 14,000 attendances per quarter by the third quarter of 2016, up from 10,000 in early 2014.

The number of attendees who were classed as “frequent testers” increased in London from 6400 in the first quarter of 2014 to 9700 in the first quarter of 2015 and then stayed at that level. Again, the increase was slower to take hold outside London but increased from 4000 in the first quarter of 2014 to 6000 in the first quarter of 2016.

The quarterly number of HIV tests among frequently testing gay men increased from roughly 3500 per quarter in 2012 to over 8200 in 2017 and in men who tested less frequently from about 4500 to about 7000. However, the number of tests in the less-frequent testers has stayed at that level since early 2015 and may even have fallen slightly. This may indicate that there needs to be new encouragement for frequent testing among gay men who are not aware of the importance of testing frequently, or who are not at high risk or do not see themselves as ‘high risk’.

This is especially important as there were more HIV diagnoses among the less-frequent testers than among the frequent testers. This may seem counter-intuitive, but frequent testers are presumably more health-conscious, and may already belong to networks where most of the HIV-positive people are diagnosed and on HIV treatment. Or, because tests are spaced more widely in infrequent testers, the proportion of results that are positive are higher, simply because more time has elapsed. And finally, ‘infrequent testers’ includes ‘first testers’ – a proportion of the diagnoses are late diagnoses in people infected years ago.

Whatever the reason, the quarterly number of diagnoses in frequently testing gay men averaged about 40 in 2012, increased to 70 in 2014-15 and then decreased again to 40 in 2016.

In infrequent testers there were more diagnoses, but the decline in diagnoses was also more marked. They averaged 150 per quarter in 2012-13, increased to about 200 a quarter in 2014, but started to decline from mid-2015 onwards and in the second half of 2016 were only averaging 80 per quarter.

The public health significance of frequent testing is only fully realised if people who are diagnosed start antiretroviral therapy (ART) as soon as possible, as reducing the time spent between infection and viral suppression is the most critical factor in bringing down HIV transmission.

In 2012, the time taken until half of those diagnosed were on ART was 1.2 years and until 90% were on ART was 3.6 years. By 2014 this had been reduced to 3 months and 1.9 years respectively. The latest figures, from 2016, show that 50% of people diagnosed are on ART within a month and 90% within 3 months.

So far, Gill said, the three most important factors contributing to the observed decline were:

  • A 50% increase in STI clinic attendance in gay men since 2011
  • An increase in the frequency of gay men’s HIV testing, with the average now 2.5 tests a year
  • Putting 90% of those diagnosed with HIV on treatment within less than a year.

He did not speculate on whether there was an additional role for pre-exposure prophylaxis (PrEP), as the decline in diagnoses started happening before its more widespread availability. However, PrEP may have subsequently accelerated the decline in the inner-London clinics, as the rate of decline in clinics like Dean Street and Mortimer Market is both more recent and steeper than that seen in the Public Health England data. San Francisco is another example of a city where HIV diagnoses were already declining but where the rate of decline increased after clinic attendees started using PrEP.

By Gus Cairns

Reference

Gill N. What is happening with new HIV diagnoses in gay men in England and why? Mini-Lecture no ML3, Session PS11, Understanding our Evolving Epidemic. 16th European AIDS Conference, 25-27 October, Milan, 2017.

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High HIV incidence from non-primary partners and low PEP and PrEP use seen in PARTNER study http://www.eatg.org/news/high-hiv-incidence-from-non-primary-partners-and-low-pep-and-prep-use-seen-in-partner-study/ Wed, 08 Nov 2017 21:26:22 +0000 http://www.eatg.org/?post_type=news&p=6722

HIV incidence among the HIV-negative gay men in the PARTNER 1 and 2 studies, due to sex with partners outside the main relationship, was high, and very high in partners who admitted having condomless anal sex with non-primary partners, the 16th European AIDS Conference (EACS 2017) heard recently.

The conference heard that even now, in the latest data from the PARTNER 2 study, only 5% of HIV-negative participants are taking pre-exposure prophylaxis (PrEP), even though over a third have had condomless anal sex with non-primary partners.

The data were presented by Valentina Cambiano of University College London, who is one of the investigators in the PARTNER studies.

PARTNER is arguably one of the most significant HIV prevention studies ever conducted. It studies couples where one partner has HIV and the other does not and its primary aim is to try to quantify the risk of transmission from a person on HIV treatment who has a fully suppressed viral load. While enrolment of heterosexual couples stopped at the end of PARTNER 1 in 2014, it was decided more data on gay men was needed so PARTNER 2, for gay couples only, is still underway.

PARTNER made headlines when in 2014, and again in 2016, the researchers confirmed that there had been no transmissions from an HIV-positive partner who was on antiretroviral therapy and virally suppressed in, by 2016, an estimated 58,213 condomless sex acts. These data allowed the researchers to establish the maximum possible likelihood of transmission, and to announce that, most likely, the chance of an HIV-positive partner with a fully suppressed viral load of below 200 copies/ml passing on HIV was zero, or statistically indistinguishable from it.

PARTNER, and other studies like Opposites Attract and HPTN 052, have provided the evidence base for the success of ‘Treatment as prevention’ and for the U=U (Undetectable = Untransmittable) campaign.

However, there were HIV infections in PARTNER: eleven of them by 2016, ten in gay men. In all cases, however, phylogenetic testing showed that the infecting virus came from someone other than the primary partner. Eight of the eleven infected people told researchers they had had condomless sex with partners other than their primary partner: the other three must have done too.

Cambiano told the conference that multiplying the number of infections by the amount of time people were in follow-up before infection leads to an estimated HIV incidence of 2.3% a year – quite high. However, if only the eight men who admitted to having condomless anal sex with other partners are counted, then incidence becomes very high – 7.2% a year, or higher than that seen in the placebo arm of the IPERGAY PrEP trial.

In short, just because your main partner is undetectable, it does not mean you are safe from HIV if you have condomless sex elsewhere. In these cases, it would make sense to use post-exposure prophylaxis (PEP) or PrEP – but how many in PARTNER were doing so?

Cambiano and colleagues studied PEP and PrEP use in the 737 HIV-negative partners who had answered both the baseline sexual behaviour questionnaire and a questionnaire on at least one follow-up visit.

They had been in the study on average 1.6 years and had averaged one year of condomless anal sex with their primary HIV-positive partner. Thirty-five per cent said they had had condomless anal sex with other partners and 22% had been diagnosed with a sexually transmitted infection other than HIV. The researchers estimated that on average they had 35 acts of condomless anal sex per year with other partners. They also worked out that the total number of condomless anal sex acts with main partners now amounted to 69,098 acts, strengthening the conclusion that HIV transmission is not taking place when the main partner has undetectable viral load.

At baseline, in both phases of the study, over one in six men (17.5% in PARTNER 1 and 17.9% in PARTNER 2) had ever taken PEP. But far fewer had ever taken PrEP; only 1.5% in PARTNER 1 and 3.9% in PARTNER 2. This is not that surprising as PARTNER is a mainly European study, and PARTNER 1 recruited in 2010 and PARTNER 2 in 2014.

During the studies a further 3% in PARTNER 1 and 4.6% in Partner 2 used PEP, and 3% and 5% used PrEP. This means that in PARTNER 2 8.2% of the HIV-negative partners used PEP and/or PrEP.

However, if the partners admitted to having had condomless anal sex with other men in the follow-up questionnaire, then they were twice as likely to have used PEP and three times as likely to take PrEP: 8.7% of these men took PEP and 10.3% were using PrEP, meaning that nearly 16% had used PEP and/or PrEP.

The 10.3% using PrEP numbered 253 men. A majority (58%) were in the UK, with smaller numbers in other countries: 11% each in France and Switzerland, 8% each in Germany and the Netherlands, and 4% in Spain.

This finding meant that in men reporting condomless anal sex with outside men, PEP or PrEP only covered 12% of sex acts that risked HIV infection and only 1.5% of acts in men who did not report it. It can easily be seen that if the negative partners had covered, say, 80% of their possibly risky sex acts with PEP or PrEP instead of 16%, then HIV incidence would have been considerably lower.

Valentina Cambiano commented that the low level of PEP and PrEP use and the high HIV incidence seen from sex outside the main relationship were of concern.

“PrEP eligibility discussions with HIV-negative MSM [men who have sex with men] should ensure that risks from all sexual contacts are taken into consideration, and routes to securing PrEP discussed,” she added.

By Gus Cairns

Reference

Cambiano V et al. Use of PEP and PrEP among HIV Negative MSM in the PARTNER Study. 16th European AIDS Conference, 25-27 October, Milan, abstract PS11/4, 2017.

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European AIDS Clinical Society strengthens HPV vaccination advice http://www.eatg.org/news/european-aids-clinical-society-strengthens-hpv-vaccination-advice/ Wed, 08 Nov 2017 21:17:59 +0000 http://www.eatg.org/?post_type=news&p=6721 New European guidance responds to growing evidence of anal cancer risk in HIV-positive men who have sex with men

The European AIDS Clinical Society (EACS) has recommended HPV (human papillomavirus) vaccination for everyone living with HIV aged under 26 and all men who have sex with men up to the age of 40.

HPV is a sexually transmitted virus that causes genital warts, and in some forms, leads to the development of cervical, anal and oropharyngeal cancers. Anal cancer, rare in the general population, is becoming more common in people living with HIV, especially men who have sex with men.

HPV vaccination

Deborah Konopnicki of St Pierre University Hospital, Brussels presented a review of the evidence supporting vaccination against HPV in people living with HIV at last month’s 16th European AIDS Conference (EACS 2017) in Milan.

Screening for HPV-related cancers is inconsistent and for anal cancer, the choice of screening technique is still a matter of debate, she said. As for oropharyngeal cancers caused by HPV, whether to screen for these conditions is still unclear.

Greater use of preventive vaccines has the potential to reduce HPV-associated morbidity. Vaccination of girls and young women has resulted in significant reductions in HPV-associated morbidity in Australia, Denmark and Scotland, within ten years of the first vaccination programmes.

Only one study, the ACTG 5298 study, has looked at the effect of vaccination on protection against HPV infection in HIV-positive adults. That study found that in a predominantly male population with a median age of 47 years vaccination did not reduce persistent infection with HPV.

This finding led EACS to recommend that HPV vaccination should be offered to people with HIV aged 26 and under. EACS has also followed the British HIV Association in recommending vaccination for all men who have sex with men with HIV under the age of 40. Previous guidance issued in 2015 recommended that doctors should follow national guidance on HPV vaccination.

Although EACS states that the efficacy of the vaccine is questionable in people who have already been exposed to HPV, Deborah Konopnicki said it is still plausible that vaccination could improve protection against HPV-associated disease.

The ACTG A5240 study showed that in women already seropositive for any of the HPV types included in the quadrivalent vaccine, vaccination resulted in a substantial increase in HPV antibody titres (levels) (+1.5 log10 IU/ml).

There is also some evidence from studies in HIV-negative women and men who have sex with men that vaccination after the treatment of HPV-associated cervical or anal lesions is associated with reductions in recurrence of lesions. Two ongoing studies are likely to provide further information on vaccination’s role in the prevention of recurrence in people living with HIV.

Vaccination results in greater antibody responses in women living with HIV who already have undetectable HIV viral load at the time of the first vaccination, probably because viral suppression permits immune restoration.

EACS recommends the 9-valent HPV vaccine if available (active against nine common types of HPV). Dr Konopnicki noted that there is no evidence in people living with HIV to support anything less than a 3-dose vaccination schedule, although several studies in young women have shown that a single vaccination is just as immunogenic as multiple vaccinations.

Anal cancer

Research from Austria presented at the conference by Robert Zangerle of the Medical University, Innsbruck, showed that by 2015, anal cancer had already affected at least one in forty men who have sex with men receiving care in clinics affiliated to the Austrian HIV Cohort Study. Dr Zangerle said that the rate was already “alarmingly high”.

The cohort covers around three-quarters of people receiving HIV care in Austria (7511 people). Between 2003 and 2015, 46 cases of anal cancer were diagnosed, 63% in men who have sex with men. The overall incidence was 52.5 cases per 100,000 person-years of follow-up but was higher in men who have sex with men (95.1 per 100,000 person-years) and lower in women (36.5 per 100,000 person-years).

By 2015, 0.8% of men who have sex with men in care who were under the age of 50 had ever been diagnosed with anal cancer, but the cumulative prevalence rose to 2.6% in men who have sex with men over the age of 50 and 1.6% in women with HIV aged 50 and over. In summary, the Austrian cohort study found that one in forty men who have sex with men with HIV aged 50 and over had already been diagnosed with anal cancer, and the median age of the over-50 age group was 56 years, suggesting that anal cancer could continue to be a significant cause of disease as men age.

By Keith Alcorn

References

Konopnicki D et al. HPV vaccination: who to vaccinate, which vaccine to use, how to evaluate the success of vaccination. 16th European AIDS Conference, 25-27 October, Milan, mini-lecture 3, 2017.

Zangerle R et al. The incidence rate of anal cancer in the Austrian HIV Cohort Study. 16th European AIDS Conference, 25-27 October, Milan, abstract PS7/2, 2017.

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HIV patients live longer, require intricate geriatric care http://www.eatg.org/news/hiv-patients-live-longer-require-intricate-geriatric-care/ Wed, 08 Nov 2017 21:04:29 +0000 http://www.eatg.org/?post_type=news&p=6720 DALLAS – HIV adds to the typical health concerns that affect people as they age, and with fewer people dying of AIDS, healthcare providers are facing more complicated geriatric cases.

By 2030, 73% of people with HIV will be older than 50 years, according to one report (Lancet Infect Dis. 2015;15:753-754). But despite advances in antiretroviral therapy, life expectancies are still lower for people with HIV than for those without, according to a population-based study (J Acquir Immune Defic Syndr. 2016;71:213-218).

One of the key issues of concern for people with HIV is that they will develop more comorbidities as they age than uninfected people, said Kristine Erlandson, MD, from the Divisions of Infectious Diseases and Geriatric Medicine at the University of Colorado Hospital in Aurora.

Polypharmacy, which is already common in older patients, is an even greater issue in people with HIV because of their added comorbidities. And it can lead to a host of health problems.

The Problem of Polypharmacy

“We know that more medications are associated with decreased drug adherence, an increased risk of drug side effects, increased drug-to-drug interactions, and a risk for geriatric syndromes, including falls, cognitive impairment, and frailty,” Dr Erlandson said here at the Association of Nurses in AIDS Care (ANAC) 2017.

The use of five or more medications is associated with increased mortality in older adults, but the association is stronger in people with HIV, according to data from one cohort of veterans (Drugs Aging. 2013;30:613-628).

And a recent review of 248 older San Franciscans with HIV – presented by Meredith Greene, MD, from the UCSF School of Medicine in San Francisco at the 8th International Workshop on HIV & Aging in October – showed that patients were taking a mean of 14 medications, 11 of which were not related to HIV.

Alarmingly, 16% of the patients were taking more than 20 medications, and 63% were taking at least one potentially inappropriate medication, Dr Erlandson reported.

“This is clearly a huge problem in the geriatric population of HIV-positive patients,” she pointed out.

The best strategy to address polypharmacy is to enlist the help of the pharmacist.

“Have your patients take all of their medications, including supplements, over-the-counter medications, ointments, nasal sprays, eye drops – everything – to the pharmacist, who can help sort things out,” she advised. And, she added, recommend that patients use a single pharmacy for their HIV care.

When a patient presents with a complaint, clinicians should explore whether the symptoms are an adverse drug effect, a drug-drug interaction, or an underlying medical problem, Dr Erlandson said.

One resource for the latest information on drug interactions is the Beers Criteria for Inappropriate Medication Use in the Elderly, from the American Geriatrics Society, she added.

Bone Health

Bone loss is a common problem in older patients with HIV. The risk for osteoporosis that can be up to 3.7 times higher in infected than uninfected people, she reported.

Clinicians might want to avoid antiretroviral regimens that contain tenofovir disoproxil fumarate and instead use a combination of abacavir and lamivudine or tenofovir alafenamide and emtricitabine, she said.

Patients should also be evaluated for other possible contributors to osteoporosis, such as low testosterone level, low vitamin D level, phosphate wasting, hyperparathyroidism, substance use, and smoking.

Because of the increased risk for osteoporosis in older people with HIV, the risk for fracture is also elevated. The Partners HealthCare System study, which included 8525 people infected with HIV and more than 2 million uninfected people, showed that after the age of 50, fractures are significantly more common in women (P = .002) and men (P < .0001) with HIV than in those without ( J Clin Endocrinol Metab. 2008;93:3499-3504).

Falls are the cause of many, if not most, fractures. In a study of 359 HIV-positive patients conducted by Dr Erlandson and her colleagues, 30% had fallen at least once in the previous year, and 18% had fallen more than once (J Acquir Immune Defic Syndr. 2012;61:484-489).

The key risk factors for falls were difficulty completing a tandem stand, defined as standing with one foot directly in front of the other, heel to toe, for 10 seconds without stumbling (odds ratio [OR], 13.5), antidepressant use (OR, 3.7), exhaustion (OR, 3.7), diabetes (OR, 3.6), and being female (OR, 3.5).

Fall prevention measures – including discontinuing medications that contribute to dizziness and exercising to improve balance and strength – can make a difference. “Tai chi has been shown to have particular benefit in some studies,” Dr Erlandson noted.

Exercise can also help manage the weight gain that is associated with antiretroviral therapy and that may contribute to comorbidities such as fatty liver and diabetes, she explained.

Adults with HIV can also experience muscle loss accompanied by generalized weight gain, leading to sarcopenic obesity. “Treatment should focus on reducing weight through dietary change and increasing muscle mass through exercise and adequate protein to maximize function,” she said.

Frailty

Clinicians are probably used to resistance from patients when it comes to exercise recommendations, but they should keep in mind that older patients with HIV face unique challenges, such as greater perceived or actual fatigue, said Dr Erlandson.

Patients can feel stigmatized by their HIV status and have difficulty adopting a long-term perspective on health and wellness. And they might be in various stages of frailty, which often is “easy to recognize but hard to define,” she pointed out.

The Rockwood Index and other tools can help identify frailty, but it is important to remember that it is a “multisystem clinical syndrome that reflects biologic rather than chronologic age and a vulnerability to stressors,” she said.

The recent observational HAILO study showed that 6% of HIV-positive men and women aged 40 years and older were frail (AIDS. 2017;31:2287-2294). The risk for recurrent falls was more than 17 times greater in frail than in nonfrail patients.

“Knowing frailty status can provide an excellent assessment of fall risk,” Dr Erlandson said.

Other research has shown that early intervention can significantly help frail patients.

In general, frail patients tend to have greater responses to multidomain interventions that include elements such as exercise, nutritional counseling, and ― as some studies suggest ― vitamin D supplementation and hormone replacement.

The care of HIV patients needs to be better coordinated, said Veronica Njie-Carr, PhD, from the University of Maryland School of Nursing in Baltimore.

In a focus group conducted at her center, patients discussed the fact that HIV practitioners should be trained in geriatric medicine, Dr Njie-Carr reported.

“This presentation validates that at the patient level,” she noted.

“The patients also expressed how they have to go to one practitioner for their renal problem and another for arthritis, etc. So there clearly is the need for better coordination of care,” she added.

Dr Erlandson reports receiving funding from the National Institutes of Health National Institute on Aging and research funding or speaker fees, paid to the University of Colorado, from Gilead Sciences and Theratechnologies. Dr Njie-Carr reports no relevant financial relationships.

Association of Nurses in AIDS Care (ANAC) 2017. Presented November 3, 2017.

By Nancy A. Melville

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Promising new drug for hepatitis B tested http://www.eatg.org/news/promising-new-drug-for-hepatitis-b-tested/ Wed, 08 Nov 2017 21:02:20 +0000 http://www.eatg.org/?post_type=news&p=6718 Promising new drug for hepatitis B tested at Texas Biomedical Research Institute

San Antonio, Texas (November 7, 2017) – Research at the Southwest National Primate Research Center (SNPRC) on the campus of Texas Biomedical Research Institute helped advance a new treatment now in human trials for chronic hepatitis B virus (HBV) infection. Testing at SNPRC provided proof this novel therapeutic approach and drug delivery mechanism would be safe and effective, as recently published in the international journal Science Translational Medicine.

The World Health Organization characterizes hepatitis B as a major global health problem. An estimated 250 to 400 million people are chronically infected with the virus. More than 800,000 people a year die from complications of cirrhosis of the liver and liver cancer. A vaccine that is 95% effective in preventing hepatitis B infections has been available since 1982, but there is currently no cure for the millions already chronically infected.

The novel therapy by Arrowhead Pharmaceuticals uses a mechanism called RNA interference to reduce the surface antigens created by chronic HBV infections. Surface antigens (called HBsAg) are small molecules involved in virus entry into liver cells. In chronic infection, they may prevent the immune response from clearing the virus. For example, a high level of HBsAg can lead to a greater risk of long-term, chronic infection with hepatitis B and life-threatening complications like cirrhosis and liver cancer. In this setting, reducing HBsAg by RNA interference will have beneficial effects.

Much of the groundbreaking work lies in the technology Arrowhead developed for delivering this small interfering RNA precisely to the liver. Experiments involving chimpanzees at the SNPRC from 2013-2015 provided the proof that this technology works and is safe for humans, laying the groundwork for the patient clinical trials that have followed. Trials of targeted HBV intervention in non-human primates showed the experimental drug was safe and effective enough to be tested in people.

The Director of the SNPRC, Robert Lanford, Ph.D., explained this novel treatment — in combination with conventional HBV therapy — could empower the immune system to kill the HBV-infected cells and potentially cure people of the disease.

“We now have a drug that can knock down hepatitis B surface antigen and determine whether or not we can actually cure people with that,” Dr. Lanford said.

The drug is delivered by subcutaneous (under the skin) injection. Scientists designed a molecule that delivers the medicine directly to the liver where it binds to a receptor. Then, another molecule that’s derived from bee venom, helps break through membranes in the liver cells to deliver the medicine directly into the cytoplasm of the cells where it takes effect. The siRNA interferes with the expression of the HBV messenger RNA that produces the surface antigen.

“The idea is if you could knock the levels of surface antigens down far enough, the immune system would kick back in,” Dr. Lanford said. “This technology is pretty specific for the liver right now, but there are a lot of problems in the liver that you can fix with this besides hepatitis B.”

This kind of targeted therapy may someday be used to develop drugs for other chronic liver conditions like a genetic disorder called Alpha-1 antitrypsin deficiency, caused by mutated inherited genes, which can cause cancer.

The paper outlining the phase two clinical trials in people and the previous studies involving non-human primates was published in the September 27, 2017 edition of the journal Science Translational Medicine, an interdisciplinary medical journal established by the American Association for the Advancement of Science.

Although the SNPRC no longer uses chimpanzees for biomedical research, studies conducted with these non-human primates over decades continue to yield significant scientific information that will advance human health.

###

Texas Biomed, formerly the Southwest Foundation for Biomedical Research, is one of the world’s leading independent biomedical research institutions dedicated to advancing health worldwide through innovative biomedical research. The Institute is home to the Southwest National Primate Research Center (SNPRC) and provides broad services in primate research. SNPRC contributes to a national network of National Primate Research Centers (NPRCs) with specialized technologies, capabilities and primate resources, many of which are unique to the SNPRC. The Center also serves investigators around the globe with research and technical procedures for collaborative projects. For more information on Texas Biomed, go to www.TxBiomed.org or for more information on SNPRC, visit www.SNPRC.org.

Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. For more information, please visit www.arrowheadpharma.com.

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Scratching the surface of mature monocytes…and coming up with CXCR7 http://www.eatg.org/news/scratching-the-surface-of-mature-monocytes-and-coming-up-with-cxcr7/ Wed, 08 Nov 2017 20:16:28 +0000 http://www.eatg.org/?post_type=news&p=6719 New research in the Journal of Leukocyte Biology reveals potential therapeutic target to reduce brain inflammation in disease

New research published online in the Journal of Leukocyte Biology showed for the first time that mature monocytes (a specific type of white blood cell) express the CXCR7 receptor on their surface. This receptor may be a therapeutic target for controlling inflammation in the brain associated with diseases like multiple sclerosis, Parkinson’s and AIDS.

“Since mature monocytes appear to be the only white blood cells that primarily use CXCR7 to respond to the CXCL12 brain stimulus, we may have hit upon a novel method to block inflammation and HIV infection in the brain,” said Mike Veenstra, a researcher involved in the work from the Departments of Pathology, and Microbiology and Immunology, at Albert Einstein College of Medicine in Bronx, New York. “We hope our findings spur further research and development of targets against the receptor so that novel treatment for NeuroAIDS and other diseases can become readily available.”

To conduct the experiment, Berman and colleagues obtained cells from the peripheral blood of HIV-negative and HIV-infected individuals. Within these cells, the researchers examined the surface receptors CXCR4 and CXCR7 that were expressed on mature monocytes. They then performed blocking studies with pharmacological agents against each of the receptors using a tissue culture model of the human blood brain barrier to determine which of the surface receptors was used to enter the brain.

“Migration of blood monocytes to the brain can be involved in many diseases, including autoimmunity and spread of infections like HIV to the brain,” said John Wherry, Ph.D., Deputy Editor of the Journal of Leukocyte Biology. “These new findings might provide a novel approach to prevent these ‘Trojan horses’ in the cases of HIV from transporting their payload to the brain.”

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The Journal of Leukocyte Biology publishes peer-reviewed manuscripts on original investigations focusing on the cellular and molecular biology of leukocytes and on the origins, the developmental biology, biochemistry and functions of granulocytes, lymphocytes, mononuclear phagocytes and other cells involved in host defense and inflammation. The Journal of Leukocyte Biology is published by the Society for Leukocyte Biology.

Details: Mike Veenstra, Dionna W. Williams, Tina M. Calderon, Kathryn Anastos, Susan Morgello, and Joan W. Berman. Frontline Science: CXCR7 mediates CD14+CD16+ monocyte transmigration across the blood brain barrier: a potential therapeutic target for NeuroAIDS. J Leukoc Biol November 2017 102:1173-1185; doi:10.1189/jlb.3HI0517-167R ; early online: July 28, 2017, final version: Nov. 1, 2017 ; http://www.jleukbio.org/content/102/5/1173.abstract

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Clues to body’s defense against common oral ailment http://www.eatg.org/news/clues-to-bodys-defense-against-common-oral-ailment/ Wed, 08 Nov 2017 20:14:38 +0000 http://www.eatg.org/?post_type=news&p=6729 An international team, led by researchers at the University of Pittsburgh School of Medicine, has identified the mechanism by which the immune system first learns that the fungus Candida albicans, which causes oral thrush, has invaded the body. The culprit is a fungal toxin called Candidalysin, which punches holes in cells lining the mouth and is sensed by the immune system, which then begins to mount a defense.

The new findings, published today in the journal Science Immunology, could eventually lead to better treatments for oral thrush, which can produce pain severe enough to cause difficulty eating and swallowing, as well as other fungal infections.

The mouth is home to a large number of microbes, termed commensals, which are harmless in healthy individuals. However, suppression of the immune system can lead to severe and reoccurring painful oral infections from these organisms, explained the study’s co-senior author Sarah Gaffen, Ph.D., who holds the Gerald P. Rodnan Endowed Chair in the Division of Rheumatology & Clinical Immunology at Pitt.

One such example is the fungus Candida albicans. The harmless commensal form exists as a small single-celled organism, but when the immune system is compromised, Candida elongates into an invasive form, characterized by long filaments called hyphae, that causes a pervasive infection called oral candidiasis, or “thrush.”

The immature immune systems of infants make them particularly susceptible to thrush, which can lead to a failure to thrive and nutritional deficiencies. The infection also is prevalent among HIV/AIDS patients, denture wearers and those on immunosuppressants, including chemotherapy and drugs to prevent the rejection of transplanted organs. In fact, at least 50 percent of HIV patients struggle with repeated thrush infections.

However, surprisingly little is known about how fungal immunity in the mouth operates, and, until now, it was unclear why Candida does not establish an invasive infection in healthy humans, said Gaffen.

Her lab previously showed that an immune hormone called interleukin-17 (IL-17) and the specific cells that make it — a subclass of immune cells called helper T cells — are essential to immunity against oral thrush.

Oral epithelial cells (OECs), which are part of the mucous membrane lining the inside of the mouth, are the first cells in the body to encounter Candida. They ignore the yeast until it begins to grow hyphae, at which point the OECs stimulate helper T cells to produce IL-17.

In the new study, the researchers used a combination of human OECs cultured in laboratory dishes and mice infected orally with Candida, to show the central importance of Candidalysin, a toxin secreted by Candida that allows the fungus to create holes in OECs and invade the tissue. Further experiments revealed that IL-17 and Candidalysin act in a synergistic manner to amplify antifungal signals in cultured OECs.

Candidalysin was discovered in 2016 by the study’s other co-senior author, Julian Naglik, Ph.D., professor of fungal pathogenesis and immunology, King’s College London, United Kingdom.

“To use a Game of Thrones analogy: the oral epithelial cells form a protective ‘wall’ that keeps the marauding Candida invaders at bay. Patrolling the wall are the helper T cells, which use IL-17 as their weapon to protect the kingdom,” said the paper’s first author, postdoctoral fellow Akash Verma, Ph.D.

Despite millions of fungal infections worldwide, there are no commercially available anti-fungal vaccines. “Our research provides vital clues to understand the immune defense network at barrier sites of the body. This knowledge may ultimately be harnessed to design antifungal vaccines,” Gaffen said.

Journal Reference:

  1. Akash H. Verma et al. Oral epithelial cells orchestrate innate type 17 responses to Candida albicans through the virulence factor candidalysin. Science Immunology, 2017 DOI: 10.1126/sciimmunol.aam8834
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ACHIEVE Coalition sends open letter to Romanian MoH http://www.eatg.org/news/achieve-coalition-sends-open-letter-to-romanian-moh/ Tue, 07 Nov 2017 22:59:07 +0000 http://www.eatg.org/?post_type=news&p=6699 The ACHIEVE Coalition sent this open letter to the Minister of Health of Romania today. The letter, co-signed by EATG as a member of ACHIEVE, calls the Romanian government to prioritise viral hepatitis in health policies of the European Union when acting as the President of the EU Council in 2019.

“Your support would be invaluable in helping the European Union, its Member States and countries across Europe to deliver on their commitments to eliminate hepatitis B and C by 2030 as set out in the WHO Global Strategy and WHO Europe Action Plan. Action in this area will also complement implementation of the EU’s UN Sustainable Development Goals’ (SDG) commitments to end the epidemics of AIDS, tuberculosis and combat hepatitis” – states the open letter.

Read the full letter here: 171107 ACHIEVE letter Minister Bodog on priorities for Romanian Council Presidency

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Worldwide 52 million children living with viral hepatitis http://www.eatg.org/news/worldwide-52-million-children-living-with-viral-hepatitis/ Tue, 07 Nov 2017 22:55:59 +0000 http://www.eatg.org/?post_type=news&p=6706 New data presented at this year’s World Hepatitis Summit in Sao Paulo, Brazil (1-3 November) show that 52 million children are living with viral hepatitis worldwide, compared to 2.1 million children living with HIV/AIDS.

An estimated 325 million people were living with viral hepatitis worldwide in 2016. Of these, 4 million were children living with hepatitis C (under 19 years) and 48 million (under 18 years) were children living with hepatitis B. Both viruses can lead to liver disease, liver cancer and deaths.

