Looking Forward in Hepatitis C Treatment, With Trepidation

An Interview With Tracy Swan

Tracy Swan
Tracy Swan

Each year at the Conference on Retroviruses and Opportunistic Infections (CROI), a unique panel convenes on the first day of the meeting. This event -- the Martin Delaney Panel -- highlights a critical issue that lies at the intersection between HIV clinical research and HIV advocacy.

At CROI 2014, the theme of the panel was "Hepatitis C: From Trials and Tribulations to Triumph." One of the panelists was Tracy Swan, Hepatitis/HIV Project Director at Treatment Action Group and a longtime, outspoken patient advocate on issues related to HIV/hepatitis C coinfection. Our correspondent Terri Wilder spoke with Swan shortly after the panel.

It feels like this year, 2014, is shaping up to be the year of hepatitis C. What are your thoughts about developments that are coming down the pipe, and what do you think about the challenges that are going to come with these new hepatitis C drugs?

It's funny. You keep seeing these trials with cure rates of 95% and 100%. And it's wonderful -- don't get me wrong -- but it's almost mind-numbing after a little while. You just think: How do you distinguish? Everything is well tolerated. What is going to be the best way to get things out there to people?

I think we really need screening programs. We need to identify more infected people. And we really need an infrastructure. So, as excited as I am about the drugs, and as grateful as I am to not have to keep talking to people about drugs that give them a lot of side effects and won't work very well ... Think about it: If the number of people with HIV quadrupled overnight and all the things we take for granted were stripped away -- the infrastructure, the funding, the programs, the case management, the services, and even the community; when so many people are undiagnosed, it's kind of hard to form a community -- if you strip that all away, you've got hepatitis C, on the downside.

Then, on the upside of things, you've got a cure.

I think 2014 is the year we bring those two together. But we have to figure out how to bring the cure to the people. And the drug prices are going to be a horrendous problem.

Let's talk about screening. The U.S. Centers for Disease Control and Prevention [CDC] came out with its recommended age cohort screening. The New York State Department of Health implemented a rule, effective Jan. 1, that folks in a certain cohort be screened for hep C. It feels like people are trying to roll these rules out, maybe in reaction to these new drugs.

How effective do you think these kind of cohort-based screening programs are going to be?

They can't be less effective than what we had before. I think some of these are really beginning to pick people up. What concerns me is, there are so many people newly entering care because of the Affordable Care Act. They may be getting slammed with multiple diagnoses all at once, because they haven't been in health care and don't know why they're feeling so crummy.

There might be providers that now feel that they need to screen, but then don't know what to do with people once they have a positive antibody test. I still think it's much better to screen as a critical public health step.

But there are a few things. It should be tied to surveillance programs, so you could collect the data while you're providing services to people, or nested within them, somehow. Also, yes, the baby boomer cohort is an important group, but you keep seeing all these reports of high infection rates among young people who are injecting drugs. If you're telling doctors who are already feeling pretty overloaded to do one more thing, they're not going to step out of that and start saying, "Hmm. I wonder who else I should be looking at now?" if they're trying to squeeze five people into an hour.

The cohort that we're talking about is people born between 1945 and 1965. I would assume that data drove that decision. But your point is that we're still missing people.

Well, the data we have are limited. It's from the NHANES survey -- incarcerated and homeless people -- and other very high-prevalence populations were not included. So, (1) we have an underestimate for the whole population; and (2) I don't quite understand how the incidence went from 300,000 cases a year down to about 16,000 cases over a decade and a half.

There are some reasons. Crack: People stopped injecting and started smoking more. But I think nobody was really counting, and we never developed the health care infrastructure that we needed to really characterize and then begin to address this epidemic. We have a lot of assumptions. There could be way more people of every age out there with hepatitis C.

Earlier, you mentioned the Affordable Care Act [ACA]. What do you think is going to complicate ACA implementation and getting folks who have hep C on treatment and into care?

I'm a big fan of single-payer health care. I would have much rather seen a system like that. I think we have a collapsing health care system with people entering it who don't even know how to use it.

No one's saying, "Look: People probably aren't going to be that nice to you. They're going to demand all this information from you. You're going to have five minutes with the doctor. You might hear something scary." You're not having anyone say, "What's on your mind?" How do you ask these questions? "How can we make the most of this appointment?"

