FDA Approves Simplified Pill for HIV

The Food and Drug Administration has just approved a new once-daily, three-in-one pill used to treat HIV, the virus that causes AIDS. Dr. Joel Gallant, professor at the Johns Hopkins University School of Medicine, tells Madeleine Brand about the pill's possible impact.

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MADELEINE BRAND, host:

The Food and Drug Administration has approved a new once-a-day pill for people with HIV. The head of the FDA called it a landmark treatment. Previously, patients have had to take up to a dozen pills a day at specific times and under certain circumstances. AIDS activists hope this new simpler regimen will mean it'll be easier for people to stick with their medication, making it more effective, especially in the Third World. Dr. Joel Gallant joins us now to talk about the promise of this new drug. It's called Atripla. He's an AIDS researcher at Johns Hopkins University in Baltimore. And welcome to the program.

Dr. JOEL GALLANT (Johns Hopkins University): Thank you very much, Madeleine.

BRAND: Now, do you think this is a landmark treatment?

Dr. GALLANT: I think it is a landmark. I think this is a big day. Think back to 10 years ago when the idea of highly active anti-retroviral therapy was first introduced. With that therapy we went from an inevitably fatal illness to a chronically manageable disease. On the other hand, the therapy was very difficult, and demanding and unforgiving and toxic. And although it saved people's lives and really revolutionized the way we look at HIV, people had difficulty and either failed therapy because it was so difficult or stuck with it but developed a lot of problems.

When you fast forward 10 years and think that we're now able to treat HIV with one pill that really doesn't have a lot of major toxicity in comparison with the other regimens, it really becomes clear that it is a landmark.

BRAND: The FDA fast-tracked the approval for this drug. And who will receive it immediately?

Dr. GALLANT: Well, first of all, it's important to remember this is not a new drug. It's a new co-formulation of three previously approved drugs, and that's one of the reasons that it's so easy to get this approved quickly. Initially this will be a product that will be used primarily by people who are starting anti-retroviral therapy for HIV infection for the first time, or for people who are currently on an initial regimen and want to make a switch over to this single pill. But it's not going to be for everybody. If you're on a very complicated regimen these days, it's probably because over the years you've developed drug resistance and for people like that this is probably not going to be an option.

BRAND: But isn't one of the problems with drug resistance that people have not been able to stick with the complicated regimen and that this might actually make it easier for, for people to take and therefore it won't be as likely for them to become drug resistant?

Dr. GALLANT: Yeah, I think that's true for people who are starting out now or who have been doing well on an initial regimen. I think this will make it easier for them to adhere to therapy and could definitely decrease the risk of resistance. It doesn't undo resistance that already exists, though, so that's the important distinction.

BRAND: And what is its promise in the Third World, where the AIDS problem is the most severe?

Dr. GALLANT: Many resource limited countries already use generic co-formulated products. So they're actually used to doing this sort of thing, although I'd have to say that the combination that just got approved by the FDA is - most people would feel is a better product from a toxicity standpoint. Now, of course by comparison with these generic products, this product in the U.S., Atripla, is quite expensive.

BRAND: How much is it?

Dr. GALLANT: Well, it's the same as the individual components were before the combination was approved. I believe that's about $1,150 a month wholesale.

BRAND: That's a lot.

Dr. GALLANT: Well, it's a lot, but it's not a lot - much - it's not much more than what we're used to paying for anti-retroviral therapy. And I think, you know, in countries like the United States, where we can afford this, we have to remember that while the dollar amount may seem high, anti-retroviral therapy is really considered to be one of the most cost effective medical interventions of the last few decades.

BRAND: Is there any move to make a generic version of this new drug?

Dr. GALLANT: You know, the patent has a long way to go in the United States, but certainly in other countries, where they have been making generic version of drugs that we use in the United States, generic forms of some of the components of this combination are already available.

BRAND: Is there any fear on the part AIDS activists, people who work in the community, that this may send a message to people that, you know, AIDS isn't so bad if you only have to take a pill a day. So maybe I'll engage in some more risky behavior.

Dr. GALLANT: Oh, absolutely. The fear of HIV in some communities has, has diminished markedly now that it's a manageable illness. And we all worry that people will slowly relax their tendency to try to prevent HIV and just assume it's better to treat it.

BRAND: And we should note that people still die from AIDS.

Dr. GALLANT: They do, and these simple regimens don't work for everybody. You may have remembered the famous the New York case a little while ago, the man who was infected with a virus that was so resistant that he had very few treatment options. This is happening more and more, not to that extreme but certainly we're now seeing in the United States anywhere from 14 to 16 percent of patients who are newly infected being infected with drug resistant virus.

And in fact they're often infected with a virus that's resistant to one of the components of Atripla. So for that percentage of patients, this new landmark is really irrelevant because they are going to have to take a more complicated and potentially more toxic combination.

BRAND: Dr. Joel Gallant is a professor at the Johns Hopkins University School of Medicine in Baltimore. Thank you for joining us.

Dr. GALLANT: Thank you.

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