“Children are suffering a huge burden of viral hepatitis worldwide, and the public health implications of this are enormous,” says Raquel Peck, CEO of World Hepatitis Alliance. “Most infected infants and children are not diagnosed, prioritised or treated effectively.”

According to new analysis on hepatitis C in children, from Manal El-Sayed, Professor of Pediatrics at Ain Shams University, Cairo, Egypt, and Dr Homie Razavi and his team from the Polaris Observatory, the Center for Disease Analysis (CDA) Foundation, Lafayette, CO, USA, just 21 countries* are responsible for around 80% of these pediatric hepatitis C infections, with the highest prevalence rates generally found in developing countries.

Mother to Child Transmission is one of the main causes of hepatitis C in children. However, neither pregnant women nor young children with this cancer-causing illness can be treated with the highly-effective direct-acting antiviral (DAA) medications. Various regulatory agencies such as the US FDA and the European Medicines Agency have now approved DAAs for use in children aged 12 years and over*. But in high-income countries, there is as yet little evidence they are being used in this age group. WHO is also yet to recommend DAA in any children regardless of age.

As a result, almost all children are only treated with older pegylated interferon regimens, which often have severe side effects including stunting growth, influenza-like symptoms, anaemia and weight loss, and do not always cure the virus. Trials of DAA drugs in children under 12 years are also ongoing, but they have not been approved yet in any country for these younger children.

“Currently, 4 million children are living with hepatitis C, which can be cured and 48 million with hepatitis B, which has a vaccine”, said Charles Gore, President of the World Hepatitis Alliance. “Enough is enough. Governments and global health organisations must ensure all children are vaccinated for hepatitis B and provided with DAAs for hepatitis C, and that all pregnant women are screened.”

Compared to hepatitis C, new hepatitis B infections among children are declining -from approximately 4.7% prevalence in the pre-vaccination era of the early 1980s to 1.3% – due to scaled-up efforts to prevent mother-to-child transmission and global coverage with the three doses of hepatitis B vaccine. Currently, 84% of countries offer hepatitis B vaccinations. However, coverage with the initial birth dose vaccination needed to provide protection to newborns, is still low at 39%.

Cases of hepatitis C in children are, however, likely to continue growing for years to come, given the lack of prevention and control programs for pregnant women living with hepatitis C and women of child bearing age. This is exacerbated by the absence of a public health approach for case definition and management of expectant mothers or children.

“We must act and treat as many children as possible. The economic and social benefit of early hepatitis C treatment in children is substantial,” Professor El-Sayed explains. “This includes avoiding disease progression, removing social stigma and improving activity and school performance, and reducing fatigue. However, the fundamental principle is to avoid transmission by adopting ‘cure as prevention’ at an early age and before high risk behaviours emerge that enable transmission.”

“Children are the future.” Peck concluded. “It’s imperative that we get it right from the beginning and give them the best possible start in life. Without eliminating viral hepatitis amongst children, its elimination will be impossible”.

 

Read also:

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Hepatitis C buyers’ clubs grow worldwide as a way to obtain affordable treatment http://www.eatg.org/news/hepatitis-c-buyers-clubs-grow-worldwide-as-a-way-to-obtain-affordable-treatment/ Tue, 07 Nov 2017 22:50:34 +0000 http://www.eatg.org/?post_type=news&p=6714 Hidden amongst the thousands of Facebook pages given over to holiday snaps and gossip are groups of patients who have hepatitis C, a disease that affects more than 70 million worldwide and kills around 400,000 people a year.

But importantly, these groups of patients from Russia to Australia have got together to help each other import a relatively new class of drug that is able to cure most of the patients who take it.

These buyers’ clubs, as they’re called, are reminiscent of a Hollywood film Dallas Buyers’ Club, where a group establishes to access cheaper HIV drugs.

Dr James Freeman, who was behind the first hepatitis C buyers’ club in Australia and has consulted for others, said in an interview, “There are around a hundred of these around the world and the least one in every [high-income] country.”

The reason that these buyers’ groups have popped up is because many of the hepatitis C drugs on offer in their own countries are extremely expensive. Most can’t access these drugs through their health systems and have now, controversially, taken to importing them from cheaper sources abroad.

The originator companies that first brought these blockbuster drugs to market have offered them for has much as $84,000 for a 12-week course.

Of course, many countries have now negotiated much lower prices with the companies that make the drugs.

The problem is, prices are still not low enough to pay for everybody who has hepatitis C, according to governments, activists and many patients. As a result, only the sickest patients access the drugs, which are heavily rationed in many countries.

And that’s why buyers have now begun to get together to import them from countries where they are much cheaper, said Dr Andrew Hill, a pharmacology expert from the University of Liverpool, United Kingdom. He spoke last week at the World Hepatitis Summit in Sao Paulo, Brazil (1-3 November) and was to present data on the hugely varying cost of a 12-week course of sofosbuvir and daclatasvir, a common combination of such drugs, from $78 in India and $174 in Egypt, and US$6000 in Australia. but it is still $77,000 in the UK, and a staggering $96,404 the USA.

“The negotiated prices of the drugs from originators are still far higher than prices available from generic companies, so there is still a big incentive for people to import the drugs,” he said. “Very few people are aware that this is legal in a range of countries such Australia and the UK.”

Prices are so much lower in India and Egypt because generic companies sell them at close to cost price, according to Hill. They cannot sell their drugs within Europe, for example, because there is a patent.

Speaking from Tasmania, FixHepC’s Freeman said buyers’ groups help individual patients source and buy from drug suppliers in India, Algeria and Egypt, often accessing laboratory tests to confirm their consignments are acceptable, and provide advice on taking the course of medication.

Personal Use

Buyers’ groups are relying on a loophole that allows them to import small amounts of medication for personal use from generics abroad.

These so-called personal importation rules, were designed to allow patients to bring in small amounts of medication even if that medication has not been registered in the country; tourists can visit a country and bring their own medication, or foreign visitors can use their usual medication from home while working and living overseas.

The buyers’ groups are basing their actions on a few elements of the TRIPS agreement (World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights). The most important, Article 60, states that small quantities of goods of a non-commercial nature contained in travellers’ personal luggage or sent in small consignments are permitted.

Freeman said the size of “a small consignment” is not precisely defined within TRIPS but is usually interpreted within many national rules as under 2 kg.

How such consignments are bought and paid for, however, must be managed extremely carefully. “If I bought the medications and sold them to patients that would be illegal. Only licensed pharmacists can sell medications,” he said.

They work something like this: Buyers’ clubs act in the role of the patient’s agent. The buyer is the patient and they are exercising their rights, the seller is in the country of the medication’s origin and is operating within their laws, said Freeman. “Buyers’ clubs link the two – this is legal and no different from any other agent helping a person exercise a transaction,” he added. “So what buyers’ clubs do is de-risk the process, which is, after all a pretty uncommon way of getting a medication.”

Interestingly, several governments from Uruguay to Denmark are relaxing or have relaxed their personal import rules to help patients access drugs from abroad. Switzerland, for example, allowed just one month’s worth of medication to be imported. That has been extended to 3 months.

And at the end of March, Italian Minister of Health Beatrice Lorenzin issued a circular stating that patients and their doctors are allowed to import medicines authorised for sale in other countries for personal use when there is no therapeutic alternative authorised in Italy or when a treatment authorised in Italy is not accessible to patients due to restrictive prescription criteria or because it is too expensive for the patient.

“She did this with only a veiled reference to the high-priced hepatitis C (HCV) medicine sofosbuvir, marketed under the trade name Sovaldi,” Ellen ‘t Hoen at the Global Health Unit Department of Health Sciences, UMCG Groningen, said on her Medicines Law and Policy blog at the time.

But not all countries allow personal imports, however. The US is one example.

That said, individual US states are understood to be discussing strategies to access hepatitis C drugs, some related to personal importation. Louisiana, for example, is mooting the idea of using an old federal law known as 28 USC 1498, which permits the government to directly purchase drugs without regard to their patent status.

“The importation debate is really happening in the US as well, because the states cannot afford these hepatitis C treatments for their people,” said Tahir Amin, a lawyer at I-MAK, which is challenging the hepatitis C drug patents in various countries including the US.

Gilead said it has been working with national healthcare systems toward the goal of enabling unrestricted access to its curative HCV treatments. “Patients in most developed countries have access to our curative HCV medicines via their national healthcare system and do not need to resort to unregulated and uncontrolled buyer’s clubs to receive treatment,” said a spokesperson.

It said it is concerned with patient safety and that the patients cannot be sure what they are receiving through the clubs. “The source and quality of hepatitis C medicines secured through medical tourism and buyers’ clubs are unknown,” the spokesperson said.

Nevertheless, patients worldwide are looking at alternative methods to access the drugs; Irish citizens unable to import drugs are getting on the ferries to buy them in the UK, said FixHepC’s Freeman. Before the import rules changed, Italians were nipping over to Vatican City for cheaper drugs too, said Paolo Corciulo, of Cure-HepC, a company that provides hepatitis C treatment services.

He welcomes the changes, but says there are some drawbacks. For example, quite a bit of paperwork is required beforehand – such as an import request from an Italian doctor. “The main problem is that most of the doctors refuse to fill up the form. They don’t know the generic brand or they just don’t want responsibility,” he said.

Additionally, there are no guidelines on how to deal with reputable dealers, which may expose unsuspecting patients to unscrupulous criminals, he warned. Corciulo has opted instead to take patients to the drugs – 200 have already been on Hep C holidays to India. Here patients can buy the drugs at source and are treated by doctors at reputable Indian hospitals.

But many believe a more wide-reaching strategy is necessary. Countries such as Malaysia recently announced that it will override the patent, and issue a compulsory licence (CL) to import generics medicines so that more of its citizens can be treated.

It is unclear which countries may follow, said the University of Liverpool’s Hill, although Thailand and Brazil have historically issued the most CLs.

“The first step is for these countries to understand how much they could save by going down this path. Few countries realise just how cheaply these drugs can be made, and how much extra they are paying,” he said.

By Tatum Anderson

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For cancer patients with HIV, immunotherapy appears safe http://www.eatg.org/news/for-cancer-patients-with-hiv-immunotherapy-appears-safe/ Tue, 07 Nov 2017 22:45:49 +0000 http://www.eatg.org/?post_type=news&p=6716 Checkpoint inhibitor study suggests new treatment options for patients long excluded from cancer immunotherapy clinical trials.

Read the full publication here.

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Some women with HIV breast-feed in secret http://www.eatg.org/news/some-women-with-hiv-breast-feed-in-secret/ Tue, 07 Nov 2017 22:40:22 +0000 http://www.eatg.org/?post_type=news&p=6715 MILAN — Current guidelines recommend that women with HIV avoid breast-feeding, but some do so without advising their physician and without monitoring for the safety of their baby.

However, when a woman has an undetectable viral load, the risk is minimal, according to some specialists.

“What we need now is a protocol,” Mona Loutfy, MD, from the University of Toronto, said here at the 16th European AIDS Conference.

That just might be on the way. During a lively debate at the conference, Women Against Viruses in Europe (WAVE) — a subgroup of the European AIDS Clinical Society (EACS) — committed to creating formal breast-feeding guidelines.

“This is probably the first group to come together as an organization to put together a recommendation on how to support women,” Dr Loutfy told Medscape Medical News.

The WAVE subgroup plans to work with pediatricians and other clinicians to share effective practices, and to determine whether the field is at the point that it can acknowledge that women are likely breast-feeding without the consent or knowledge of their physicians.

The groundwork for the debate was set when updated clinical guidelines were released by EACS. In addition to updating vaccine recommendations and adding information about comorbidities, the guidelines recommend against breast-feeding. But in case a woman insists on breast-feeding, “we recommend follow-up with increased clinical virological monitoring of both the mother and the infant.”

Even with the strong air of discouragement, this statement is “a breakthrough,” said Dr Loutfy. Three years ago, “no one would have even talked about this.”

What has changed is the thinking about transmission risk in people with suppressed viral loads. In the past few years, some high-profile studies have shown that immediate treatment that results in a suppressed viral load for at least 6 months protects against transmission.

The randomized controlled HPTN 052 trial (N Eng J Med. 2011;365:493-505), the prospective PARTNER cohort (JAMA. 2016;316:171-181), and the Opposites Attract Trial — presented at the International AIDS Society 2017 Conference — all showed that in people with fully suppressed viral loads, there were no transmissions of HIV between partners, whether they were straight or gay, and whether or not they used condoms.

That research, followed by the public information campaign known as Undetectable = Untransmittable, or U=U, has pushed the conversation from strict abstinence or sex only with condoms to the possibility of natural conception between straight serodiscordant couples, as reported by Medscape Medical News.

It has “completely changed the way I practice,” said Dr Loutfy.

She recalled a community meeting that she, HIV physicians, women living with HIV, and other healthcare professionals attended a few years ago. A midwife asked: “Are we going to have this conversation [an insistence on strict bottle-feeding] like we always do? Or are we going to actually acknowledge that women are breast-feeding already and not telling us?”

Dr Loutfy said she was sure that was not true, but woman after woman broke the news to her: they had been breast-feeding. They’d just been doing it in secret, with no support and no viral load monitoring for their infant.

“I was shocked,” she said. “Before, it was just like, no breastfeeding. Now it’s a conversation.”

Switzerland to the Front

Switzerland has been at the front of this conversation for nearly a decade. Before HPTN 052, the Swiss AIDS Federation published a statement saying that if a person with HIV has an undetectable viral load for 6 months, no other sexually transmitted infections, and a monogamous relationship, he or she can have sex without a condom.

That drew counterstatements — insisting on continued condom use — from the World Health Organization and health policy organizations from individual countries.

Now, Switzerland is poised to be one of the first countries in Europe to support breast-feeding by women with undetectable viral loads, albeit accompanied by monthly viral load tests for mothers and weekly tests for infants.

The goal is not universal breast-feeding, said Karoline Aebi-Popp, MD, from the University of Bern in Switzerland. The goal is patient-centered informed consent, where women and their clinicians talk openly about the pros and cons of breast-feeding on an individual basis and discuss the risks and benefits to the mother and child.

“Following that discussion, some may elect to breast-feed,” said Karina Butler O’Connell, MD, from University College Dublin, a pediatrician who advocated for the child in the debate. “But others may change their minds.”

It’s a conversation physicians are already having among themselves, as reported by Medscape Medical News.

“If the woman is undetectable through the whole pregnancy and she insists on breast-feeding, we would support her,” said Dr Aebi-Popp. “The worst thing is if they do it and they don’t tell us.”

Dr Aebi-Popp said she will be collecting data from all the Swiss women who do decide to breast-feed for future research.

Different Ways to Monitor

During the debate, panel members did not agree what monitoring should entail or which clinicians should be involved. Pediatricians, who recently came out against women with HIV breast-feeding in the United States, “are always going to be thinking of the child and say, no.” So physicians must work to build bridges to that specialty, said Dr Aebi-Popp.

Justyna Kowalska, MD, from the Medical University of Warsaw in Poland, said she would never support breast-feeding without the help of a lactation consultant and input from the woman’s obstetrician. A woman might get support from her infectious disease clinician, only to have her obstetrician discourage her from breast-feeding, she told Medscape Medical News.

“It’s a process that requires a lot of people to get on board and understand,” she said.

In addition, physicians grapple with how exactly to monitor viral load.

As mentioned, in Switzerland, the protocol is monthly plasma viral load testing for the mother and weekly testing for the infant. In Germany, the regimen includes monthly breast-milk and plasma viral load testing and an antiretroviral pharmacokinetics test of the infant whenever blood is drawn for routine tests, said Annette Haberl, MD, from Frankfurt University in Germany, who worked with a woman who breast-fed exclusively about 6 years ago. In Canada, Dr Loutfy reported, there is no access to pharmacokinetic tests, but blood tests are conducted.

“Is that good? Is that bad? I don’t know,” said Dr Haberl.

It is a question that will take time to answer with evidence, said Dr Kowalska. The next step will be meeting with individual specialists and women living with HIV to hammer out protocols.

“It won’t come forward in the next year or the year after,” she said, “but it’s a start.”

Dr Loutfy, Dr Aebi-Popp, Dr Haberl, and Dr Kowalska have disclosed no relevant financial relationships.

16th European AIDS Conference. Abstract PS8/2. Presented October 27, 2017.

By Heather Boerner

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Peripheral neuropathy in patients with HIV: association with additional pain disorders http://www.eatg.org/news/peripheral-neuropathy-in-patients-with-hiv-association-with-additional-pain-disorders/ Tue, 07 Nov 2017 22:18:23 +0000 http://www.eatg.org/?post_type=news&p=6713 Patients with a diagnosis of HIV and peripheral neuropathy (HIV-PN) often have ≥1 additional pain disorders, according to an analysis published in Pain Medicine.

Investigators obtained patient data from the Clinical Data Warehouse, using International Classification of Diseases-9/10 diagnostic codes to identify patients with HIV-PN. Of 638 patients with HIV, 68 also had peripheral neuropathy (HIV-PN) and had received primary care and combination antiretroviral therapy, and the remaining patients had not been diagnosed with PN.

Patients with HIV-PN had a greater history of substance use disorder (49% vs 30%; P =.002), which the researchers suggest may be an HIV-PN risk factor. According to the findings, patients with an HIV-PN diagnosis had double the chance of being diagnosed with additional chronic pain syndromes (66% vs 32%; P <.001).

Approximately 36% of patients with HIV-PN had spinal degenerative disorders vs 12% in the population without HIV-PN (P <.001). Following adjustment for potential and clinically relevant confounders, the researchers observed that patients with HIV-PN continued to have significantly more chronic pain disorders (P <.001).

The investigators suggested that the findings may not be generalizable to the entire HIV-PN patient population, since this study examined characteristics of patients living in a low-income, urban community. Also, clinical records were the primary source of patient data, which brings into question the accuracy of HIV-PN and accompanying chronic pain diagnoses as these often depend upon the physician.

Since many patients with HIV-PN appear to have ≥1 chronic pain conditions, physicians are urged to “ask patients with HIV-PN about other types of pain and formulate the pain management plan accordingly.”

By Brandon May

Reference

Navis A, Jiao J, George MC, Simpson D, Robinson-Papp J. Comorbid pain syndromes in HIV-associated peripheral neuropathy. Pain Med [published online August 7, 2017]. doi:10.1093/pm/pnx129

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Australia: Uptake of medications for HIV treatment and prevention changes sexual practices http://www.eatg.org/news/australia-uptake-of-medications-for-hiv-treatment-and-prevention-changes-sexual-practices/ Tue, 07 Nov 2017 21:55:13 +0000 http://www.eatg.org/?post_type=news&p=6711 The latest report by UNSW’s Centre for Social Research in Health shows increasing use of HIV medications to prevent the spread of HIV by gay and bisexual men.

The Annual Report of Trends in Behaviour 2017 released today (November 6) by the Centre for Social Research in Health (CSRH) at UNSW Sydney finds the proportion of non-HIV-positive gay men who reported pre-exposure prophylaxis (PrEP) use in the six months prior to the annual Gay Community Periodic Surveys increased from 2% in 2013 to 5% in 2016.

The increase was mostly seen between 2015 and 2016, suggesting PrEP uptake was boosted by increased availability through the large state-funded PrEP access programs in NSW, Victoria and Queensland in 2016.

PrEP is HIV medication taken by HIV-negative men before sex to prevent HIV. If taken as prescribed, PrEP stops a person from getting HIV.

“Particularly in the last three years, gay and bisexual men are increasingly using PrEP and treatment as prevention (TasP) to manage HIV transmission risk,” said Associate Professor Martin Holt, the project leader of the Gay Community Periodic Surveys at CSRH. “This underscores the growing range of strategies adopted by gay and bisexual men to reduce HIV transmission.”

Also encouraging was that the proportion of HIV-positive gay and bisexual men on antiretroviral treatment (ART) was at a record high for the second year running, which maintains the health of people living with HIV and also contributes significantly to eliminate HIV transmission.

Nationally, 88% of HIV-positive gay men reported being on ART in 2016. ART uptake has increased significantly over the last 10 years, from 57% in 2007. The proportion of HIV-positive gay and bisexual men having an undetectable viral load (which carries no risk of HIV transmission) has also increased by more than 30 percentage points to 88% (the highest on record), from 56% in 2007.

Key findings from the Gay Community Periodic Surveys show that gay and bisexual men are also taking a number of critical steps to negotiate relationships, sex and HIV risk. These measures include:

  • Frequent HIV testing: In 2016, close to one-third of non-HIV-positive gay men had a minimum of three tests within the previous 12 months (one HIV test every four months on average).
  • Comprehensive STI testing: In 2016, 45% of gay and bisexual men reported comprehensive STI testing (a minimum of one blood sample, urine sample, throat swab and rectal swab each) in the previous year.
  • Consistent condom use: For those who had sex with casual male partners in the previous six months, the number reporting consistent condom use during casual encounters in 2016 was just below 40%, down from 44% in 2013.
  • “Serosorting” (seeking partners of the same HIV status): This remains the most commonly used risk reduction strategy by HIV-negative men (45% in 2012, increasing to 52% in 2016). Both HIV-negative and HIV-positive gay men increasingly disclose their HIV status during casual sexual encounters.

“Some gay and bisexual men have gradually moved away from consistent condom use and rely on a range of biomedical and behavioural strategies to reduce HIV transmission,” said Dr Limin Mao, the leading author of this CSRH report.

Continued investment in developing innovative approaches to engage gay and bisexual men in HIV and STI health promotion through various online and mobile platforms should be prioritised.

“This should be carefully monitored and interpreted in the context of increased uptake of testing, treatment and PrEP. We need to better understand these rapid changes and ensure health promotion messages emphasise the effectiveness of a combination prevention approach to suit diverse population needs.”

Dr Mao also said: “Using mobile apps is one of the most efficient ways to find other male sex partners. Continued investment in developing innovative approaches to engage gay and bisexual men in HIV and STI health promotion through various online and mobile platforms should be prioritised.”

CSRH Associate Professor Christy Newman said apart from gay-identified men, there are other priority populations who require better understanding and more attention to address potential disparities in access to new prevention technologies and behavioural risk reduction strategies.

For example, qualitative studies from CSRH offer a range of insights for engaging and serving heterosexual-identified men who sometimes have sex with men, young people from migrant and refugee backgrounds, people who are Medicare ineligible, other people living with HIV (adolescents and children) and heterosexual couples with mixed HIV status.

The Director of CSRH, Professor Carla Treloar, summarised: “Our report highlights the need for further concerted efforts to promote a combination of biomedical and behavioural prevention strategies to drive down rates of HIV or STI infection.

“Equally important is the need to support community-based responses to HIV and STIs, and to substantially reduce stigma, discrimination and other structural barriers associated with diverse populations affected by HIV and STIs.”

Read the full report here.

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Australia: Gonorrhoea and syphilis on the rise, HIV stable, and some good news on hepatitis http://www.eatg.org/news/australia-gonorrhoea-and-syphilis-on-the-rise-hiv-stable-and-some-good-news-on-hepatitis/ Tue, 07 Nov 2017 21:50:48 +0000 http://www.eatg.org/?post_type=news&p=6710 Australia’s annual report card on STIs and blood-borne viruses finds that gonorrhoea has increased by 63% over the past five years.

Gonorrhoea and syphilis diagnoses are increasing in Australia, HIV is stable, and more than 30,000 Australians have been cured of hepatitis C, according to the latest Annual Surveillance Report on HIV, viral hepatitis and sexually transmissible infections (STIs) in Australia, released today (November 6) by the Kirby Institute at UNSW Sydney.

The latest data shows that gonorrhoea has increased by 63% over the past five years, with particular rises among young heterosexual people in major cities.

“Up until recently, gonorrhoea had been uncommon in young heterosexual people living in major cities. Rising rates in this group highlight the need for initiatives to raise awareness among clinicians and young people about the importance of testing,” said Associate Professor Rebecca Guy, head of the Surveillance, Evaluation and Research Program at the Kirby Institute. “With the national strategies for HIV, hepatitis and STIs up for review, reducing STIs in young people will be an important target.”

Among Aboriginal and Torres Strait Islander peoples, chlamydia and gonorrhoea rates were three and seven times higher than in the non-Indigenous population and the gaps were greater in regional and remote areas. Since 2011, there has been a resurgence of infectious syphilis among young Aboriginal and Torres Strait Islander people living in regional and remote areas of Northern Australia.

“Initiatives underway to address the syphilis resurgence include enhanced testing and treatment, and culturally appropriate health promotion campaigns,” said Associate Professor James Ward, head of Infectious Diseases Research, Aboriginal Health Infection and Immunity, South Australian Health and Medical Research Institute. “Comprehensive strategies are needed to reduce STIs in Aboriginal and Torres Strait Islander peoples.”

HIV diagnoses stable for fifth year in a row

The report shows that HIV diagnoses have remained stable in Australia for the past five years, with 1,013 new diagnoses in 2016.

Associate Professor Guy said these results are due to high levels of testing and treatment in Australia. “We’re seeing increased uptake of HIV testing, particularly among gay and bisexual men, who are the population most affected by HIV in Australia,” said Associate Professor Guy. “It is also encouraging that 86% of people diagnosed with HIV were on treatment in 2016.”

However, gaps in testing remain, particularly among heterosexual people, where one in five HIV diagnoses occurs. Nearly half of heterosexual people diagnosed with HIV were diagnosed late, meaning they were likely to have acquired HIV at least four years before diagnosis.

“For HIV to decline nationally, we must focus on a combination of prevention strategies, including enhancing our testing and treatment efforts, making HIV self-testing available and ensuring equitable access to pre-exposure prophylaxis (PrEP) across Australia,” said Associate Professor Guy. PrEP is a treatment which prevents people at risk from acquiring HIV, but is currently only accessible through clinical trials.

“A recent announcement from NSW Health shows early evidence of the impact of this combination of strategies, with a 31% reduction in new HIV diagnoses in gay and bisexual men in the first half of 2017 compared to the previous five years, the lowest count on record,” said Associate Professor Guy.

In contrast, the report indicates that HIV diagnoses among Aboriginal and Torres Strait Islander people have increased by 39% since 2012, with a greater proportion of diagnoses due to injecting drug use and heterosexual sex, compared to non-Indigenous populations.

Associate Professor Ward said that this disparity highlights the need for culturally relevant HIV prevention programs for Aboriginal people. “We need enhanced community education, targeted testing and treatment initiatives – including access to PrEP, and greater access to sterile needle and syringes, and drug dependence treatment for people who inject drugs.”

Some good news on hepatitis, but more work to be done

Between March and December 2016, an estimated 30,434 people have been cured of hepatitis C due to the availability of new direct acting antiviral therapy for hepatitis C.

“The new therapies have been game-changing for hepatitis C in Australia”, said Associate Professor Jason Grebely from the Viral Hepatitis Clinical Research Program at the Kirby Institute.

“Our estimates indicate that the number of people with hepatitis C who have advanced liver disease has fallen for the first time in 10 years. This is excellent news, but to achieve hepatitis C elimination in Australia we must sustain our efforts to ensure all people living with hepatitis C are tested and have access to these cures.”

The report also shows that over the past five years hepatitis B diagnoses have declined by 27% in people aged less than 25 years, reflecting the impact of the infant and adolescent vaccination programs. However, only 63% of the estimated 230,000 people living with chronic hepatitis B in Australia by the end of 2016 were diagnosed. Of those, only 27% were having appropriate clinical monitoring tests for their infection.

“The significant gaps in diagnosis and care highlight the need for better strategies to reach people living with hepatitis B in Australia,” says Associate Professor Ben Cowie, director of the WHO Collaborating Centre for Viral Hepatitis, Doherty Institute.

The decline in hepatitis B diagnoses is also evident in younger Aboriginal and Torres Strait Islander peoples. “It is encouraging to see that immunisation programs for hepatitis B have had a clear benefit in reducing the gap in hepatitis B between Aboriginal and Torres Strait Islander people and the non-Indigenous population,” said Associate Professor Ward. “However, hepatitis B diagnoses in the population over 30 years remain high and a continued focus on testing and vaccination among this population is needed.”

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Metabolic syndrome’s link to liver fibrosis in patients with HIV http://www.eatg.org/news/metabolic-syndromes-link-to-liver-fibrosis-in-patients-with-hiv/ Tue, 07 Nov 2017 21:31:39 +0000 http://www.eatg.org/?post_type=news&p=6709 Although incredible advances in the development and dissemination of antiretroviral therapy (ART) have enabled many individuals with HIV to avoid progressing to AIDS, the efficacy of this therapy means the population may now live long enough to succumb to diseases that often plague the non- HIV–infected population. Chief among these is liver disease, specifically nonalcoholic fatty liver disease (NAFLD), which is characterized by fatty deposits in the liver and can lead to liver fibrosis (stiffness), cirrhosis, or death.

In patients who do not have HIV, the primary driver of NAFLD is metabolic syndrome. According to the National Heart, Lung, and Blood Institute, metabolic syndrome pertains to a cluster of risk factors that predispose a person to heart disease, diabetes, and stroke, and its incidence is rising worldwide. Prominent among these risk factors is obesity concentrated in the abdominal area. Additional risk factors include hypertension, a high fasting blood glucose level, and high triglyceride and low high-density lipoprotein (HDL) cholesterol levels. Now, NAFLD driven by metabolic syndrome is becoming more common in individuals with HIV as well—approximately one-third have NAFLD, according to the authors of a new study on the link between liver fibrosis and metabolic syndrome in individuals living with HIV.1

The study was conducted by a European team that analyzed 405 HIV-monoinfected adults, mostly male, who appeared in a database of patients being followed for treatment at a Paris hospital. The subjects all had been diagnosed with HIV at least 5 years prior to the study, and none had a history of excessive alcohol consumption. Their average age was 53, and 203 had metabolic syndrome. Upon enrollment, each participant had the stiffness of his or her liver measured using transient elastography, a noninvasive method similar to an ultrasound. Blood samples also were taken after a 12-hour fast.

The team found that liver stiffness, along with cirrhosis, was measurably higher in patients who had markers of metabolic syndrome, including low HDL cholesterol and high triglycerides. The higher the patient’s body mass index (BMI), the higher the risk of fibrosis and cirrhosis. Patients with a BMI of at least 30 kg/m2 were especially likely to have fibrosis, as were patients whose blood work suggested insulin resistance. Overall, 25.1% of HIV-monoinfected patients who had metabolic syndrome had significant fibrosis, with 8.4% found to have cirrhosis. Among HIV-monoinfected patients without metabolic syndrome, fewer than 8% had fibrosis. Because fibrosis is a known marker of the severity of chronic liver disease, and because it has a proven association with deaths due to liver disease in individuals with NAFLD who don’t have HIV, these findings have important implications for the HIV community.

Liver disease has long been a concern in individuals living with HIV, especially as they’ve seen their lives extended thanks to ART. “Most of the time, patients with HIV develop liver fibrosis/ cirrhosis in a background of viral hepatitis (hepatitis B virus [HBV] or hepatitis C virus [HCV]) coinfection,” Maud Lemoine, a senior clinical lecturer at Imperial College London and the lead author of the study, told Contagion®. “But in patients without HBV or HCV coinfection, metabolic syndrome [arises] mainly due to obesity inducing fat into the liver, which can progress to inflammation and fibrosis.”

Exactly how and why NAFLD and metabolic syndrome contribute to liver fibrosis in individuals living with HIV is not well understood. Researchers are unsure of the causative biological processes, but they have confirmed that HIV-monoinfected patients with metabolic syndrome experience changes in the levels of proteins emitted by fat tissue as well as higher levels of cells that induce an immune response. “The HIV infection itself is connected to a chronic inflammatory state,” Dr. Lemoine said, but added that scientists do not know whether HIV has a direct impact on the liver. “We analyze patients that are very well suppressed, with no detectable viral load.”

