Transcript: Hepatitis C Briefing

Press Briefing Transcript

Thursday, June 29, 2023

Audio recording [MP3 – 4 MB]

Please Note: This transcript is not edited and may contain errors.

JavaScript is required to play this audio. The audio file can be found atnone.

00:00

For standing by. At this time all participants’ lines are on a listen only mode until the question and answer session of today’s call. It is also being recorded. If you have any objections, you may disconnect at this time. I will now turn the call over to Benjamin Haynes. Sir, you may begin.

00:18

Thank you Christy. And thank you all for joining us for today’s briefing to discuss CDC’s most recent analysis of U.S. hepatitis C data. We’re joined by Dr. Jonathan Mermin, Director of CDC’s National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention. Dr. Carolyn Wester, Director of CDC’s Division of Viral Hepatitis and Dr. Francis Collins from the National Institutes of Health, who serves as the lead for the White House’s National Hepatitis C Elimination Initiative. Following their remarks, we will open up the lines for your questions. I will now turn the call over to Dr. Mermin.

00:57

Thank you, Ben. And good morning, everyone. And thank you for joining us today. So to understand the gravity and the importance of today’s findings, I’d like to start with some background. CDC estimates that more than 2 million people in the United States have hepatitis C. It’s known as the silent killer because initial infection usually has few to no symptoms. 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 a hepatitis C virus even though it is potentially causing severe disease. Nearly 10 years ago, medical researchers developed several highly effective cures for hepatitis C. The nation had in our hands the key to preventing tens of thousands of cases of liver cancer, liver failure and deaths from hepatitis C. And yet, today nearly 15,000 Americans die annually for hepatitis C. These deaths could have been prevented. Thousands of people are dying every year in our country, and many more are suffering from an infection that has been curable for over 10 years. So the data we will present today shows that only 1/3 of people diagnosed with hepatitis C have been cured.

The barriers preventing breakthrough treatments from reaching the people who need them are not inevitable. This is mostly because insurers have placed obstacles in the way of people and their doctors preventing patients from accessing treatment. It is time we remove these barriers and expanded public health systems to prevent new infections. Eliminating hepatitis C would be cost saving and lifesaving. And I’m honored to have Dr. Francis Collins here with us today to discuss how we can address these challenges through the President’s proposed National Hepatitis C Elimination Initiatives. And now I’d like to turn the mic over to Dr. Carolyn Wester, the director of our division of viral hepatitis at CDC, and she’ll provide more detail on today’s report.

03:23

Thank you, Dr. Mermin. And thank you all for joining us today. The study released today uses commercial laboratory data from more than a million people nationwide who were diagnosed with hepatitis C between 2013 and 2022. As Dr. Mermin explained, this period is significant as it represents the first 10 years since safe and highly effective cures for hepatitis C became available.

This study provides data on the percent of people with hepatitis C who cleared the virus, an indication of being cured. This analysis also provides the first clear picture of hepatitis C treatment among people without health coverage. We found jarringly low cure levels across the board for people diagnosed with hepatitis C. Overall, only one in three people diagnosed with hepatitis C were cured, and only one in six adults under the age of 40, without health coverage, were cured.

The highest cure rates were among adults 60 years and older who had Medicare or commercial insurance, yet less than half of these folks were cured. Today’s study shows that nearly a decade after highly effective cures became available. The vast majority of people with hepatitis C have not been cured. So why is this? There are multiple reasons. I will highlight two. First, health coverage policies often make it difficult for people with hepatitis C to access treatment. 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. Second, as Dr. Mermin mentioned, Hepatitis C is a silent killer, and many people don’t even know they have it. In fact, we estimate that about 40% of the people with hepatitis C are unaware of their infection. So while this study looks at treatment gaps among people with diagnosed hepatitis C, there is also a great need to increase screening and testing for hepatitis C. CDC recommends that everyone be tested for hepatitis C at least once in their lifetime. Overcoming these barriers can make the difference between life and death. Everyone with hepatitis C deserves the chance to be cured.

I’ll now turn it over to Dr. Francis Collins to discuss how we could address some of these barriers through the proposed National Hepatitis C Elimination Program.

06:03

Well, thank you, Dr. Wester. 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? We have an opportunity to do something truly historic. The CDC report you’ve just heard about highlights an urgent need for a bold response to hepatitis C.

And the cure that’s been available now for 10 years is very simple, one pill a day for eight to 12 weeks, very limited side effects. A lot of people remember the bad old days when the treatment for hepatitis C was very toxic and didn’t always work, involving interferon. That is not the case now. The available cure is both safe, highly effective, and very well tolerated.

