More than 2 million individuals in the US are chronically infected with hepatitis C, and nearly 15 000 die every year. Antivirals are available but are not reaching the majority of infected individuals. In this Q&A, JAMA Editor in Chief Kirsten Bibbins-Domingo, PhD, MD, MAS, and Francis S. Collins, MD, PhD, discuss a plan to eliminate hepatitis C included in the Biden-Harris 2024 budget proposal.
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Kirsten Bibbins-Domingo: Hello and welcome. I'm Dr. Kirsten Bibbins-Domingo, editor-in-chief of JAMA and the JAMA Network. I'm joined today by Dr. Francis Collins. Dr. Collins is a physician and a scientist, and the former director of the National Institutes of Health. Dr. Collins led the NIH for 12 years serving under three presidents, stepping down at the end of 2021. Dr. Collins is currently a special advisor to President Biden for special projects. The White House announced today a major new proposal to launch a national Hepatitis C elimination program in the US. Dr. Collins authored a viewpoint that is published today in JAMA that lays out the rationale and details of this proposal and its importance for the US. Dr. Collins and his co-author Dr. Rachael Fleurence, described the elimination of hepatitis C in the US as a historic opportunity. Dr. Collins, I'm so pleased to speak with you today.
Dr. Francis Collins: I'm very happy to talk with you also. Please call me Francis.
Kirsten Bibbins-Domingo: Wonderful, and you can call me Kirsten. So I'm really happy to have this conversation with you. This viewpoint lays out so clearly, not only a call to action for hepatitis C, but really very specific plans that suggest we might actually get there if we think together about this. And so I want to talk with you about the details, but I'd love it if you would just lay out the case. There are a lot of health problems, why hepatitis C?
Dr. Francis Collins: How often, Kirsten, do we have the chance to actually eliminate a disease that is killing 15,000 people a year because we have a cure? We have a cure for hepatitis C, a simple oral medicine, one pill a day for eight to 12 weeks, 95% cure rate, FDA approved, and yet there are two and a half million people in the United States who are chronically infected with hepatitis C who don't have access to that. So we could do something here that is truly historic. Basically, find those folks, give them access to the cure and eliminate this disease with all of its consequences for liver failure and needing for liver transplantation and liver cancer. And not to do that when we can do that just doesn't seem right for a country that cares about all of its people. I've been in medical research and medical practice now for 40 years, 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.
Kirsten Bibbins-Domingo: All right. Well, there are a lot of smart people. If we have the medicines and we know what the problem is, why haven't we done this before?
Dr. Francis Collins: Well, yeah, you could say, it seems like a public health success story that should have already happened. Because the medicines have been approved now for seven or eight years. There've been a number of issues. The people who need this particular cure, many of them are in marginalized communities. They are not in a circumstance where they have had good access to healthcare. Many of them are on Medicaid, many of them uninsured, quite a number of them incarcerated. They are people whose health inequity just strikes you as very strong already. Native Americans are particularly hard hit with hepatitis C, but that doesn't mean that we should just say, "Oh, well, we have to work harder in that circumstance." The way you get hepatitis C is generally through needles, and there's a baby boomer generation that's positive and many of them don't know it from blood transfusions back before 1993 when we didn't know how to screen for Hep C. But younger folks, maybe a tattoo needle, maybe intravenous drug experimentation. That's where an awful lot of the cases now are. And it's a silent killer. This is a chronic infection with a virus in your liver that generally doesn't cause any symptoms for years. And then when it starts to, you're already in real trouble. The idea that we should wait until people get sick to cure them just doesn't seem like the right answer. If we can cure people now and prevent all of that, we certainly should be doing that. But it's going to take the full engagement of our medical system, all the care providers who many of them not that familiar with, just what a wonderful opportunity this is to cure somebody, to empower them, to figure out how to make the cost affordable, because we should talk about that, that's a big part of the barrier up until now, and to have the healthcare delivery system reaching out to people who traditionally are not very well reached out to to provide this kind of remarkable cure of a terrible disease that otherwise is going to threaten their future.
Kirsten Bibbins-Domingo: We're going to get to some of the details. One of the things that always impressed me as a primary care provider is that sometimes these exposures that lead to the chronic infection, they happened decades ago, either through transfusion, through drug use, through needles, other types of things. And so the first time that I become aware of it as a physician is because the patient already has some abnormalities on their liver tests or something else before we were actively screening. So sometimes it just comes up on people for these 2.4 million unaware. One of the things you say in your viewpoint is that a substantial fraction fraction of people who are infected are not aware that they're infected.
Dr. Francis Collins: Right, about 40% of them, as best we can tell, have not been tested and don't know, despite the fact that the CDC and the USPSDF have recommended universal screening of adults, it really hasn't been implemented very effectively and particularly so in high risk populations. So people, lots of them, more than a million, walking around right now unaware that this virus is incubating in their liver and heading for real trouble a few years from now.