What she and her team do know is that adipose tissue from obesity is the main driver of this condition. “So far, it has been a neglected problem in HIV patients,” she said, noting that there have been many studies examining the role of obesity and metabolic disease in individuals without HIV.

Helping Patients Who Have HIV and Metabolic Syndrome

As it is now recognized that individuals living with HIV are becoming more likely to fall prey to non-AIDS–related maladies as their lifespans increase, the health care community needs to respond accordingly. The causes of obesity in individuals living with HIV, said Dr. Lemoine, include poor diet and lack of exercise—much as they do in the general population. Practitioners who treat individuals living with HIV must be aware of the impact of these factors and help patients create and adhere to strategies to lose weight, get more active, and control their diabetes and hypertension, if those conditions are present.

Alcohol, too, may play a role in the development of liver fibrosis, which physicians and other providers should address. “Excess alcohol consumption is definitely a risk factor for fibrosis, and any discussion about fibrosis must make note of this reversible cause,” Benjamin Young, MD, PhD, senior vice president and chief medical officer of the International Association of Providers of AIDS Care (although not an author of this study), told Contagion®. “Alcohol consumption and dependency should be assessed and addressed, and for those with chronic hepatitis or liver fibrosis, a harm reduction approach should be used to support reduction and cessation.”

According to the National Institute on Drug Abuse, alcohol and drugs are significant problems for individuals living with HIV: one of 3 used drugs or binged on alcohol between 2005 and 2009, and 24% have a problem serious enough that they should be in a substance-abuse treatment program.2

Patients with HIV also need to be screened for hepatitis, traditionally a major driver of liver disease in this population. “Diagnosis, treatment, and—in the case of hepatitis C—cure, of viral hepatitis should be done, and for uninfected individuals, vaccinations to prevent hepatitis A and B should be administered,” Dr. Young said.

What role, if any, does ART play in the development of liver fibrosis? “This has not been clearly demonstrated,” Dr. Lemoine told Contagion®. “Probably [there is] an indirect role…but in our study, the role of ART was not significant.”

A more accurate question might be which drugs used in ART pose the most risk rather than whether ART itself is problematic, as the medical community recognizes that the risks of forgoing ART are greater than the potential risks of administration. “It’s generally appreciated that treating HIV with antiretrovirals reduces the risk of liver fibrosis,” said Dr. Young. “Yet there remains controversy as to whether any particular antiretroviral drug might increase the risk over others.” Older drugs, such as d4T (stavudine) and azidothymidine (AZT), Dr. Lemoine said, seem to be more toxic than newer therapies and might best be avoided. Other studies have shown, for example, that when HIV-infected patients with NAFLD switch from efavirenz to raltegravir, liver steatosis is significantly improved.3

Treatment for NAFLD remains a work in progress. A recent study out of Case Western Reserve University in Cleveland, Ohio, examined whether statins are an appropriate therapy for people living with HIV who have NAFLD, as they have been suggested as a viable NAFLD treatment option for people without HIV.4 Interestingly, the HIV-positive subjects treated with statins experienced an increase in their liver fat scores after 96 weeks compared with the liver fat scores of the HIV-positive placebo takers. Therefore, it would seem that although statins are effective at reducing cardiovascular risks, they cannot be relied upon to treat fatty liver disease—and in fact may be counterproductive.

This study had a few limitations, including its use of a noninvasive method to scan for liver fibrosis and the absence of histological confirmation of this diagnosis with liver biopsies. A small percentage of participants (13%) had invalid transient elastography results that could not be used. The participants were overwhelmingly male, which could have skewed the findings as a previous study found that women living with HIV have significantly lower levels of liver steatosis, or fatty liver, than women without HIV. Also, as this was a cross-sectional study, follow-up is necessary to examine rates of morbidity and mortality in this population. The authors hope the medical community engages in further research to learn more about the exact mechanisms that lead patients with HIV to experience liver fibrosis and how this can be prevented.

By Laurie Saloman

References:

  1. Lemoine M, Lacombe K, Bastard JP, et al. Metabolic syndrome and obesity are the cornerstones of liver fibrosis in HIV-monoinfected patients. AIDS. 2017;31(14):1955-1964. doi: 10.1097/QAD.0000000000001587.
  2. National Institute on Drug Abuse. Drug and alcohol use – a significant risk factor for HIV. NIH website. drugabuse.gov/related-topics/trends-statistics/infographics/drug-alcohol-use-significant-risk-factor-hiv. Updated April 2015. Accessed on October 14, 2017.
  3. Macias J, Mancebo M, Merino D, et al. Changes in liver steatosis after switching from efavirenz to raltegravir among human immunodeficiency virus-infected patients with nonalcoholic fatty liver disease. Clin Infect Dis, online edition. DOI: 10.1093/cid/cix467.
  4. El Kamari V, Hileman CO, Mccomsey G. Fatty liver disease in HIV: Predictors and response to statin therapy. Open Forum Infectious Diseases, 2017 Fall; 4(Suppl 1): page S58. DOI: 10.1093/ofid/ofx162.136.
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Italian and U.S. researchers look to the future and explore aging-related issues http://www.eatg.org/news/italian-and-u-s-researchers-look-to-the-future-and-explore-aging-related-issues/ Tue, 07 Nov 2017 21:26:40 +0000 http://www.eatg.org/?post_type=news&p=6708

— Researchers in Italy and the United States predict that by 2035, three-quarters of HIV-positive people in both countries will be over the age of 50.
— 90% of HIV-positive older people will have at least one non-communicable disease such as high blood pressure, elevated lipids, diabetes, or cancer.
— HIV care costs attributable to non-communicable disease are expected to double in Italy and increase 40% in the United States.
— Researchers call for “multidisciplinary patient management” and geriatric medicine training for doctors who care for people living with HIV.

Researchers in Canada and other high-income countries increasingly expect that many people who take combination anti-HIV treatment (ART) every day and achieve and maintain an undetectable viral load and keep up with regular clinic and laboratory visits will achieve a near-normal life span. In light of this tremendous effect of ART on people’s life spans, ministries and departments of health should begin planning for the care that will be required by a growing proportion of aging HIV-positive people. A first step in this process is estimating which diseases and health conditions are occurring in older HIV-positive people now, and then projecting these estimates into the future and calculating their costs.

A team of researchers in Italy and the United States has collected health-related information from about 11,000 HIV-positive people and used this to produce a computer model that could explore some effects of aging. The computer model focused on non-communicable diseases (NCD) and projected health outcomes for aging HIV-positive people in both countries, comparing the years 2015 and 2035.

The computer model predicted that in 2035 the average age of HIV-positive people in Italy will be nearly 60 years and in the U.S. it will be 58 years. Furthermore, it predicted that nearly 90% of HIV-positive older people will have at least one of the following NCDs in 2035:

  • higher-than-normal blood pressure
  • elevated levels of lipids (cholesterol and/or triglycerides) in their blood
  • diabetes
  • cancers unrelated to HIV

To a lesser extent, there will also be increases in heart attacks and strokes.

The researchers therefore predicted that the cost of caring for HIV-positive people will likely rise due to the increased presence of NCDs. The model likely underestimates some of the costs of care, as it takes into account only a handful of NCDs. The research team also made recommendations for interventions to reduce NCDs among older patients and for enhancing the training of doctors and nurses so they can better help look after an aging population.

Study details

The research team adapted a well-validated model previously used in the Netherlands to explore aging among HIV-positive people in that country. The researchers used data from an ongoing study in Italy called ICONA, which is focusing on 7,499 HIV-positive people. Data from the U.S. were obtained from 3,748 HIV-positive people with private insurance coverage from a nationally representative sample.

The researchers’ model focused on the following NCDs:

  • abnormal lipid levels in the blood
  • higher-than-normal blood pressure
  • type 2 diabetes
  • chronic kidney disease
  • cancers unrelated to HIV
  • heart attack
  • stroke

Results—What the future likely holds

By the year 2035, the model predicted the following:

Italy

The average age of HIV-positive patients will be nearly 60 years.

U.S.

The average age of HIV-positive patients will be 58 years.

The proportion of patients who are aged 50 years or older will be as follows:

  • Italy – 76%
  • U.S. – 74%

The proportion of patients who are aged 65 years or older will be as follows:

  • Italy – 29%
  • U.S. – 27%

Focus on non-communicable diseases

According to the researchers, in 2035 “the increasing burden of NCDs will be driven by” the following:

  • higher-than-normal blood pressure
  • abnormal lipid levels in the blood
  • type 2 diabetes
  • cancers unrelated to HIV

The proportions of HIV-positive people who had these conditions in 2015 are as follows:

Higher than normal blood pressure and elevated lipid levels

  • Italy – 60%
  • U.S. – 61%

Type 2 diabetes

  • Italy – 9%
  • U.S. – 12%

Cancers unrelated to HIV

  • Italy – 6%
  • U.S. – 14%

The computer model predicted that the following proportions of HIV-positive people will have NCDs in 2035:

Higher-than-normal blood pressure and elevated lipid levels

  • Italy – 85%
  • U.S. – 84%

Type 2 diabetes

  • Italy – 27%
  • U.S. – 23%

Cancers unrelated to HIV

  • Italy – 16%
  • U.S. – 30%

When researchers assessed trends in heart attacks and strokes, they expected the following proportions of people to have one or more of these conditions in 2035, as follows:

  • Italy – 10%
  • U.S. – 21%

This difference in rates of serious cardiovascular disease between the two countries is, according to the researchers, “driven by the higher age-specific prevalence and incidence of serious cardiovascular disease observed in the U.S. compared to Italy.”

Costs of managing NCDs expected to rise

The researchers estimated the annual costs of care directly related to NCDs and found that the computer model suggested it would increase between 2015 and 2035 in both countries, as follows:

Italy

The researchers estimated that currently 11% of the cost of caring for HIV-positive people arises from treatment of NCDs. By 2035 this figure is expected to rise to almost 23%. The greatest proportion of this increase will be due to the cost of care associated with abnormal lipid levels and chronic kidney disease.

U.S.

The researchers estimated that currently 40% of the total costs of care for HIV-positive people arises from treatment of NCDs. By 2035 this figure is expected to rise to almost 56%.

These findings are supported by studies in the Netherlands, which also suggest that NCDs and in particular cardiovascular disease (and its cost) will increase as HIV-positive people age.

The need to prevent NCDs

According to the researchers, “The aging of the HIV-positive populations in Italy and the U.S. will have major implications for HIV care. Our forecasts suggest that three-quarters of HIV-positive patients on ART will be over 50 years in both countries by 2035, resulting in an increased NCD burden in this population.” Recall that the main drivers of this burden of NCDs will be as follows:

  • higher-than-normal levels of blood pressure
  • abnormal lipid levels in the blood
  • type 2 diabetes
  • cancers unrelated to HIV

Furthermore, the researchers said:

“These shifts [toward NCDs] will have considerable implications for direct HIV care costs, with average care costs attributable to NCD treatment expected to double in Italy and increase by 40% in the U.S. Evidence-based approaches on effective prevention interventions and treatment protocols will be vital to mitigate this growing burden.”

A change in health management

In high-income countries, as patients initiate ART earlier in the course of HIV disease, care provided by doctors, for the most part, continues to shift from preventing the life-threatening infections that are the hallmark of AIDS to what the research team called “the long-term prevention, screening and treatment of NCDs.” The researchers underscored that as this shift continues the following aspects of care and treatment will need particular attention:

  • choice of the best ART regimen
  • management of interactions between ART and medicines used to prevent and treat NCDs
  • adherence not just to ART but also to NCD medicines

As patients age, the researchers call for “multidisciplinary patient management” focusing on the following elements of optimal health:

  • principles of geriatric medicine
  • personalized treatment protocols
  • interventions with patients to help prevent or minimize the effects of NCDs, such as guidance on risk factors that can be modified (quitting smoking, dietary changes, exercise and so on)

To help effect these changes, the researchers call for training in geriatric medicine to become available for healthcare providers, particularly family medicine specialists.

The publication of the model’s results should stimulate other countries and regions to conduct their own assessments of the trajectories of people with HIV as they age and which NCDs need to be prevented and treated.

Bear in mind

There are several issues that may affect the present model’s accuracy:

  • Researchers focused on a handful of NCDs. Future computer models could add other NCDs such as asthma, chronic obstructive pulmonary disease, obesity and so on.
  • Researchers did not take into account cognitive impairment, which can occur because of HIV and also because of aging.
  • The U.S. data came from patients who had private health insurance coverage that provided what the researchers called “the best access to health care.” Such patients might be healthier than patients who rely on public health programs or those without health insurance.

These and other reasons suggest that the computer model is likely to have underestimated future NCDs and associated healthcare costs.

By Sean R. Hosein

REFERENCES:

  1. Smit M, Cassidy R, Cozzi-Lepri A, et al. Projections of non-communicable disease and health care costs among HIV-positive persons in Italy and the U.S.A.: A modelling study. PLoS One. 2017 Oct 23;12(10):e0186638.
  2. Smit M, van Zoest RA, Nichols BE, et al. Cardiovascular disease prevention policy in HIV: recommendations from a modelling study. Clinical Infectious Diseases. 2017; in press.
  3. Smit M, Brinkman K, Geerlings S, et al. Future challenges for clinical care of an ageing population infected with HIV: a modelling study. Lancet Infectious Diseases. 2015 Jul;15(7):810-8.
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Adolescents at risk for HIV should be offered PrEP http://www.eatg.org/news/adolescents-at-risk-for-hiv-should-be-offered-prep/ Tue, 07 Nov 2017 21:04:07 +0000 http://www.eatg.org/?post_type=news&p=6705 AIDS is the second leading cause of death among adolescents globally; approximately 1.8 million individuals aged 10 to 19 years were reported to have HIV in 2015.1 In that age bracket, it was estimated that a new HIV infection occurred every 2 minutes. According to 2014 statistics for the United States, 80% of new cases among individuals aged 13 to 24 years affected young men who have sex with men (YMSM).2

Although tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) received approval from the US Food and Drug Administration in 2012 for HIV preexposure prophylaxis (PrEP), the efficacy trials only included adults, and therefore TDF/FTC was not approved for use in minors.3-5 “Thus, a critical gap in approved prevention products exists for adolescents, a population that is highly vulnerable to HIV worldwide,” wrote the authors of a new study published in JAMA Pediatrics.6

To that end, the authors conducted the Adolescent Medicine Trials Network for HIV/AIDS Interventions 113 (Project PrEPare) to examine the safety, tolerability, and adherence to PrEP among healthy YMSM aged 15 to 17 years, as well as patterns of adherence to the daily regimen and risky sexual behavior.

The sample included 78 individuals with a mean age of 16.5 years (SD, 0.73 years), representing a variety of races and ethnicities, who were recruited from clinics in 6 US cities. Participants had negative test results for HIV but a high risk for infection. For inclusion, they were required to participate in a behavioral intervention, in addition to accepting a 48-week PrEP intervention.

The findings show 23 sexually transmitted infections diagnosed in 12 participants during the study period, as well as 3 new cases of HIV (HIV seroconversion rate, 6.4 [95% CI, 1.3-18.7] per 100 person-years). Tenofovir diphosphate levels indicating a high degree of protection against HIV (>700 fmol/punch) were noted in 54%, 47%, 49%, 28%, 17%, and 22% of participants at weeks 4, 8, 12, 24, 36, and 48, respectively. These results “strongly support the need for an adolescent PrEP indication for TDF/FTC,” the authors concluded. “The waning adherence, especially with quarterly visits, demonstrates that more time, attention, and resources may need to be allocated to adolescents who are seeking prevention services.”

To further explore this topic, Infectious Disease Advisor checked in with 2 experts: study coauthor Bill G. Kapogiannis, MD, program director of the Adolescent Medicine Trials Network for HIV/AIDS Interventions of the Eunice Kennedy Shriver National Institutes of Child Health and Human Development; and Helen C. Koenig, MD, MPH, associate professor of clinical medicine in the Division of Infectious Diseases at the Perelman School of Medicine at the University of Pennsylvania, and director of the PrEP program at Philadelphia FIGHT.

Disclaimer: The comments and views below are of the author and do not necessarily represent the views of the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

Infectious Disease Advisor: Dr Kapogiannis, regarding the findings from your most recent paper, what are the main takeaways for our clinical audience?

Dr Kapogiannis: In this first safety and demonstration licensure-bridging study of PrEP to prevent HIV in adolescent minors who are at risk for infection, PrEP was safe and well tolerated. Adherence to PrEP as measured by objective drug levels started off high but decreased over time, and this decline seemed to be associated with decreasing study visit frequency (monthly to quarterly). The 3 incident HIV infections that occurred among participants with very low to undetectable PrEP levels are a stark reminder that the drug cannot work if it isn’t taken. Adolescents at risk for HIV can safely use and should be offered PrEP to reduce their risk of becoming infected, but may need additional support compared with adults, such as more frequent in-person clinic contact, cell phone reminders, and peer support group, to ensure they maintain high adherence.

Infectious Disease Advisor: What are some of the top points of debate regarding PrEP for adolescents?

Dr Kapogiannis: The main point that seems to surface is whether adolescents who are at risk for HIV infection can maintain the high levels of adherence needed for PrEP to be effective. Another, albeit less common, point that comes up is whether prescriptions of PrEP to at-risk adolescents will lead to more risky behaviors or a behavioral phenomenon that is termed disinhibition, which has not been seen in studies so far. Finally, the poor access and uptake in the very communities of young people in the United States who are at greatest risk of becoming infected by HIV is concerning and needs to be addressed.

Dr Koenig: We know that the group in which the HIV incidence is rising the fastest is youth and young adults aged 13 to 24 years, and that among this group the hardest hit subpopulation is young MSM of color and young transwomen of color. Top points for debate are the following:

  • How to get pediatricians to talk with youth about PrEP in a systematic and nonjudgmental way; that is, at a routine visit, to talk about exercise, diet, smoking, routine vaccines, family planning, and HIV prevention options including PrEP with all patients, not just those deemed “at risk”
  • How to get PrEP offered and discussed in schools
  • The difficulty of reaching out to young sexually active women: In my experience, when we have started a young at-risk woman on PrEP and she has been enthusiastic, she then goes home and talks with her friends and none of them have heard about or been offered PrEP, and so the patient stops PrEP, given the absence of peer knowledge or support of PrEP in the young female adult community
  • The need for parental consent
  • The fact that TDF/FTC is not approved for PrEP for those younger than 18 years
  • Concern about TDF affecting bone mineral density in youth who are still growing and laying down bone matrix
  • Medication coverage for minors who do not want to use their parents’ insurance

Infectious Disease Advisor: Is parental permission necessary for PrEP in minors?

Dr Kapogiannis: The answer here is a bit complex, with some important caveats, and in the United States, it is guided at the local/jurisdictional or state level. First, the requirement for parental permission may make it very difficult to nearly impossible for adolescents who are at risk for HIV infection to access PrEP because they may not be willing to disclose required information about their risk behaviors to their parents. Also, the parent-child relationships may not be optimal, or the parent may be absent: Many of the teenagers at risk are at higher risk because they lack a stable, supportive home and family environment. In such situations, there are precedents for foregoing parental consent in adolescents when it comes to protecting their health and safety. One of those sample precedents includes medical care for the diagnosis or treatment of sexually transmitted infections (STIs).

All US jurisdictions expressly allow some minors to consent to medical care for the diagnosis or treatment of STIs. These laws are intended to encourage adolescents to seek treatment for reproductive health concerns through protecting their right to privacy in reproductive health decisions. Because HIV is mainly a STI, adolescents should be allowed to consent for HIV treatment regardless of whether state law specifically mentions HIV. However, state laws may not explicitly address an adolescent’s right to consent to medical care for the prevention of STIs. One could argue, and I would, that the extension of treatment statutes to STI prevention would be consistent with the intent of such state laws to protect the health of adolescents.

Finally, I always encourage adolescents to involve their parents in making healthcare decisions whenever possible, and they feel safe and supported in doing so.

Dr Koenig: “Is” and “should” are 2 different questions, as every state has different policies on STI/HIV prevention and treatment, and different institutions within the same state vary on what they deem medico-legally acceptable. At FIGHT, as in many other places, we believe that PrEP is just like any other state-sanctioned STI prevention intervention that can be legally offered to minors without parental consent. As a parent, I believe consent can and should be obtained wherever possible, as parental involvement can be a wonderful thing that facilitates adherence and engagement in care. However, sometimes obtaining parental consent endangers a young person’s safety; for example, if parents are not aware the patient is MSM and starting TDF/FTC “outs” them in some way, jeopardizing the emotional or physical well-being of an adolescent or financial support or housing for a young adult.

Youth not wanting parents to know they are sexually active for a variety of reasons has been a barrier with the approval of the Gardasil vaccines, home pregnancy testing kits, and so on. In these cases, PrEP can and should be offered without parental consent, again in keeping with the laws of each particular state. At FIGHT, we have codified policy allowing us to prescribe PrEP to minors. However, at the Children’s Hospital of Philadelphia, PrEP cannot be prescribed to minors, given the academic center’s legal concerns, just to give you a sense of some of the variation in practice.

Infectious Disease Advisor: Should PrEP be offered on a wider scale as part of sex education?

Dr Kapogiannis: We don’t know yet whether a “school-based clinic” alternative to the more traditional clinic-based model works better at improving uptake and adherence to PrEP for adolescents at risk for HIV infection, so more research is needed to inform whether this approach is feasible and appropriate.

Dr Koenig: A resounding “Yes,” for all of the above reasons and more. It works! Also, the question, “Why not?” must be asked. Why not share a widely available, acceptable, safe, and effective technology that can prevent a lifelong life-threatening disease, a technology that also serves to engage young people in healthy ongoing care with a healthcare provider, where they can be offered continual risk reduction prevention interventions such as STI testing, family planning assistance, condoms, flu shots, nutrition guidance, smoking cessation support, and general wellness interventions? PrEP IS primary care for youth.

By Tori Rodriguez

References

  1. UNAIDS. Global AIDS update. http://www.unaids.org/en/resources/documents/2016/Global-AIDS-update-2016. Updated May 31, 2016. Accessed October 17, 2017.
  2. Centers for Disease Control and Prevention. HIV among youth fact sheet. https://www.cdc.gov/hiv/pdf/group/age/youth/cdc-hiv-youth.pdf. Updated April 2017. Accessed October 17, 2017.
  3. Grant RM, Lama JR, Anderson PL, et al; iPrEx Study Team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010;363:2587-2599.
  4. Baeten JM, Donnell D, Ndase P, et al; Partners PrEP Study Team. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367:399-410.
  5. Thigpen MC, Kebaabetswe PM, Paxton LA, et al; TDF2 Study Group. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med. 2012;367:423-34.
  6. Hosek SG, Landovitz RJ, Kapogiannis B, et al. Safety and feasibility of antiretroviral preexposure prophylaxis for adolescent men who have sex with men aged 15 to 17 years in the United States [published online September 5, 2017]JAMA Pediatr. doi:10.1001/jamapediatrics.2017.2007
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Should dolutegravir be used as maintenance therapy for HIV? http://www.eatg.org/news/should-dolutegravir-be-used-as-maintenance-therapy-for-hiv/ Tue, 07 Nov 2017 19:57:48 +0000 http://www.eatg.org/?post_type=news&p=6704 For patients who take antiretroviral drugs after being diagnosed with HIV, getting viral levels under control is the first step. The next step is keeping viral levels suppressed indefinitely via maintenance therapy. Figuring out which medications provide the best chance of achieving ongoing viral suppression while causing the fewest side effects is, therefore, of paramount importance.

Based on the results of an earlier small retrospective observational study, which suggested that dolutegravir’s high barrier to drug resistance—along with its once-a-day dosing schedule and lack of impact on blood lipid levels—might make it a good choice for a maintenance monotherapy, researchers from the Netherlands conducted their own trial to confirm whether this was true.

They recruited 104 subjects living with HIV who had already been treated with antiretroviral therapy (ART); all were virologically-suppressed, with RNA counts of less than 50 copies per mL and CD4 counts that had never dropped below 200. Fifty-one patients were assigned to immediately switch from combination ART to dolutegravir, and 53 patients switched to dolutegravir after 24 weeks of continuing on their regimen of combination ART. One goal of the study was to see how many patients had RNA viral loads of less than 200 copies per mL at the end of 24 weeks, which would signify adequate viral suppression. The patients were assessed again at 48 weeks.

During the study, one of the subjects who had immediately switched to dolutegravir had to drop out due to sleep disturbances. Of the subjects who continued taking combination ART for 24 weeks, six left the study before the 24 weeks were up for various reasons, including noncompliance and physicians’ recommendations. At 24 weeks, the 47 remaining subjects switched from combination ART to dolutegravir, with one subject subsequently dropping out because of sleep disturbances and one leaving the trial due to headaches.

The researchers found that at 24 weeks, dolutegravir was not inferior to combination ART when it came to viral suppression. Only one patient out of the 50 subjects who switched to dolutegravir immediately had RNA viral loads of 200 copies per mL or higher. None of the patients who delayed switching to dolutegravir had RNA viral loads at that level. However, the scientists concluded that they cannot recommend dolutegravir as a maintenance drug.

“Despite these promising results, virological failure was observed in seven additional patients after week 24, which led to virological suppression in 92% of patients at the time of study discontinuation,” the authors wrote in the study, which was published in The Lancet. “This result was statistically inferior to the 98% suppression rate observed in patients in the concurrent control group.”

The authors noted that all 8 patients who failed to achieve viral suppression on dolutegravir did achieve it once they returned to a regimen of combination ART, although that alone did not mean dolutegravir was an inappropriate choice for maintenance therapy. Upon sequencing the virus in six study subjects, the team discovered that mutations associated with medication resistance had arisen.

“Given the detection of resistance mutations in the integrase gene of more than two patients on dolutegravir monotherapy in our study, with the potential for cross resistance to other available and future integrase inhibitors, one of the stopping rules was met and the study was terminated,” they wrote.

The researchers’ conclusion? Dolutegravir is not an appropriate choice for maintenance monotherapy, a sentiment shared by Janine M. Trevillyan, MBBS, and Jennifer F. Hoy, MBBS, FRACP, Australian scientists who provided additional commentary in The Lancet. “The focus must now switch to the more promising dual-therapy options (such as dolutegravir and lamivudine or rilpivirine), or which large, randomised trials are underway,” they wrote.

By Laurie Saloman

 

Read also:

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CDC contraception recommendations updated for women at risk for HIV http://www.eatg.org/news/cdc-contraception-recommendations-updated-for-women-at-risk-for-hiv/ Tue, 07 Nov 2017 19:43:59 +0000 http://www.eatg.org/?post_type=news&p=6703 In a recent update published in the Morbidity and Mortality Weekly Report, the Centers for Disease Control and Prevention (CDC) revised its US Medical Eligibility Criteria for Contraceptive Use (US MEC) categorization for depot medroxyprogesterone acetate (DMPA) injection in women at high risk for HIV infection from US MEC category 1 to US MEC category 2.

The US MEC update was based on the recent publication of studies evaluating the impact of hormonal contraception on the risk of HIV acquisition and the recent World Health Organization (WHO) guidance published on the same matter. The review committee was comprised of 8 participants who are experts on family planning and HIV infection, seven of whom were from outside the CDC.1

After reviewing the available evidence and information regarding contraception and risk of acquiring HIV, the US MEC recommendation for DMPA injections in women at high risk for HIV infection was revised from category 1 (no restrictions) to category 2 (benefits outweigh theoretical or proven risks). The change was in accordance with the recent WHO guidelines.

Implants, progestin-only pills, and combined hormonal contraceptive remained category 1 in the US MEC.

The change in the US MEC stemmed in part from evidence in a systematic review that indicated that women who used DPMA injections were at an increased risk for HIV acquisition (adjusted hazard ratio 1.4, 94% CI 1.2-1.6).2 The results across studies were inconsistent, and studies may have had methodologic flaws, according to the authors of the report.1

The report further stated that the sociodemographic factors that overlap with DMPA use and increased risk for HIV infection are the same globally and in the United States.1

In an interview with Infectious Disease Advisor, Naomi Tepper, MD, MPH, of the Division of Reproductive Health at the CDC, noted that based on the category 2 recommendation, “women should not be denied the use of DMPA because of concerns about a possible increased risk, but should be counseled about the risks and about how to reduce their risk of acquiring HIV.”

By Jessica Martin

Reference

Tepper NK, Krashin JW, Curtis KM, Cox S, Whiteman MK. Update to CDC’s U.S. medical eligibility criteria for contraceptive use, 2016: revised recommendations for the use of hormonal contraception among women at high risk for HIV infection. MMWR Morb Mortal Wkly Rep. 2017;66:990-994.

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Treating HCV in HIV-coinfection: still a therapeutic dilemma? http://www.eatg.org/news/treating-hcv-in-hiv-coinfection-still-a-therapeutic-dilemma/ Tue, 07 Nov 2017 19:36:51 +0000 http://www.eatg.org/?post_type=news&p=6702 All patients with HIV infection should be screened at least once for HCV. In patients with continued risk factors, such as injecting drug use or men who have sex with men, HCV screening should be repeated. Consequently, there are several treatment sensitivities that need to be taken into account when treating coinfected individuals.

Read the full publication here.

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CATIE: October/November 2017 issue of TreatmentUpdate now online http://www.eatg.org/news/catie-octobernovember-2017-issue-of-treatmentupdate-now-online/ Tue, 07 Nov 2017 15:35:03 +0000 http://www.eatg.org/?post_type=news&p=6707 TreatmentUpdate is CATIE’s flagship digest on cutting-edge developments in HIV and hepatitis C research and treatment.

TreatmentUpdate 222: Anti-HIV agents, October/November 2017 issue is available at:

http://www.catie.ca/en/treatmentupdate/treatmentupdate-222

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News from EACS 2017 http://www.eatg.org/news/news-from-eacs-2017/ Tue, 07 Nov 2017 15:33:10 +0000 http://www.eatg.org/?post_type=news&p=6697 The 16th European AIDS Conference (EACS 2017) took place on 25-27 October 2017 in Milan, Italy.

 

HIV i-Base reports:

 

NATAP reports:

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UNAIDS launches 2017 World AIDS Day campaign—My Health, My Right http://www.eatg.org/news/unaids-launches-2017-world-aids-day-campaign-my-health-my-right/ Mon, 06 Nov 2017 22:55:20 +0000 http://www.eatg.org/?post_type=news&p=6693

GENEVA, 6 November 2017—In the lead up to World AIDS Day on 1 December, UNAIDS has launched this year’s World AIDS Day campaign. The campaign, “My Health, My Right” focuses on the right to health and explores the challenges people around the world face in exercising their rights.

“All people, regardless of their age, gender, where they live or who they love has the right to health,” said Michel Sidibé, Executive Director of UNAIDS. “No matter what their health needs are everyone requires health solutions that are available and accessible, free from discrimination and of good quality.”

The right to health is enshrined in the 1966 International Covenant on Economic, Social and Cultural rights as the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. This includes the right of everyone to the prevention and treatment of ill health, to make decisions about one’s own health and to be treated with respect and dignity.

The campaign reminds people that the right to health is much more than access to quality health services and medicines, but that it also depends on a range of important assurances including, adequate sanitation and housing, healthy working conditions, a clean environment and access to justice among others.

