By Abdullahi Tsanni

In 2005, Nick Voyles was diagnosed with hepatitis C after being released from five years of incarceration. A nurse told him he had only six months to live. He was prescribed a drug cocktail, a combination of interferon and ribavirin, that proved ineffective and gave him severe side effects. “It ripped me apart — the entire treatment was killing me,” Voyles, who lives in Bloomington, Ind., recalled.

Voyles’ experience highlights the challenges that patients faced back when doctors prescribed hepatitis C drugs that turned out to be unsuccessful in treating the viral infection that attacks the liver. Thankfully, in his case, his symptoms resolved after several weeks, and he was eventually able to access a cure.

Over the past decade, scientists have developed new therapeutic drugs to combat hepatitis C. Simple, orally administered direct acting antiviral (DAAs) drugs, such as the combination medicine sofosbuvir/velpatasvir, can cure the highly contagious disease effectively within just 12 weeks.

But these breakthrough treatments are not getting to the people who need them, according to a Centers for Disease Control and Prevention study released Thursday. Only one 1 of 3 adults diagnosed with the disease have been cured since 2013, when those highly effective curative drugs for hepatitis C were first approved in the U.S.

The medications cost roughly $24,000 per course of treatment, posing a major barrier to many people infected with hepatitis C. These accessibility issues are “really disappointing,” said Francis Collins, former director of the National Institutes of Health, who is now leading a proposed program for the federally funded national elimination of hepatitis C plan in the U.S. “I don’t think we as a society can look at that and say that’s OK — it’s not OK.”

The CDC report notes that cure rates are lowest among people without health insurance or Medicaid coverage. Among adults under the age of 40 — the age group that has the highest rates of new hepatitis C infections — only 1 in 4 people were cured. And although treatment rates were highest among people 60 and older who were covered by Medicare or commercial insurance, still less than half had been cured.

Experts on hepatitis C told STAT that the disease is a public health crisis that requires a robust response.

“Hepatitis C infections are worsening,” said Adrienne Simmons, the director of programs at the National Viral Hepatitis Roundtable. Cases of the disease surged between 2013 to 2019, increasing by 15%, according to the CDC. “We are probably just seeing the tip of the iceberg.”

The cost of treatments isn’t the only barrier faced by people with the infection. In the U.S., getting diagnosed with hepatitis C is a complicated process.

First, it requires a blood test, known as an antibody screening, that looks for proteins that help fight off infections. If that test is positive, doctors then need a genomic test to confirm the hepatitis C virus itself.

“It’s very cumbersome,” said Anne Spaulding, associate professor of epidemiology at Emory University in Atlanta. That means patients face delays in getting a confirmed diagnosis and treatment. “We need to develop a one-step test and just look for the virus,” she said.

Collins’ national hepatitis C elimination program aims to help people get tested faster by supporting the development and approval of rapid point-of-care viral tests for hepatitis C. “A point of care test can give you an answer and you can start treatment in that same visit,” said Collins.

This strategy, known as test and treat, could have a big impact, said Meg Doherty, director of the global HIV, hepatitis, and STIs programs at the World Health Organization. “If the U.S. can do this, there may be other high-income countries who are going to take this on toward achieving hep C elimination targets,” she said.

About 90% of people living with hepatitis are unaware they have it, according to the WHO. Rapid tests would not only help people access treatment faster, but also help curb the spread of new hepatitis C infections.

The White-House backed program also aims to establish a national hepatitis C drug delivery model that would lower the cost of the treatment by negotiating and purchasing a large quantity of the medications at a fixed price. “The cost per patient is going to be extremely low,” said Collins.

The White House has requested $11 billion in funding across federal agencies to enact this and other key steps to reach hepatitis C elimination in the U.S.

Collins told STAT that the plan would prevent tens of thousands of cases of cirrhosis, end-stage liver disease, and liver cancer, and ultimately save billions in health care spending. “If we could right now find, over the course of five years, those people who are hep C positive and get them cured, we’d save the government about $13.3 billion in the first 10 years.”

More than 2 million people in the U.S. have hepatitis C, and nearly 15,000 died from the infection in the year 2020. Among the people most affected by the disease are drug users and incarcerated people — populations who are often stigmatized and hidden from public view. A STAT investigation last year documented how hundreds of incarcerated people were dying from hepatitis C without medical care.

“About a third of the hepatitis C epidemic is represented by individuals who spend at least part of their life in a jail or prison,” said Spaulding, who researches infectious disease, including hepatitis C, in institutionalized populations. This makes the prisons an important setting for target in elimination efforts. “Without treating individuals who are incarcerated, especially those in prisons, we’re not going to achieve elimination of hepatitis C in the U.S.,” she said.

Simmons added that one of the most important aspects of the White House’s proposed plan is the push to remove restrictive coverage policies by some state Medicaid programs and commercial insurance providers that bar patients from treatment until they receive prior authorization and unless they have severe liver damage and go months without using alcohol or drugs.

Collins said the new CDC report underscores the need for a bold, strategic response to eliminate hepatitis C. He notes that even some medical professionals are unaware of the barriers people infected with the disease continue to face in the U.S. “This disease is preventable and here we have this unique opportunity that doesn’t come along often,” he said. “It’s both saving money and saving lives.”