Kirsten Bibbins-Domingo: And the medications, even though we have them, and even though presumably insurance cover this, only about a third of the people who have some type of public or private insurance are actually treated. And I'm sure that's even more if you don't have insurance.
Dr. Francis Collins: And well, exactly. And that was a pretty dramatic result from CDC last August where they did collect the data. They looked to see, "Okay, if you've had a hepatitis C diagnosis, what's the chance you have been offered to cure?" And I figured, well, if you have private insurance, it'll be really high. It's not, it's only about a third. If you have Medicare, it's only about a third. If you had Medicaid, it's less than a third. And they didn't have any data on the uninsured, but I'm sure it's even less than that. So it's just a dramatic and bizarre paradox. This is one of the most amazing achievements of medical research in the last 20 years to develop this small molecule, this direct acting antiviral that targets part of the life cycle of the hepatitis virus, therefore it does not hit any host targets and therefore the side effects are essentially zero. You can't imagine a more wonderful viral story in terms of a cure and then this one, and yet, even for people who have insurance, they're not getting it. So why is that? Well, cost is a big part of it. The initial cost of the direct acting antivirals, and initially this is Gilead, and then AbbVie and then Merck were in the neighborhood of $90,000 per patient. And that immediately set off alarm bells in terms of our reimbursement system so that all kinds of barriers got put up there to try to keep people from just willy-nilly getting cured. So for instance, many Medicaid systems, you can't have access to the cure unless you prove that you already have liver damage, you have to have fibrosis or maybe even cirrhosis. You have to go to a specialist, and oftentimes the specialists are kind of busy. And the way in which you have to prove that you're completely free of any drug use is also discriminatory against people who could maybe really benefit from this. So all those barriers were put in the way and people noticed that and they said, "Well, I don't feel so bad right now." And so the cure was not getting to them. The cost is still pretty high, Kirsten, it's probably in the neighborhood of $20,000 per patient, even for somebody on Medicaid where you have various ways of trying to keep the costs down. And talking to the state Medicaid directors, which I've done a fair amount of, they're like, "If we really were going to try to treat all the people in our system who are hep C positive, it would absolutely break our budget. So we can't do anything other than put out those barriers and try to screen people," even though they all kind of know this doesn't make any sense. You can cure the disease, let's cure it before it does damage not after.
Kirsten Bibbins-Domingo: So let's go a little bit deeper on the cost. So it's costly and yet we're going to roll out this big plan to eliminate hepatitis C. How are we going to make that cost work? One of the points you make that's so interesting to me is that there are some cost savings downstream if we were to absorb the upfront costs.
Dr. Francis Collins: Right. Well, basically there are two issues here that both work in the favor of actually mounting this national program to eliminate the disease. One is there are methods that we can do to reduce the cost per patients. I'll tell you about those in a minute. And the other is to recognize that if we're really talking about the long-term cost of hepatitis C, we also should be thinking about all of the medical consequences of not curing people. JAMA Internal Medicine just a month ago published the largest study ever of following up hep C positive individuals, a quarter a million people followed through Optum. And not only did it show dramatic differences in those who got cured, which was only about 20% of them, versus those who didn't in terms of liver failure, in terms of liver cancer, we kind of expected that, also showed highly significant differences in diabetes, in kidney disease, in cardiovascular disease, all of which were significantly higher in the untreated people even though they were otherwise pretty well matched. So there's all of these consequences that are preventable if we can get people access to the cure, but which are otherwise going to cost tens of billions of dollars to the federal government in terms of Medicare and Medicaid costs. So it would be very shortsighted to simply say, "Oh well, it's going to cost a lot right now, so we can't do anything." Think about this the way you would your own family budget, if you're going to save probably multiple times the cost of the cure downstream by avoiding all those healthcare costs, wouldn't you want to do that? So that's one thing.
Kirsten Bibbins-Domingo: Sounds like we should, sounds like we should. So tell us about the four points here that make up this program. We're starting first with addressing the barriers that we've already talked about, most people don't know that they even have this infection. So maybe we can start there.
