WASHINGTON – “We don’t get to use the ‘eliminate’ word all that often with a disease that’s taking thousands or tens of thousands – or worldwide, hundreds of thousands – of lives every year, but we have that opportunity with hepatitis C.”
So said Francis S. Collins, MD, PhD, special projects advisor to the Executive Office of the President of the United States, and former director of the National Institutes of Health, speaking at a special session outlining ambitious goals for a national plan to eliminate hepatitis C virus (HCV) infections by the year 2050.
The session was held at the annual meeting of the American Association for the Study of Liver Diseases.
A public health crisis
Dr. Collins labeled HCV a public health crisis, citing statistics from the Centers for Disease Control and Prevention that show that the rate of reported acute HCV infection cases increased 400% between 2010 and 2020, with the highest rates among young adults aged 20-39 years.
In addition, an estimated 2.4 million people in the United States are living with chronic HCV infections, but as many as 40% of these people are unaware of their infection, despite broad recommendations for the screening of all adults aged 18 years and older, he said.
“Our goal is to try to do something to change this,” Dr. Collins said. He noted that for the past 8 years we have had highly effective oral agents that don’t just treat the disease but cure it – 95%-97% of the time, with only 8-12 weeks of oral therapy and relatively few side effects.
“A wonderful story, one of the most exciting stories that’s come out of biomedical research in the last couple of decades,” he said.
Yet Dr. Collins also acknowledged that the task of developing a national plan is daunting, despite that pharmaceutical triumph.
National pharmacy claims data show that the number of persons treated for HCV with direct-acting antiviral agents (DAAs) in the United States declined from a high of 164,247 in 2015 to 83,740 in 2020.
Furthermore, CDC data from 2019 and 2020 show that, of persons with a diagnosis of HCV infection, only 23% of those on Medicaid, 28% of those on Medicare, and 35% of those with private insurance were treated for their infections.
“We have a huge gap here between the ability to know you have the disease and to get treatment, and we don’t see the numbers here for the uninsured, or people in prisons, but they’re probably much worse,” he said.
Obstacles abound, as do ways to overcome them
Current barriers to treatment include the aforementioned lack of awareness of infection, a “clunky” two-step diagnosis requiring an antibody test followed by an RNA or core antigen test necessitating three visits often separated by several weeks, and the high cost of treatment (around $90,000 per patient).
In addition, insurers commonly require proof that patients remain sober for extended periods, insist that treatment monitoring be performed by specialists only, and often approve treatment only for those patients who have documented evidence of liver damage.
“Does that make sense to you?” Dr. Collins asked. “You’ve got a cure for a liver disease, and you have to wait and show that the liver’s been damaged before you receive it? That just doesn’t fit,” he said.
Dr. Collins also pointed out that we’re dealing with hard-to-reach populations (underserved, uninsured, justice-involved), and people who are in tough times. “Anything that you put in the way as a barrier is going to make this worse in terms of its ability to be implemented,” he said.
To demonstrate how a coordinated HCV-elimination program could work, Dr. Collins pointed to a Medicaid cohort study in Louisiana conducted from July 2019 through December 2021, in which 8,867 patients started on therapy, 7,763 (88%) completed therapy, and 5,882 (66%) returned for testing. Of those tested, 5,285 (90%) had sustained virologic responses.
Another model of a hepatitis C elimination program was provided by the Veterans Health Administration. They received funding for an effort for all veterans, and in the space of 7 years were able to reach out even to some of their difficult-to-reach populations and achieve high diagnosis and treatment rates in a way that could be a model for what we would want to do across the nation, Dr. Collins noted.