“These deaths could have been prevented,” said Jonathan Mermin, MD, director of the Centers for Disease Control and Prevention’s (CDC) National Center for HIV, Viral Hepatitis, STD, and TB Prevention, at a recent press conference. “The nation has in our hands the key to preventing tens of thousands of cases of liver cancer, liver failure, and deaths from hepatitis C.”
Expensive treatment and bureaucratic obstacles with insurance and referral policies have created a situation that borders on being ethically untenable.
“How often do we have the chance to eliminate a terrible disease that has already taken way too many lives, and to do so with a simple oral therapy that has very few side effects?” said Francis Collins, MD, PhD, one of the leaders of the Biden Administration’s National HCV Elimination Program. “We have an opportunity to do something truly historic. You can’t know about this and just walk away.”
Another obstacle is the lack of testing, although the CDC has recommended for years that everyone should be tested at least once in their lifetime for HCV.
Now is a good a time as any, since the CDC estimates that about 40% of the people who have HCV are not aware the virus is circulating in their blood. Needle sharing during the opioid epidemic has driven rates of HCV higher and into a younger population. HCV can be transmitted by blood exposures and, less often, by sexual activity.
“It’s known as the silent killer because initial infection usually has few to no symptoms,” Mermin said. “But over time, the virus can slowly cause damage to the liver. It can cause liver cancer, liver failure, and death. And this means that there may be up to a million Americans who don’t know they have HCV even though it is potentially causing severe disease.”
A former director of the National Institutes of Health, Collins said the current HCV testing protocol is too cumbersome and the Food and Drug Administration is being asked to approve a point-of-care rapid test available in Europe and Australia.
“[Currently] you need first an antibody test and then an RNA [ribonucleic acid] test, and those have to be sent away to central laboratories,” he said. “There can be a long delay, and we lose a lot of people along the way. The point-of-care test gives a result in an hour or less; the goal being then to get testing and treatment [started] in a single visit.”
The treatment generally is one pill per day for eight to 12 weeks. “A lot of people remember the bad old days when the treatment for hepatitis C was very toxic — involving interferon — and didn’t always work,” Collins said. “That is not the case now. The available cure is safe, highly effective, and very well tolerated. We have the tools to win a victory here.”
Money, or Lack Thereof
So, if people will get tested and get into treatment, suddenly a virus that has caused many hospital infections — usually through contamination of multidose vials, drug diversion, or needlesticks to healthcare workers — is on the ropes?
Not yet. There is another problem, and it is a common one: money.
“The cost of the therapy has been a real barrier to many programs,” Collins said. “Medicaid programs reacted to the initial costs of treatment — which were in the neighborhood of $90,000 for patients — and put up barriers. And while that cost has come down somewhat, now to $20,000 to $24,000, it still remains a major obstacle.”
The expense of treatment and the lack of testing reveals why HCV is so prevalent. Adding a ribbon of red tape by insurance companies puts a bow on this package, so even if you get tested and seek treatment, odds are you will not get it.
“Health coverage policies often make it difficult for people with hepatitis C to access treatment,” said Carolyn Wester, MD, director of the CDC division of viral hepatitis. “Due to the high cost of treatment, some payers limit which patients are eligible for treatment or require burdensome preauthorization before treatment can begin, or even limit the types of providers who can prescribe treatment. All of these restrictions can delay or even prohibit access to these lifesaving medications.”
In a recent study, Wester and her CDC colleagues found “jarringly low cure levels across the board for people diagnosed with hepatitis C,” she noted.1
The investigators looked at commercial laboratory data from more than 1 million people nationwide who were diagnosed with HCV between 2013 and 2022 — a period in which treatment was available. They found that only one-third of people with diagnosed HCV cleared the virus and were cured.
“Overall, only one in three people diagnosed with hepatitis C were cured, and only one in six adults under the age of 40 [years], without health coverage, were cured,” she said. “The highest cure rates were among adults [age] 60 years and older who had Medicare or commercial insurance, yet less than half of these folks were cured. This is mostly because insurers have placed obstacles in the way of people and their doctors, preventing patients from accessing treatment.”
These barriers include requiring consultation with a specialist, sobriety, and evidence of liver disease to get treatment, Collins said. To that last one, he added, “Does that make sense? We’re trying to prevent liver disease.”
A literal barrier is the prison wall: It is estimated that 30% of incarcerated people at any given time have HCV.
The ‘Netflix’ Model
To get access to affordable treatment for these populations, the Biden Administration is proposing the so-called “subscription” payment model and lobbying Congress for the funds to do it by passing legislation to support the national HCV elimination plan.
“This was piloted quite successfully in Louisiana,” Collins said. “Some people have called it the ‘Netflix’ model. When you sign up for Netflix, you pay a lump sum, and then you are able to browse as many films and shows as you want to without paying any additional funds. Louisiana went to the [drug] manufacturers and said, ‘We'll give you a lump sum now [if] you make the drug available essentially for free to anybody on Medicaid and anybody in the federal prison system.’ And guess what? It worked.”
A similar federal program could save thousands of lives while being paid for in downstream savings by preventing cases of HCV.
Under this scenario, the federal government would negotiate with the drug companies to agree to a lump sum payment in exchange for making treatment free to those uninsured, on Medicaid, incarcerated, or living on a Native American reservation, where HCV remains a significant problem, he said.
“Another critical step is to increase the awareness of infection,” he said. “Many people don’t know they have this and don’t have symptoms to cause them to go get tested.”
That necessitates a comprehensive public health effort to expand HCV prevention, provider education, and testing and treatment to more settings, he said.
“The President has asked Congress to front load this five-year initiative, with $5 [billion] to $6 billion over the current expenditures on hepatitis C,” Collins said. “That’s a significant investment, [but] initiating this program would save the federal government more than $13 billion dollars just in the first 10 years, and $44 billion in 20 years — savings that come about because we won’t be having to pay for very expensive liver transplants, and treatments for cirrhosis and liver cancer.”
Asked about the political viability of such a proposal in the current divisive climate, Collins came up with a line that no doubt will be in any testimony he gives before Congress. “It’s rare, in my experience, to have an opportunity to both save lives and save money, but that’s exactly what this is,” he said. “There is interest in the Congress, both the House and the Senate, across parties. But it is still not to the point, I think, to be able to say exactly how that is going to take shape.”
REFERENCE
- Wester C, Osinubi A, Kaufman HW, et al. Hepatitis C virus clearance cascade — United States, 2013-2022. MMWR Morb Mortal Wkly Rep 2023;72:716-720.
About 2 million people in the United States are living with an infectious disease that has been curable for a decade but remains the leading cause of liver cancer and kills about 15,000 people annually: hepatitis C.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content