RGB GLI Logo

The Case for Universal Access to Hepatitis C DAA Treatment for Your Patients

Hepatitis C is a viral infection of the liver caused by the hepatitis C virus (HCV) and spread through blood-to-blood exposure. The majority of people exposed to HCV develop chronic infection, which can cause cirrhosis resulting in liver failure, liver cancer, or even the need for liver transplantation. It has no vaccine to prevent infection. It is treatable, however. Until 2014, interferons, proteins that can induce an antiviral state in cells, were standard treatment, but they resulted in many long-term side effects and only led to a sustained virologic response (SVR) in less than half of patients (and even less for Black patients). In 2014, direct-acting antiviral (DAA) treatment was approved. DAAs directly stop HCV from replicating and achieve cure as demonstrated by SVR at 12 weeks post-treatment in more than 95% of cases.

DAAs have proven their worth in the real world. Observational studies have shown that in a general cohort study at community hepatitis clinics, nearly all (98%) patients achieved SVR – and these findings have held true in populations with mental disorders (97%), in populations living with HIV (92%), and in populations who inject drugs (94%).

PCORI R1G3

This benefit extends beyond improvements in liver health. A multi-center observational cohort study with 1,601 patients treated at 11 US-based gastroenterology/hepatology outpatient practices has shown significant improvement in fatigue, sleep, stomach pain, and functional well-being, sustained for 12 months post-treatment for those who achieved SVR. The study had retention greater than 95% and had high rates of achieving SVR. These health-related quality-of-life factors are linked to somatic and gastrointestinal symptoms of those infected with HCV and can have a notable impact on a patient’s quality of life, beyond outcomes that are typically measured. 

Interestingly, certain subgroups experienced the most pronounced improvements: those aged 35 to 55 years, those using drugs at baseline, and those with a greater number of comorbidities (including mental health issues). Taken with studies that have achieved high SVR through DAAs among patients with drug use and mental health conditions, there is a compelling argument for universal access to DAA treatment.

What prevents this vision from becoming a reality? There are several factors at play. Even with insurance, only about 1 in 3 people receives timely treatment after diagnosis. Initially, only hepatologists and infectious disease specialists were trained and authorized to prescribe DAAs for hepatitis C, which has left lingering confusion and is not routinely integrated by primary care providers. Several state Medicaid programs, for instance, require prior authorization, a period of sobriety, or even a specific level of fibrosis before treatment can be approved. These demands and bureaucratic hurdles can be insurmountable, especially for patients with limited resources. Furthermore, although the cost of treatment has come down considerably from the $90,000 required when it first became available, high cost remains a barrier for many.

To clear these barriers, restrictions and requirements should be lifted, while primary care practices should be trained and equipped to test and treat for HCV. This is a worthwhile investment: The cumulative 10-year per-patient medical costs are estimated to reduce after successful DAA treatment by $57,000 for those without cirrhosis, by $37,500 for those with compensated cirrhosis, and by nearly $400,000 for patients with end-stage liver disease. This means the breakeven point for a nation typically will occur between years two and three of implementing a comprehensive HCV elimination plan (or a net savings of nearly $50 billion in ten years). The U.S. Congressional Budget Office has also indicated that savings from health care costs avoided by increased hepatitis C treatment would more than offset spending on that treatment – but intentional outreach and implementation would be necessary to increase these testing/treatment rates.

Though viral hepatitis and liver disease often face support due to stigma, universal access to treatment would actually align with several national and global health goals. The White House’s Biden Cancer Moonshot aims to “end cancer as we know it.” HCV infection is the most common cause of liver cancer in the US. Thus, treatment of the infection contributes directly to the Moonshot goal to “Prevent More Cancers Before They Start.” Early treatment of individuals who have tested positive for HCV will prevent much progression to liver cancer.

Expanded treatment of HCV also supports the Sustainable Development Goals detailed in the United Nations 2030 Agenda for Sustainable Development. SDG Goal 3 is to ensure healthy lives and promote well-being for all at all ages. HCV treatment falls specifically within SDG Target 3.3: End the epidemics of AIDS, tuberculosis, malaria, and neglected tropical diseases and combat hepatitis, water-borne diseases and other communicable diseases (emphasis added). Expanding this treatment supports SDG Target 3.8: Achieve universal health coverage, including financial risk protection, access to quality essential health-care services, and access to safe, effective, quality, and affordable essential medicines and vaccines for all. The United States will not achieve its part in achieving these components of SDG Goal 3 without universal access to effective HCV treatment for all who need it.

Clearly, hepatologists and other clinicians alike should support universal access to DAA therapy for their patients and patients, including through insurance, hospital, local, and federal policies. Advocacy for liberal policies for treatment within healthcare systems, at the level of state government, and by Congress are necessary. Building on the Biden administration’s inclusion of $11.3 B in funding in its FY2024 budget proposal for a nationwide program to fight HCV, comprehensive plans must be passed by the US Congress in order to launch this ambitious national effort. Though additional advocacy is necessary, the investment in equitable healthcare access for all patients is more than worthwhile.

The statements and opinions presented in this blog post are solely the responsibility of the author(s) and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute® (PCORI®), its Board of Governors, or the Methodology Committee.