Speakers
Rachael L. Fleurence, PhD, MSc
Senior Advisor
National Institutes of Health
Joshua M. Sharfstein, MD
Vice Dean for Public Health Practice and Community Engagement
Director, Bloomberg American Health Initiative
Professor of the Practice in Health Policy and Management
Keywords
Hepatitis C, NIH, PCORnet
Key Points
- The advances in Hepatitis C drugs is one of the greatest successes in clinical research in the last 20 years, yet Hepatitis C is a public health crisis in the U.S. with the rate of reported acute Hepatitis C cases increasing 400% during 2010-2020. Rates are the highest among 20-39-year-olds.
- Untreated, chronic Hepatitis C infection leads to liver damage, liver cancer, and death. There is now a cure for Hepatitis C, but many people are not able to access it. Many people do not know they have Hepatitis C (about 40% of patients). There is a lack of point-of-care diagnostics; it can take up to 3 steps to treatment initiation. There is high cost of treatment and insurance prior-authorization requirements. The treatment is not a routine part of primary care, and there is an underserved and hard-to-reach population.
- Even when diagnosed, only 1 in 3 adults are cured of Hepatitis C in the U.S. Pilots for elimination programs for Hepatitis C have been successful in individual states and other countries.
- To address this crisis, the NIH is embarking on a National Initiative on Hepatitis C. The initiative would bring to the U.S. point of care diagnostic tests, provide broad access to curative Hepatitis C medications with a national subscription model, with Medicare co-pay assistance and commercial insurance coverage.
- The initiative will also empower implementation efforts through a public awareness campaign, expansion of screening strategies and settings, especially for high-risk populations; expansion of the number of providers using innovative telehealth methods such as the ECHO program; and expansion of the number of community health workers who can link people to care.
- There are possible clinical research components that would include research on treatment during pregnancy, vaccine development, and implementation model research.
- The economic benefits of a Hepatitis C elimination program would save lives and have enormous financial benefits to Medicare and Medicaid, paying for the program within 10 years.
- PCORnet has been an important resource by executing a query to identify the volume of HCV tests conducted by participating health systems and the number of co-infections with Hepatitis B virus. A manuscript is under development. PCORnet is engaging with sites to support the ITAP clinical study for de novo clearance of a qualitative POC HCV test-to-treat platform. Discussions are currently underway with 13 partner sites.
- Unless we take action, our system will be spending tens of billions of dollars for Hepatitis C care over the coming decades for people already infected. The current trends of Hepatitis C epidemiology in the U.S. show that a cure is not sufficient to guarantee disease elimination.
Discussion Themes
–When did NIH begin to think a program like this was possible? In early 2022 Dr. Collins was asked to serve as Biden’s acting science advisor, and Dr. Collins wanted to use his position at the White House to help advance health and medical space. He came to the conclusion that Hepatitis C has the most untapped potential to benefit from White House support. We spent 15 months working with the White House to get the program in the president’s budget and now our focus is on the Hill.
-What are the policy considerations to get to easier testing? Our review of the data from other countries is that having same-day tests available for certain settings and populations is a helpful strategy. The hope is that we can have coherent and national organization to roll out this program and get the point of care tests in places where it really matters to have these tests.
Tags
#pctGR, @Collaboratory1