If a person’s right to health is compromised they are often unable to effectively prevent disease and ill health, including HIV, or to gain access to treatment and care. The most marginalized in society, including sex workers, people who inject drugs, men who have sex with men, people in prisons and migrants, are often the least able to access their right to health, they are also the most vulnerable to HIV.

Most of the Sustainable Development Goals are linked in some way to health. To achieve the Sustainable Development Goals, including ending the AIDS epidemic as a public health threat by 2030, will depend heavily on ensuring the right to health for all.

“My Health, My Right” encourages people share their views and concerns around ensuring their own right to health and to create a movement, highlighting the importance of erasing health inequalities. Campaign materials include suggested tweets, downloadable posters and postcards and an information brochure which includes key messages about the right to health.

For more information go to: www.unaids.org

UNAIDS

The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org and connect with us on Facebook, Twitter, Instagram and YouTube.

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UNAIDS: Living with HIV but dying from TB http://www.eatg.org/news/living-with-hiv-but-dying-from-tb/ Mon, 06 Nov 2017 22:50:15 +0000 http://www.eatg.org/?post_type=news&p=6692

Global progress to End TB not fast enough to reach global TB and HIV targets

03 November 2017 – Tuberculosis (TB) retains its undesirable status as the leading infectious cause of death globally. According to the latest WHO Global Tuberculosis Report 2017 launched this week, global progress in reducing new tuberculosis (TB) cases and deaths is insufficient to meet the global targets for TB and HIV, despite most deaths being preventable with early diagnosis and appropriate treatment of tuberculosis and HIV.

As part of global efforts to advance the response to TB is now being pushed higher up the global development agenda with hundreds of global leaders attending the first WHO Global Ministerial Conference on Ending TB in Moscow from 14-17 November and a dedicated United Nations General Assembly High-Level Meeting on TB in 2018.

“We have an unprecedented opportunity to shine the political spotlight on the inequalities that drive the epidemics of TB and HIV,” said Michel Sidibé, UNAIDS Executive Director, “The return on investment in TB and HIV is more than just dollars, it’s in voices heard, rights protected and lives saved.”

In 2016, the risk of developing TB disease among the 37 million people living with HIV was around 21 times higher than the risk in the rest of the world population. There were more than one million TB cases among people living with HIV—10% of all global TB cases in 2016. People living with HIV are much more likely to die from TB disease than HIV-negative people, and one in five (22%) TB deaths occurs among people living with HIV. In 2016, there were 374 000 TB deaths among people living with HIV, which represents almost 40% of all AIDS-related deaths.

TB disease and deaths can be avoided with TB preventive therapy but most people living with HIV who can benefit are not receiving it. In 2016, fewer than 1 million people newly enrolled in HIV care were started on TB preventive treatment. South Africa accounted for the largest share of the total (41%), followed by Mozambique, Zimbabwe and Malawi.

The global burden of drug-resistant tuberculosis continues to rise with an estimated 600,000 cases requiring treatment but only one in five were enrolled on treatment in 2016.

Global TB incidence is only falling at about 2% per year and 16% of TB cases die from the disease; by 2020, these figures need to improve to 4–5% per year and 10%, respectively, to reach the first (2020) milestones of the WHO End TB Strategy. Major gaps remain in global funding for TB prevention and treatment (US$2.3 billion) and TB research into new drugs, vaccines, and diagnostics (US$1.2 billion) for 2017.

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HCV: Miracle cure costs less than a budget airline flight http://www.eatg.org/news/hcv-miracle-cure-costs-less-than-a-budget-airline-flight/ Mon, 06 Nov 2017 22:45:42 +0000 http://www.eatg.org/?post_type=news&p=6696 The revolution in generic drugs means that a 12-week course of drugs to cure hepatitis C can be manufactured for just US$50 – as low as the cost of a plane ticket on many low-cost airlines. Furthermore, new data shows that these generic copies are just as effective as the branded medicines. Yet restrictions and patent issues around the world mean that hardly any patients can access the drugs at these low costs, say experts speaking at the World Hepatitis Summit in Sao Paulo, Brazil (1-3 November).

“As there are around 70 million people infected with hepatitis C worldwide, the basic cost of the drugs to treat everyone infected globally, at $50 each, would be around US $3.5 billion,” explains Dr Andrew Hill, a pharmacology expert from the University of Liverpool, UK. This represents less than a fraction of 1% of the global health budget of some US$ 8 trillion. “Much more must be done to enable all countries — but especially developing countries — to produce or buy drugs for these lower prices. Without significant changes to pricing structures, the battle against the global hepatitis C epidemic simply can’t be won.”

In his presentation, Dr Hill will present data on the hugely varying cost of a 12-week course of sofosbuvir and daclatasvir, a common combination of the new directly acting antiviral drugs (DAAs) that have revolutionised hepatitis C treatment by providing rapid cure with few or no side effects. The list price for this combination of drugs ranges from close to cost price in India ($78) and Egypt ($174) to $6,000 in Australia, $77,000 in the UK, and a staggering $96,404 the USA. Yet the basic cost of the active ingredients, including formulation and packaging costs and even allowing a small profit margin for the generic companies brings the basic cost down to under $50 per course.

In high-income countries, most of which have treatment restrictions allowing only those with advanced disease to be treated first, some infected patients have resorted to buying generic drugs from international buyers’ clubs (who buy in bulk from developing countries) or directly from countries where they are manufactured. For example, in the UK, those not wanting to wait for advanced disease to be treated have been able to legally purchase a 12-week generic course for prices ranging from US $1000 to $1200. Research studies on these patients show that cure rates are as high as for the branded medicines, ranging from 90% to 95%.

An analysis presented at the summit on the efficacy of generic DAAs looked at 1160 patients who have imported DAAs for personal use into 88 countries on 5 continents. Data from these patients show that cure rates are well over 90%, the same as for the branded products, but at a fraction of the cost.

“In 2016, for every person cured of hepatitis C globally (1.76 million), another person was newly infected (1.5 million). We simply cannot eliminate this epidemic unless we treat more people. And we can only do this if the prices of the drugs come down,” explains Dr Hill.

He adds that the manufacturers of DAAs must do more to provide voluntary licences in countries that do not currently have them for generic companies to produce cheaper (but just as effective) generic DAAs. This is what has happened in Egypt, which had nearly 7 million people to treat, but now have fewer than 5 million. However, more than half of those people infected globally live in countries with no voluntary licence to allow generic production. “For example, China and Russia, two countries with very large hepatitis C epidemics, have no voluntary licence in place to produce cheap generic drugs,” explains Dr Hill.

However, Dr Hill makes clear that any efforts to reduce drug prices and enable mass generic DAA production worldwide will be futile unless countries also step up their efforts to find and diagnose their infected populations. “We cannot treat people if we do not know who they are,” explains Dr Hill. “Countries must massively step up their screening efforts, or they will simply run out of people to treat – a diagnostic ‘burn-out’. The proportion of patients with hepatitis C who know they have it ranges from 44% in high-income countries to just 9% in low-income countries.”

He concludes that lessons can and should be learned from the HIV epidemic to successfully end the hepatitis C epidemic worldwide. “It has taken the world 15 years to get 19 million people globally on antiretroviral treatments for HIV,” he says. “We already have the drugs necessary to eliminate hepatitis C. Let’s learn from the past, and repeat the medical success story of global HIV treatment.”

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MPP and USAID sign Memorandum of Understanding http://www.eatg.org/news/mpp-and-usaid-sign-memorandum-of-understanding/ Mon, 06 Nov 2017 22:40:25 +0000 http://www.eatg.org/?post_type=news&p=6695 Geneva, 02 November 2017 — The Medicines Patent Pool and the United States Agency for International Development (USAID) signed a Memorandum of Understanding (MoU) to accelerate the introduction of quality, affordable new medicines for diseases that disproportionately affect developing countries.

The two parties currently collaborate as part of the OPTIMIZE consortium, supported by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and dedicated to rapidly improving treatment outcomes for people living with HIV in low- and middle-income countries.

The USAID-MPP partnership aims to facilitate the development and early introduction of better-formulated antiretrovirals, including those prioritized by OPTIMIZE. The MPP and USAID will coordinate efforts on market intelligence, supplier engagement and technical support in key PEPFAR countries. The MoU also envisions the two parties working together in other areas to address access to medicines issues for HIV as well as for other select diseases in the future.

The MPP’s HIV, hepatitis C and tuberculosis activities are fully funded by Unitaid. USAID and Unitaid are collaborating to accelerate access to optimal antiretroviral regimens for people living with HIV. This collaboration supports a number of projects to develop and introduce better, more affordable treatments in low- and middle-income countries. The Project Advisory Committee (PAC) established by Unitaid and USAID is currently convening in Washington D.C. The committee brings together partners to find new ways to optimise treatments for HIV.

Access the MoU

Learn more about OPTIMIZE

Access the press release in Spanish

About the Medicines Patent Pool

The Medicines Patent Pool is a United Nations-backed public health organisation working to increase access to HIV, hepatitis C and tuberculosis treatments in low- and middle-income countries. Through its innovative business model, the MPP partners with industry, civil society, international organisations, patient groups and other stakeholders to prioritise, forecast and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, the MPP has signed agreements with nine patent holders for thirteen HIV antiretrovirals, one HIV technology platform, two hepatitis C direct-acting antivirals and a tuberculosis treatment. The MPP was founded and is funded by Unitaid.

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Starting ART immediately after HIV diagnosis cuts mortality risk by two-thirds for people with high CD4 cell counts http://www.eatg.org/news/starting-art-immediately-after-hiv-diagnosis-cuts-mortality-risk-by-two-thirds-for-people-with-high-cd4-cell-counts/ Mon, 06 Nov 2017 22:15:47 +0000 http://www.eatg.org/?post_type=news&p=6691

People with a high CD4 cell count who start antiretroviral therapy (ART) immediately after diagnosis with HIV cut their 12-month mortality risk by two-thirds, according to research conducted in China and published in Clinical Infectious Diseases.

The retrospective study involved over 35,000 people who were newly diagnosed with HIV between 2012 and 2014. All had a CD4 cell count above 500 cells/mm3. Over 12 months of follow-up, individuals who started antiretrovirals within 30 days of their diagnosis had a 63% reduction in their mortality risk compared to people who remained antiretroviral-naïve. Delayed treatment (initiation after 30 days of diagnosis) also reduced mortality, but only by 26%.

“Our results demonstrate that PLWH [people living with HIV] with a CD4 cell count > 500 cells/mm3 who initiated ART within 30 days of diagnosis…experienced a 63% decrease in mortality,” write the investigators. “Additional risk factors for mortality in this study were older age, being male, having lesser education, and becoming infected via injection drug use or heterosexual contact.”

Since 2015, the World Health Organization has recommended that all people with HIV should take antiretroviral therapy, regardless of CD4 cell count. This is because research has proved that treatment, even at high CD4 cell counts, reduces the risk of illness and death. Moreover, people taking treatment who have an undetectable viral load have an effectively zero risk of transmitting HIV to their sexual partners.

Investigators in China wanted to see if immediate ART cut the mortality risk for people with a high CD4 cell count (above 500 cells/mm3) at the time of their diagnosis. They therefore designed a retrospective study involving approximately 35,500 adults newly diagnosed with HIV between 2012 and 2014. All had a CD4 cell count above 500 cells/mm3 and were followed for 12 months after their diagnosis. Study participants were divided into three groups according to their use of HIV therapy:

  • Immediate ART: initiation within 30 days of diagnosis.
  • Deferred ART: initiation more than 30 days after diagnosis.
  • No ART: no HIV treatment.

The researchers hypothesised that immediate ART would be associated with a reduced risk of mortality.

The participants had a median age of 32 years, 75% were male, 64% had a primary education or less, 39% were married, 60% acquired HIV through heterosexual contact. Median baseline CD4 cell count was 616 cells/mm3.

ART was started within 30 days of diagnosis by 5% of the cohort. A further 16% initiated therapy more than 30 days after diagnosis and the remaining people remained ART naïve.

A total of 790 (2% of the cohort) deaths were documented over 12 months of follow-up, a mortality rate of 2.31 per 100 person-years.

There were 19 deaths in the immediate ART group, a mortality rate of 1.04 per 100 person-years. A total of 58 deaths occurred in the deferred ART group, a mortality rate of 2.25 per 100 person-years. The remaining 713 deaths were documented in the treatment-naïve group, a mortality rate of 2.39 per 100 person-years.

Three-quarters of the deaths were attributed to non-AIDS-related causes. The most common non-AIDS-related cause of death was cardiovascular disease (37%).

Compared to the ART-naïve group, immediate ART provided strong protection against mortality (aHR = 0.37, p < 0.001). Delayed ART also provided modest protection against mortality (aHR = 0.74, p = 0.04).

“In addition to the direct benefit of ART for survival, it is also likely that regular follow up and comprehensive care services associated with ART use contributed to the decreased mortality observed,” suggest the investigators. “After ART initiation, patients entered into the stable care system and received multidisciplinary services including regular medical visits as well as psychosocial support.”

Other factors associated with death were older age (under 50 years vs over 50 years, aHR = 2.03; p < 0.001), being male (aHR = 1.90; p < 0.001), having only a primary education or less (aHR = 1.85; p < 0.001), infection with HIV via heterosexual contact (aHR = 4.16, p < 0.001) or injecting drug use (aHR = 5.07; p < 0.001).

“Our results highlight the significant negative impact of delays in ART initiation in a real-world setting in China,” conclude the authors. “Our results support the urgent need to increase the number of PLWH identified early, and started on effective, long-term ART immediately, as predicted by the UN 90-90-90 targets.”

By Michael Carter

Reference

Zhao Y et al. Immediate antiretroviral therapy decreases mortality among patients with high CD4 counts in China: a nationwide, retrospective cohort study. Clin Infect Dis, online edition, 2017.

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Swiss study examines which years gay men decided to stop consistent condom use http://www.eatg.org/news/swiss-study-examines-which-years-gay-men-decided-to-stop-consistent-condom-use/ Mon, 06 Nov 2017 21:48:47 +0000 http://www.eatg.org/?post_type=news&p=6690 Did new information guide their decisions?

An innovative study presented at the 16th European AIDS Conference (EACS 2017) in Milan two weeks ago used a machine-learning algorithm (originally developed to help astronomers classify galaxies) to tease out whether there were specific groups of gay men within a large national cohort whose sexual risk behaviours followed similar trajectories over time, and if so, whether they were influenced by external factors such as new scientific data.

The analysis of gay men from the Swiss HIV Cohort Study by Luisa Salazar-Vizcaya from the University of Bonn in Germany found that an apparently steady and homogeneous increase in the proportion of men who reported ever having had condomless anal sex with non-steady partners (nscAI) between 2000 and 2016 was in fact due to quite sudden changes in behaviour in three specific groups of gay men who between them numbered less than half of the men in the study. What distinguished the three groups was that their decision to drop 100% condom use with non-steady partners happened at three different time periods.

The study

The Swiss HIV Cohort Study comprises a large majority of all the people diagnosed with HIV in Switzerland. For the purposes of this study, the researches selected a subgroup of 2614 gay men who were diagnosed with HIV and so joined the study between 2000 and 2016. The average length of time men were followed up in the study was nearly nine years and the number of men increased over time, as more were diagnosed than died or dropped out.

Over the cohort as a whole, the proportion of men who said they had ever had nscAI increased from under 20% in 2000 to approximately 60% in 2016. This appeared to be a fairly steady increase, though there was an acceleration in the rate at which men abandoned 100% condom use with non-steady partners after 2008 – the year of the Swiss Statement, the first statement ever publicly issued by researchers about the association between viral undetectability and non-infectiousness.

However, Salazar-Vizcaya emphasised, “Aggregated trends are often over-simplifications”. They therefore used a technique called Hierarchical Agglomerative Clustering to find out whether men clustered into groups that changed behaviour at specific times. This technique, which uses a computer algorithm to generate groups with similarities that are maximal within that group, and minimal between groups, was originally developed by astronomers to sort galaxies into types. The result was a “phylogenetic tree” of behaviour as regards condom use. Phylogenetic trees are more familiar as graphical way of representing genetic differences, but can be used to analyse the degree to which any attribute of individuals within the group is shared by others.

This found that condom usage among about 50% of the men did not change over time. In these individuals, about 25% in any one year reported ever having had condomless anal sex. Note that this actually represents a decrease over time in the frequency of condomless anal sex per individual, because as time goes by, follow-up time increases.

In a second group, comprising 23% of the men, the proportion reporting ever having had nscAI increased steadily from a very low base of about 10% in 2000 to over 90% in 2016. The rate of increase in reported condomless sex took a noticeable turn upwards around 2010.

The other two, smaller groups exhibited much more sudden and dramatic changes in behaviour. In one group, representing 12% of the men, reported nscAI stayed steady at about 10-15% till 2008, then increased steadily to 25% by 2013. After this it took a sudden upward jump to nearly 100% by 2016 – in other words within the space of three years, the situation changed from only one in four of these men answering “yes” to the question “have you ever had condomless anal sex with a non-steady partner?” to nearly all of them answering “yes”.

In the last and smallest group, comprising 9.4% of the men, the situation was even more polarised. This group, numbering roughly 250 men, were historically the most consistent condom users: in any one year only 10% of them reported ever having had nscAI till 2015. Then suddenly, a year later, 95% of them were reported having had nscAI; it was as if this group had, within the space of a single year, taken an en-masse decision to stop using condoms every time.

Further analysis of these groups showed no demographic differences between them in terms of age, ethnicity or education. Only one cluster, the third one, had any distinctive characteristic: its members tended to be more recently diagnosed, with an average date of diagnosis of November 2012 and a quarter of them diagnosed since the mid-2015 (though another quarter were diagnosed before 2005).

Although this is speculative, Luisa Salazar-Vizcaya hypothesised that the second group were people who from 2001 or so onwards were trying to use ‘serosorting’ as a method of avoiding transmitting HIV. An increase in the rate of their reporting nscAI occurred around 2008, the year of the Swiss Statement, as did the first increase in condomless sex reported by group 3. The sudden jump in condomless sex in group 3 happened at around the same time as the first results of the PARTNER study – findings that were widely reported in the gay media. Finally, the sudden increase in condomless sex in group 4 coincides with the publication of the results of the PROUD and IPERGAY pre-exposure prophylaxis (PrEP) studies. Were these men – who had previously been the most consistent condom users – ones who had negative partners who started taking PrEP?

These remain speculations at present, and Salazar-Vizcaya said that qualitative research was needed to discover whether changes in condom use in different men were associated with different findings being publicised.

As a general point, she added, the study showed that it was a mistake to assume homogeneity of behavioural change and therefore of motivations for change in cohorts under study: similar analyses could help to identify how different pieces of knowledge and thought processes influenced different groups, which could lead to more precision and effectiveness when it came to spreading positive health messages.

By Gus Cairns

Reference

Salazar-Vizcaya L et al. Highly Dissimilar Patterns of Sexual Risk Behaviour among HIV-positive Men who Have Sex with Men: Clustering Individual Trajectories in the Swiss HIV Cohort Study from 2000 to 2017. 16th European AIDS Conference, October 25-27, Milan, abstract PS12/1, 2017.

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HIV Outcomes Conference in Brussels – Register Now http://www.eatg.org/news/hiv-outcomes-conference-in-brussels-register-now/ Fri, 03 Nov 2017 17:10:05 +0000 http://www.eatg.org/?post_type=news&p=6649 On behalf of the multi-stakeholder initiative “HIV Outcomes: Beyond viral suppression”, you are warmly invited to attend the launch of the initiative’s recommendations on “Long-term health, well-being, and chronic care for people living with HIV (PLHIV)”, which will take place at the European Parliament in Brussels on 29 November (13:00-15:00).

The HIV Outcomes initiative reflects a widespread conviction among HIV experts and those living with HIV that important issues relating to the long-term health and quality of life of PLHIV currently receive insufficient attention at the policy level. Launched ahead of World AIDS Day on 1 December, the HIV Outcomes recommendations will focus on improving health system responsiveness to these challenges, and the need to strengthen monitoring of health system performance in that context.

The opening part of the meeting will feature patient, clinician and policy perspectives on the above challenges. WHO Europe will discuss how the work of the initiative corresponds to wider health system responses to the increasing burden of chronic disease and comorbidities in Europe. This will be followed by the presentation of the HIV Outcomes initiative recommendations on long-term health, well-being and chronic care for PLHIV, which are intended to inform thinking at the national level.

The second half of the meeting will focus on the need for continued political action on HIV/AIDS.European Commissioner for Health, Vytenis Andriukaitis, will give the keynote address focusing on EU action in relation to HIV/AIDS. He will be followed by Ricardo Baptista Leite, Founding President of UNITE – the Parliamentarians Network to End HIV/AIDS, Viral Hepatitis and Tuberculosis – who will update us on the work and progress of UNITE.

The agenda for the meeting is available here. The event is supported by MEPs Christofer Fjellner from the European People’s Party (Sweden), Eva Kaili from the Socialists and Democrats (Greece) and Gesine Meissner from the Alliance of Liberals and Democrats for Europe (Germany).

This initiative comprises stakeholders from across the HIV community – patients, healthcare professionals, academics and industry (a full list of Steering Group members is provided below). As it is enabled by sponsorship from Gilead Sciences and ViiV Healthcare, the attached principles of engagement contain terms and conditions relating to your participation in this meeting and compliance with relevant industry codes. Please read them carefully.

If you have any questions, please contact us at HIVoutcomes.secretariat@gmail.com. You can also contact Hannah Garrett (secretariat) on +32 2 613 28 28. ]]> The Lancet on U=U http://www.eatg.org/news/the-lancet-on-uu/ Fri, 03 Nov 2017 14:24:08 +0000 http://www.eatg.org/?post_type=news&p=6646 This editorial was published in The Lancet on 4 November 2017. Following previous communications from the CDC of the USA and other scientific sources, The Lancet now also confirms that the evidence is conclusive: People living with HIV who have an undetectable viral load do not transmit the virus through sexual contact. 

The fact that people infected with HIV who are virally suppressed cannot sexually transmit the virus to others is now accepted in the HIV/AIDS community as a result of accumulating evidence since the early 2000s. In early 2016, the Undetectable=Untransmissable (U=U) slogan was launched by the Prevention Access Campaign to promote the finding. The campaign has been rapidly gathering momentum, having been endorsed by more than 400 organisations from 60 different countries since its launch. Last month, the US Centers for Disease Control and Prevention (CDC) joined the movement by endorsing the science in a letter released on National Gay Men’s HIV/AIDS Awareness Day.

The evidence to support the effectiveness of viral suppression in blocking transmission is clear. In addition to some smaller studies done since 2000, three larger studies of sexual HIV transmission in thousands of serodiscordant couples including thousands of acts of sex were done between 2007 and 2016, with, strikingly, not a single case of sexual transmission of HIV from a virally suppressed HIV-positive person to their HIVnegative partner reported. The HPTN 052 trial, the largest study to date, studied 1763 serodiscordant couples (both homosexual and heterosexual) from nine different countries and randomly assigned HIV-positive participants to either early or delayed antiretroviral treatment (ART). Interim results published in 2011 showed that 39 HIV-negative partners had become HIV positive so far, of which 28 were phylogenetically linked (ie, 28 people acquired their infection from their partner). Of these 28, only one occurred in the early ART group. After this analysis, ART was then offered to all patients with HIV and all patients continued to be followed up to 2015, with the final results published in September last year. Over the entire course of the study, 78 infections were observed, of which phylogenetic linkage was established in 72. Of these infections, 46 were linked to the HIV-positive partner, eight of which occurred after the partner commenced antiretroviral therapy. Of these final eight, four occurred before viral suppression and the other four occurred when ART failed to achieve viral suppression. In other words, not one virally suppressed HIV-positive patient transmitted their infection to their partner during the entire study. The PARTNER study, published in July last year, was an observational study of 1166 HIV-serodiscordant couples (also both homosexual and heterosexual) from 14 countries across Europe with more than 58000 instances of unprotected sex reported. Although 11 HIV-negative partners became HIV positive, none of these transmissions were linked. Finally, results of the most recent study, the Opposites Attract study, were presented this July at the 9th International AIDS Society Conference on HIV Science in Paris. This cohort study followed up 358 homosexual men with HIV from three different countries with about 17000 acts of sex taking place. Three new cases of HIV infection were observed but, as expected, none of these infections were linked either. The fact that HIV treatment has advanced to the point that people infected with HIV can live full-length, healthy lives with zero chance of sexually transmitting the virus to others as long as they are on effective ART is a huge success.

Although evidence for this fact has been growing since 2000, it has been slow to influence public perception. However, the U=U campaign, launched just under 2 years ago now, has been directly tasked with tackling this unfortunate public ignorance, and to flying success in its fairly short lifespan to date. The slogan embodies the idea of treatment as prevention. This idea has been around since at least 2010, but since the easy to-grasp U=U slogan has been established, the concept has been firmly pushed into the public sphere and has been a major talking point in the HIV/AIDS community this year. The CDC officially backing the science behind the campaign is another key step towards U=U being the most important message of 2017 in the fight against HIV.

U=U is a simple but hugely important campaign based on a solid foundation of scientific evidence. It has already been successful in influencing public opinion, causing more people with HIV (and their friends and families) to comprehend that they can live long, healthy lives, have children, and never have to worry about passing on their infection to others. The clarity of the message will make it easier to promote the undeniable benefits of treatment, which will encourage more and more people with HIV to seek treatment, bringing the HIV community one step closer to achievement of the UNAIDS’ 90-90-90 target by 2020 and to complete elimination of the entirely unfair and outdated stigma still faced by many people living with HIV today. ■ The Lancet HIV

Download The Lancet editorial here: LANCET U=U 11 2017

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CoPE Call for Applications http://www.eatg.org/news/cope-call-for-applications/ Fri, 03 Nov 2017 09:25:11 +0000 http://www.eatg.org/?post_type=news&p=6645 We are pleased to announce a special CoPE call for hepatitis, addressing the need for access to hepatitis prevention, testing, treatment and care services by co-infected key populations. Please find below detailed information on how to apply for this grant. The submission deadline is Monday 30 November 2017 (23:59 CET).

What is CoPE?
The CoPE project is a funding mechanism that enables the production and translation of patient education materials, brochures and other resources related to HIV/AIDS & co-infections in multiple languages. More information about CoPE can be accessed here: www.eatgtrainingacademy.com/cope.

Who can apply and receive a grant?

Any community-based organisation in the European and Central Asian region dealing with prevention and treatment of HIV/AIDS and co-infections can submit an application to CoPE. The selection is based on the soundness of the proposed project and available funding.

What type of publications are supported?
CoPE supports publications which:

  • Promote necessary, objective, reliable and up-to-date knowledge and skills about HIV/AIDS and co-infections among patients, patient groups, groups at-risk, and healthcare providers;

  • Raise awareness and appreciation of facts and issues related to HIV/AIDS treatment among PLWH (such as women, men who have sex with men, injecting drug users, sex workers, migrant communities and other groups at-risk);

  • Offer objective, scientifically-accurate, high-quality, patient-focused and user-friendly overview and summary of relevant health and treatment information on specific and generic HIV-related topics and issues;

  • Engage, support and empower local HIV-positive community for the preparation and development of necessary and relevant treatment materials.

  • The final format of the resource may be a printed brochure, booklet, handout etc. or an online document/website.

Specific focus for this call
This call is specifically focused on the topic below. Applications dealing with other topics will not be considered during the selection process.

  • Applications addressing the need for access to hepatitis prevention, testing, treatment and care services by co-infected key populations. This includes publications that support the local community in better understanding HCV and HBV as co-infections.  

Application procedure
Please fill in and submit an application form online via this link:
www.eatgtrainingacademy.com/application-form.
Please fill in all the sections of the application form in English. Incomplete applications will not be considered.

Submission Deadline
The deadline for submission is Monday 30 November 2017 (23:59 CET).

Notification of selection outcome
The outcome of your application will be announced five weeks after the submission deadline.

Before applying

  • Map the existing resources in the local language and in English/other languages. An archive of the materials previously funded by CoPE is available here.

  • Define if you would like to translate an existing publication or develop something entirely new.

    • For a translation, ask for authorization from the original author for the use of the material. Specify the eventual changes you would like to make to the original (adapting it to the local context).

    • For a new publication, develop a summary of the main topics and themes covered. Make sure you have access to leading expert(s) in the field who can guarantee the accuracy of the information.

  • Make a detailed cost estimate of the cost of production of the publication, including writing/translating, proofreading, design & layout, printing and dissemination. The estimate should be based on actual quotes from different service providers. Please note that, if accepted, the CoPE grant is paid in two instalments: first 50% when a print-ready document is submitted and the remaining amount upon receipt of financial and narrative reports (incl. copies of all invoices and receipts).

  • Please note that the maximum amount that is available for this call is 1,100 EUR. Applications requesting lower amounts will be considered favourably in the selection process.

  • Make a realistic timeline for the production process. Please note that, if accepted, the project should be finalized within 3 months (for translations) or 6 months (for new publications) from the signing of the grant agreement. The final grant amount may be decreased in case of delay caused by the grantee. Therefore, make sure you and your collaborators are ready to start working instantaneously if your application is approved.

  • Draft a dissemination plan. The publication should be widely promoted (locally, regionally and nationally) via different channels.

Questions:
If you have any questions regarding the CoPE project or the application form please contact Maria Dutarte (EATG Project Manager) at projects@eatg.org.

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World Hepatitis Summit – Declaration of the Hepatitis Community http://www.eatg.org/news/world-hepatitis-summit-declaration-of-the-hepatitis-community/ Thu, 02 Nov 2017 22:52:18 +0000 http://www.eatg.org/?post_type=news&p=6638 The World Hepatitis Summit passed and published the Declaration of the Hepatitis Community “NO ELIMINATION WITHOUT DECRIMINALIZATION!” today. The Declaration calls for the decriminalization of people who use drugs, and the global upscale and support of prevention, harm reduction and treatment services available to them.

It urges states “to remove all barriers to the uptake of the full range of prevention services by people who use drugs by reforming laws, law enforcement procedures and discrimination that hinder access, including the criminalization of minor, non-violent drug offences and to adopt an approach based overwhelmingly on public health promotion, respect for human rights and evidence”.

The consortium of signatories was led by Medecins du Monde, and EATG has also been a member.

Declaration website: http://www.medecinsdumonde.org/en/actualites/hepatite-c/2017/10/31/hepatitis-no-elimination-without-decriminalization

Declaration in French: Hepatitis-declaration-FR

Declaration in English: Hepatitis-declaration-EN

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Report: TB medicine crisis in Romania http://www.eatg.org/news/report-tb-medicine-crisis-in-romania/ Thu, 02 Nov 2017 22:24:16 +0000 http://www.eatg.org/?post_type=news&p=6642

Authorities in Romania are unable to provide the full range of essential medicines needed for the treatment of TB, the Romanian Health Observatory said in its latest report, TB medicine crisis in Romania. While the contagious disease is designated a public health priority in the country, the root cause is “the existence of absurd and self-contradictory legislation and widespread government red tape” that blocks Romanian tuberculosis patients’ access to treatment, it said.

Missing meds: From 28 drugs considered necessary for treatment by the World Health Organization or Romania’s national prevention program, 15 are unavailable or have supply disruptions. One medicine not reimbursed for tuberculosis is reimbursed for HIV. “Practically, patients diagnosed with HIV and TB are more fortunate than patients who have only a diagnosis of tuberculosis,” the report observed. Meanwhile, the fact that only some drugs are available could increase prevalence of multidrug-resistant tuberculosis if patients end up taking an incomplete treatment. With more than 500 new cases of drug-resistant tuberculosis detected annually, Romania has the highest number of cases in the EU but one of the lowest rates of successful management.

