WHO_EU | 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 ViiV Healthcare, Medicines Patent Pool extend licence for dolutegravir to all lower middle-income countries http://www.eatg.org/news/viiv-healthcare-medicines-patent-pool-extend-licence-for-dolutegravir-to-all-lower-middle-income-countries/ Wed, 04 May 2016 13:15:15 +0000 http://www.eatg.org/?post_type=news&p=515

Specifically benefits more than 270,000 people living with HIV in Armenia, Moldova, Morocco and Ukraine 

Geneva, 25 April 2016  The Medicines Patent Pool (MPP) and ViiV Healthcare announced an extension of their current licensing agreement today to increase access to dolutegravir (DTG), a promising new antiretroviral, to cover all remaining lower middle-income countries. The amendment to the 2014 licence specifically allows generic medicine distribution in four countries with patents – Armenia, Moldova, Morocco and Ukraine – that were not covered in the initial agreement. MPP sub-licensees can now sell in countries that are home to 94% of people living with HIV in the developing world.

The expansion comes on the heels of ViiV Healthcare majority shareholder GlaxoSmithKline’s March 31 announcement of its new approach to managing intellectual property based on country economic maturity, and its intention of broadening licensing for countries that fall under the lower middle-income category as defined by the World Bank.

As a result, the MPP licence for DTG adult formulations now includes 92 developing countries, including 59 middle-income nations. In addition, countries without patents in force are able to procure generic products from MPP sub-licensees, extending access to many more countries.

“This is great news for communities battling the epidemic in lower middle-income nations, specifically for Armenia, Moldova, Morocco and Ukraine where an estimated 270,000 people live with the virus,” said Greg Perry, Executive Director of the MPP. “We congratulate ViiV Healthcare, a longtime MPP partner, for taking this key step in expanding our already broad licence.”

In 2014, ViiV Healthcare granted MPP two non-exclusive licences for DTG: one for the production of the medicine for adults and another for children. Both licences permit generic manufacturers based anywhere in the world to manufacture DTG and to combine the medicine with other drugs to develop fixed-dose combinations (FDCs). To date, nine generic manufacturers have signed MPP sub-licences for DTG and are actively developing the treatment.

“ViiV Healthcare has worked with the Medicines Patent Pool for many years and we are pleased to continue our work with the organisation to further improve access to innovative medicines to address the burden of HIV,” said Dr. Dominique Limet, CEO of the company. “It is also a great testament to the success we have had working with the MPP that GSK is now looking at expanding this collaboration for access to medicines beyond HIV treatments.”

DTG is considered a significant advancement in HIV treatment. The medicine does not require boosting and has a good barrier to resistance, and efficacy and tolerability profile at very small doses. Moreover, the medicine can be used for patients that have never taken HIV therapy as well as for many that have developed resistance to their current regimens. The World Health Organization recommended DTG as an alternative first-line treatment for adults in 2015.

The DTG licences and amendment build on the MPP and ViiV Healthcare’s long-term partnership. In February 2013, ViiV Healthcare granted the MPP a paeadiatric licence for abacavir (ABC), a key WHO-recommended antiretroviral for children, for 121 countries.

Supportive Endorsements:

“I salute this remarkable advancement,” said Philippe Douste-Blazy, Chair of the Executive Board at UNITAID, MPP’s funder. “Five years ago when we started the Medicines Patent Pool, it was just a novel concept. Now the organisation is a key player in the global health community in helping speed life-saving medicines such as dolutegravir to low- and middle-income countries. Ensuring these medicines reach the poorest and most vulnerable citizens is our overriding goal.”

“This announcement comes at an important time for Ukraine, as we seek to ensure access to HIV treatment for those in need, and need access to the best possible medicines at the lowest possible prices. We welcome the inclusion of Ukraine in the licence,” said Ihor Perehinets, Deputy Minister, Ministry of Health of Ukraine.

“For people living with HIV in Morocco, access to new generation HIV medicines, like DTG, is crucial. DTG has great potential for improving treatment options in middle-income countries given its high effectiveness and low side effects. We welcome this announcement,” said Hakima Himmich, President of the Association de lutte contre le sida (ALCS).