I think we really need some health care literacy training for people so they feel comfortable going to a medical doctor. And when they get a diagnosis, whatever it is, they feel more like they have some control over what their next steps are. Hepatitis C has last-on-the-list syndrome. It doesn't progress quickly. "I don't have to deal with it right away." Treatment's too yucky. Treatment's too expensive.

Hopefully, the new drugs will really push the envelope, and people who need to be treated and cured will be. But it's not really clear how that's going to play out.

Let's talk about the new treatments for hep C. What is the reality? What are we looking at, in terms of people being cured?

I think we're really looking at something: 90% and over. It might be a little lower for people with cirrhosis. It might be a little lower for people who have more advanced liver disease.

The one group of people I'm worried about the most are the people that have late-stage or decompensated cirrhosis. There's very little known about what will be safe and effective. We don't want people to have to get a transplant, and even if they wind up there, there are insurance issues; there's organ scarcity. That's not the outcome we want to see.

And if they get a transplant, we want to be able to treat their hep C if it comes back afterwards -- because it almost always does.

Is this for both monoinfected and coinfected folks with HIV? Is the cure rate about the same, or is there a difference?

Today, we heard it's better in people with HIV. There was a moment when people were stunned, because we're all so used to hearing it's not. I thought it must be due to adherence. The presenter said, "Yeah. I think people really are used to taking pills. They know how to do it." To get in a trial, they had to have an undetectable viral load. They're taking their pills, and if they take their pills, their pills are working. It's always nice when that happens.

Let's talk about the cost of the new hep C drugs. It is a very sore spot for a lot of community activists who care about this issue. I think the worry is that if you don't have the right health insurance coverage, you're not going to be able to get access. What's happening out in the community? What are you hearing?

One of the things that we've thought about is how to get access for people who need treatment the most right away, with what's available now, whether it's off-label or not. I've done some work with the National Viral Hepatitis Coalition and [various doctors and advocates]. There's a "Dear Payor" letter explaining why this off-label expensive combination is good.

But, quite frankly, it's a very distasteful position to be put in, to [have to say], "Let me sell your totally overpriced drugs, just for people who need them." Something's got to give. The pharmaceutical industry should profit. We need to support innovation. But there is a point where you really have to ask: How much does a company really need to make?

We've seen data that say it costs less than $150 to make 12 weeks of sofosbuvir [Sovaldi]. That's Andrew Hill's study. It's based on a few million treatment courses.

I realize there are acquisition costs; there are development costs. But maybe when everybody starts shutting down the tap, that's when Gilead will be ready to come to the table and say, "We're going to have to make this affordable."

We're having this conversation in March 2014. What do you think the conversation is going to be like in March 2015, when we're all back at CROI? Do you have any guesses as to what the next year is going to look like?

I think a lot of people will start entering treatment. More people will get screened. More people will get cured. But the floodgates are open [in regards to] paying for things right now. As soon as there are more drugs and uptake surges, I think they're going to start shutting down. What I'd hate to see is [health care providers] putting people on a regimen that's a lot harder for them to get through, and possibly less effective; and then saying, "OK. That didn't work. Now you get this stuff."

Do we think that there's going to be something in the future that's better than the Gilead drug? Is there anything else that's coming?

We need another good pan-genotypic drug to pair with it. There is one, an NS5A inhibitor called daclatasvir, from a different company, BMS, that will be out later this year. That's going to be a good combination. When you look from a global standpoint, you'll need less testing, less monitoring. It's a very good combination.

But affordability is going to be such a huge issue, particularly for people in middle-income countries, let alone people in the U.S.

Can we talk about acute hep C? We don't have fourth-generation HIV testing rolled out to help with identifying acute HIV. Can you talk about how folks typically screen for acute hep C?

I think those infections get picked up in the context of routine HIV monitoring when people have really high liver enzyme levels. A lot of savvy clinicians have said, "Hey, what's going on? Could these be an acute infection?" And word has gotten out.

That's really how they're being picked up. I don't know any other way that they are.

Is it a challenge?

It's asymptomatic. If someone's been at risk, they might have been at risk multiple times. They might not feel sick. Someone else might not share the information: "Hey, I just found out I have hep C. And we were all at the same sex party." I think it's a failure of public health that there are no messages about how it's transmitted for HIV-positive men who are having sex with men.

Any closing thoughts? Messages that you would want to give medical providers, in light of all these changes that are happening in hep C?

Get ready for two things: fighting with a lot of reimbursement systems; and the great pleasure you're going to have when you get to cure somebody in two or three months, and see them return to health.

Great. Thank you very much.

This transcript has been edited for clarity.