At this point, international organizations are providing and co-financing the procurement of essential medicines needed for Romanian TB patients. The international funding will end in the first quarter of 2018. The patients will be left without access to the full course of treatment if the Romanian authorities will not be able to take over the procurement. Currently, the Government of Romania – an European Union member state – is not fulfilling its legal obligations towards TB patients.

A summary of the report in English can be downloaded here.

The full version of the report can be accessed here (in English) and here (in Romanian).

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November 2017 issue of The Lancet HIV now online http://www.eatg.org/news/november-2017-issue-of-the-lancet-hiv-now-online/ Thu, 02 Nov 2017 21:11:45 +0000 http://www.eatg.org/?post_type=news&p=6644 The Lancet HIV is an exclusively online journal dedicated to publishing original research that advocates change in, or illuminates, HIV clinical practice. It publishes translational, epidemiological, clinical, operational, and implementation studies.

The November 2017 issue is available here.

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U=U unites with ITPC to improve the lives of people living with HIV http://www.eatg.org/news/uu-unites-with-itpc-to-improve-the-lives-of-people-living-with-hiv/ Wed, 01 Nov 2017 22:59:30 +0000 http://www.eatg.org/?post_type=news&p=6636 GABORONE, Botswana – Nov 1, 2017 – The International Treatment Preparedness Coalition (ITPC) and Prevention Access Campaign (PAC) announced today a groundbreaking partnership that will amplify the Undetectable=Untransmittable (U=U) message among communities of people living with HIV worldwide.

U=U reinforces the public health benefits of antiretroviral therapy (ART), affirming that a person living with HIV on ART with an undetectable viral load cannot sexually transmit HIV. The growing campaign has already been endorsed by more than 450 community partners in 65 countries, and the U=U science confirmed by leading public health bodies including UNAIDS, the U.S. Centers for Disease Control and Prevention (CDC), the European Centers for Disease Control and Prevention (ECDC), and the International AIDS Society (IAS).

When people in power, like U.S. House Representative Betty Price, are still asking in 2017, if there are ‘any methods, legally, that we could use that would curtail the spread [of HIV]?’ the answer is a bold YES! – provide the medicine needed to be undetectable. This partnership is timely and critical; there is no question that communities should know the science behind what U=U means. This knowledge alone can be life-changing – not only for people living with HIV, but their families, friends, and loved ones,” said Solange Baptiste, ITPC Executive Director.

The collaboration builds on the work of both organizations and will equip activists across the globe to integrate U=U into their on-going advocacy efforts to improve access to optimal HIV treatment. The partnership will enable the U=U message to better reach and be utilized by those who it concerns most: communities.

“The ITPC team and those of us who are a part of the U=U campaign share the same belief in international solidarity among people living with and affected by HIV,” said Bruce Richman, Executive Director of PAC. “With its roots in the Global South and an internationally recognized track record for capacity building and community engagement, ITPC is the ideal implementing partner to empower communities with U=U knowledge and strategies in accurate and meaningful ways.”

The partnership will work in parallel with PAC’s existing partnership with the International Association of Providers of AIDS Care (IAPAC), focused on providing U=U training and education for clinical and allied health professionals to integrate into clinical practice in specialized and primary care settings.

* * *

A copy of this press release (PDF) is available here.

Note: An undetectable viral load is typically under 40 copies/ml depending on the diagnostic tests. However, studies show a person living with HIV on antiretroviral therapy (ART) with a viral load of 200 copies/ml or less also cannot sexually transmit HIV. This is called being “virally suppressed.” For the purposes of the U=U campaign and any Prevention Access Campaign materials, the term “undetectable” is used synonymously with the term “virally suppressed,” meaning a person living with HIV with a viral load of 200 copies/ml or less cannot transmit HIV.

About ITPC Global

The International Treatment Preparedness Coalition (ITPC) is a worldwide coalition of people living with HIV and community advocates working to achieve universal access to optimal HIV treatment of those in need. Formed in 2003 by a group of 125 HIV activists from 65 countries at a meeting in Cape Town, South Africa, ITPC actively advocates for treatment access in eight regions across the globe. ITPC believes that the fight for HIV treatment remains one of the most significant global social justice issues. For more information about ITPC, please visit www.itpcglobal.com.

About the Prevention Access Campaign

The Prevention Access Campaign’s Undetectable = Untransmittable (U=U) campaign is an international community of HIV advocates, activists, researchers, and over 450 community partners from more than 65 countries uniting to disseminate the scientifically supported message that people living with HIV who are on effective antiretroviral therapy with an undetectable viral load do not sexually transmit HIV.  For more information about the Prevention Access Campaign, please visit www.preventionaccess.org.

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Survey of dating app users finds that PrEP usage has not increased in Europe in the last year http://www.eatg.org/news/survey-of-dating-app-users-finds-that-prep-usage-has-not-increased-in-europe-in-the-last-year/ Wed, 01 Nov 2017 22:55:28 +0000 http://www.eatg.org/?post_type=news&p=6635

A study of men who have sex with men (MSM) conducted by the European Centre for Disease Control and Prevention (ECDC) in collaboration with the gay contact site Hornet has found that PrEP usage has not increased, on average, among its respondents over the proportion reported last year, when a similar survey was made.

The results were presented recently at the 16th European AIDS Conference.

It found that 10% of its respondents were currently taking PrEP, though this varied from hardly any in some countries to 17% in the case of Ukraine.

Other countries where higher numbers of respondents were taking PrEP included Turkey (16%) and Sweden (15%). The proportion in the UK was the survey average, 10%, with no increase since last year.

Although PrEP usage in France was 11% and Russia was 8%, there were a large number of French and Russian replies so numerically, French PrEP users represented 27% of all those reporting PrEP use and Russians 18%.

The ECDC’s Teymur Noori told the conference that the survey ran for a month in July and August 2017. Altogether 12,053 men responded, with replies from every one of the 55 countries of the WHO European region.

Noori prefaced the survey by noting that although HIV infections among MSM were starting to fall in some countries, the annual number of new HIV diagnoses in MSM had risen by 16% in the last decade throughout the European Union and European Economic Area (EU/EEA: this excludes most of the former Soviet states). Diagnoses in all other groups has fallen.

Although PrEP was slowly being introduced in more countries, progress was slow, Noori said. The cost of PrEP was overwhelmingly cited as the main barrier to adopting it, with two-thirds of 36 nations in the EU/EEA mentioning cost as a principal barrier. In the face of national health systems’ unwillingness to spend on PrEP, the survey provided evidence that MSM throughout the European region were attempting to access it in other ways.

France and Russia drew the most responses to the survey, with nearly half of survey respondents coming from these two countries (23% each). The other three countries in the ‘top five’ of responses were the UK (13%), Italy (8%) and Turkey (6%).

Participants were generally young; 75% were under 40 and 28% under 25. Eleven per cent of participants had HIV, the same as in the last survey (ranging from 19% in Portugal to 7% in the UK) and 9% said they did not know their HIV status. These were excluded from the analysis of answers about PrEP. This left 10,038 men who said they were sure they were HIV-negative, of whom 1056 said they were currently taking PrEP.

Of these, roughly a third each said they had it prescribed by their doctor (36%) or bought it online (32%). The 27% of French respondents on PrEP represented the majority who said they had it prescribed; Noori said the other 9% would be partly due to new rollout programmes in other countries and partly due to physicians prescribing off-label generic PrEP in the mainly eastern countries where Truvada is not patented.

Thirteen per cent of respondents said they received PrEP as part of a study, another 13% acquired it from friends, and 5% said they got it by requesting PEP (post-exposure prophylaxis). This meant that roughly half the respondents were accessing PrEP from physicians and half were getting hold of it informally. Incidentally, 48% of those currently on PrEP said they had received PEP during the last year, indicating that it may be a ‘gateway’ to PrEP use.

One-third said their doctor did not know they were taking PrEP and thus must be presumed not to be receiving adequate medical monitoring.

Unsurprisingly 85% of those currently on PrEP (621 respondents) said they intended to continue taking it within the next year. In contrast only 22% of those not on PrEP said they were likely to start during the year (1969 respondents), and they were outnumbered by 35% (N=3132) who said they would definitely not take it in the next year.

People taking PrEP were in the main getting tested regularly for sexually transmitted infections (STIs); 87% (690 respondents) had had an STI checkup in the last year and 48% of them (N=277) had been diagnosed with an STI. STI checking was pretty high in respondents not on PrEP too, with 69% (8613 men) saying they had had an STI checkup during the year and 17% (N=975) diagnosed with an STI.

Use of sex-associated ‘Chemsex’ drugs (mephedrone, GHB/GBL, ketamine, methamphetamine) within the last three months was reported by 28% of PrEP users (N=190) but only 5% of non-users (N=425).

Noori commented that these figures showed that PrEP was largely being accessed by the people who needed it most, namely those at the highest risk of HIV.

One interesting finding was that PrEP users were generally happier with their sex lives, possibly, Noori commented, due to lower rates of anxiety. Seventy-six per cent of PrEP users were happy with their sex life and only 10% unhappy: in contrast 54% of non-users were happy and 28% unhappy.

Noori concluded by noting that formal PrEP roll-out is still slow in the European region; that there was evidence of significant informal PrEP use across European countries; and that a significant number of men using PrEP informally are still doing so without informing their sexual health providers.

By Gus Cairns

Reference

Noori T et al. The use, and willingness to use, PrEP among men who have sex with men in Europe: Results from a 2017 Hornet/ECDC Survey. 16th European AIDS Conference, Milan. Abstract 12/4. 2017.

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Global progress towards hepatitis C elimination still blocked by cost of treatment, lack of diagnosis http://www.eatg.org/news/global-progress-towards-hepatitis-c-elimination-still-blocked-by-cost-of-treatment-lack-of-diagnosis/ Wed, 01 Nov 2017 22:50:10 +0000 http://www.eatg.org/?post_type=news&p=6625

Nine countries — Australia, Brazil, Egypt, Georgia, Germany, Iceland, Japan, the Netherlands and Qatar — are on course to eliminate hepatitis C by 2030, according to data released at the World Hepatitis Summit in São Paulo, Brazil, this week.

The World Health Organization’s elimination target challenges countries to aim for a 90% reduction of new hepatitis B and C infections and a 65% reduction in hepatitis B and C related mortality by 2030.

Estimates presented by the Polaris Observatory, developed from all available national data, show a stark contrast in progress towards HCV elimination in two of the world’s wealthiest countries, Australia and the United States.

Low awareness and barriers to care in the United States

According to the Polaris Observatory estimates just over half of people with hepatitis C in the United States are aware of their infection. Although rates of diagnosis are high in New York state (81%) and California (71%), other states are doing less well, and the United States is also experiencing a sharp increase in new hepatitis C infections in young adults and adolescents as a result of sharing of injecting equipment.

In 2015, the USA treated around 256,000 patients and some 230,000 in 2016. Polaris’s latest projections suggest that without new initiatives to boost treatment and diagnosis rates the annual number treated across the USA will fall to just 130,000 per year by 2020. To reach the WHO 2030 elimination target, treatment levels must be sustained at 250,000 per year leading up to 2030. The USA is also unlikely to meet the targets set out in its own national plan, some of which are even more ambitious – such as a 60% fall in both hepatitis B and hepatitis C new infections by 2020.

In two thirds of states, treatment on Medicaid programs has been restricted to people with advanced disease, preventing treatment access for those without private insurance. However, the outlook is not entirely bleak — recent developments have meant the approval of new and cheaper hepatitis C drugs, which can be used to treat all types of the virus (genotypes 1-6), requiring just 8 weeks of treatment to achieve cure.

These lower prices are allowing states such as Delaware, which previously restricted treatment to the sickest patients, to open up Medicaid coverage to all hepatitis C patients from January 2018. Delaware joins 16 other states (including Alaska and Georgia) that will open up restrictions (or never had them).

At the recent Liver Meeting in Washington, DC (October 28) all states and Puerto Rico were graded on how easy it is to obtain Medicaid treatment for hepatitis C. States receiving the best grade of A were Alaska, Connecticut, Massachusetts, Nevada, and Washington. States that received an “F”, the worst grade, were Arkansas, Louisiana, Montana, Oregon, and South Dakota.

Australia

The Australian government responded to the call for universal access to the hepatitis C DAAs with an AUS $1billion dollar investment over 5 years. This risk-sharing agreement with pharmaceutical companies provides government-funded treatment to all adults without restriction and has paved the way for the elimination of hepatitis C by 2030. More than 30,000 patients with hepatitis C were treated and cured in 2016.

Following this agreement, huge numbers of people came forward for treatment immediately (some 5,000 in March 2016 alone). However, the number treated each month has steadily declined, from over 5,000 in March 2016 to less than 2,500 in March 2017, with signs the number will decrease further still.  The Polaris estimate shows that Australia must treat around 20,000 patients with hepatitis C per year to reach the WHO elimination target it endorsed (a reduction of new hepatitis B and C infections by 90% and mortality by 65% by 2030). Polaris predicts annual treatment numbers for HCV could fall to 14,000 by 2018.

“Australia set off at a cracking pace on the journey to elimination of hepatitis C due to our unrestricted and easy access to treatment,” says Helen Tyrell, Chief Executive Officer, Hepatitis Australia. “From March 2016, when the cures became available, to December of that year around 14% of all people living with hepatitis C commenced treatment. However, the pace has slowed dramatically over time.”

She adds: “Worryingly, the latest estimates from the Polaris Observatory should be taken as a clear warning that the elimination of hepatitis C is unlikely to be achieved by 2030 if we continue ‘business as usual’. What we need now is a rapid scale up of a suite of programs to help connect all people with hepatitis C to the new cures while also continuing to prioritise evidence-based prevention. Provided Australia invests in this work and maintains a strong partnership approach across government, the community, clinicians and researchers, we can reach the goal of elimination of hepatitis C by 2030.”

By Keith Alcorn

 

Read also:

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Countries risk ‘running out’ of hepatitis C patients to treat, says World Hepatitis Alliance http://www.eatg.org/news/countries-risk-running-out-of-hepatitis-c-patients-to-treat-says-world-hepatitis-alliance/ Wed, 01 Nov 2017 22:45:52 +0000 http://www.eatg.org/?post_type=news&p=6630 The latest data on the global hepatitis C epidemic, released at the World Hepatitis Summit in Sao Paulo, Brazil (1-3 November) reveal that most countries (especially high-income countries) are running out of patients to treat because of the low diagnosis rates worldwide.

Globally, just one in five patients with hepatitis C knows they are infected (14 million out of 69 million). The proportion ranges from 44% across high-income countries down to just 9% across low-income countries. And while a record 1.76 million people with hepatitis C were treated in 2016, countries cannot hope to achieve elimination without boosting diagnosis rates.

“Hepatitis C is a silent killer and there are nearly 70 million people worldwide who need treatment, but we must find them,” said Charles Gore, President of the World Hepatitis Alliance. “Yet, because of the historic lack of national and international investment in viral hepatitis programmes, the vast majority of patients with hepatitis C – some 80% –remain undiagnosed, and less than 5% are able to access treatment.”

The data, released by the CDA Foundation’s Polaris Observatory* (led by Dr Homie Razavi in Lafayette, CO, USA), show that new diagnoses of hepatitis C must triple from 1.5 million to 4.5 million each year and treatment rates from 1.76 million to 5 million in order achieve WHO’s elimination targets by 2030.

“We have the right to know if we are living with a cancer-causing virus” said Raquel Peck, CEO of World Hepatitis Alliance. “In addition to the need for people to be diagnosed to access treatment, a high proportion of the 1.5 million new hepatitis C infections last year could have been avoided if people were aware of their health status.”

To confront this challenge a number of countries are using innovative strategies to improve their diagnosis rates, from testing at dental appointments and in hospital emergency rooms to screening entire villages, alongside offering financial incentives.

In Egypt, the entire village of El Othmanya (population 3,500 people) was screened, with 215 cases of hepatitis C detected. So far, this same methodology has now been extended to 50 villages in 26 regions of Egypt, as the country targets screening 30 million of its 90 million population by the end of 2018.

In New Zealand’s remote Northland region, the local health board provided NZ$300 to general practices for each patient successfully diagnosed and treated for hepatitis C infection, allowing them to waive the co-payment fees that patients are required to pay for doctors’ appointments. The New Zealand government has also recently announced a nationwide programme to pay the medical transport costs of all people with hepatitis C.

In Chicago, USA, Mount Sinai Hospital ran a program up to March 2017 that automatically screened any patient over 16 years entering the emergency department and needing blood tests. This resulted in a diagnosis of nearly 200 patients with hepatitis C in the six-month program.

Emergency room screening is also helping detect some 70% of new cases in the Cherokee Nation American Indian Tribe in Oklahoma, USA, which has its own elimination plan. All patients visiting the doctor or the dentist are also offered a test for hepatitis C.

“Only with a combination of political will, increased access to diagnostics and greater awareness of the disease can we vastly improve diagnosis rates,” says Dr Razavi. “Unless we crack this diagnosis challenge, the ambitious elimination targets for hepatitis set by WHO will remain out of reach for decades to come.”

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UK elimination of hepatitis C in jeopardy unless more patients found http://www.eatg.org/news/uk-elimination-of-hepatitis-c-in-jeopardy-unless-more-patients-found/ Wed, 01 Nov 2017 22:40:19 +0000 http://www.eatg.org/?post_type=news&p=6624 New data show that more than 100,000 people living with hepatitis C in the UK are undiagnosed

Just one in three people with hepatitis C in the United Kingdom have been diagnosed according to the latest estimates released at this year’s World Hepatitis Summit in São Paulo, Brazil (1-3 November).

The estimate comes from a global synthesis of data on hepatitis C prevalence and diagnosis carried out by the Polaris Observatory, led by Dr Homie Razavi. The Polaris Observatory study shows that out of an estimated 162,000 people living with hepatitis C in the UK, only 62,200 (38%) are diagnosed.

“Even these numbers overestimate how many people are available for treatment because the majority of the ‘diagnosed’ are not in touch with services for a variety of reasons”, says Charles Gore, CEO of the national hepatitis C charity, The Hepatitis C Trust, and also President of the World Hepatitis Alliance.

“Many were diagnosed years ago. They were never informed how deadly hepatitis C can be and they do not know about the new drugs and how extraordinarily effective and easy to take they are.”

The poor rates of diagnosis in the United Kingdom call into question the possibility of achieving the World Health Organization target of hepatitis CV elimination by 2030, according to Dr Razavi.

“To make the 2030 elimination target, at least 10,000 patients need to be treated each year, and there are already signs that it is becoming harder to find diagnosed patients to treat” said Dr Razavi. “Although in 2016 some 10,000 people were treated and in 2017 this could reach 12,500, the projections suggest the annual total will drop to an estimated 5,000 patients treated per year by 2020 without better diagnosis and linkage to care.”

When direct-acting antivirals were introduced in the United Kingdom treatment was tightly rationed in order to contain costs. As a result of large price reductions negotiated with pharmaceutical companies it has been possible to expand the number of people treated, but according to the World Hepatitis Alliance, some areas are already running out of patients to treat. Having vetoed 2 years ago a Hepatitis C Improvement Framework designed to improve diagnosis and linkage to care, the NHS is now scrabbling to put in place initiatives to do just that.

According to Public Health England’s most recent report on hepatitis C, the number of tests carried out for hepatitis increased by around 20-25% between 2011 and 2015. Public Health England suggests that the World Health Organization’s European target of diagnosing 50% of people with hepatitis C by 2020 has already been met in England and Wales, and points to a high rate of testing among people who have ever injected drugs, the group with the highest HCV prevalence in England and Wales.

But, although HCVB prevalence is high among people who have injected drugs, anyone exposed to blood in the past could be infected. People who received blood transfusions or blood products prior to the introduction of screening in the United Kingdom in 1992, and people who have received blood or undergone medical procedures in countries with lower infection control standards, could be living with undiagnosed hepatitis C.

“We have at least 100,000 people to find,” says Charles Gore. “If we don’t find them, not only will we never reach the goal of elimination, but significant numbers will die. To be honest, with these new drugs available, if anyone dies of hepatitis C, it should be viewed as an appalling failure of the system.”

By Keith Alcorn

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Tenofovir prodrug goes head to head against abacavir in HIV http://www.eatg.org/news/tenofovir-prodrug-goes-head-to-head-against-abacavir-in-hiv/ Wed, 01 Nov 2017 22:35:21 +0000 http://www.eatg.org/?post_type=news&p=6626 MILAN — When the new tenofovir alafenamide prodrug is added to emtricitabine, viral suppression is as good as it is with abacavir plus lamivudine, and bone and renal safety are similar, new research shows.

So far, the prodrug has not been associated with cardiovascular risks, as abacavir was in the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) study; however, long-term studies have not been completed.

“The message here is not that everyone should switch their patients from abacavir to tenofovir alafenamide,” said Alan Winston, MD, from Imperial College London.

“This is now an evidence base for another option. And you’ve still got a triple antiretroviral regimen,” he told Medscape Medical News.

Dr Winston presented 48-week data here at the 16th European AIDS Conference, although the patients will be followed for 96 weeks. The findings add to the body of evidence that tenofovir alafenamide is a meaningful nucleoside backbone for aging people living with HIV.

The Same or Better?

Many studies have already found that the prodrug is superior to the older tenofovir disoproxil fumarate formulation, Dr Winston reported.

“When you switch from tenofovir disoproxil fumarate to many other agents, we see improvement in renal and bone markers,” he told the audience. But “is there still a renal or bone signal in tenofovir alafenamide, just not as pronounced as with tenofovir disoproxil fumarate? Or is tenofovir alafenamide actually quite clean when it comes to bone and renal signals?”

To examine the issue, Dr Winston and his colleagues randomized 500 adults with HIV who were being treated with abacavir and lamivudine plus another agent to stay on their current regimen or to switch to tenofovir alafenamide plus emtricitabine but continue with their third agent.

Because the abacavir and lamivudine combination is well known and considered to be “clean” of renal and bone toxicity, it is a good comparator with which to test the safety of tenofovir alafenamide, Dr Winston explained.

The patient population was older — median age was 52 years — and largely white and male. The prevalence of comorbidities, similar in the two groups, was high: 47% of the patients had hyperlipidemia, 39% had hypertension, 12% had diabetes, and 6% had cardiovascular disease.

Fewer patients in the switch group than in the nonswitch group achieved viral suppression — an HIV RNA viral load below 50 copies/mL — although the difference was not significant (90% vs 93%). It is also within the 4% noninferiority threshold specified by the US Food and Drug Administration.

Resistance rates were identical in the switch and nonswitch groups, and rates of discontinuation were similar (4% vs 3%).

“I’ll remind you that this is a double-blind study, and in the abacavir–lamivudine arm, these individuals have been on that regimen for a median of 8 years,” he pointed out. “So it’s quite reassuring that we aren’t seeing high rates of discontinuation in the interventional arm.”

The majority of adverse events were nasopharyngitis, upper respiratory tract infection, diarrhea, and headache. However, some adverse events in the switch group were deemed to be related to tenofovir alafenamide, including elevated blood creatinine, anxiety, and blurred vision.

Importantly, no participant in either treatment group experienced proximal renal tubulopathy. And renal, bone mineral density, and lipid changes were similar in the two groups.

A Question About Lipids

This last measure “intrigued” Peter Reiss, MD, from the Academic Medical Center in Amsterdam. A previous study showed a bump in total cholesterol when patients switched from the older tenofovir to tenofovir alafenamide, which left physicians wondering whether tenofovir alafenamide itself is associated with dyslipidemia, he explained.

“This study confirms that that effect is actually the withdrawal of tenofovir, which reduces lipids; when you take it away, they go up,” he said. So “what do we do with people with dyslipidemia?’ You can still switch them to tenofovir alafenamide, but you may want to give them a statin or another lipid-lowering agent.”

The results drew animated reactions from the audience, with clinicians asking for a subanalysis of the 40% of participants who had taken the older tenofovir previously (reasons for initial switch were unknown), and for more details about the renal changes. And, as with any new drug, there were questions about cost.

“In Spain, the cost of abacavir–lamivudine is about €500. Tenofovir alafenamide–emtricitabine is more than €4000,” one member of the audience reported. “After your research, do you think there’s any reason to change any patients from abacavir to the much more expensive therapy with tenofovir alafenamide?” he asked.

That is a really good question, Dr Winston replied.

“I don’t think these data say we should go back and switch everyone’s antiretroviral therapy,” he emphasized. “I think these data say that, for individuals on abacavir and lamivudine, if you are worried about toxicity, or if the patient is getting older and you’re worried about cardiovascular disease, then this is another option, with data behind it.”

This study was funded by Gilead Sciences. Dr Winston reports financial relationships with Abbott/AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Janssen Cilag, Roche, Pfizer, and ViiV Healthcare. Dr Reiss has disclosed no relevant financial relationships.

16th European AIDS Conference: Abstract PS8/4. Presented October 27, 2017.

By Heather Boerner

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Strong maternal antibodies for HIV ineffective for protecting infants from HIV http://www.eatg.org/news/strong-maternal-antibodies-for-hiv-ineffective-for-protecting-infants-from-hiv/ Wed, 01 Nov 2017 22:30:40 +0000 http://www.eatg.org/?post_type=news&p=6632 Researchers caution against using antibodies to prevent transmission

HIV+ mothers who possess a strong neutralizing antibody response may be more likely to pass the virus on to her infant through breast feeding. In addition, infants born to mothers with a strong antibody response are significantly more likely to have a serious illness or death, regardless of whether or not they acquire the virus.

The study, published in the journal mBio, appears to question conventional wisdom that passive immunization with neutralizing antibodies (nAbs) may help prevent HIV transmission from mother to child.

A significant number of infants acquire HIV-1 through their infected mother’s breast milk.

Researchers compared plasma antibodies from Malawian mother-infant pairs who transmitted HIV-1 subtype C through breastfeeding and those that did not. The two groups were matched on timing of blood sample collection after birth to ensure mothers exclusively breastfed for the same amount of time in both groups. The groups also were matched on maternal viral load and CD4 T cell counts (which are clinical factors known to effect transmission). Importantly, pre-existing plasma antibodies were sampled prior to the time of estimated transmission which is most analogous to examining the efficacy of envisioned vaccine and passive immunization strategies.

“We found that infants who escaped infection did not possess antibodies that were more effective at neutralizing a global panel of viruses or their maternal variants compared to infants that acquired HIV. Importantly, we did find that mothers who transmitted the virus to their infant were significantly more likely to have a broad and potent neutralizing antibody response and possibly a stronger response against their own virus. In addition, infants born to mothers with a broad and potent antibody response were more than three times as likely to have serious illness or death post-partum,” explained corresponding author Manish Sagar, MD, associate professor of medicine at Boston University School of Medicine (BUSM).

According to the researchers this study is important because despite the effectiveness of anti-retrovirals, 160,000 infants were infected with HIV from their mother in 2016. “Currently, there is a lot of focus on the use of antibodies transferred passively or through a vaccine to prevent infection in infants, however this study cautions against that and suggests that broadly neutralizing antibodies may actually aid in enhancing transmission from mother to child,” added Sagar, an attending physician in infectious diseases at Boston Medical Center.

The researchers hope these findings will elicit a sense of caution in future HIV clinical trials set out to use antibodies for prevention, especially in the mother-to-child setting. “This study finds that not only are antibodies not effective at preventing transmission they may adversely influence both frequency of breast milk transmission and subsequent infant morbidity.

Journal Reference:

  1. Melissa Ghulam-Smith, Alex Olson, Laura F. White, Charles S. Chasela, Sascha R. Ellington, Athena P. Kourtis, Denise J. Jamieson, Gerald Tegha, Charles M. van der Horst, Manish Sagar. Maternal but Not Infant Anti-HIV-1 Neutralizing Antibody Response Associates with Enhanced Transmission and Infant Morbidity. mBio, 2017; 8 (5): e01373-17 DOI: 10.1128/mBio.01373-17
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Gene discovery in monkeys could shed light on defense against HIV http://www.eatg.org/news/gene-discovery-in-monkeys-could-shed-light-on-defense-against-hiv/ Wed, 01 Nov 2017 22:25:22 +0000 http://www.eatg.org/?post_type=news&p=6634 Vervet monkeys found in Africa and the Caribbean are the most abundant natural hosts of the simian immunodeficiency virus (SIV), a close relative of HIV/AIDS.

Unlike humans with HIV however, vervets infected with SIV rarely get sick with simian AIDS.

In a new study, a research group that includes UWM anthropologist Trudy Turner found that the animals’ curious tolerance comes from evolution that has favored certain genes in their DNA.

This discovery of a possible defense mechanism against the virus, described in a paper published Oct. 30 in Nature Genetics, could offer clues for developing new treatments for HIV/AIDS and could inform the future evolution of genes involved in HIV.

Vervet monkeys, also called African green monkeys, have long been used as biomedical models for a variety of human diseases.

While it’s a long way from monkeys to humans, Turner said, this work has comparative value. For example, it could help scientists determine whether HIV and SIV share a common ancestry, as some research has suggested.

Among the researchers’ findings is that selection occurred in the animals’ genes that regulate viruses, rather than fight them. And genes that govern progression of immunodeficiency were highly selected.

The team’s sampling strategy was designed to investigate the selection of genes across a diverse group of the monkeys from sub-Saharan Africa to the Caribbean.

“The diversity of the sample was important so that we could determine how widespread the evolutionary selection is from a large geographical area,” said Turner, professor of biological anthropology.

The animals’ tolerance for SIV was the main reason an international consortium of scientists who study the monkeys formed in 2009. The consortium had the whole genome sequenced in 2015, opening up new lines of inquiry.

“We trapped and released 2,000 animals and looked at all sorts of biological questions from that,” said Turner, who directed the African fieldwork operations. “But the hot part of it was the relationship that showed up between some of the genes and SIV.”

The group’s discovery of genomic adaptation to viruses agrees with recent evidence that viruses played a major role in the evolution of proteins, which carry out all the functions of life, in mammals.

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Marijuana use associated with cognitive dysfunction in people with HIV who have substance abuse disorder, study finds http://www.eatg.org/news/marijuana-use-associated-with-cognitive-dysfunction-in-people-with-hiv-who-have-substance-abuse-disorder-study-finds/ Wed, 01 Nov 2017 21:49:51 +0000 http://www.eatg.org/?post_type=news&p=6633 Marijuana use is associated with cognitive dysfunction in people with HIV infection who have an alcohol or other drug use disorder, according to a new study from researchers at Boston University School of Public Health (BUSPH), Boston University School of Medicine (BUSM), and Boston Medical Center (BMC).

While researchers did not detect effects of lifetime cumulative exposure, the study, published in Substance Abuse, showed that more frequent current marijuana use was associated with a measure of cognitive dysfunction on the Medical Outcomes Study HIV Health Survey cognitive function scale.

“People with HIV infection have many reasons to have cognitive dysfunction, from the virus itself to medications for HIV infection and related conditions, particularly as they age,” said co-author Richard Saitz, professor and chair of community health sciences at BUSPH, who served as principal investigator on the study. “They also have symptoms like chronic pain and mental health symptoms, and use of marijuana, medically or recreationally, may seem like an option to consider. But at least among people with substance use disorders, it appears to have detrimental effects on cognitive function.”