So we have the tools to win a victory here. And that’s what I want to tell you about right now. It’s called the National Hepatitis C Elimination Program, proposed by the Biden Harris administration, and now seeking support from the U.S. Congress. The program will prevent cases of liver cancer and liver failure; it will save 1000s of lives, and importantly, it will be more than paid for by future reductions in health care costs by preventing tens of thousands of cases of liver cancer, liver failure, and even diabetes and kidney failure, which are part of hepatitis C as well. That will add up to a huge amount of cost savings downstream. Why aren’t we doing this already? Well, there’s several barriers. One is the cost of the therapy has been a real barrier to many programs. Medicaid programs are reacting to the initial costs of treatment, which were in the neighborhood of $90,000 for patients, are put up barriers. And while that cost has come down somewhat now to $20,000 to $24,000. This still represents a major obstacle for Medicaid programs. So many of them in the states still require evidence of liver disease. Does that make sense? We’re trying to prevent liver disease, or they require sobriety or they require a specialist has to be involved in a circumstance where testing and treating are actually pretty straightforward.

Medication costs have particularly been a problem for the uninsured who may get their care through a community health center that doesn’t have the resources to necessarily cover this high cost. In prison systems, where as many as 30% of inmates may be infected with hepatitis C, the resources in the staff assistance to test and treat are often not present. And for Medicare, which covers the costs theoretically, you’ve seen the data that less than half of Medicare patients who are known to be positive, get cured. And of course, there probably many others that haven’t actually found out their infection status because Medicare patients have one reason that, maybe this is an obstacle, is that co-pays can run as high as $4,000.

So the program proposed by the president has an innovative model to deal with the cost issues. And this was piloted in Louisiana, and quite successfully so, and it’s called a subscription model. 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 Gilead, one of the manufacturers along with Abbey and said, “How about this? We’ll give you a lump sum and now you can then, after that, make the drug available essentially for free to anybody on Medicaid and anybody in the federal prison system. And guess what? It worked. If it worked in Louisiana, why not in the United States?

The proposal here is that such a negotiation would be done with the companies that have the FDA approved oral therapy. Gilead and Abbey agreed to a lump sum and then they would make the drugs available for free to anybody on Medicaid, who’s uninsured, who’s in the prison system, or who’s on the Native American reservation where Hepatitis C is also a significant problem. This can be a win, win, and save lives and remove a major obstacle to getting those, over 2 million people who are known to be infected, access to the cure.

But that’s not all. Another critical step is to increase the awareness of infection. You heard from Dr. Mermin that many people don’t know they have this and don’t have symptoms to cause them to go get tested. Even though CDC recommends that everyone gets tested for hepatitis C, at least once in their lifetime, only a minority of Americans have done so. One of the reasons is that testing can be cumbersome. Effectively, you need first an antibody test and then an RNA test, and those have to be sent away to central laboratories, so there can be a long delay, and we lose a lot of people along the way.

A rapid point of care test as is already available in Europe, Australia, and a few other places could change all of that. And so an active effort is underway right now, working with NIH and FDA to get approval of that point of care test in the U.S. a test that gives a result in an hour or less. The goal being then to get test and treat done in a single visit. That is the way we really can address this most successfully. But then having the technology and reducing the cost while good are not quite sufficient. We will also need a well-funded comprehensive public health effort to expand prevention, provider education, testing and treatment to more settings. And that is also part of the plan that is fully fleshed out by the administration. And that plan has included our CDC colleagues who are speaking today, and numerous other senior leaders at HHS who are fully behind this, as well as the Bureau of Prisons. So the President has asked Congress to front load this bold five year initiative, with five to $6 billion over the current expenditures on hepatitis C. That’s a significant investment. But really importantly here very sophisticated economic analysis by colleagues at Harvard and USC estimate that 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, treatments for cirrhosis, and treatments of liver cancer, as well as cases of diabetes and kidney failure that can be prevented if people get cured now of this viral disease. This is compassionate care. But it can also contribute to deficit reduction. If other countries like Australia, Egypt and the United Kingdom can do this, and they are, why not the United States? Do we want to be last here? It’s rare, in my experience, to have an opportunity to both save lives and save money, but that’s exactly what this is. I don’t know too many people who have looked at this situation and not felt like we have to do something. You can’t know about this and just walk away. How can we not do this? Let me turn this back over to Dr. Mermin.