“This is very good news for Moldova. New medicines with high efficacy and low side effects like dolutegravir can contribute to improving living conditions for people living with HIV. We look forward to working with all stakeholders in Moldova to make sure new and improved treatments become accessible to all people in need as soon as possible,” said Alexandr Curasov, Executive Director at the Positive Initiative in Moldova and Communities Delegation Board Member at the Global Fund to Fight AIDS, Tuberculosis and Malaria.

“We welcome the expansion of the Medicines Patent Pool licence, as dolutegravir is a promising new treatment. Taking into account the huge demand for treatment in Ukraine and the existing funding gap due to currency devaluation, we stress the urgent need for improving access to patented antiretrovirals like dolutegravir in Ukraine. The All-Ukrainian Network’s mission is to ensure access to HIV treatment for all people living with HIV, and this announcement is an important step in that direction,” said Dmytro Sherembey, Head of Coordination Council of the All-Ukrainian Network of PLWHA.

Additional Supportive Endorsements:

“The inclusion of Morocco in the MPP-ViiV licence on dolutegravir is great news for us.  Dolutegravir is a very interesting new treatment that could play an important role in the HIV response in our country.  Having access to the drug at affordable prices is key and we congratulate both parties for this important agreement” said Pr El Houssaine Louardi, Minister of Health of the Kingdom of Morocco.

The amended and restated agreements are available here.

About the Medicines Patent Pool

The Medicines Patent Pool is a United Nations-backed public health organisation working to increase access to HIV, viral 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 six patent holders for twelve HIV antiretrovirals and for one hepatitis C direct-acting antiviral. Its generic partners have distributed more than three billion doses of low-cost medicines to 117 countries. The MPP was founded and remains fully funded by UNITAID.

HCV associated with increased risk of cancers of the head and neck http://www.eatg.org/news/hcv-associated-with-increased-risk-of-cancers-of-the-head-and-neck/ Wed, 04 May 2016 13:13:20 +0000 http://www.eatg.org/?post_type=news&p=514

Infection with hepatitis C virus (HCV) is associated with an increased risk of head and neck cancer (HNCs), investigators from the United States report in the Journal of the National Cancer Institute. The risk of certain cancers was especially high for patients who were also infected with human papillomavirus (HPV).

Overall, HCV was associated with an almost three-fold increase in the risk of head and neck cancers.

“Our results add to the growing body of epidemiological evidence that HCV infection has extrahepatic manifestations and may well be associated with non-liver related cancers,” comment the authors. “Clinicians should be aware that nonliver cancers…can develop in patients chronically infected with HCV.”

Approximately 2.7 to 3.9 million individuals in the United States are chronically infected with HCV. It is well known that HCV infection increases the risk of liver cancer and it has also been associated with an increased risk of non-Hodgkin lymphoma.

In 2009, clinicians from the National Cancer Institute established a centre specialising in the treatment of cancers in patients with HCV. An unexpectedly large number of cases of head and neck cancers were observed. Investigators therefore designed a case-controlled study to determine if HCV infection increased the risk of these cancers.

Records of patients who received care at the clinic and who were tested for HCV between 2004 and 2014 were analysed.

Cases were patients with head and neck cancers, including oropharyngeal and non-oropharyngeal (oral cavity, nasopharynx, hyopharynx and larynx) cancers. Controls were patients with smoking-related cancers (lung, esophagus and urinary bladder). Biopsy reports were obtained to see if cancers were positive for HPV. Patients with lymphoma were excluded.

The study population comprised 1103 patients: 409 cases and 694 controls.

Most patients were male, white and were born between 1945-65. Approximately half were current smokers and 52% reported alcohol consumption at the time of cancer diagnosis. Overall, 11% of patients had antibodies to HCV infection.

HCV prevalence was higher among patients with oropharyngeal cancers (14%), particularly HPV-related oropharyngeal cancers (17%) compared to controls (6.5%).

After adjustment for age, sex, age, smoking and alcohol consumption, HCV was associated with a more than two-fold increase in the risk of oropharyngeal cancers (OR = 2.04; 95% CI, 1.04-4.01). Separate analyses were then performed for HPV-related and non-HPV-related oropharyngeal cancers. HCV was associated with an increased risk of HPV-related cancers (OR = 2.97; 95% CI, 1.31-6.76) but not non-HPV-related tumours (OR = 1.44; 95% CI, 0.39-5.30).