Substance use and substance use disorder are disproportionally common among people living with HIV (PLWH) — estimated at 40 percent to 74 percent. As PLWH are successfully treated for their infections and are now getting older, information about how alcohol and marijuana might affect their symptoms and physical function is critical to their continued health. Aging with HIV infection is associated with many of the same comorbid health conditions that occur in people without HIV infection. These include cardiovascular diseases and dementia, both of which can be affected by substance use.

“Few, if any, studies have examined the combined effects that alcohol use and marijuana use may have on cognition in PLWH,” the authors wrote. “Such an understanding could contribute to efforts to reduce harmful substance use and prevent clinical consequences, particularly in an era in which ‘moderate’ drinking is at times discussed in terms of possible beneficial effects, and in which marijuana is discussed as a relatively safe and even therapeutic substance.”

The researchers conducted cross-sectional regression analyses on 215 HIV-infected adults diagnosed with substance disorder, based on the current Diagnostic and Statistical Manual of Mental Disorders (fourth edition). Participants were part of the Boston Alcohol Research Collaboration on HIV/AIDS cohort, 18 years or older, and had current alcohol or other drug dependence. The study included measures of both current and lifetime alcohol and marijuana use.

There were no effects detected of alcohol or past marijuana exposure on cognitive function, nor did there appear to be any evidence for synergistic effects on cognition. Furthermore, neither alcohol nor marijuana appeared to affect simple tests of memory or attention. The authors postulated that such effects were not detected, even though they are expected at the least with heavy alcohol use, because of multiple other exposures and comorbid health conditions that participants had.

The study was led by Sara Lorkiewicz, who earned her Master of Medical Science at BUSM and is currently a doctoral student at Palo Alto University. The other authors were: Alicia Ventura, director of operations and special projects at BMC; Timothy Heeren, professor of biostatistics at BUSPH; Michael R. Winter, associate director of the Data Coordinating Center at BUSPH; Alexander Y. Walley, associate professor of medicine at Boston University; Meg Sullivan, clinical director of HIV services at Boston Medical Center; and Jeffrey Samet, professor of community health sciences at BUSPH.

Journal Reference:

  1. Sara A. Lorkiewicz, Alicia S. Ventura, Timothy C. Heeren, Michael R. Winter, Alexander Y. Walley, Meg Sullivan, Jeffrey H. Samet, Richard Saitz. Lifetime Marijuana and Alcohol Use, and Cognitive Dysfunction in People with Human Immunodeficiency Virus Infection. Substance Abuse, 2017; DOI: 10.1080/08897077.2017.1391925
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Genetic Immunity developing next generation of DNA vaccine platform for HIV therapy, various cancers http://www.eatg.org/news/genetic-immunity-developing-next-generation-of-dna-vaccine-platform-for-hiv-therapy-various-cancers/ Wed, 01 Nov 2017 19:54:57 +0000 http://www.eatg.org/?post_type=news&p=6627 Genetic Immunity, a US clinical stage biotechnology company, is developing DermaVir, a nanomedicine lead product candidate for the treatment of HIV and other chronic diseases. The company is looking for financial partners that can help offset the costs associated with the Breakthrough Therapy Designation submission to the FDA.

Genetic Immunity, a US clinical stage biotechnology company, is developing DermaVir, a nanomedicine lead product candidate for the treatment of HIV.

“DermaVir is the next generation of plasmid DNA-based vaccine for the treatment of chronic diseases,” said Viktor Rozsnyay, CEO of Genetic Immunity. “Based on FDA classification, it is a combination of a new biologic product DermaVir and our new medical device DermaPrep.”

DermaVir contains a novel plasmid DNA that encodes most HIV genes, administered topically using the DermaPrep medical device.

‘Proof of concept’ for the immunological and antiviral activities of DermаVir was demonstrated in infected macaques, some of them with advanced stages of AIDS. Analysis of data derived from these animal trials showed that repeated DermaVir administration resulted in a cumulative strengthening of the antiviral immune response without adding significant toxicities or adverse effects.

Plasmid DNA-based vaccines have been proven safe, but poorly immunogenic, in human subjects. Genetic Immunity has developed several technologies to improve the immunogenicity of DNA-encoded antigens, including:

  • Antigeneering of plasmid DNA to safely and authentically express most of the antigens of HIV or other pathogens.
  • The formulation of plasmid DNA to a pathogen-like nanoparticle called NanoComp. These nanoparticles target professional antigen-presenting cells, such as Langerhans cells and dendritic cells.
  • A targeted transdermal delivery device called DermaPrep. It has been shown that topical DermaPrep administration results in antigen expression in the lymph.

“Following successful preclinical studies, we completed a Phase I, Phase I/II, conducted by the IDS Clinical Trials Group and funded by the National Institutes of Health in the USA, and a Phase II trial,” continued Rozsnyay.

“In these studies, we successfully demonstrated that DermaVir immunization induces new, HIV-specific memory T-cells that correlated to the amount of nanomedicine the subject received. Our data to date supports proof of concept, the relationship between DermaVir-induced antiviral immune responses and clinical benefit.”

Based on these results, Genetic Immunity believes that DermaVir would bring significant benefit to HIV patients worldwide.

“As our first step towards a marketed product we applied for Breakthrough Therapy Designation with the FDA, and received regulatory feedback and a request for additional information. To supply this information, we are looking for financial partners that can help offset the costs associated with the submission,” concluded Rozsnyay.

According to the WHO, there were 36.7 million people living with HIV/AIDS, and one million deaths of HIV-related illnesses, in 2016 worldwide.

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Only half of people in USA living with curable cancer-causing disease are aware http://www.eatg.org/news/only-half-of-people-in-usa-living-with-curable-cancer-causing-disease-are-aware/ Wed, 01 Nov 2017 19:34:51 +0000 http://www.eatg.org/?post_type=news&p=6631 New data released at this year’s World Hepatitis Summit in Sao Paulo, Brazil (1-3 November) show that out of an estimated 2.7 million (1) people now living with hepatitis C in the US, only just over half (55%) are aware, contributing to increasing infection rates and poor treatment outcomes. This means that the US is very unlikely to meet either the WHO hepatitis elimination target* or its own national targets set out in the National Viral Hepatitis Action Plan 2017-2020 (2).

Hepatitis C is a ‘silent killer’, accounting for around 23,000 deaths across the US in 2016, a figure that is rising each year. In 2007, mortality related to hepatitis C surpassed that of HIV in the US; and since 2012, hepatitis C-related deaths have surpassed deaths from all the other 60 nationally reportable infectious diseases combined. Only half of people living with the disease are aware of their condition, largely due to the disease being mostly asymptomatic and the lack of routine screening. The result for many is a missed opportunity to access the highly effective cures that can stop them succumbing to liver disease, cirrhosis and liver cancer and can cure them of the virus entirely.

Risk factors for hepatitis C infection include injection drug use past or present, including steroids, medical or dental procedures abroad, unsterile tattoos and piercings, and blood transfusions for any reason before 1992 when the US began screening all donated blood for hepatitis C.

These latest data from The Polaris Observatory, Center for Disease Analysis Foundation, Lafayette, CO, USA (led by Dr Homie Razavi and his team) reveal that, like other high-income countries, the USA is facing a problem with diagnosis, although state level data from the six states for which Polaris has data show that diagnosis rates are above the national estimate of 55%: Rhode Island (60%); Ohio (61%); Louisiana (64%); California (71%); Washington (76%) and New York (81%). However, even these are not high enough to enable enough patients to enter treatment.

“Despite the different levels of diagnosis across the US, there are also problems linking people to care,” said Dr Homie Razavi. “The fact is that even when people are diagnosed, they are not being referred and often don’t get treated,” adding that “there are many possible reasons for patients not accessing treatment.”

Among these reasons are that, in two thirds of states (3), treatment on Medicaid programs has been restricted to people with advanced disease, preventing treatment access for those without private insurance. Some patients (and doctors) may not view treatment as a priority due to lack of symptoms and disease progression. Some people may not be aware of the short and generally side effect-free treatment (direct acting antivirals [DAAs]) now available. And others may be lost in the system or out of reach of care providers, including injection drug users.

In 2015, the USA treated around 256,000 patients and some 230,000 in 2016. Polaris’s latest projections suggest that without new initiatives to boost treatment and diagnosis rates the annual number treated across the USA will fall to just 130,000 per year by 2020. To reach the WHO 2030 elimination target, treatment levels must be sustained at 250,000 per year leading up to 2030. The USA is also unlikely to meet the targets set out in its own national plan, some of which are even more ambitious – such as a 60% fall in both hepatitis B and hepatitis C new infections by 2020.

Another issue facing the USA is the explosion of new infections faced by certain states caused by the opioid crisis, with steep increases in young white men and women in certain urban areas. As a result, the CDC reports a 250% increase in new HCV cases from 2011-2014, and reported infections are now at a 15-year high. However, most people do not know they are infected and thus many new infections go unreported. The new data from Polaris suggests almost 38,000 people contracted hepatitis C in 2016 alone. All states are at risk in the opioid crisis, which has just been declared a national public health emergency by US President Donald Trump.

“Policymakers are starkly aware of the heroin-fentanyl epidemic sweeping America,” said Michael Ninburg, President Elect of the World Hepatitis Alliance. “They also need to be aware of the resulting ballooning hepatitis C infections in certain states, most notably amongst young adults and adolescents, and be proactive about diagnosing and treating those in need.”

Across the USA, certain populations continue to face an enormous struggle to access hepatitis C drugs, including prisoners and people who inject drugs. An estimated 1 in 6 prisoners has HCV, but access to new treatments is severely restricted by prison budgets. And although some critics may argue that people who inject drugs may not be suitable for hepatitis C treatment that requires a daily pill, recent studies3 have reported cure rates equal to those in other people with HCV. Thus the central issue for people who inject drugs is to be diagnosed and start treatment, not whether or not treatment works.

However, the outlook is not entirely bleak — recent developments have meant the approval of new and cheaper hepatitis C drugs, which can be used to treat all types of the virus (genotypes 1-6), requiring just 8 weeks of treatment to achieve cure. At $26,400 per course, this combination of 2 drugs glecaprevir and pibrentasvir (made by AbbVie) is cheaper than courses of similar hepatitis C medications ($55,000-95,000).

These lower prices are allowing states such as Delaware, that previously restricted treatment to the sickest patients, to open up Medicaid coverage to all hepatitis C patients from January 2018. Delaware joins 16 other states (including Alaska and Georgia) that will open up restrictions (or never had them). At the recent Liver Meeting in Washington, DC (October 28) all states and Puerto Rico were graded on how easy it is to obtain Medicaid treatment for hepatitis C. States receiving the best grade of A were Alaska, Connecticut, Massachusetts, Nevada, and Washington. States that received an “F”, the worst grade, were Arkansas, Louisiana, Montana, Oregon, and South Dakota (4).

For patients with private insurance, it has generally (but not always) been much easier to obtain hepatitis C treatment. However, as many of these patients may have already accessed care and been cured, the pool of patients to treat is rapidly declining.

Similarly, at a state level, various initiatives are ongoing to boost diagnosis rates. In New York State, a 2014 law required primary care providers to test all people born 1945-1965 for hepatitis C. This increased the number of tests in this age group from 538,229 in 2013 to 813,492 in 2014, a 51% rise. The proportion of newly diagnosed patients who were then linked to care also increased by a third state-wide.

In Chicago, USA, Mount Sinai Hospital automatically tested anyone over 16 needing blood tests in the emergency room for 6 months, resulting in 200 new diagnoses. Emergency room screening is also helping detect some 70% of new cases in the Cherokee Nation in Oklahoma, which has its own hepatitis C elimination plan. All patients visiting the doctor or the dentist are also offered a test for hepatitis C.

Ninburg concludes: “We have the tools to eliminate hepatitis C in the US. We have effective cures for hepatitis C, and also effective vaccination to prevent hepatitis B. Now we just have to make ending hepatitis a political priority and prevent hundreds of thousands of needlessly premature deaths.”

###

Notes to editors:

1 2.7 million is the latest estimate of total chronic HCV cases requiring treatment in 2016 across the whole of the USA, produced by the Polaris Observatory, continuing on from their 2015 estimate. The Polaris Observatory is the source used by WHO for regional and global estimates on hepatitis C, based on the latest modelling and data available. Although this is considerably lower than the US CDC estimate of 3.5 million in 2010 (source Edlin 2015), the new Polaris estimate also incorporates the changing population after 2010 due to deaths*, new infections*, and cure (an estimated 684,000 cured from 2010-2016, based on treatment data from IMS Health and standard SVR rates).

For USA data and projections, see: http://tonykirby.com/hepatitis/PolarisDataUSA2017.xlsm

2 For details of the US National Viral Hepatitis Action Plan 2017-2020, see: https://www.hhs.gov/hepatitis/action-plan/u-s-viral-hepatitis-action-plan-overview/index.html

3 the PREVAIL sand SIMPLIFY studies have been recently presented at scientific meetings and are due for publication. Both show cure rates above in injectiob drugs users of 90-95%, similar to those in other persons with HCV.

4 the latest Medicaid report card, released at the Liver Meeting in Washington, DC, on Monday October 23, shows the latest situation regarding treatment restrictions in all states. Please see: https://stateofhepc.org/report/

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Transgender women take triple the number of HIV tests as trans men http://www.eatg.org/news/transgender-women-take-triple-the-number-of-hiv-tests-as-trans-men/ Wed, 01 Nov 2017 19:11:19 +0000 http://www.eatg.org/?post_type=news&p=6628 Blacks and Hispanics seek twice the amount of HIV tests as whites in transgender community, study finds

BUFFALO, N.Y., October 31, 2017 – A new University at Buffalo study has shown that HIV testing among transgender adults was higher in those who identified as female, were African-American or Hispanic, or had a history of incarceration.

The preliminary research, which sought to identify HIV testing patterns in urban, transgender individuals in Western New York, also found that among participants, those with history as a sex worker, who only engaged in sex with males or had access to stable housing were also more likely to seek HIV testing.

The study was recently published in Volume 2 of Transgender Health, the first peer-reviewed journal dedicated to the health care of transgender individuals.

The findings will help health care professionals understand which segments of the transgender population are not receiving HIV testing and tailor interventions to reach them.

“Knowing specific attributes and characteristics linked to testing will assist in better targeting of this often hidden population,” says Adrian Juarez, PhD, co-investigator and assistant professor in the UB School of Nursing.

The investigation was also led by Yu-Ping Chang, PhD, Patricia H. and Richard E. Garman Endowed Professor and associate dean for research and scholarship in the UB School of Nursing.

The transgender community experiences numerous barriers to access to medical care, ranging from social discrimination to limited clinical knowledge by care providers of transgender health needs. They also have an increased likelihood of substance abuse, prostitution and other risk behaviors.

Current HIV treatment strategies use seek, test, treat and retain (STTR) models to ensure HIV-negative populations remain negative and positive populations achieve an undetectable viral load to lower the risk of transmission.

While STTR has been successful in several populations, little evidence suggests the intervention is feasible in transgender communities due to the various barriers they face.

To better understand which segments of the transgender community are not receiving testing, the researchers examined survey data from the New York State AIDS Institute Reporting System. The de-identified data, collected from 2007-13, included HIV testing history, perceived HIV risks and related medical care.

They also interviewed 27 self-identified transgender men and women above the age of 18 who consented to receiving an HIV test at a Western New York community health care organization.

Of the participants, 23 were transgender females, 40 percent were Caucasian and nearly 30 percent African-American, and more than half were current sex workers or had been incarcerated. Nearly all of the respondents reported a history of substance abuse and most were uninsured.

“Substance use disorder (SUD) is a highly prevalent issue in transgender individuals,” says Chang. “Research evidence indicated that SUD is significantly associated with HIV and other sexually transmitted diseases. Therefore, SUD should be properly screened and managed.”

Participants reported receiving an average of three HIV tests and one STD test before joining the study. The majority of them did not receive an STD test within a year of the study.

The results found that transgender women received, on average, more than three times as many HIV tests as transgender men.

African-American and Hispanic participants also received, on average, more than twice as many HIV tests as Caucasian transgender men and women. The highest average was reported among African-Americans.

Those who had access to stable housing had an average test rate that was more than twice that of participants who were homeless or lived at a residential drug treatment facility.

Averages were slightly higher among individuals who only had male sex partners, were previously incarcerated or performed sex work.

“Testing rates are likely higher in these populations because of testing availability in an incarcerated setting with an inmate clinic,” says Juarez.

“Current evidence also shows that self-perceived HIV risk is a huge motivator for some to seek out an HIV test, which in turn may be the factor as to why trans individuals with only male sex partners and sex workers tested more frequently.”

The researchers also found that participants who were enrolled in support groups were more likely to receive a higher number of tests.

They believe an intervention that brings the HIV test to the individual by increasing opportunities at support groups and various forms of housing could increase testing among marginalized populations.

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Major European men who have sex with men internet survey, EMIS 2017, launched http://www.eatg.org/news/major-european-men-who-have-sex-with-men-internet-survey-emis-2017-launched/ Tue, 31 Oct 2017 19:29:09 +0000 http://www.eatg.org/?post_type=news&p=6618 A major online survey for gay, bisexual and other men who have sex with men has just been launched across Europe in 33 languages. The European Men-who-have-sex-with-men Internet Survey (EMIS 2017) is intended to help with planning HIV prevention and support activity and is open to all men who have sex with men, however they define their sexuality and whatever their HIV status.

“We all want better sex with less harm,” the welcome page for EMIS 2017 declares. “By taking part you might find out something new. Although there will be no direct benefit to you from the information you provide, it will help health and social services to better meet the communities’ needs. It could also mean that services for gay and bisexual men are funded.”

EMIS 2017 aims to identify the health promotion needs of gay men, bisexual men and other men who have sex with men (MSM), including transgender men and men living with HIV. The survey will generate data required to understand the sexual health needs of MSM populations across Europe and will help direct prevention programmes. The last EMIS survey was carried out across Europe in 2010.

The questions were developed by a network of 70 academic, public health and LGBT community partners, led by Sigma Research at the London School of Hygiene & Tropical Medicine. The 2017 survey is a mixture of questions asked in 2010 and new topics. The new areas of investigation include ‘chemsex’ (combining sex and drugs) and PrEP (pre-exposure prophylaxis for HIV). Chemsex has generated a lot of concern in the last few years, with mental health problems and death being among the serious harms that can arise.

The survey is open to you if you are: a “man who has sex with men”; “a man who is attracted to other men”; or “a man who thinks he might have sex with men in the future.” The research “asks about relationships, sex life, risks and precautions, and use of health services” and the data from the survey will be used to help improve health services for MSM across Europe.

Peter Weatherburn of Sigma Research at the London School of Hygiene & Tropical Medicine said, “We had a large response to first EMIS survey. The gay and bisexual community appreciate the value of such surveys. EMIS 2017 takes around 20 minutes to complete and is anonymous. We are encouraging as many men as possible to be a part of this survey. If you are living in Europe and are a man who has sex with other men, then this survey is for you”.

Matthew Hodson, Executive Director of NAM aidsmap commented: “Gay, bisexual and other men who have sex with men continue to be disproportionately affected by HIV and other STIs. The data that we get from EMIS is invaluable in helping those involved in sexual health and HIV prevention understand the needs of some of the communities most affected, enabling us to ensure that the right services and support can be provided.”

EMIS 2017 is now open for participation at: www.emis2017.eu?origin=eu-eatg-website&survey=true and is available in 33 languages.

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Global TB Report 2017 http://www.eatg.org/news/global-tb-report-2017/ Tue, 31 Oct 2017 19:28:14 +0000 http://www.eatg.org/?post_type=news&p=6622 WHO report signals urgent need for greater political commitment to end TB; TB remains leading infectious killer.

30 October 2017 | GENEVA – Global efforts to combat tuberculosis (TB) have saved an estimated 53 million lives since 2000 and reduced the TB mortality rate by 37%, according to the Global TB Report 2017, released by WHO today.

Despite these achievements, the latest picture is grim. TB remains the top infectious killer in 2016. TB is also the main cause of deaths related to antimicrobial resistance and the leading killer of people with HIV. Progress in most countries is stalling and is not fast enough to reach global targets or close persistent gaps in TB care and prevention.

“While the world has committed to ending the TB epidemic by 2030, actions and investments don’t match the political rhetoric. We need a dynamic, global, multisectoral approach.” said Dr Tedros Adhanom Ghebreyesus, Director-General of WHO. “The good news is that we finally have two great opportunities to move forward: the first WHO Global Ministerial Conference to End TB in Moscow in 2017, followed by the first UN General Assembly High-Level Meeting on TB in 2018. These will build momentum, get different sectors engaged, and accelerate our efforts to make TB history.”

High global burden of disease and death in 2016

In 2016, there were an estimated 10.4 million new TB cases worldwide, 10% of which were people living with HIV. Seven countries accounted for 64% of the total burden, with India bearing the brunt, followed by Indonesia, China, Philippines, Pakistan, Nigeria and South Africa. An estimated 1.7 million people died from TB, including nearly 400 000 people who were co-infected with HIV. This is a drop by 4% compared to 2015.

Multidrug-resistant TB (MDR-TB) remains a public health crisis and a health security threat. WHO estimates that there were 600 000 new cases with resistance to rifampicin – the most effective first-line drug, of which 490 000 had MDR-TB. Almost half of these cases were in India, China and the Russian Federation.

“The sheer numbers of deaths and suffering speak for themselves – we are not accelerating fast enough,” said Dr Mario Raviglione, Director of the WHO Global TB Programme. “Prompt action towards universal health coverage and social protection, as well as breakthroughs in research and innovations – will be critical to enable access to patient-centered care of the highest standards for all, especially the poorest, most disadvantaged people everywhere.”

Persistent gaps in care and financing

Tackling the epidemic requires action to close gaps in care and financing. It also requires progress in a particular subset of high TB burden countries (1).

  • Underreporting and underdiagnosis of TB cases continues to be a challenge, especially in countries with large unregulated private sectors and weak health systems. Of the estimated 10.4 million new cases, only 6.3 million were detected and officially notified in 2016, leaving a gap of 4.1 million. India, Indonesia and Nigeria accounted for almost half of this global gap.
  • Only one in five MDR-TB cases were started on treatment. India and China accounted for 39% of the global gap. Treatment success remains low, at 54% globally.
  • Of the almost half a million reported cases of HIV-associated TB, 15% were not on antiretroviral therapy (ART) as recommended by WHO. Most of the gaps related to HIV-associated TB were in the WHO African Region.
  • TB preventive treatment is expanding in two priority risk groups – people living with HIV and children under 5 years. However, most people eligible for TB preventive treatment are not accessing it.
  • For TB care and prevention, investments in low- and middle-income countries fall almost US$ 2.3 billion short of the US$ 9.2 billion needed in 2017. In addition, at least an extra US$ 1.2 billion per year is required to accelerate the development of new vaccines, diagnostics, and medicines.

“Shortfalls in TB funding are one of the main reasons why progress is not fast enough to be on track to reach the end TB targets,” said Dr Katherine Floyd, Coordinator of WHO’s Monitoring and Evaluation Unit at the Global TB Programme. “We have a double challenge. More domestic funding is needed in middle-income countries, and more international donor support is needed to support low-income countries”.

Political commitment and multisectoral action

Ending the TB epidemic requires action beyond the health sector to address the risk factors and determinants of the disease. For the first time the Global TB Report presents results from a new multisectoral monitoring framework that identifies linkages with the TB epidemic across seven Sustainable Development Goals (SDGs). Analysis of the latest status of the indicators for the 30 high TB burden countries show that most will be challenged to reach SDG targets.

In order to increase multisectoral action, plans to galvanize all sectors and secure attention at the highest levels have resulted in the WHO Global Ministerial Conference on Ending TB in the Sustainable Development Era, in Moscow, 16–17 November 2017. This will be followed by the very first UN General Assembly High-Level Meeting on TB in 2018, which will seek commitment from heads of state.

(1) The ten countries were: India, Indonesia, Nigeria, the Philippines, South Africa, Pakistan, Bangladesh, the Democratic Republic of the Congo, China and the United Republic of Tanzania.

Global TB Report 2017

Related links

 

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Close to 3 million people access hepatitis C cure http://www.eatg.org/news/close-to-3-million-people-access-hepatitis-c-cure/ Tue, 31 Oct 2017 19:20:05 +0000 http://www.eatg.org/?post_type=news&p=6615 World Hepatitis Summit 2017 calls for accelerated action to eliminate viral hepatitis

31 October 2017 | São Paulo, Brazil On the eve of the World Hepatitis Summit in Brazil, WHO reports increasing global momentum in the response to viral hepatitis. A record 3 million people were able to obtain treatment for hepatitis C over the past two years, and 2.8 million more people embarked on lifelong treatment for hepatitis B in 2016.

“We have seen a nearly 5-fold increase in the number of countries developing national plans to eliminate life-threatening viral hepatitis over the last 5 years,” says Dr Gottfried Hirnschall, Director of WHO’s Department of HIV and Global Hepatitis Programme. “These results bring hope that the elimination of hepatitis can and will become a reality.”

Hosted by the Government of Brazil, the World Hepatitis Summit 2017 is being co-organized by WHO and the World Hepatitis Alliance. The Summit aims to encourage more countries to take decisive action to tackle hepatitis, which still causes more than 1.3 million deaths every year and affects more than 325 million people.

“We cannot lose sight of the fact that last year 194 governments committed to eliminating viral hepatitis by 2030. For sure we are still a long way from this goal but that doesn’t mean it’s some unattainable dream. It’s eminently achievable. It just requires immediate action,” says Charles Gore, President of World Hepatitis Alliance. “The World Hepatitis Summit 2017 is all about how to turn WHO’s global strategy into concrete actions and inspire people to leave with a ‘can do’ attitude.”

“Brazil is honored to host the World Hepatitis Summit 2017 – and welcomes this extraordinary team of experts, researchers, managers and civil society representatives to discuss the global health problem posed by viral hepatitis,” says Dr Adele Schwartz Benzaken, Director of the Brazilian Ministry of Health’s Department of Surveillance, Prevention and Control of STIs, HIV/AIDS and Viral Hepatitis.”Brazil is committed to taking recent advances in its response to hepatitis forward – on the road to elimination.”

Progress in treatment and cure

Many countries are demonstrating strong political leadership, facilitating dramatic price reductions in hepatitis medicines, including through the use of generic medicines—which allow better access for more people within a short time.

In 2016, 1.76 million people were newly treated for hepatitis C , a significant increase on the 1.1 million people who were treated in 2015. The 2.8 million additional people starting lifelong treatment for hepatitis B in 2016 was a marked increase from the 1.7 million people starting it in 2015. But these milestones represent only initial steps – access to treatment must be increased globally if the 80% treatment target is to be reached by 2030.

However, funding remains a major constraint: most countries lack adequate financial resources to fund key hepatitis services.

Diagnosis challenge

To achieve rapid scale-up of treatment, countries need urgently to increase uptake of testing and diagnosis for hepatitis B and C. As of 2015, an estimated 1 in 10 people living with hepatitis B, and 1 in 5 people living with hepatitis C, were aware of their infection. Countries need to improve policies, and programmes to increase awareness and subsequent diagnosis.

Prevention gaps

Countries need to provide a full range of hepatitis prevention services that are accessible to different population groups, particularly those at greater risk.

Largely due to increases in the uptake of hepatitis B vaccine, hepatitis B infection rates in children under 5 fell to 1.3% in 2015, from 4.7% in the pre-vaccine era.

However, the delivery of other prevention services, such as birth-dose vaccination for hepatitis B, harm reduction services for people who inject drugs, and infection control in many health services, remains low. This has led to continuing rates of new infections, including 1.75 million new hepatitis C cases every year.

Need for innovation

Innovation in many aspects of the hepatitis response must continue. New tools required include a functional cure for hepatitis B infection and the development of more effective point-of-care diagnostic tools for both hepatitis B and C.

“We cannot meet the ambitious hepatitis elimination targets without innovation in prevention interventions and approaches, and implementing them to scale,” said Dr Ren Minghui Assistant Director-General for Communicable Diseases, WHO. “The great successes of hepatitis B vaccination programmes in many countries need to be replicated and sustained globally in the context of moving forward to universal health coverage.”

Implementation of elimination strategy

The World Hepatitis Summit 2017 will be attended by over 900 delegates from more than 100 countries, including Ministers of Health, national programme managers, and representatives from organizations of people affected by viral hepatitis. The Summit will review progress and renew commitments by global partners to achieve the elimination of viral hepatitis by 2030 – a target reflected in WHO’s elimination strategy and the UN Sustainable Development Goals.

 

Fact sheets

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MSF secures generic hepatitis C treatment at $120 compared to $147,000 launch price tag http://www.eatg.org/news/msf-secures-generic-hepatitis-c-treatment-at-120-compared-to-147000-launch-price-tag/ Tue, 31 Oct 2017 19:15:36 +0000 http://www.eatg.org/?post_type=news&p=6617 Geneva/Sao Paolo, 31 October 2017—On the eve of the World Hepatitis Summit in Sao Paolo, the international medical humanitarian organization Médecins Sans Frontières (MSF) today announced that it had secured deals for generic hepatitis C medicines for as low as US$1.40 per day, or $120 per 12-week treatment course for the two key medicines sofosbuvir and daclatasvir.

In the US, pharmaceutical corporation Gilead launched sofosbuvir at $1,000 per pill in 2013, and Bristol-Myers Squibb (BMS) launched daclatasvir at $750 per pill in 2015, leading to the original price tag of $147,000 for a person’s 12-week combination treatment course. The corporations have also been charging exorbitant prices in many developing countries, paralyzing the launch of national treatment programs and causing treatment rationing in many countries around the world.

“What good is a breakthrough medicine that people cannot afford?” asked Jessica Burry, Pharmacist for MSF’s Access Campaign. “Pharmaceutical corporations price hepatitis C medicines far out of reach for people paying out of pocket around the world, and also for many governments struggling to provide treatment in the public sectors; but the prices for generic versions keep coming down. Governments must use every tool in their toolbox to fight for access to lower-priced generics so they can scale up treatment for the millions of people who need it; they should follow the lead of countries like Malaysia and issue compulsory licenses when patents block people’s access to this life-saving treatment.”

In 2015, MSF started procuring sofosbuvir and daclatasvir from Gilead and BMS through their ‘access programs’ at a price of $1,400 to $1,800 per 12-week treatment. Today, MSF pays a fraction of that, at $120, sourced from quality-assured generic manufacturers.

An estimated 71 million people have chronic hepatitis C infection worldwide, 72 per cent of whom live in low- and middle-income countries. Direct-acting antiviral medicines (DAAs) represent a treatment breakthrough for people with hepatitis C, with cure rates of up to 95%, and with far fewer side effects than previous treatments. Yet access to DAAs has remained limited because pharmaceutical corporations charge unaffordable prices, leading many countries to reserve treatment only for people with the most advanced stages of the disease. By the end of 2016, three years after sofosbuvir was launched, only an estimated 2.1 million people globally had been treated with the medicines, leaving 69 million people still without access.

These high prices have also put a major strain on health systems in wealthy countries, in particular those enacting universal health care. Treatment is being rationed in countries such as Australia, Canada, Italy and the US, in addition to developing countries, and is a stark reminder of the early days of HIV treatment.

“Almost two decades ago, MSF and others worked hard to get access to generics and bring down prices for HIV medicines,” said Mickael Le Paih of MSF in Cambodia, where MSF treats people living with hepatitis C. “History is repeating itself with hepatitis C—the medicines we need are again too expensive, but we are finding ways to make treatment affordable so that our patients can be cured.”

