FDA May Support Pill That Would Prevent HIV A Food and Drug Administration advisory panel is recommending that the agency approve the first pill to protect people from getting infected with the HIV. The recommendation is being hailed as a potential milestone in the battle against the AIDs epidemic. If the Food and Drug Administration goes along with the recommendation, the drug would become the first to be approved to prevent HIV infections. Melissa Block talks to Rob Stein.

FDA May Support Pill That Would Prevent HIV

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It's ALL THINGS CONSIDERED from NPR News. I'm Audie Cornish.


And I'm Melissa Block. There's big news in the battle against the AIDS virus. Federal advisers are recommending that the government approve a pill that can prevent infection with HIV. If the FDA follows the advice, it would mark the first time a drug has been approved for that purpose.

NPR's Rob Stein joins us now to explain this development. And Rob, this is a drug that's actually been around for a while, to help treat people already infected with HIV. Tell us more about it.

ROB STEIN, BYLINE: That's right. The drug is called Truvada. And it was approved back in 2004, as you said, to treat people who are already infected with the virus. It works like other AIDS drugs, by inhibiting the ability of the virus to reproduce. That keeps the virus in check, and it keeps the virus from destroying people's immune systems and making them get sick.

BLOCK: So that's how it's been used to treat people already infected with HIV. But now that they're expanding that to say aha, this can also be used to prevent HIV, what populations are they talking about?

STEIN: That's right. This would be for a different use, which is to prevent people from getting infected in the first place. And this would be targeted at people who are at high risk of getting infected for various reasons. For example, it would be targeted at gay men who have a lot of sexual partners and therefore, get exposed to the virus a lot and have a high chance of getting infected. But it would also be targeted at heterosexuals where it's a couple; one member of the couple is infected, the other one isn't; so the one who isn't is getting exposed a lot, and has a high risk of getting infected.

BLOCK: And how does the drug work?

STEIN: It works the same way as it works for treating people. It basically inhibits the ability of the virus to reproduce. By keeping the virus in check, it prevents the virus from getting a foothold in people's bodies and therefore, reduces the chances of them getting infected. There have been a couple of studies that have been done that shows that it's really, pretty effective.

One study among gay men showed that it reduced the risk by 44 percent. And among those who were really good at taking the drug, it was almost as much as 90 percent. Then there were some other studies that showed that it reduced the risk by between 60 and 70 percent, something in that range.

BLOCK: There are, though, concerns about the drug, and let's talk about some of those. One is side effects.

STEIN: That's right. That's right. Like all drugs, this one has side effects. Initially, when people start taking the drug, they can get symptoms like dizziness, nausea, vomiting. But there are also more serious side effects; like, it can cause liver damage, kidney damage. So people who are taking the drug have to be monitored very closely. And beyond that, there are even bigger concerns. People are worried that if people don't take the drug correctly - which means taking it every day diligently, never missing a drug - it could lead to new strains of the AIDS virus emerging that are harder to treat, and may be resistant to getting treated at all.

And then beyond that, there's a big concern that it could sort of lull people into a state of complacency where they'll stop doing other things to protect themselves - like stop using condoms, for example. That's a big concern.

BLOCK: And that, obviously, is a significant concern. How important would this drug be, do you think, in the fight against AIDS?

STEIN: You know, this possibility of approving the first drug that could prevent somebody from getting infected with the AIDS virus in the first place is creating a lot of excitement. People have been trying for years to develop an AIDS vaccine, and it's been one disappointment after another. They haven't been able to come up with anything.

This way, people could reduce the risk of getting infected beyond the things we all know about - using condoms, and being careful who you have sexual relations with.

BLOCK: And what about the price of this drug?

STEIN: It's an expensive drug. It costs about $14,000 a year, so we're talking about a lot of money here if a lot of people start using it. And that's one of the key points here - is that if the Food and Drug Administration does approve it, more insurance companies are likely to start paying for it.

BLOCK: And we mentioned that the advisory panel has recommended that the FDA do just that, approve this drug. What happens now?

STEIN: Well, the FDA has until June 15th to make a final decision. And the agency doesn't have to follow the advice of its advisory panel, but it usually does. And in this case, it's fairly likely that they will because the vote was really lopsided in favor of improving this drug. That means it could be available by this summer because the drug is already available for doctors to use, to treat people who are infected.

Now, once the company that makes the drug gets the final approval from the FDA, they can go ahead and start marketing it for that purpose.

BLOCK: OK. NPR's Rob Stein, thank you.

STEIN: Sure thing. Thanks for having me.


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