Most Americans with HCV not receiving DAAs

More than 2 million people in the United States have hepatitis C virus (HCV), and most of them have not received direct-acting antivirals (DAAs) that could cure more than 95% of these infections, according to a new report by the CDC.

The new CDC study indicates “jarringly low numbers” of people with known HCV infection are being cured, said Carolyn Wester, MD, MPH, the director of the Division of Viral Hepatitis at the CDC (MMWR Morbid Mortal Wkly Rep 2023;72(26):716–720).

More than 15,000 people with HCV die each year in the United States, most of whom could have been cured with DAAs, which cure more than 95% of patients who receive them (JAMA 2023;329[15]:1251-1252. doi:10.1001/jama.2023.3692).

“[HCV is] known as the silent killer because initial infection usually has few to no symptoms. But over time, the virus can slowly cause damage to the liver. It can cause liver cancer, liver failure and death,” said Jonathan Mermin, MD, MPH, the director of the CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention. He added that up to 1 million Americans could be undiagnosed.

“Nearly 10 years ago, medical researchers developed several highly effective cures for hepatitis C. The nation had in our hands the key to preventing tens of thousands of cases of liver cancer, liver failure and deaths from hepatitis C,” he said at a media briefing on June 29.

“Thousands of people are dying every year in our country and many more are suffering from an infection that has been curable for over 10 years. Only one-third of people diagnosed with hepatitis C have been cured,” Dr. Mermin said.

Dr. Mermin put the abysmal statistic clearly at the feet of third-party payors. “This is mostly because insurers have placed obstacles in the way of people and their doctors, preventing patients from accessing treatment. It is time we remove these barriers and expanded public health systems to prevent new infections.”

The CDC study used data from commercial laboratories about more than 1 million people nationwide who were diagnosed with HCV between 2013 and 2022, according to Dr. Wester, which she called a significant period because several DAAs were available then.

The data indicate the proportions of people cured were:

• low overall and across all age and insurance groups analyzed;
• lowest among people without health insurance or with Medicaid coverage, as well as adults younger than 40 years—a group that has the highest rates of new HCV infections; and
• highest among people 60 years and older with Medicare or commercial insurance, yet still less than half had been cured.

“Overall, only one in three people diagnosed with hepatitis C were cured, and only one in six adults under the age of 40 without health coverage were cured,” Dr. Wester said.

“Today’s study shows that nearly a decade after highly effective cures became available, the vast majority of people with hepatitis C have not been cured. So why is this?” she asked.

Although there are many reasons, she highlighted two:

One, because of the high cost of treatment, some payors limit eligibility for treatment or require burdensome prior authorization before treatment can begin, or even limit the types of providers who can prescribe treatment. “All of these restrictions can delay or even prohibit access to these lifesaving medications,” she said.

“The cost of therapy has been a real barrier to many programs,” added Francis S. Collins, MD, PhD, of the National Institutes of Health (NIH), lead of the White House National Hepatitis C Elimination Program, including government programs like Medicaid for people with low incomes.

However, he said, many insurers are reacting to pricing from several years ago, which has gone down significantly from about $90,000 to $24,000 for treatment. Still, he admitted that was still high for many insurers.

Two, hepatitis C is a silent killer. The CDC estimates about 40% of people with HCV are unaware of their infection.

“So, while this study looks at treatment gaps among people with diagnosed hepatitis C, there is also a great need to increase screening and testing for hepatitis C. The CDC recommends that everyone be tested for hepatitis C at least once in their lifetime,” Dr. Wester said, adding that “overcoming these barriers can make the difference between life and death.”

The findings highlight the urgent need to act boldly, according to Dr. Collins, who discussed a proposed national program that could eliminate HCV in the United States, if DAAs were more widely prescribed.

“The CDC report you’ve just heard highlights an urgent need for a bold response to hepatitis C. And the cure that’s been available now for 10 years is very simple: one pill a day for eight to 12 weeks, very limited side effects,” Dr. Collins said, as opposed to previous more toxic interferon treatment, which was not very effective.

If implemented, the National Hepatitis C Elimination Program, seeking support from Congress, could prevent tens of thousands of cases of liver cancer and liver failure. The cost of the program would be offset by the prevention of cancer and other conditions, which “will add up to a huge amount of cost savings downstream.”

Because Medicare copays can run as high as $4,000, cost can still be an obstacle, even if it is covered and approved, Dr. Collins said. So, the new program will create an innovative model, called a subscription model, to deal with the cost. The program was piloted in Louisiana, and was quite successful.

Louisiana worked with Gilead and AbbVie, companies that manufacture DAAs, and paid a lump sum to make the drug available for free to Medicaid patients and federal prisoners. The arrangement was successful in getting more people on DAAs, Dr. Collins said.

The proposal on the table is to do the same on a national level to ensure that underserved individuals have access to these lifesaving treatments, he said.

In addition, Dr. Colllins wanted to see more people tested for HCV to find asymptomatic infections. However, testing can be cumbersome because an antibody test and then an RNA test are needed, and both must be sent to a laboratory for the results.

“There can be a long delay, and we lose a lot of people along the way,” Dr. Collins said. Some overseas countries have access to a rapid point-of-care test, and the NIH and FDA are working on clearance of a test that could give results in an hour or less.

The final piece would be a “well-funded” public health education campaign to get people tested, provide information about HCV and see more people treated for infection.

Although the program would be expensive, it would be offset by the number of lives saved and expensive treatments like liver transplants that were not done, according to Dr. Collins. In the long-run the program would save the government more than $13 billion in 10 years.

“The president has asked Congress to front-load this bold five-year initiative, with $5 billion to $6 billion over the current expenditures on hepatitis C. That’s a significant investment,” he admitted, but said an economic analysis by the National Bureau of Economic Research estimate this program would save the federal government more than $13 billion just in the first 10 years and $44 billion in 20 years, by preventing liver transplants, treatment for cirrhosis and treatment for liver cancer, as well as cases of diabetes and kidney failure (another symptom of HCV).

“It’s rare, in my experience, to have an opportunity to both save lives and save money,” Dr. Collins said. “How often do we have the chance to eliminate a terrible disease that has already taken way too many lives and to do so with a simple oral therapy that has very few side effects? We have an opportunity to do something truly historic.”

By Marie Rosenthal, MS

SEE ALSO:

• MedPage Today: ‘Jarringly’ low hep C cure rates a decade after new treatments, CDC says