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New app helps treatment adherence for people living with HIV http://www.eatg.org/news/new-app-helps-treatment-adherence-for-people-living-with-hiv/ Tue, 31 Oct 2017 18:27:55 +0000 http://www.eatg.org/?post_type=news&p=6612

A new mobile app for people living with HIV, Life4me+, is now available for free in 156 countries and in six languages—Armenian, English, Estonian, German, Russian and Ukrainian. The app was created by a German–Russian activist living with HIV and his team and aims to simplify medical information and treatment for people living with HIV in eastern Europe and central Asia and beyond.

The app was developed based on the experiences of its developers and HIV activists. For people living with HIV, the app works like a personal electronic patient card. It allows users to stay in touch with doctors online, saving and displaying test results, a calendar of blood tests and a prescription history, and sets up reminders about when to take medication and schedule appointments. There are also functions for recording weight, chest volume, blood pressure, disease history, HIV drug resistance, etc.

It has an interactive map that shows the location of medical centres and nongovernmental organizations supporting people living with HIV, daily HIV-related news and up-to-date information and popular scientific articles on HIV. A help button contains links to hotlines on HIV treatment and prevention and psychological and legal support for women, adolescents and drug users. Currently, the links to the hotlines are available only to people living in some countries in eastern Europe.

With the patient’s permission, doctors can monitor medicine intake and track adherence. The app has special provisions to protect anonymity and confidentiality. All the data are depersonalized, so there is no risk of a person being identified as living with HIV, even if a user’s phone or computer is used by someone else. Life4me+ can be downloaded from Google Play and the Apple App Store.

An updated version of the app will be released on 1 December, which will include functions aimed at preventing new HIV infections, hepatitis C and sexually transmitted infections such as syphilis and gonorrhoea, with automatic reminders to test for those diseases.

Quotes

“New technologies have an essential role in quickening the end of AIDS. The Life4me+ app can be a life-saver for enhancing treatment adherence, which is essential to reaching 90–90–90 by 2020.”

Vinay P. Saldanha, Director, UNAIDS Regional Support Team for Eastern Europe and Central Asia

“The world is moving towards e-health. The mobile application Life4me+ is a tool for quality medical care of people living with HIV, especially in eastern Europe and central Asia, where the number of new HIV infections continues to rise.”

Alex Schneider, founder of the Life4me+ app

“I have lived with HIV for seven years and been on antiretroviral therapy for five years. I’ve been waiting for an app like this for a long time. I sometimes forgot to take my medicine, but there is a function in the app that reminds me constantly until I say yes. Then I can always see whether I have missed taking my medicine.”

Timur Goncharov, Ukraine

“I actively use the app’s reminders because I sometimes forgot to take my medicine. The app keeps me updated with news about HIV and I keep in touch with my doctor.”

Alexander Alexandrovich, Russian Federation

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Hepatitis C test-and-treat programme reduces HCV by two-thirds among men who have sex with men in Swiss HIV Cohort http://www.eatg.org/news/hepatitis-c-test-and-treat-programme-reduces-hcv-by-two-thirds-among-men-who-have-sex-with-men-in-swiss-hiv-cohort/ Tue, 31 Oct 2017 14:38:10 +0000 http://www.eatg.org/?post_type=news&p=6611

A systematic policy of test-and-treat cured 99% of men who have sex with men with hepatitis C in the Swiss HIV Cohort in an 8-month period and reduced the prevalence of hepatitis C by almost two-thirds, Dominique Braun of the University Hospital, Zurich, reported at the 16th European AIDS Conference (EACS 2017) last week in Milan.

Dr Braun was presenting results of the Swiss HCVree trial, a non-randomised study of hepatitis C virus (HCV) testing, treatment and behavioural counselling designed to eliminate chronic HCV infection in men who have sex with men with HIV/HCV co-infection in the Swiss HIV Cohort.

The Swiss HIV Cohort has seen a 20-fold increase in the prevalence of HCV in men who have sex with men since 1996, with the greatest increase occurring since 2008, in common with other western European countries.

Reducing onward transmission and prevalence of HCV requires a reduction in the number of people with chronic HCV infection and a reduction in risk behaviours. Chemsex – especially the use of drugs and sharing of injecting equipment during sex – and group sex are strongly implicated in the increase in hepatitis C in men who have sex with men.

In an 8-month period between October 2015 and May 2016 all men who have sex with men in the Swiss HCV Cohort were screened for active HCV infection. Screening identified 177 men with chronic HCV infection (4.8%) of which 147 had been diagnosed previously. Thirty new and previously undiagnosed HCV infections were diagnosed as a result of the screening exercise.

All men with genotype 1 or 4 infection were offered immediate treatment with a course of grazoprevir/elbasvir (Zepatier) for 12 or 16 weeks depending on baseline resistance, with additional ribavirin for all genotype 1a and 4 patients with previous experience of pegylated interferon and ribavirin, for previously untreated genotype 1a patients with baseline NS5A resistance mutations and genotype 1b patients with prior HCV protease inhibitor experience.

Of the 177 people diagnosed with chronic HCV infection, 122 took part in the study (34 received treatment elsewhere, 11 had a genotype other than 1 or 4, 6 had contraindications for treatment and the remainder were either lost to follow-up or unwilling to take part in the study).

Men who joined the trial had a median age of 46 years, 88% were white and all but one was taking antiretroviral therapy. Participants had been diagnosed with HCV a median of three years before joining the study and 79% had F0-F1 stage fibrosis, indicating little liver damage since infection. Six per cent had F3-F4 stage fibrosis.

The predominant genotypes were 1a (67%) and 4 (26%), with 7% having genotype 1b infection. HCV RNA was relatively low at baseline (865,279 IE/ml).

All participants except one achieved a sustained virologic response and was cured of hepatitis C infection. The exception was a previously untreated man with genotype 4 infection who experienced viral rebound after treatment.

Treatment was well tolerated with no serious drug-related adverse events. Drug-related adverse events were reported in 29% of participants and were predominantly fatigue, diarrhoea, nausea and itching.

Preventing onward transmission and reinfection

Sixty-eight men recruited to the study reported condomless sex with non-regular partners. Of these men, 51 agreed to take part in a four-session behavioural intervention devised by Professor Dunja Nicca of Zurich University that accompanied the treatment phase of the study.

The first session focused on emotional responses to safe sex problems, the second on individualised solutions, the third on developing a personal risk reduction plan and the fourth session a reflection on the post-treatment achievement of hepatitis C cure and how to maintain it.

The study found that 65% of men reported condomless anal intercourse as a potential risk factor for acquiring HCV; only 30% reported sharing injecting equipment or other equipment for snorting drugs and 29% reported sharing sex toys or fisting as potential risk factors. Forty out of 51 reported drug use, mainly methamphetamine (43%) and GBL or GHB (57%)

The overall completion rate of the behavioural intervention was 90%. No cases of reinfection have been identified to date.

By Keith Alcorn

References

Braun D et al. High SVR12 rates with grazoprevir/elbasvir +/- ribavirin for 12-16 weeks guided by genotypic resistance testing among HIV/HCV coinfected MSM in the Swiss HCVree trial. 16th European AIDS Conference, 25-27 October, Milan, abstract PS9/4, 2017.

Nicca D et al. Doing the impossible: an e-health-assisted counselling intervention to reduce risk in HCV-reinfection in men who have sex with men. 16th European AIDS Conference, 25-27 October, Milan, abstract PE25/24, 2017.

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High rate of hepatitis C reinfection in German men who have sex with men http://www.eatg.org/news/high-rate-of-hepatitis-c-reinfection-in-german-men-who-have-sex-with-men/ Tue, 31 Oct 2017 14:35:52 +0000 http://www.eatg.org/?post_type=news&p=6610

Around one in seven gay and bisexual men cured of hepatitis C at major treatment centres in Germany has become reinfected since 2014, according to findings from the German Hepatitis C Cohort presented on Friday at the 16th European AIDS Conference (EACS 2017) in Milan.

At least half of these men became reinfected within a year of completing treatment and all reinfections occurred within 18 months.

The risk of reinfection is thought to be highest among men who share drug injecting equipment during sex – chemsex – but Dr Stefan Mauss of the Center for HIV and Hepatogastroenterology in Dusseldorf said that sharing drug injecting equipment during sex might explain only a quarter of these cases of reinfection.

People infected with hepatitis C who are cured of the infection are vulnerable to reinfection. Although a proportion of people will cure hepatitis C infection spontaneously, it is not clear if a successful response to previous treatment increases the likelihood of clearing hepatitis C virus (HCV).

Several studies with varying periods of follow-up have looked at the risk of reinfection among men who have sex with men in Europe.

A study in London carried out prior to the introduction of direct-acting antiviral treatment found an incidence of reinfection of 9.6 cases per 100 person-years of follow-up.

More recently, a multicentre study in western and central Europe found an incidence of reinfection of 7.3 per 100 person-years. The study also found big variations between cities.

The German Hepatitis C Cohort collects information on everyone treated with direct-acting antivirals at nine treatment centres in Germany. In this analysis, investigators reviewed reinfection rates among 1533 people who had been cured of hepatitis C and compared rates of reinfection according to potential risk factors.

Thirty-two cases of reinfection were identified, all in men. Five cases occurred in men who injected drugs (an incidence of 0.96%). Twenty-seven cases occurred in men who have sex with men (an incidence of 13.1%). Only seven of the men who have sex with men said that they had used intravenous drugs, suggesting either a discomfort about disclosing drug use or predominantly sexual transmission.

Reinfection occurred fairly soon after completing treatment, in a median of 53 weeks (range 36-70 weeks).

In almost half of cases (44%) the reinfection was a new genotype.

A study of acute HCV infections at one of London’s largest sexual health and HIV clinics, the Mortimer Market clinic, found that among 95 people diagnosed with acute HCV infection between 2015 and 2017, 27% reported condomless anal intercourse as their only risk factor. Almost all those acutely infected with HCV were men who have sex with men (94%) and only 27% reported injecting drugs.

Almost a quarter of the infections (22 cases) occurred in people who were HIV negative, leading presenter Emily Chung to recommend that risk-based screening for HCV infection should now be considered for HIV-negative men who have sex with men.

By Keith Alcorn

Reference

Ingiliz P (S Mauss presenting). High incidence of HCV reinfection in HIV-positive MSM in the DAA era. 16th European AIDS Conference, 25-27 October, Milan, abstract PS9/1, 2017.

Chung E et al. Acute hepatitis C infections in men who have sex with men: changing patterns of risk. 16th European AIDS Conference, 25-27 October, Milan, abstract PE15/1, 2017.

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Twice-daily tenofovir alafenamide dose might overcome interaction with rifampicin http://www.eatg.org/news/twice-daily-tenofovir-alafenamide-dose-might-overcome-interaction-with-rifampicin/ Tue, 31 Oct 2017 14:26:37 +0000 http://www.eatg.org/?post_type=news&p=6609 Twice-daily tenofovir alafenamide (TAF) plus rifampicin provided similar exposures to once-daily TAF in pharmacokinetic study. This strategy might be a suitable option for people with HIV/TB coinfection.

The results were presented at the 16th European AIDS Conference (EACS 2017), held on 25-27 October 2017 in Milan, Italy.

Read the full report by Polly Clayden, HIV i-Base here.

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EACS 2017: NATAP reports http://www.eatg.org/news/eacs-2017-natap-reports/ Tue, 31 Oct 2017 14:14:47 +0000 http://www.eatg.org/?post_type=news&p=6607 The 16th European AIDS Conference (EACS 2017) took place on 25-27 October 2017 in Milan, Italy.

NATAP reports:

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Investigating where patients go when they leave HIV care http://www.eatg.org/news/investigating-where-patients-go-when-they-leave-hiv-care/ Tue, 31 Oct 2017 13:35:23 +0000 http://www.eatg.org/?post_type=news&p=6621

— Previous research has found HIV-positive Canadians stop attending follow-up HIV appointments at rates between 11% and 24%.
— Alberta researchers find that many patients “lost to follow-up” are seeking healthcare outside HIV services, often in hospital emergency rooms.
— This research has implications for programs that seek to re-engage patients in HIV care.

Potent combination anti-HIV therapy (ART) can reduce levels of HIV in the blood (viral load) to very low levels that cannot be detected with routinely used tests. These low levels are commonly called “undetectable.” Keeping HIV at such low levels with ART is associated with improved health. This effect of ART is so powerful that researchers in Canada and other high-income countries expect that many HIV-positive people who continue to take ART every day and keep regular clinical and laboratory appointments will have a near-normal lifespan.

Studies have found another benefit of ART that comes from achieving and maintaining an undetectable viral load: The sexual spread of HIV does not occur.

These twin benefits of ART and an undetectable viral load (improved health and the prevention of HIV transmission) are so profound that the Joint United Nations Programme on AIDS (UNAIDS) has encouraged countries, regions and cities to engage with their populations so that the following goals are achieved by 2020:

  • 90% of people with HIV know their infection status
  • 90% of people diagnosed with HIV are taking ART
  • 90% of people taking ART have an undetectable viral load

To help achieve these goals (often shortened to 90-90-90) it is essential for there to be more opportunities for HIV testing accompanied by supportive counselling and, in cases of a positive test result, swift referral to care where an offer of ART can be made.

Dropping out of HIV care

Research in the United States suggests that a large proportion of HIV-positive people— perhaps as high as 40% in some cases—drop out of care. According to researchers at the Southern Alberta Clinic (SAC), figures from several studies in larger Canadian provinces suggest that dropout rates are between 11% and 24%, depending on the clinic/region surveyed. Researchers label people who have dropped out of care as “lost to follow-up” (LTFU).

Not surprisingly, studies have found that people who drop out of HIV care are at heightened risk for developing serious HIV-related complications and dying.

What’s more, researchers at SAC who have reviewed studies published in the past several years have found that “innovative approaches to facilitate reengagement in HIV care, including intensive outreach, patient navigators and use of case managers, have shown modest benefits.”

In Alberta

Researchers at SAC sought to find out where patients who dropped out of HIV care went to receive their non-HIV care, as these could potentially be places where they may be helped to re-enter HIV care.

To find out more about where patients who were LTFU went for non-HIV care, the researchers accessed Alberta’s comprehensive and province-wide electronic health record (EHR). They reviewed information collected by the EHR between January 2010 and August 2014 on patients who had gone more than one year without a visit to SAC.

According to the researchers, there were a total of 1,928 patients registered at SAC. However, 178 (9%) patients dropped out of HIV care at SAC. Further analysis revealed that some patients had moved out of the province, others sought HIV care elsewhere and a small portion had died. By the end of the study, many participants who were residing in Alberta had returned to HIV care. However, analysis of the EHR data revealed that 29 (16%) patients who left SAC had no further contact with HIV care yet sought non-HIV care in Alberta.

These 29 patients had many contacts—a total of 188 (at least six per person)—with the medical healthcare system for care unrelated to HIV during the study period. The majority of these contacts (nearly 70%) occurred in the Emergency Departments of hospitals. In 25 cases, hospitalization was required. The remaining participants interacted with hospitals and community clinics for their non-HIV care.

Implications of the study

According to the researchers, “an important implication of this finding is that health-care based reengagement efforts, such as medical or social service referral, will miss this population [who are LTFU]” because it depends on patients visiting the HIV clinic to receive such referrals.

There may be an alternative method of finding out more about patients who are LTFU. The Southern Alberta researchers drew attention to research from Seattle, Washington, where an HIV clinic collaborated with local health departments and made use of a care linkage specialist for outreach. The Seattle researchers were somewhat able to re-engage patients into care and find out why they appeared to disengage in care. In the Seattle study, the majority of patients who stopped visiting the HIV clinic did so because they had been sent to prison or had moved out of the region or sought care at other HIV clinics. Furthermore, the Seattle researchers stated the following: “The ongoing movement of patients between correctional settings and community, between different geographic areas, and between different clinical care sites is a challenging issue for both clinic and health department–based relinkage interventions to address.”

The Emergency Department

Research from Baltimore, Maryland, suggests that intensive efforts to help HIV-positive people who enter the Emergency Department link to care can be effective. According to the Alberta researchers, such intensive interventions can include “physically escorting patients to an HIV clinic or in-person interaction with an HIV specialist.” However, the Baltimore researchers noted that interventions to help patients in the Emergency Department link to and stay in care often required additional funding because the services of “multidisciplinary non-Emergency Department staff” were required.

What is needed

Based on the findings from their regions and their review of other studies related to patients who are LTFU, the Alberta researchers call for studies to better understand why some HIV-positive patients drop out of HIV care. They add that while focusing on HIV-positive patients who seek care from Emergency Departments may help to re-engage many who are LTFU, such attempts will not find patients who have disengaged with the healthcare system altogether.

The main issue raised by the Alberta researchers—dropping out of HIV care—is important and can affect the health and well-being of some HIV-positive people as well as the ability of cities and regions to reach the UNAIDS 90-90-90 targets.

Technical notes about the EHR

The EHR database captures visits to Emergency Departments, urgent care facilities, community clinics and more than 90% of lab tests and prescriptions for Alberta residents (regardless of HIV status). According to the Alberta researchers, at the time of the study there were some “rural and private community providers who are not yet contributing to the provincial [data] platform and represent sources of uncaptured data in the EHR.” The EHR is also linked to registries in the province so that deaths can be incorporated into the database. However, it is possible, likely even, that the EHR database has limitations (it was not designed for the purpose of the present study). It is possible that some patients who left the care of SAC were in care in other parts of the province with clinics not yet registered with the EHR.

By Sean R. Hosein

REFERENCES:

  1. Connors WJ, Krentz HB, Gill MJ. Healthcare contacts among patients lost to follow-up in HIV care: review of a large regional cohort utilizing electronic health records. International Journal of STD and AIDS. 2017 Nov;28(13):1275–1281.
  2. Menon AA, Nganga-Good C, Martis M, et al. Linkage-to-care methods and rates in U.S. Emergency Department-based HIV testing programs: A systematic literature review brief report. Academic Emergency Medicine. 2016 Jul;23(7):835–842.
  3. Bove J, Golden MR, Dhanireddy S, et al. Outcomes of a clinic-based, surveillance-informed intervention to relink patients to HIV care. Journal of Acquired Immune Deficiency Syndromes. 2015;70(3):262–268.
  4. Hart-Malloy R, Brown S, Bogucki K, et al. Implementing data-to-care initiatives for HIV in New York state: assessing the value of community health centers identifying persons out of care for health department follow-up. AIDS Care. 2017; in press.
  5. Stein R, Xu S, Marano M, Williams W, et al. HIV Testing, linkage to HIV medical care, and interviews for partner services among women – 61 Health Department jurisdictions, United States, Puerto Rico, and the U.S. Virgin Islands, 2015. Morbidity and Mortality Weekly Report. 2017 Oct 20;66(41):1100–1104.
  6. Singh S, Mitsch A, Wu B. HIV care outcomes among men who have sex with men with diagnosed HIV infection – United States, 2015. Morbidity and Mortality Weekly Report. 2017 Sep 22;66(37):969–974.
  7. Hall HI, Frazier EL, Rhodes P, et al. Differences in human immunodeficiency virus care and treatment among subpopulations in the United States. JAMA Internal Medicine. 2013 Jul 22;173(14):1337–1344.
  8. Skarbinski J, Rosenberg E, Paz-Bailey G, et al. Human immunodeficiency virus transmission at each step of the care continuum in the United States. JAMA Internal Medicine. 2015 Apr;175(4):588–596.
  9. Cohen MS, Chen YQ, McCauley M, et al. Antiretroviral therapy for the prevention of HIV-1 transmission. New England Journal of Medicine. 2016;375:830–839. Available from: http://www.nejm.org/doi/pdf/10.1056/NEJMoa1600693
  10. Rodger AJ, Cambiano V, Bruun T, et al. Sexual activity without condoms and risk of HIV transmission in serodifferent couples when the HIV-positive partner is using suppressive antiretroviral therapy. Journal of the American Medical Association. 2016;316(2):171–181. Available from: http://jama.jamanetwork.com/article.aspx?articleid=2533066
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Fatty liver common after direct-acting antivirals for hep C http://www.eatg.org/news/fatty-liver-common-after-direct-acting-antivirals-for-hep-c/ Tue, 31 Oct 2017 13:32:57 +0000 http://www.eatg.org/?post_type=news&p=6614 WASHINGTON, DC — Evidence of steatosis is found in almost half the patients with hepatitis C who achieved a sustained virologic response after treatment with direct-acting antivirals, results from a prospective study show.

“Fatty liver is very common now that hepatitis C is being treated effectively,” said Mazen Noureddin, MD, from Cedars-Sinai Medical Center in Los Angeles.

American and European guidelines state that a patient can be discharged from care in the absence of cirrhosis and elevated liver enzymes, but “we wanted to see what happens after direct-acting antiviral treatment,” he said.

Steatosis was “very prevalent” in the study population, “although liver enzymes were normal,” Dr Noureddin reported here at The Liver Meeting 2017.

Monitoring people for steatosis after a sustained virologic response is not common practice, he told Medscape Medical News, but these findings suggest that long-term monitoring is warranted.

Long-term Monitoring Needed

In their study, Dr Noureddin and his colleagues compared transient elastography findings (FibroScan, Echosens) in 101 patients — 49 men and 52 women — before and after they were treated with direct-acting antivirals. After each participant achieved a sustained virologic response, the researchers used the controlled attenuation parameter (CAP) to assess liver fat.

Mean age of the participants was 60 years and mean body mass index (BMI) was 28 kg/m². In addition, 36% of the patients were white, 25% were Hispanic, and 90% had diabetes. The hepatitis C infection was genotype 1 in 86% of the patients, genotype 2 in 13%, and genotype 4 in 1%. People with genotype 3 infection were excluded from the analysis because the etiology of hepatic steatosis is different in this population.

Decreases were significant in alanine transaminase (ALT) and aspartate transaminase (AST) levels and fibrosis scores from baseline to the achievement of sustained virologic response (P < .05).

In the study cohort, 48% of the patients showed evidence of steatosis after treatment, 6% of whom had advanced fibrosis. None of the 52% of patients without steatosis showed evidence of advanced fibrosis, defined as a score of at least 11 kPa.

For patients with steatosis, weight did not change during the study period. However, there were significant differences between these patients and those without steatosis.

Table. Mean Values After Patients Achieved a Sustained Virologic Response

Parameter Patients With Steatosis Patients Without Steatosis P Value
BMI 29 m/kg² 26 m/kg² <.05
Glucose level 108 mg/dL 96 mg/dL <.05
ALT level 20 mg/dL 15 mg/dL <.05
CAP score 297 dB/m 214 dB/m <.05
Fibrosis score 7.0 kPa 5.3 kPa <.05

“We need more follow-up,” said Dr Noureddin. “We looked at patients 48 weeks after treatment. Next, we want to follow patients longitudinally to see if more patients with a fatty liver also develop fibrosis.”

“This is one of the most important studies presented at this meeting,” said Naim Alkhouri, MD, from the Texas Liver Institute in San Antonio.

“The treatment of chronic hepatitis C infection has been revolutionized by the introduction of highly effective direct-acting antivirals, with cure rates of 95% or higher,” he told Medscape Medical News. “However, the study showed that even after achieving a cure for hepatitis C, approximately 50% of those patients demonstrated evidence of NAFLD, which may increase their risk for liver cirrhosis and liver cancer.”

“The use of FibroScan with CAP to assess for the presence of NAFLD and fibrosis progression should be considered in patients who are cured from hepatitis C infection,” Dr Alkhouri said.

Dr Noureddin is a speaker and advisor for EchoSense. Dr Alkhouri has disclosed no relevant financial relationships.

The Liver Meeting 2017: American Association for the Study of Liver Diseases (AASLD): Abstract 2155. Presented October 23, 2017.

By Damian McNamara

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People with HIV still expect a lower quality of life than their negative peers, European survey finds http://www.eatg.org/news/people-with-hiv-still-expect-a-lower-quality-of-life-than-their-negative-peers-european-survey-finds/ Sat, 28 Oct 2017 12:04:29 +0000 http://www.eatg.org/?post_type=news&p=6591 Nearly 40% with an undetectable viral load still consider themselves infectious

A study commissioned by the drug company Gilead Sciences and conducted in five European countries has found that, compared with their HIV-negative peers, people with HIV still expect to die sooner and think they are less likely to achieve a long-term relationship.

The results were announced yesterday during the 16th European AIDS Conference (EACS 2017) in Milan, Italy.

The survey found that 54% of HIV-positive people considered HIV to be a barrier to sex with others, and of them 87% (47% of the whole group) said that they feared transmitting the virus to others.

This could be seen as a rational or well-informed fear, as this was a relatively young group of people with HIV and just under two-thirds of them were actually on antiretroviral therapy (ART), with under half with a reported undetectable viral load.

However, whether people were virally suppressed or not in fact made little difference, with 38% of those with an undetectable viral load fearing transmitting the virus to others, and 43% who were detectable.

Similarly nearly half said their HIV would be a barrier to having a family naturally if they wanted children, with 73% of those (35% of all HIV-positive people) saying that they would be afraid to transmit their HIV either to their partner or, in the case of women, to their unborn child.

More on the survey

The HIV is: Expectations from Life survey was conducted online between November and December 2016 by the marketing research company Censuswide on behalf of Gilead, using a methodology similar to market surveys. Firstly a target number of HIV-positive people were recruited in the five European countries, namely France, Germany, Italy, Spain and the United Kingdom. Roughly 20 HIV-positive women were recruited from each country, to a total of 102 women, and an average of 84 men each, to a total of 420.

Of these 522 people, 11% had never started ART, and a surprisingly high 11% had taken ART but currently said they were not taking it. Of the 338 people who were on ART (65%), 229 (67% or 44% of the whole group) said they had an undetectable viral load.

Respondents were recruited from a ‘consumer panel’ and went through a stringent verifying process before taking part to guarantee they were who they claimed to be.

The 522 people with HIV were then matched against 2723 HIV-negative people in the general population, matched for age, gender and sexual orientation.

All respondents were asked: do you expect to live a longer of shorter life than your friends, peers, older siblings and colleagues? People with HIV were three times more likely to expect they would have shorter lives; 35% expected they would die sooner than their friends, compared with 10% of the HIV-negative group.

Viral undetectability changed this little, with 31% of those on fully suppressive ART still considering they had a shorter life expectancy.

Perhaps because they saw achieving it as more difficult, when asked about priorities in life such as love, financial stability and career, HIV-positive people were more likely to prioritise love (37 vs 27%) and a healthy sex life (28 vs 17%) than HIV-negative people.

While over half considered HIV to be a barrier to sex with others, fewer (38%) considered HIV to be a barrier to dating and meeting potential sexual partners. By far the most commonly cited barrier to dating was the fear of having to disclose their HIV status, with 59% of those saying HIV was a barrier to dating saying this was a major problem (22% of the whole group).

As well as having a lower estimate of life expectancy, people with HIV were less likely to rate their current health as excellent, with 44% rating their health as good or excellent, compared with 69% of the matched HIV-negative respondents.

Country differences: Spanish and Italians feel less well, but British fear stigma the most

There were some interesting differences in attitudes between countries. Respondents in Spain and Italy were least likely to describe their health as excellent or good (only 34% in Spain, compared with 53% in Germany).

They were also more likely to be fatalistic about their health: 71% of people in Spain vs 38% in Germany said that their HIV status had actually made them less likely to engage in activities to support health and wellbeing such as healthy eating and exercise, because they did not believe they would help now they had HIV.

Notably, however, it was British respondents that were most likely to fear disclosing their status, and to say that the prevailing stigma against HIV was a challenge to getting a long-term relationship.

Sixty-eight per cent of UK respondents, vs 50% of Spanish ones, feared disclosing their status, and 44% of UK respondents vs only 12% of Italians said they feared that the continued stigma against HIV would be a barrier to their achieving a relationship.

In their press release, Gilead comment that “The survey findings indicate a disconnect between the advances in HIV treatment and the aspirations of people living with HIV; they demonstrate an uncertainty around their long-term health and risk of transmission.”

By Gus Cairns

Reference

Further information about the survey can be found at http://campaigns.visit-gbu.eu/expectations-from-life

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Hepatitis C halved in Spanish people living with HIV in one year due to treatment http://www.eatg.org/news/hepatitis-c-halved-in-spanish-people-living-with-hiv-in-one-year-due-to-treatment/ Sat, 28 Oct 2017 12:02:31 +0000 http://www.eatg.org/?post_type=news&p=6592

Spain is making dramatic progress towards eliminating hepatitis C in people living with HIV because of widespread use of direct-acting antivirals, Juan Berenguer of Hospital Gregorio Marañón, Madrid, reported on Friday at the 16th European AIDS Conference (EACS 2017) in Milan.

Sampling patients at 43 clinics in Spain, researchers found that the proportion of people living with HIV who have chronic hepatitis C virus (HCV) infection has fallen dramatically since 2009, from approximately one-third of all patients in care to 11.7% of all patients in late 2016. In just one year, from late 2015 to late 2016, the prevalence of chronic hepatitis C in people living with HIV fell by 47%, from 22% to 11.6%.

The Spanish health care system has been providing direct-acting antiviral treatment for hepatitis C to everyone with F2 grade fibrosis or above since early 2016 and provides direct-acting antiviral treatment to anyone who might transmit HCV, regardless of fibrosis stage.

The GeSIDA network of Spanish researchers carried out a cross-sectional study to evaluate the effect of improved treatment access on the prevalence of HCV co-infection in people with HIV in Spain. They sampled patients from 43 HIV treatment centres in Spain in proportion to their patient population, taking a random sample from each clinic. The total population in care was 38,904 in October and November 2016 (the sample period) and the random sample comprised 1588 patients, of whom 35% were men who have sex with men and 29.6% were people who had acquired HIV through injecting drug use.

This sample was compared with previous samples in 2002, 2009 and 2015.

Whereas 60.8% of those sampled had HCV antibodies in 2002, this proportion had declined to 34.6% by 2016. Similarly, the proportion with chronic HCV infection (HCV RNA positive) fell from 54% in 2002 to 34% in 2009 and 11.7% in 2016.

In part this can be explained by the declining proportion of the sample who had acquired HIV through injecting drug use: 55.2% in 2002, and 29.6% in 2016.

However, the study also found that the proportion who had ever received HCV treatment rose from 23% in 2002, 48% in 2009, and 59.3% in 2015 to 74.7% in 2016. Of the 548 people who had HCV antibodies in the 2016 sample, 292 (53.2%) had been cured of hepatitis C. Of the remaining 186 people with chronic infection, 41 were undergoing treatment at the time of the survey, suggesting that if 95% were cured, HCV RNA prevalence could have been as low as 9.1%.

HCV continuum EuroSIDA

Only half of people with diagnosed HIV/HCV co-infection in Southern Europe have ever started a course of treatment to cure hepatitis C infection, and less than 40% in Central and Eastern Europe, an analysis of people receiving HIV care in the European region shows.

The findings, also presented to EACS 2017 on Friday, by Sarah Amele of University College London, come from the EuroSIDA study, an amalgamation of HIV treatment cohort studies in Western, Central and Eastern Europe.

The study was designed to evaluate the continuum of care for hepatitis C in people with HIV/HCV co-infection, from testing to treatment, who were in care in January 2015.

