Biden Administration Unveils HCV Initiative: A Significant Step Towards Public Health

For decades, many Americans with hepatitis C have struggled to get into the continuum of care. And unfortunately, some have died waiting for treatment that remains to be sometimes inaccessible or egregiously expensive in the United States. Within the Biden administration’s proposed budget, they are seeking to turn the situation around with an $11 billion plan to eradicate hepatitis C in the United States by 2030.¹

Per the Centers for Disease Control and Prevention (CDC), there were an estimated 69,800 acute hepatitis C virus infections in 2021 and 107,540 cases of newly reported chronic hepatitis C during 2021.² Hepatitis C is one of several hepatitis infections that affect the liver and is commonly spread through blood contact from an infected person. Most who become infected by hepatitis C include those who engaged in risky behaviors such as shared needles for intravenous (IV) drug use, have unprotected sexual intercourse, had blood transfusions before 1992, or have received unregulated tattoos. While hepatitis C can often be a short-term illness, more than half of infected people develop chronic infections—putting them at risk for serious, even life-threatening health issues such as cirrhosis and liver cancer.

In March 2023, the Biden administration proposed a strategic plan to provide a comprehensive resolution for more screening, testing, treatment, and follow-up solutions to eliminate HCV. With the amount budgeted for this strategic plan and if Congress keeps this part of the White House proposal intact, the Biden administration intends to work in the next 5 years to provide Americans with rapid diagnostic testing, make proven treatments accessible for Medicaid, Medicare, and commercially insured patients, and to expand public health strategies to detect, cure, and prevent infection. The White House says these initiatives will eventually save money since it ensures that the government wouldn’t fund care for some of the disease’s more progressive stages and complications.

What You Need to Know

The proposed plan takes a comprehensive approach to tackling hepatitis C, focusing on screening, testing, treatment, and follow-up care. By addressing each aspect of the disease's lifecycle, the initiative aims to improve detection rates, provide accessible treatment options, and support patients through the entire care process.

The plan incorporates innovative solutions such as point-of-care (POC) testing and a national subscription model for purchasing direct-acting antivirals (DAAs). These approaches aim to streamline the testing and treatment process, making it more efficient and accessible, particularly for underserved populations.

Collaboration with various stakeholders, including government agencies, healthcare providers, pharmacies, and community organizations, is central to the success of the initiative.

The Biden-Harris project predicts that the initiative will diagnose almost 93% of all people with HCV and cure around 90% of people who are infected. The initiative will also prevent a predicted 24,000 deaths adding 220,000 life years. The national program has 3 main priorities: (1) accelerating the availability of point of care (POC) diagnostics tests, (2) providing broad access to curative hepatitis C medications, and (3) creating a comprehensive public health effort to engage, inform, identify, and treat acutely HCV infected people.³

Regarding POC testing, most countries outside of the United States have implemented a test-and-treat approach where patients receive immediate HCV RNA viral load testing in-office and, if positive, can receive their medications at the same visit.⁴ HCV RNA POC testing has remained unavailable in the United States due to lack of regulatory approval and commercial availability. The proposal suggests that it will collaborate with the FDA and the National Institutes of Health to help speed up approvals for these tests, similarly seen for COVID-19 testing.³ The expected plan is to expand testing locations in communities to increase access and use new POC tests to allow for rapid testing and treatment. The intent is to be impactful in settings such as community health settings, substance use disorder clinics, correctional centers, emergency departments, and mobile clinics.

The second initiative emphasizes extending medication access to patients. A key component of this initiative is a national subscription model to purchase direct-acting antivirals (DAAs) for underserved populations. The idea comes from the government to negotiate with drug manufacturers to purchase as much treatment as needed for all designated patient groups. In one direction, this benefits certain vulnerable patient populations such as Medicaid beneficiaries, people involved in the justice system, uninsured people, and American Indian and Alaska Native individuals treated through the Indian Health Service.

This model plans to theoretically provide unlimited and at no-cost supply of direct-acting antiviral therapy to these underserved patients. Pharmaceutical manufacturers will obtain more revenue but at a much lower per-patient cost. Beyond this, the project will provide further co-pay assistance to Medicare patients and private insurers will be encouraged to increase HCV testing coverage and treatment while limiting out-of-pocket costs. At a high-level view, this appears to be an overall win-win situation.

Thirdly, the proposal plans to include a public effort to identify and treat HCV patients. The plans include supporting organizations and trusted community partners to create conditions for more people to seek testing and treatment. One avenue is to use a network of pharmacies where possible to provide screening and testing for HCV. Another option is forming an innovative model such as the Extension for Community Healthcare Outcomes program to build up training programs for clinicians to build upon skills to provide models of care including mobile clinics, telehealth visits, primary care treatment, and advanced pharmacy practice models. This initiative will also support reaching out to different sets of people in the community by supporting federally qualified health centers and utilizing case managers, perinatal case coordinators, and community health workers to link patients to care. Efforts to expedite research for a potential HCV vaccine will also be advocated to provide the best insurance to prevent re-infection.

The benefits of treating hepatitis C extend beyond liver disease but can greatly develop efforts to focus on overall public health. If Congress supports this budgetary initiative, they will have a unique opportunity to make a historic public health effort that saves lives, prevents further disease, and provides a cost-savings to everyone.