HCV prevalence was also higher among patients with non-oropharyngeal cancers (20%) than controls (6.5%).

After adjustment for confounding factors, the investigators found that HCV increased the risk of non-oropharyngeal cancers almost three-fold (OR = 2.85; 95% CI, 1.38-5.88).

Final analysis showed that HCV was associated with a significant increase in the risk of non-oropharyngeal cancers (OR = 3.17; 95% CI, 1.49-6.73) but not nasopharyngeal cancers (OR = 1.3; 95% CI, 0.22-7.64).

“HCV is statistically significantly associated with not only non-oropharyngeal cancer (except nasopharyngeal) HNCs but also with HPV-related oropharyngeal cancers,” comment the investigators. “Oncologists treating patients with HNCs should consider testing patients for HCV to enable early identification and linkage to care for this disease to prevent progression of underlying liver disease.”

The authors conclude that HCV appears to increase the risk of head and neck cancers. They call for further research to validate their findings.

By Michael Carter


Mahale P et al. Association between hepatitis C virus and head and neck cancers. J Natl Cancer Inst 108(8): djw035. DOI:10.1093/jnci/djw035 (2016).

Source Sourceinfohep

From over 90 000 cases to zero in two decades: the European Region is malaria free http://www.eatg.org/news/from-over-90-000-cases-to-zero-in-two-decades-the-european-region-is-malaria-free/ Tue, 03 May 2016 17:14:26 +0000 http://www.eatg.org/?post_type=news&p=508 The European Region is the first in the world to have achieved interruption of indigenous malaria transmission. The number of indigenous malaria cases dropped from 90 712 in 1995 to zero cases in 2015. Ahead of World Malaria Day 2016, WHO announces that the European Region hit its 2015 target to wipe out malaria, thus contributing to the global goal to “End malaria for good”. Key partners funded malaria elimination efforts in European countries substantially.

“This is a major milestone in Europe’s public health history and in the efforts to eliminate malaria globally. I applaud this achievement as the result of strong political commitment from European leaders with WHO support”, says Dr Zsuzsanna Jakab, WHO Regional Director for Europe. “This is not only the time to celebrate our success but is also the opportunity to firmly maintain the malaria-free status we have laboriously attained. Until malaria is eradicated globally, people travelling to and from malaria-endemic countries can import the disease to Europe, and we have to keep up the good work to prevent its reintroduction”.

The path towards malaria elimination: from Tashkent to the Regional Strategy

The 2005 Tashkent Declaration “The Move from Malaria Control to Elimination”, endorsed by malaria-affected countries in the Region, was a turning-point in achieving a malaria-free Europe. The Declaration led the way to the new Regional Strategy 2006–2015, which guided affected European countries to reduce the number of indigenous malaria cases to zero.

This achievement was made possible through a combination of strong political commitment, heightened detection and surveillance of malaria cases, integrated strategies for mosquito control with community involvement, cross-border collaboration and communication to people at risk. When a country has zero locally acquired malaria cases for at least three consecutive years, it is eligible for official certification of malaria elimination by WHO.

Avoiding malaria reintroduction: the Ashgabat high-level meeting

“The European Region has been declared malaria free on the basis of the present situation and the likelihood that elimination can be maintained. This means that we cannot afford to drop our guard on this disease”, concludes Dr Nedret Emiroglu, Director of Communicable Diseases and Health security, WHO Regional Office for Europe. “Experience shows that malaria can spread rapidly, and, if Europe’s countries are not vigilant and responsive, a single imported case can result in resurgence of malaria”.

On 21–22 July 2016, WHO will convene its first high-level meeting on prevention of malaria reintroduction, in Ashgabat, Turkmenistan. European countries at risk of malaria reintroduction will come together to prevent the return of malaria to the European Region through:

  • sustained political commitment;
  • strong vigilance to test and treat all malaria cases promptly;
  • understanding how malaria transmission could be reintroduced and the risk it poses; and
  • immediate action if local malaria transmission resumes.

The meeting outcome will pave the way for preventing malaria from affecting Europe again.