Dr. Francis Collins: Well, certainly. And the testing right now is not ideal. The way in which testing is done for hep C is you start out with an antibody test, if that's positive, that tells you that you've had exposure to the virus. But about a quarter of people who get hepatitis C do manage to cure themselves. Their immune system is up to the task, three quarters don't. So an antibody test doesn't mean you necessarily need the cure, and now you need to find out are you actively infected? And that's an RNA test on blood, so that's a second test. And both of these tests are done in big box laboratories, this is not point of care. So there's a big lag time after each test. So that means you've gone in twice. And then if you're positive, you need to come back the third time to get started on the treatment, to get your pills. That's not a good situation, particularly for people who are in marginalized situations, may not have access to transportation, maybe living on the reservation. Three visits to actually get started, we should have a test and treat plan here, where you have point of care testing available. You come in, you get your point of care test, you get a result in 30 minutes, here's your bottle of pills because you're positive. That's the goal. And we can do that. We learned how to do that with COVID. All of us have our point of care tests sitting in our bathrooms at home just in case we think we've got a sniffle, and there's no reason we can't do that with hep C. In fact, Europe has already done that. There is a point of care RNA test being utilized in Europe and it just needs to get reviewed to see if the FDA would approve it here. And all the experience we have with COVID is going to make that possible, FDA working with NIH and something called ITAP to do that quick review and validation of the test. So that's step one. Let's get the testing really upscale where it should be. Step two is access to the drugs. So how are we going to get the cost to the point that our nation can absorb this? There's a really wonderful Louisiana pilot that has been done over the last three years, and my hat is off to Louisiana and particularly to their health secretary and to Senator Bill Cassidy from Louisiana who's a liver doctor and had a lot to do with mounting this. And they made a deal with Gilead, one of the companies that makes the drug, and they basically said, "Look, you're not making much money on the populations that we want to reach. We want to reach Medicaid patients and we want to reach people who are incarcerated. So tell you what, we'll negotiate a lump sum for you to make your drug accessible, just a one-time deal, and if you agree to that, then you have to make the drug available to everybody we can find." Which means once you've done the deal, you're highly motivated to go and find all of those patients. Now, I don't know exactly, because it's all been a little confidential what that came to, but I think the cost per patient in Louisiana for that program was in the neighborhood of a couple thousand dollars, probably 10% of what it would've been otherwise. If you can get that good a deal on a state basis, we ought be able to do at least that well on a national basis. So that's part of this plan. And Gilead and AbbVie, the two companies that have the drugs that work on all of the viral genome variants are very interested in this because they can see their prescriptions dropping and they would like to be helpful, but they don't want to sort of be overly altruistic or their shareholders will throw them out. But this is a way, it could be a win-win. They will continue to make money, but we will have a motivation to go and find people who otherwise are not getting touched because finding that next patient doesn't cost you any more money as far as the drugs, you already have that done. So the deal would be the federal government would do that negotiation. The drugs would then be essentially free to all the state Medicaid programs, to community health centers that are helping uninsured people and to prisons where as many as 30% of prisoners may be hep C positive. And they all want to do this, but they don't have the money and now this would get rid of that big barrier of the drug cost. So that's point number two. Point number three is, how do we make sure we have the healthcare delivery? I think, some people have said, "Well, if drugs just didn't cost so much, this would all be taken care of." It's not that simple, we really do have to figure out how to beef up the outreach to marginalized communities and that means finding additional support for the federally qualified health centers, for state Medicaid programs, figuring out how to do this in a very efficient way. A lot of this can be done by telehealth, that's already been shown to work really well in this circumstance. If you do that one visit, test and treat, and then you track by telehealth to be sure people are doing okay, you can get 95% cure rates. It doesn't mean you got to come back every week and get checked on. In fact, you shouldn't, it just slows everything down and ruins the cascade of care. So all of that's going to have to be supported as well. And then the fourth point, it is the case that the drugs cure the disease, but they don't prevent reinfection. So we have to be clear that all of the public health measures to prevent new infections need to be doubled down on. If you think about it though, reducing the incidence of hepatitis C in the population is also going to reduce the number of new infections. There's just not as much virus around anymore. But I still think in the long run, we need a vaccine. We don't have one for hep C. It's a bit stalled right now. It turns out it's a virus that has an awful lot of genomic variability. But now with messenger RNA approaches where you can start to come up with ways of multiplexing your immunization, I think this is probably a solvable problem and we just ought to beef up that effort and go for it. So that's it, if we could do those four things, bang, eliminate the hepatitis C in the US.
Kirsten Bibbins-Domingo: Wonderful. I love it. So let me just go through the four points just very quickly to restate. So first is finding the people. We need easier tests. My patients oftentimes don't come back for their second test. If we can have a point of care test, a test where the answer right away, and therefore you can start on treatment right away, that eliminates some of the barriers that we all have to moving from what the doctor's telling us to actually starting the medications we all need to start. So point number one is better tests, and it sounds like they're out there. We just need to get them approved here in the US and people are going to work together to do that. The second point is the big point on the drugs. The drugs, the drugs are costly and that has been a barrier, but it sounds like the companies who are making the drugs are willing to participate. We have evidence in Louisiana that this has worked before, that paying upfront for and ensuring that those companies have the stream of revenue for this, that we can actually lower that barrier and make sure that all of the people who then test positive could actually have access to the medications, which is terrific. And then there has to be outreach. We have to out have outreach to find people, to bring them in, to let them know. We have to have a way to monitor them over time. And then there's got to be some new discovery along the way. We need a new vaccine. And that science will help us to make sure that once we get over this plan to eliminate, that we're still staying ahead of the game.
