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The Biden administration’s fiscal year 2024 budget proposal, announced yesterday, aims to eliminate hepatitis C from the United States by creating a nationwide program to fight the disease. If funded by Congress, the 5-year, $11.3 billion program would expand testing, broaden access to powerful antiviral drugs, and boost awareness.
“I can’t really recall a circumstance quite like this, where we have the chance to do something this groundbreaking, so we just have to figure out how to make it work,” Francis Collins, acting science adviser to President Joe Biden and former head of the National Institutes of Health (NIH), said in an interview with JAMA, which also published an editorial co-authored by Collins advocating the proposed program.
“The field has been waiting for this for a long time,” says transplant hepatologist David Kaplan of the University of Pennsylvania Perelman School of Medicine. Eliminating the disease “is possible and feasible,” he says, noting that other countries are on their way to meeting that goal. But that doesn’t mean the effort will be easy, adds pediatric hepatologist James Squires of the UPMC Children’s Hospital of Pittsburgh. “It will be a challenge. There’s never been an eradication of an infectious virus without a vaccine.”
Hepatitis C kills more than 15,000 people in the United States every year. The virus that causes it spreads mainly through intravenous drug use and attacks the liver, often eventually causing cirrhosis, liver failure, and cancer. Although the statistics are shaky because of limited testing, the Centers for Disease Control and Prevention estimates 2.4 million people in the United States harbor the hepatitis C virus. Pediatric hepatologist William Balistreri of the University of Cincinnati says the number could be as high as 10 million.
Despite the lack of a vaccine, researchers can talk seriously about eliminating hepatitis C because the drugs known as direct-acting antivirals (DAAs), first approved in the United States in 2013, are so effective. These drugs, such as the combination of sofosbuvir and ledipasvir sold as Harvoni, can oust the virus from more than 95% of patients with only an 8- to 12-week course of treatment. The introduction of DAAs spurred the World Health Organization (WHO) to make the elimination of hepatitis C by 2030 one of its goals. The disease wouldn’t disappear like smallpox, which was vanquished with a powerful vaccine. Instead, WHO aims to cut new cases by 90% and deaths by 65%.
A survey published earlier this year revealed that 11 countries were on track to meet the WHO targets. One is Egypt, which slashed its disturbingly high infection rate by testing more than 50 million residents and treating 4 million who tested positive. Other countries, including Australia, Japan, Georgia, and several nations in Europe, have made similar progress. The United States has lagged because it lacks a national effort and because formidable obstacles prevent many of the people who are infected from getting diagnosed and treated. “We can cure these patients,” Kaplan says. “But there are too many steps to getting them treatment.”
For example, estimates suggest about 10% of the roughly 2 million people in the United States who are in jail or prison carry the virus, but they often go without testing and treatment. For this group, “We need more resources for testing and a cultural shift in availability of treatment,” says Matthew Akiyama, a clinician-investigator at the Albert Einstein College of Medicine.
The new program proposed by the Biden administration outlines several steps to lower such barriers. In other countries, for instance, patients can undergo so-called point-of-care RNA tests at locations such as community health centers and substance abuse treatment clinics. If they test positive, they can receive treatment in the same visit. But in the United States, the tests have to be processed at off-site labs, forcing patients to return to obtain the results and further delaying their treatment. The program would accelerate approval of point-of-care RNA tests by enlisting the Independent Test Assessment Program, an NIH–Food and Drug Administration partnership.
The initiative would also tackle one of the biggest treatment obstacles—drug costs. Although the price of DAAs has fallen by about 75% since they were introduced, a full course still runs about $20,000. To improve treatment for incarcerated people and other underserved populations, the program would adopt the so-called subscription, or Netflix, model, first tested by Louisiana, in which the government pays drug companies a set amount for as much drug as it needs, rather than paying per dose.
The amount of money budgeted for the program may not be sufficient to eliminate hepatitis C, Kaplan says, but “it will make a significant dent in the problem.” The administration has proposed funding the full 5-year program as mandatory spending, which means that money would not need to be appropriated every year. Still, the effort needs approval from Congress, including a Republican-controlled House of Representatives that is intent on slashing federal spending.
Failing to seize this opportunity would be a huge loss, Balistreri says. “We can do it. Shame on us if we don’t.”