The researchers identified 6985 people in the EuroSIDA cohort with a positive HCV antibody test result prior to January 2015. Of these, 79% had a subsequent test for HCV RNA to diagnose chronic infection – meaning that almost one in five did not receive a test to determine whether or not they had active HCV infection. HCV RNA testing is an essential first step in determining whether a person with HCV antibodies is in need of treatment for HCV infection. People with HCV antibodies who have a negative HCV RNA are presumed to have cleared the infection spontaneously.

HCV RNA testing occurred much less frequently in Eastern Europe than in Western Europe: only 46.4% received an HCV RNA test in Eastern Europe compared to 93.7% in Western Europe.

People from migrant communities were less likely to receive an HCV RNA test but people who inject drugs were more likely to receive an HCV RNA test than the population as a whole.

Of the entire population of people with HCV antibodies, 5027 had a positive HCV RNA result and 57.4% of all people with HCV antibodies remained HCV RNA positive in January 2015.

Of those who tested HCV RNA positive, 45.3% had an HCV genotype test.

Less than half of all those diagnosed with chronic infection had undergone any course of treatment by January 2015 (45.3%) and in the overwhelming majority of cases the treatment consisted of interferon and ribavirin. Only 9.4% received a course of interferon-free treatment with direct-acting antivirals.

Although 2079 people completed a course of treatment, the outcome of treatment was documented for only 1305 people due to lack of virological testing during and after treatment.

Just 285 people with chronic infection were cured of HCV in the period up to January 2015, approximately 5% of all those diagnosed with chronic infection.

Overall, the study found that substantial proportions of people were being lost at each stage of the care continuum and that access to treatment remained poor for people living with HIV.

By Keith Alcorn

References

Amele S et al. The hepatitis C continuum of care among HIV-infected individuals in EuroSIDA. 16th European AIDS Conference, 25-27 October, Milan, abstract PS9/1, 2017.

Berenguer J et al. HIV/HCV coinfection in Spain: elimination is a stone’s throw away. 16th European AIDS Conference, 25-27 October, Milan, abstract PS9/3, 2017.

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UK reports its first kidney transplants from HIV+ donor to HIV+ recipients http://www.eatg.org/news/uk-reports-its-first-kidney-transplants-from-hiv-donor-to-hiv-recipients/ Sat, 28 Oct 2017 11:08:27 +0000 http://www.eatg.org/?post_type=news&p=6597 Kidneys from a deceased HIV-positive donor were successfully transplanted in two HIV-positive recipients, U.K. researchers report.

While South African researchers have performed transplants involving HIV-positive donors and recipients with positive results, this was the first time the procedure was done in the U.K. “To date we have transplanted kidneys from three deceased HIV-infected donors into six HIV-infected patients with end-stage kidney disease,” Dr. Rachel Hilton of Guy’s Hospital in London told Reuters Health by email.

Accepting organs from HIV-positive donors for HIV-positive patients on the transplant waiting list could help ease the organ shortage, Dr. Hilton and her team note in their report, online September 18 in Clinical Kidney Journal. This would likely result in one or two organ donations from HIV-positive people per year, the researcher said.

“Nevertheless, a deceased person can donate two kidneys and many other organs and tissues, so a single organ donor may save or transform the lives of many other people,” she added.

The donor in the new report was a 55-year-old white male who died after a subarachnoid brain hemorrhage. His HIV was under control, with a viral load below 50 copies/ml for the past three years and a CD4 cell count above 200 cells mm3 for the past six years.

The recipients were a 60-year-old Black Caribbean male who had been on the deceased waiting list for 563 days, and a 45-year-old Black Caribbean male who had been on the list for 306 days.

Patient 1 required dialysis after transplant when he developed oliguric delayed graft function. At day 5, a kidney biopsy found acute T-cell-mediated rejection and arteritis. He responded well to 10 days of antithymocyte globulin, with kidney function improving to an estimated glomerular filtration rate (eGFR) of 38 ml/minute.

The allograft functioned immediately in patient 2, who was discharged from the hospital eight days after the procedure. His corrected eGFR is now 56 ml/min.

Two years after transplant, both patients are well and have their HIV under control, and have not required changes to their antiretroviral regimen.

“Modern highly effective antiretroviral therapy has transformed the lives of people infected with HIV so that this is now a chronic manageable disease, like, for example, diabetes,” Dr. Hilton said. “This in turn opens up the opportunity for people living with HIV to have access to treatments such as organ transplantation and the opportunity to donate their organs after death.”

She added: “Our programme is still in its infancy so we would like to gain confidence that longer-term outcomes for these recipients remain favourable. My hope for the future however is that newer antiretroviral agents, particularly those with few or no interactions with current immunosuppressive regimens, will enable even better outcomes for HIV-infected transplant recipients.”

SOURCE: http://bit.ly/2yN68o8

Clin Kidney J 2017.

By Anne Harding

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Fostemsavir for highly treatment-experienced participants: 24-week phase 3 results http://www.eatg.org/news/fostemsavir-for-highly-treatment-experienced-participants-24-week-phase-3-results/ Sat, 28 Oct 2017 11:06:15 +0000 http://www.eatg.org/?post_type=news&p=6604 The most important results at EACS 2017 on new pipeline compounds were the first phase 3 results for the investigational entry inhibitor fostemsavir.

As with any first drug in a new class, this data will provide hope for people with multidrug HIV resistance and whose combination is failing. For people in this situation, fostemsavir could be a life-saving drug.

Read the full publication here.

 

See also:

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New molecule shows promise in HIV vaccine design http://www.eatg.org/news/new-molecule-shows-promise-in-hiv-vaccine-design/ Sat, 28 Oct 2017 11:04:44 +0000 http://www.eatg.org/?post_type=news&p=6595 Vaccine candidate spurs animals to produce antibodies against protective sugars of multiple HIV strains

Researchers at the University of Maryland and Duke University have designed a novel protein-sugar vaccine candidate that, in an animal model, stimulated an immune response against sugars that form a protective shield around HIV. The molecule could one day become part of a successful HIV vaccine.

“An obstacle to creating an effective HIV vaccine is the difficulty of getting the immune system to generate antibodies against the sugar shield of multiple HIV strains,” said Lai-Xi Wang, a professor of chemistry and biochemistry at UMD. “Our method addresses this problem by designing a vaccine component that mimics a protein-sugar part of this shield.”

Wang and collaborators designed a vaccine candidate using an HIV protein fragment linked to a sugar group. When injected into rabbits, the vaccine candidate stimulated antibody responses against the sugar shield in four different HIV strains. The results were published in the journal Cell Chemical Biology on October 26, 2017.

The protein fragment of the vaccine candidate comes from gp120, a protein that covers HIV like a protective envelope. A sugar shield covers the gp120 envelope, bolstering HIV’s defenses. The rare HIV-infected individuals who can keep the virus at bay without medication typically have antibodies that attack gp120.

Researchers have tried to create an HIV vaccine targeting gp120, but had little success for two reasons. First, the sugar shield on HIV resembles sugars found in the human body and therefore does not stimulate a strong immune response. Second, more than 60 strains of HIV exist and the virus mutates frequently. As a result, antibodies against gp120 from one HIV strain will not protect against other strains or a mutant strain.

To overcome these challenges, Wang and his collaborators focused on a small fragment of gp120 protein that is common among HIV strains. The researchers used a synthetic chemistry method they previously developed to combine the gp120 fragment with a sugar molecule, also shared among HIV strains, to mimic the sugar shield on the HIV envelope.

Next, the researchers injected the protein-sugar vaccine candidate into rabbits and found that the rabbits’ immune systems produced antibodies that physically bound to gp120 found in four dominant strains of HIV in circulation today. Injecting rabbits with a vaccine candidate that contained the protein fragment without the sugar group resulted in antibodies that primarily bound to gp120 from only one HIV strain.

“This result was significant because producing antibodies that directly target the defensive sugar shield is an important step in developing immunity against the target and therefore the first step in developing a truly effective vaccine,” Wang said.

Although the rabbits’ antibodies bound to gp120, they did not prevent live HIV from infecting cells. This result did not surprise Wang, who noted that it usually takes humans up to two years to build immunity against HIV and the animal study only lasted two months.

“We have not hit a home run yet,” Wang noted. “But the ability of the vaccine candidate to raise substantial antibodies against the sugar shield in only two months is encouraging; other studies took up to four years to achieve similar results. This means that our molecule is a relatively strong inducer of the immune response.”

The researchers’ next steps will be to conduct longer-term studies in combination with other vaccine candidates, hone in on what areas of gp120 the antibodies are binding to and determine how they can increase the antibodies’ effectiveness at neutralizing HIV.

###

Other study co-authors affiliated with the Department of Chemistry and Biochemistry at the University of Maryland include former postdoctoral associate Hui Cai, faculty assistant John Giddens, former postdoctoral associate Jared Orwenyo, assistant research scientist Qiang Yang and graduate student Roushu Zhang.

This work was supported by the National Institutes of Health (Award No. R01AI113896). The content of this article does not necessarily reflect the views of the organization.

The research paper, “Synthetic Three-Component HIV-1 V3 Glycopeptide Immunogens Induce Glycan-Dependent Antibody Responses,” Hui Cai et al., was published in the journal Cell Chemical Biology on October 26, 2017.

About the College of Computer, Mathematical, and Natural Sciences

The College of Computer, Mathematical, and Natural Sciences at the University of Maryland educates more than 7,000 future scientific leaders in its undergraduate and graduate programs each year. The college’s 10 departments and more than a dozen interdisciplinary research centers foster scientific discovery with annual sponsored research funding exceeding $150 million.

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Home HIV tests might increase access to screening http://www.eatg.org/news/home-hiv-tests-might-increase-access-to-screening/ Sat, 28 Oct 2017 10:03:29 +0000 http://www.eatg.org/?post_type=news&p=6602 People can test themselves at home to see if they’re infected with HIV, and that might help reduce the number of undiagnosed infections, researchers say.

In a study of a new in-home HIV screening test, most participants were able to follow the instructions and get a valid result, researchers found.

In addition, most of them correctly interpreted the test results.

The test kit, developed in the UK and known as the BioSure HIV Self-Test (bit.ly/2ljai26), requires a drop of blood and is available in Europe for about £30 (about US$40). Before it was approved for self-testing, the same technology was already being used to test for HIV in doctors’ offices.

“In order for any HIV self-test to be approved for sale to the general public . . . it is necessary to show that people will be able to perform the test correctly by themselves,” study coauthor Dr. John Saunders of the Institute for Global Health at the University College London told Reuters Health by email.

“The findings were very reassuring,” he added. “They showed that the majority of people were able to perform the test and interpret the result correctly. This has meant that the self-test kit can now be sold to the general public, and this increases people’s choices for how they would like to test for HIV.”

Between 2014 and 2016, researchers recruited 200 participants over age 16 from a large sexual health clinic in London. Ninety percent were male, and about 75% were white.

As reported online September 18 in Sexually Transmitted Infections, the study – which was funded by the test’s manufacturer – had two parts. First, participants were given the test kits and asked to follow the instructions and complete the self-test while researchers observed them.

During the second part of the study, participants were given three dummy tests to see if they could accurately interpret test results as positive, negative, or invalid.

About 97% of the participants completed the test properly, and 94% of participants were able to read the dummy results correctly.

An HIV self-test provides several advantages, said Saunders.

“This will help to diagnose HIV before people become unwell and reduce HIV transmission by decreasing the number of people living with undiagnosed HIV infection and increasing the number of people successfully treated so that they are no longer infectious,” he said.

However, Saunders said, anyone who is testing for HIV, regardless of how and where the test will be done, may want to talk to a health professional beforehand and think about what they’ll do when they get the result.

Also, he pointed out, the self-test kit cannot reliably detect HIV infection that was acquired within the previous three months. “People concerned about a more recent exposure risk should consider other methods for testing and seek advice from health care providers,” he said.

In the United States, according to the U.S. Centers for Disease Control and Prevention (CDC), two home tests have been approved by the U.S. Food and Drug Administration. The Home Access HIV-1 Test System, which costs about US$60, requires the user to collect a drop of blood that must be sent to a lab for the actual testing. The user calls the lab, anonymously, for the test result.

The OraQuick In-Home HIV Test, which costs about US$40, looks for the virus in saliva, rather than in blood. Test results are available in about 20 minutes, but about 1 in 12 people who actually have the infection will get a result that incorrectly says they’re negative for it, the CDC says.

SOURCE: bit.ly/2hadmce

Sex Transm Infect 2017.

By Shereen Lehman

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HIV guidelines make special HPV recommendations for gay men http://www.eatg.org/news/hiv-guidelines-make-special-hpv-recommendations-for-gay-men/ Sat, 28 Oct 2017 09:45:37 +0000 http://www.eatg.org/?post_type=news&p=6598 MILAN — Gay and bisexual men with HIV should get vaccinated for human papillomavirus (HPV) up until age 40, according to updated guidelines from the European AIDS Clinical Society (EACS), released this week at the 16th European AIDS Conference. And others with HIV should be vaccinated until age 26, the guidelines state.

“We wanted to make a strong point that patients with HIV infection, and gay men in particular, should get vaccinated,” said Georg Behrens, MD, PhD, from the Hannover Medical School in Germany, who is chair of the comorbidities subcommittee of the EACS guidelines panel.

This differs from the US guidelines, which call for both men and women to be vaccinated for HPV until age 26 if they weren’t vaccinated as preteens or teenagers, but make no special recommendations for gay or bisexual men.

Emerging data show that HPV-related cancers are growing in prevalence in all people with HIV, including gay men.

HPV-related Cancers

People with HIV are 19 times more likely than those without HIV to be diagnosed with anal cancer, and women with HIV are three times more likely to be diagnosed with cervical cancer, according to the National Cancer Institute.

Gay men with HIV are nearly five times as likely as those without HIV to develop anal cancer, one study reports (J Acquir Immune Defic SynDr. 2008;48:491-499).

A poster also presented at the meeting showed that gay men with HIV who are older than 50 years have a lifetime risk for HPV-related anal cancers of 2.8%, which the Australian researchers called “alarmingly high.” In contrast, women younger than 50 years have a lifetime risk for anal cancer of 0.2%.

But until this year, EACS guidelines for HPV vaccination did not include men at all, said Dr Behrens. This is the case for guidelines from many countries, including his home of Germany.

“As chair of the panel, I was surprised” by the recommendation, Dr Behrens acknowledged. “But there was more or less agreement that we should move forward with this.”

The recommendations are part of a larger “rigorous approach to screening for detection of precancers under the guidelines,” said Lene Ryom, MD, PhD, from the University of Copenhagen, who is assistant guidelines coordinator.

Although the effect of the vaccine on adults who have already encountered high-risk strains of HPV is unclear, the aggressiveness of anal and other HPV cancers warrant the change, Dr Ryom told Medscape Medical News.

Antiretrovirals, Comorbidities, and ICU Guidelines

The new guidelines also include updates related to antiretroviral therapy. Dolutegravir plus rilpivirine combination therapy has been added as an option, reflecting results from the SWORD 1 and 2 trials.

Possible cardiovascular events associated with darunavir are now mentioned, reflecting findings from the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) study. The combination of lopinavir plus ritonavir — an old regimen — has been removed as an option. And a description of when to use the older formulation of tenofovir instead of the new prodrug tenofovir alafenamide has been added.

But the most comprehensive guidance comes in discussions about comorbidities, drug–drug interactions, and doctors in the intensive care unit who care for severely ill people with HIV.

“I said, ‘this must be included in the EACS guidelines’,” said Manuel Battegay, MD, from the University Hospital of Basel in Switzerland, who is guidelines coordinator. “It’s always the same question from intensive care: Can we give this ARV, and how — in the tube, or crushed, or whatever?”

For example, he pointed out, tenofovir should be swallowed whole, not chewed, broken, cut, or crushed, whereas other drugs can be dissolved in water.

The updated guidelines also include comorbidity sections on pulmonary disease and nonalcoholic fatty liver disease. And for the comorbidity section on solid organ transplant, it is recommended that the same criteria applied to the general public be applied to people living with suppressed HIV.

Overall, the guidelines move the field toward helping patients through a long life with HIV, said Dr Ryom.

The decision to use a specific antiretroviral or to switch regimens should be made on the basis of a patient’s risk profile. “Throughout the guidelines, there’s a strong aim toward doing personalized medicine. A lot of energy goes into making those particular considerations with your patients,” she added.

Dr Behrens has received grant funding from Gilead Sciences, Abbott, ViiV Healthcare, and MSD, and has served as a speaker for Gilead, ViiV, MSD, Janssen, and Hexal AG. Dr Ryom and Dr Battegay have disclosed no relevant financial relationships.

16th European AIDS Conference. Presented October 26, 2017.

By Heather Boerner

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The effect of ART on cervical cancer precursor lesions http://www.eatg.org/news/the-effect-of-art-on-cervical-cancer-precursor-lesions/ Sat, 28 Oct 2017 09:37:36 +0000 http://www.eatg.org/?post_type=news&p=6600 In The Lancet HIV, researchers presented a meta-analysis of the effect of antiretroviral therapy (ART) on high-risk human papillomavirus (HPV)-induced cervical lesions in women living with HIV. Cervical cancer is the most common cancer affecting women in low-income and middle-income countries and the most common cancer in women living with HIV.

Read the full analysis here.

Read an accompanying comment here.

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Italian man sentenced to jail for infecting 30 women with HIV http://www.eatg.org/news/italian-man-sentenced-to-jail-for-infecting-30-women-with-hiv/ Sat, 28 Oct 2017 09:10:08 +0000 http://www.eatg.org/?post_type=news&p=6599 An HIV-positive man has been sentenced to 24 years in jail for infecting at least 30 women despite knowing his status. The Italian man convinced women to have unprotected sex with him by saying he’d recently been tested.

A court in Italy on Friday sentenced an HIV-positive man to 24 years in prison for intentionally infecting dozens of women with the virus over a nearly 10-year period.

Valentino Talluto, a 33-year-old accountant, seduced numerous women using social networks and internet dating sites, often dating several at the same time.

Police believe he had sex with at least 53 women between 2006 — when Talluto discovered he was HIV-positive — and his arrest in November 2015.

He passed the virus to 32 of them, often convincing his partners to have unprotected sex by saying he was allergic to condoms or that he just had an HIV test, according to testimony in the Rome court.

The male partners of three of the women and the 8-month-old baby of a fourth woman subsequently contracted the virus, which damages the immune system and causes AIDS.

Court declines life sentence

Prosecutors in Rome requested a life-sentence for Talluto, but after 12 hours of deliberation, the court decided he did not cause an epidemic by spreading a pathogen. Instead, they convicted him of “grievous and incurable bodily harm.”

“Talluto has never cooperated, he has made false statements, he has always denied any responsibility, even in the face of the evidence,” prosecutor Elena Neri told the court last month.

“His actions were intended to sow death,” she added.

The man’s defense lawyers maintained his actions were “imprudent, but not intentional.” They described Talluto as a young man eager for affection after his mother, a drug addict who was also HIV-positive, died when he was 4 years old.

Talluto expressed regret before the court for what had happened but said he didn’t realize the consequences of his actions.

Many of the women discovered they were HIV-positive by chance due to health problems or after they learned of Talluto’s arrest. The youngest of the victims was 14 years old at the beginning of her relationship with the defendant while the oldest was around 40. The age of consent in Italy is 14.

Around 35 million people around the world have died from the HIV/AIDS pandemic since it began in the 1980s.

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WHO to review its interim guidance on the use of delamanid in the treatment of MDR-TB http://www.eatg.org/news/who-to-review-its-interim-guidance-on-the-use-of-delamanid-in-the-treatment-of-mdr-tb/ Sat, 28 Oct 2017 09:00:39 +0000 http://www.eatg.org/?post_type=news&p=6601 WHO to review its interim guidance on the use of delamanid in the treatment of multidrug-resistant TB following the release of Phase III clinical trial results

The World Health Organization (WHO) has started preparations for a rapid review of its interim guidance on the use of delamanid in the treatment of patients with multidrug-resistant tuberculosis (MDR-TB). This follows the release of the phase III randomised control trial results by Otsuka Pharmaceutical at the 48th Union World Conference on Lung Health on 13 October.

Read the full announcement here.

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NIH study identifies new targets for anti-malaria drugs http://www.eatg.org/news/nih-study-identifies-new-targets-for-anti-malaria-drugs/ Sat, 28 Oct 2017 08:55:00 +0000 http://www.eatg.org/?post_type=news&p=6603 The deadliest malaria parasite needs two proteins to infect red blood cells and exit the cells after it multiplies, a finding that may provide researchers with potential new targets for drug development, according to researchers funded by the National Institutes of Health. Their study appears in the latest issue of Science.

Plasmodium falciparum, the species of parasite that causes the most malaria deaths worldwide, has developed drug-resistance in five countries in Southeast Asia.

In the current study, researchers sought to uncover the role of plasmepsins IX and X, two of the 10 types of plasmepsin proteins produced by P. falciparum for metabolic and other processes. They created malaria parasites that lacked plasmepsin IX or X under experimental conditions and compared them to those that had the two proteins.

The team found plasmepsin IX in rhoptries, specialized cell structures inside the parasite, which help it invade red blood cells. Parasites lacking plasmepsin IX had defective rhoptries. In addition, the team observed plasmepsin X in exonemes — small vesicles (balloon-like structures) that help malaria parasites exit infected cells. The team also discovered that plasmepsin X processes an important protein called SUB1. When deprived of plasmepsin X, the parasites couldn’t process SUB1 and couldn’t infect red blood cells or exit these cells after multiplying.

The researchers also identified three experimental malaria drugs that may work by targeting plasmepsin X. One drug, called CWHM-117, has already been tested in a mouse model of malaria. The new findings may help researchers modify CWHM-117 to make it more effective. Furthermore, parasites lacking the plasmepsins could potentially be used to screen candidate drugs to identify additional anti-malaria compounds.

The study was conducted in part by researchers from NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the Washington University School of Medicine in Saint Louis. Funding also was provided by the National Institute of Allergy and Infectious Diseases, the National Heart, Lung, and Blood Institute, and the National Institute of General Medical Sciences.

Who

Joshua Zimmerberg, M.D., Ph.D., study author and head of NICHD’s Section on Integrative Biophysics, is available for interviews.

Article

Nasamu AS, Glushakova S, Russo I, Vaupel B, Oksman A, Kim AS, Fremont DH, Tolia N, Beck JR, Meyers MJ, Niles JC, Zimmerberg J, and Goldberg DE. Plasmepsins IX and X are essential and druggable mediators of malaria parasite egress and invasion. Science DOI: 10.1126/science.aan1478 (2017)

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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US: HCV rates double in pregnancy, up risk for vertical transmission http://www.eatg.org/news/us-hcv-rates-double-in-pregnancy-up-risk-for-vertical-transmission/ Sat, 28 Oct 2017 08:47:42 +0000 http://www.eatg.org/?post_type=news&p=6594 Researchers in one US state have reported almost a doubling in the proportion of pregnant Medicaid recipients who had hepatitis C virus (HCV) infection, with obvious implications for vertical transmission of the virus from mother to child.

They explain that the exponential increase in hepatitis C among women of childbearing age is attributed to the opioid crisis in the United States.

“Fueled by the increase in injection drug use ensuing from the opioid epidemic, the proportion of infants born to HCV-infected women is increasing nationwide,” say Theresa Watts, MPH, and colleagues in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report, published online October 27.

“Vertical transmission is the most common mechanism of HCV infection for children, reported to occur in approximately 6% of infants born to women with HCV infection, and approximately twice as often in women who are coinfected with HCV and human immunodeficiency virus (HIV),” they explain.

But they also found that only a third of newborns in the state, Wisconsin, were tested for HCV infection.

“Improvements in HCV screening practices among pregnant women and infants could enhance identification of infants at risk for vertical transmission of HCV,” they stress.

Substantial Gap in Monitoring Infants at Risk for HCV Vertical Transmission

The aim of the current study was to estimate the proportion of women enrolled in Wisconsin Medicaid with HCV infection during pregnancy and estimate the frequency of HCV testing and infection in infants born to HCV-infected women.

Maternal name and date of birth from HCV reports in the Wisconsin Electronic Disease Surveillance System were linked to Wisconsin Medicaid data for 2011–2015 births.

During this period, in the Wisconsin Medicaid population, the proportion of women who had evidence of HCV infection during pregnancy increased 93%, from 1 in 368 pregnancies to 1 in 192.

But only 34% of the infants born to women with evidence of HCV viremia during pregnancy were tested for HCV according to recommendations, “revealing a substantial gap in monitoring infants at risk for HCV vertical transmission,” the researchers say.

Mother-to-infant vertical transmission was documented in 4% of infants (7 of 183 born to women with evidence of HCV viremia during pregnancy).

“Clinical signs of pediatric HCV infection often manifest slowly and can range in severity from being asymptomatic to fatal; liver transplantation is sometimes required,” the authors note.

The current recommendation for identification of HCV during pregnancy is for risk-based screening.

Pregnancy and postpregnancy care are ideal times to test women and link those with infection to HCV care or treatment because these are times when women typically use healthcare services, the authors explain.

However, “unlike other bloodborne infectious diseases that have a risk for vertical transmission, such as hepatitis B virus or HIV, for HCV there is no perinatal intervention available that has been shown to reduce vertical HCV transmission,” they note.

But presence of maternal HCV viremia (HCV RNA positivity) is a risk factor thought to increase the likelihood of vertical HCV transmission.

“To improve surveillance of HCV vertical transmission, support identification of cases, and evaluate health outcomes of infected infants,” it would be pertinent for state and local health departments to follow guidelines issued in a recent position statement for reporting and national notification of perinatal HCV infection, issued by the Council of State and Territorial Epidemiologists

“Adoption of this position statement…along with enhanced identification of HCV among women of childbearing age, can improve care for HCV-infected women and infants at risk for HCV vertical transmission,” the study authors conclude.

The authors have disclosed no relevant financial relationships.

MMWR Morb Mortal Wkly Rep. Published online October 27, 2017. Full text

By Troy Brown

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New EACS treatment guidelines http://www.eatg.org/news/new-eacs-treatment-guidelines/ Thu, 26 Oct 2017 21:59:14 +0000 http://www.eatg.org/?post_type=news&p=6581

Everyone with HIV and HCV co-infection should receive direct-acting antiviral treatment for hepatitis C and should receive the same treatment for hepatitis C as people with hepatitis C monoinfection, new European guidelines issued at the 16th European AIDS Conference recommend.

The guidelines, formulated by the European AIDS Clinical Society, are intended to set a standard of care for the entire European region including Eastern Europe. The guidelines are revised every two years and updated in between as new evidence arises.

Among the other major additions and changes, European experts in HIV medicine now recommend:

  • Downgrading the use of atazanavir/ritonavir in first-line treatment owing to kidney toxicity
  • People with HIV should be considered for organ transplantation according to the same criteria as everyone else.
  • Doctors should consider screening for non-alcoholic fatty liver disease, especially in patients with metabolic syndrome, owing to the high prevalence of the condition in people with HIV.
  • Screening for chronic lung disease should become standard practice in smokers and people over the age of 40.
  • HPV vaccination is now recommended for all people with HIV under 26 and all MSM up to the age of 40.

The full guidelines document is available to download from the EACS website or as an app. The guidelines also include links to video tutorials on aspects of diagnosis and consultation.

Viral hepatitis

The guidelines now recommend that people with HIV and HCV co-infection should receive direct-acting antiviral treatment for hepatitis C and should receive the same treatment for hepatitis C as people with hepatitis C mono-infection. There is no need for longer courses of treatment and the only HIV-specific consideration that should drive the selection of regimen is the potential for drug-drug interactions.

In patients who do not clear hepatitis C after a first course of direct-acting antiviral treatment, the guidelines recommend assembly of a regimen after resistance testing.

Interferon-based treatment is no longer recommended for treatment in primary HCV infection. A new algorithm guides physicians in determining when to treat acute HCV infection. Treatment should be initiated if HCV RNA has not fallen by at least 2 log four weeks after diagnosis or if the patient still has detectable HCV RNA 12 weeks after diagnosis despite a 2 log reduction at week 4.

Antiretroviral therapy

There are no changes in the first-line regimens recommended by EACS in the 2017 guidelines, except for a downgrading of atazanavir/ritonavir. EACS continues to recommend that first-line treatment should be based on tenofovir and emtricitabine or abacavir and lamivudine, with the use of tenofovir alafenamide preferred in cases where there is: an established or high risk of chronic kidney disease; co-medication with nephrotoxic drugs or prior TDF toxicity; osteoporosis / progressive osteopenia or risk factors; or, a history of fragility fracture.

All integrase inhibitors, the non-nucleoside reverse transcriptase inhibitor rilpivirine and the boosted protease inhibitor darunavir are the preferred third agents for first-line treatment. Atazanavir/ritonavir has been downgraded to an alternative option owing to the frequency of kidney toxicity in people taking the drug.

The combination of dolutegravir and rilpivirine has been added as a switch option, but the guidelines stress that dolutegravir monotherapy should not be used as a switch option owing to the high risk of viral rebound and cross-class drug resistance.

Solid organ transplantation

A new section on solid-organ transplantation has been added to the guidelines. The guidelines panel states that people living with HIV should be considered for organ transplantation using the same indications as used in HIV-negative people.

Non-alcoholic fatty liver disease

New guidance on the management of non-alcoholic fatty liver disease (NAFLD) has been added, following the findings that around half of people with HIV referred for investigation after abnormal liver function tests turn out to have NAFLD.

NAFLD consists of a spectrum of liver damage caused by metabolic disorders and lifestyle factors highly prevalent in people living with HIV, including obesity, high cholesterol and triglyceride levels, diabetes and other metabolic disorders. These disorders lead to fat accumulation in the liver and eventually to the development of fibrosis – non-alcoholic steatohepatitis (NASH) – and cirrhosis in a minority of patients. The high prevalence of NAFLD – up to 30-40% in US cohorts – in people living with HIV means that the prevalence of fibrosis and cirrhosis in people without risk factors of viral hepatitis or chronic alcohol abuse will also be higher in this population.

Diagnosis of NAFLD in patients with abnormal liver function and no viral hepatitis or history of alcohol abuse should be carried out by ultrasound with the use of biopsy to confirm NASH in more advanced cases. Ultrasound imaging of the liver should also be considered in patients with metabolic syndrome and no other risk factors for fibrosis and normal liver enzymes, with repeat follow-up every two to five years depending on the presence of steatosis (fat accumulation in the liver).

Lifestyle modification to reduce weight and metabolic risk factors is the cornerstone of treatment. Lipid-neutral antiretroviral regimens should also be considered as a means of modifying metabolic risk factors.

Chronic lung disease

The guidelines include new recommendations on chronic lung disease including chronic obstructive pulmonary disease (COPD).

Low CD4 count can exacerbate COPD but it is the high prevalence of smoking among people with HIV that makes chronic lung disease a growing problem as the population of people with HIV ages.

EACS recommends that all patients should be screened for chronic lung disease if they are aged 40 or over or if they have smoked for the equivalent of ten years. Regular wheezing, cough or shortness of breath on exertion should prompt further investigation in these patients to diagnose COPD. If symptoms do not improve with use of a single bronchodilator further treatment should be tailored to symptoms. There is no evidence that use of oral glucocorticoids has benefit in COPD and inhaled glucocorticoids should not be used with boosted antiretroviral regimens. Influenza and pneumococcal vaccinations are proven to reduce the incidence of lower respiratory tract infections in people. Smoking cessation is a lifesaving intervention in this population.

HPV

Human papillomavirus (HPV) vaccination is now recommended for everyone living with HIV aged under 26 and all men who have sex with men (MSM) up to the age of 40.

By Keith Alcorn

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