March 31, 2014
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.