Dr. Francis Collins: What a great summary, you've got all four of those points perfectly.
Kirsten Bibbins-Domingo: That sounds great. It sounds so simple, but I know, Francis, this is a lot of different agencies in the federal government working together to do this. This is the private sector, the companies that are making these therapeutics. This is a lot of people who probably all agree this is a good idea, but we haven't quite pulled it all together. So how did you get everyone to come to the table to do this?
Dr. Francis Collins: It wasn't that hard once people begin to get their heads around what this could do as a public health effort to save lives. I got asked to come to the White House a year ago to be the acting science advisor. I was asked to look at a whole bunch of potential opportunities. And this one kind of emerged in the course of my first month or two as something where people kept mentioning, "Well, there is hepatitis C, but I don't know what we're going to do there." So I began, along with my wonderful senior advisor, Rachael Fleurence, to talk to lots of people in the Department of Health and Human Services because that's where most of the action would need to be. At CMS, we got very, very into CMS as a way of thinking about these things, at CDC, at FDA, at HRSA, since they run the community health centers, at the Indian Health Service, at SAMHSA, because so many of the people who are Hep C positive are in some way connected with opioid treatment programs. And every time we had that conversation, people would go, "Oh, it would be so good if we could figure out a way to do this together. We just haven't had an organized plan." We had a White House meeting, sort of a summit in June. We continued those conversations with other meetings all through the fall. And I can't tell you a single person in a high level leadership role in HHS who has said anything other than, "We've got to do this." So the team is ready to go, what of course is needed is momentum and some initial money because you have to figure out how to find and cure these people before you can start enjoying the reduced healthcare costs downstream that will happen as a result. The administration, the Biden/Harris administration has been very interested and supportive of this. And so the fact that here today, this is being rolled out as part of the president's budget for FY 24, and the budget is the policy, as we all know, this is where the president lays down the markers of what he thinks are most important for our country to invest in, that's a big moment. That says, "Okay, this is a national priority from the view of the chief executive himself." But now of course, Kirsten, what's going to happen is Congress has to decide, do they agree? because the president proposes and the Congress disposes, and so the coming months are going to be critical to see whether in fact there's enough momentum for our somewhat fractured political system, and we all know it's all tense right now, to wrap their arms around this and say, "We just have to do this."
Kirsten Bibbins-Domingo: I hope there is some momentum behind this. As you said, this is a historic opportunity where we can advance all of these things and advance a little bit of science at the same time for the future. And it's a bold plan, but I think the benefits could be good down the road.
Dr. Francis Collins: Absolutely. And I am hopeful from the conversations I've already had with members of the Congress that there's going to be a pretty open willingness to look at this. So we're going to try to do everything we can here to try to be sure that this opportunity doesn't go by.
Kirsten Bibbins-Domingo: That's wonderful. That's wonderful to hear. And with the experience in Louisiana thinking about how we can scale that it's quite a historic opportunity, as you suggest. Dr. Collins, anything else you'd like to say to our JAMA listeners?
Dr. Francis Collins: Well, I'm really glad we had this chance for this conversation, and JAMA has been wonderful in embracing this as a topic that really our nation ought to look at and think about seriously. And certainly hoping for those care providers who are listening that you will think about this as something you'd want to get personally engaged in. I've talked to a number of such providers who've had the experience of actually deciding they're going to go and offer testing, and then they find somebody who's positive and they get such a rush out of this because, "Okay, here's your bottle of pills, 12 weeks." And then you see that person a few months later and they're cured. How often do we as physicians get to have that kind of wonderful experience, and it's out there waiting. So I do hope, and that means all kinds of primary care providers who maybe have thought this was a little bit more of a specialist issue, will see this as right in the center of what they want to be part of. So thank you for-
Kirsten Bibbins-Domingo: Primary care provider, I say, here, here. Yes. So I agree.
Dr. Francis Collins: Indeed. So Kirsten, thank you so much for the chance to have this conversation and to spread the word here about something that I really believe could make a huge difference for our country, and all those people who maybe don't even know we're talking about them whose lives we might be able to save.
Kirsten Bibbins-Domingo: Well, Francis, thank you so much for joining me to explain this important program and thank you for your work and clearly advocating and pulling this together. It's really quite remarkable. Thank you.
Dr. Francis Collins: Thank you so much, Kirsten.
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