White House budget includes ambitious plan to eradicate the spread of hepatitis C
The Biden administration’s budget proposal for the fiscal year 2024, announced on Tuesday, aims to eradicate hepatitis C within the United States by creating a national program to combat the illness. If approved by Congress, the five-year, $11.3 billion plan would increase testing, increase accessibility to potent antiviral medicines and raise awareness.
“I don’t recall any other situation as this one, where we’re able to create something so revolutionary, and so we need to find out how to achieve it,” Francis Collins, acting adviser on science to President Joe Biden and former head of the National Institutes of Health (NIH) stated in An interview with JAMA. It also published an editorial Co-authored by Collins, who is a proponent of the program with Collins, and co-authored by Collins.
“The medical field was waiting to see this happen for many years,” says transplant hepatologist David Kaplan of the University of Pennsylvania’s Perelman School of Medicine. The elimination of the illness “is feasible and possible,” he says, noting that other nations are on their way to achieving this objective. However, the work will be challenging, according to pediatric Hepatologist James Squires of the UPMC Children’s Hospital in Pittsburgh. “It will be a major challenge. There’s been no eradication of an infectious disease without a vaccine.”
Hepatitis C is responsible for the deaths of over 15,000 individuals throughout the United States annually. The virus responsible for it is spread mainly through intravenous drugs and targets the liver, frequently creating cirrhosis, liver failure, and cancer. Although the data isn’t definitive due to limited studies, it is believed that the Centers for Disease Control and Prevention estimates 2.4 million individuals in the United States harbour the hepatitis C virus. Pediatric Hepatologist William Balistreri of the University of Cincinnati states that the figure could be up to 10 million.
Even without an antiviral, researchers can discuss eliminating hepatitis C seriously because Direct-acting Antivirals (DAAs), first approved in the United States in 2013, are so efficient. The drugs, like that combination of sofosbuvir and ledipasvir, sold under Harvoni, can remove the virus from over 95% of patients with an 8-to 12-week treatment. In introducing these drugs, they prompted an initiative by the World Health Organization (WHO) to declare the elimination of hepatitis C by 2030 as one of its objectives. It won’t disappear like smallpox, eliminated by a highly effective vaccine. However, WHO aims to cut new cases by 90% and deaths by the equivalent of 65%.
A study published earlier this year showed eleven countries are on the right track to reaching the WHO goals. One of these is Egypt which has slashed its alarmingly high infection rates by conducting tests on over 50 million people and treating the 4 million who had tested positive. Other countries, like Australia, Japan, Georgia, and several countries within Europe, have made similar strides. However, the United States has lagged because it isn’t part of a more significant effort and the formidable barriers that hinder most suffering from the disease from being treated and diagnosed. “We can treat the patients suffering from this disease,” Kaplan says. “But there are many steps involved in receiving treatment.”
For example, studies suggest that around 10% of about 2 million people living in the United States who are in jail or prison carry the virus. However, they’re often left without testing or treatment. For this group, “We need more resources for testing and a cultural shift in the availability of treatment,” says Matthew Akiyama, a clinician-investigator at the Albert Einstein College of Medicine.
The proposed new program in the Biden administration includes several measures to ease the burden of these obstacles. For example, patients can take points-of-care RNA tests in community health centres or addiction treatment clinics in other nations. If they find positive results, the treatment can be provided simultaneously. However, in the United States, the tests must be processed by off-site laboratories, which means patients must come back for results, further delaying the treatment. The program will speed up the acceptance of tests for RNA at the point of care by using those who are part of the Independent Test Assessment Program, an NIH-Food and drug Administration collaboration.
The plan would also take on one of the most challenging barriers to treatment: the cost of drugs. While the price of DAAs has dropped by 75 per cent since they were first introduced, a complete course costs about $20,000. To improve the treatment of prisoners and other vulnerable groups, the program is expected to use the so-called subscription or Netflix model first tried by Louisiana and Louisiana, where the government provides drug companies with an amount that is set for every dose of drugs they require, instead of paying per dosage.
The budgeted amount for the program might not be enough to eliminate the spread of hepatitis C, Kaplan says; however, “it will be able to make a huge impact on the problem.” Administration officials have suggested that the program be funded for the whole five years in a mandatory way, which means that funds do not have to be allocated each year. Still, the effort needs approval from Congress, including a Republican-controlled House of Representatives that is intent on slashing federal spending.
If we don’t take advantage of this opportunity, it is a significant loss, says Balistreri. “We can do it. It’s a shame for failing to.”