As part of his fiscal year 2024 budget, which would run from October 1, 2023 to September 30, 2024, President Joe Biden has asked Congress to fund an $11.3 billion program to eliminate hepatitis C in the United States.
If approved, the five-year program would expand testing and access to antiviral drugs and increase awareness about hepatitis C virus (HCV) infection. The program would build on the Inflation Reduction Act and enable the federal government to negotiate lower drug prices for people covered by Medicare.
Hepatitis C is a potentially contagious but curable disease caused by a virus that infects the liver. The blood-borne virus can cause lifelong infection, liver fibrosis (mild to moderate liver scarring), cirrhosis (serious scarring), liver cancer, liver failure and death. Hepatitis C kills more than 15,000 people in the United States each year, and most infections are spread through intravenous drug use.
In an interview with Science, transplant hepatologist David Kaplan, MD, of the University of Pennsylvania Perelman School of Medicine, said eliminating hepatitis C “is possible and feasible” and that this field “has been waiting for this for a long time.” “Elimination,” in this context does not mean total eradication as was achieved with smallpox in 1980, but rather cutting new cases by 90% and deaths by 65% per the goal set by the World Health Organization. Indeed, countries such as England are already on track to meet this goal.
While there is no vaccine for HCV, direct-acting antivirals such as Harvoni (sofosbuvir/ledipasvir), Epclusa (sofosbuvir/velpatasvir) and Mavyret (glecaprevir/pibrentasvir) can cure more than 95% of patients after only eight to 12 weeks of treatment.
The Biden administration’s program intends to eliminate barriers to care by increasing access to testing and decreasing wait times for results and treatment. Currently, in the United States, tests are typically processed at off-site labs, forcing patients to return for a second visit, which delays results and treatment. What’s more, two separate tests are usually used to screen for HCV antibodies (indicating exposure) and HCV RNA (indicating active infection that requires treatment).
“We can cure these patients,” Kaplan said. “But there are too many steps to getting them treatment.”
The initiative also aims to reduce the cost of direct-acting antivirals, which can cost about $20,000 for a complete treatment. It also seeks to improve treatment for incarcerated and underserved people by adopting a subscription model via which the government would pay drug companies a fixed amount for as much drug as needed, instead of paying per dose.
Kaplan said the money budgeted for the program “will make a significant dent in the problem [of HCV].”
Former National Institutes of Health director Francis Collins, MD, PhD, and senior advisor Rachael Fleurence, MSc, PhD, described the need for the plan in a recent viewpoint article in JAMA.
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