Drug For HIV-Negative People Raises Questions

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Peninsula-based drugmaker Gilead Sciences received permission from the FDA on Monday to sell its landmark daily pill, Truvada, to HIV-negative people as a way of protecting them from getting infected. Some researchers call it a step toward eradicating AIDS, while others fear it may be a step back from years of encouraging safer sex habits. Gilead already provides Truvada for HIV-positive people.  Joshua Johnson discusses the issue with Dr. Andrew Zolopa, director of Stanford's Positive Care Clinic, an HIV services facility.


Edited transcript:

JOSHUA JOHNSON, HOST: What do you think would be the impact of Truvada on your practice? What do you expect your patients to say about it?

DR. ANDREW ZOLOPA: Well at this point I don't think it's going to have a major impact in that patients who generally are accessing health care tend not to be at high risk for HIV infection. That's not universally true, but it's true in our practice. So even though our patients and patients around the community that we're serving have known about these study results for quite some time, the uptake for this preventative pill has not been that great.
I think what we need to do as a community is reach out to high-risk populations who would benefit from this therapy, and that's where the challenge is going to be. Trying to identify those populations, get them into care and try to get them onto medication.
JOHNSON: So in terms of deploying Truvada, if I’m someone who wants to start using the pill, or maybe if I’m someone who perhaps is considered a high-risk man who has sex with men and should be using the pill, how might that work?
ZOLOPA:  Well they’d have to access health care, that’s number one. And a lot of those people  you’re describing are not patients. They’re young men that are healthy and otherwise going about their life so they have to find some way of connecting to the health care system. Once they do that, then if this medication seems appropriate after they’ve discussed it with their health care provider, that has to be monitored, so all of that requires a health care infrastructure.
JOHNSON: It sounds like what you’re saying is that there is a layer of the solution above Truvada, or really wrapped around Truvada, which is the health care system at large. It kind of falls apart if you don’t have a way of getting the pill to the people who need it and making sure people who need it know they need it.
ZOLOPA: There’s no magic bullet here. It’s not just a pill by itself. It really does require careful prevention planning, safe-sex education, the use of condoms. All of those things still are required as well as medical monitoring for the medication because of course there are side effects to medications. All medications, even a medication as good as Truvada.
JOHNSON: The side effects seemed relatively minimal according to the studies, but what other concerns might you have about unintended consequences?
ZOLOPA: Well that’s true, the overall side-effects profile is quite good for this medication it doesn’t make people feel sick. But we’re more concerned about long-term use, so in the studies we see that there can be slight increases in kidney function abnormalities as well as long-term bone abnormalities that may be an issue. Those have to be monitored. It does seem to be safe in the short term, but it’s really the long- term effects.
JOHNSON: Truvada costs thousands of dollars a year in the U.S. It is not a cheap medication. How do you expect insurance companies to deal with this or react to this?
ZOLOPA: Well that’s true, it is an expensive medication. I think the estimates are between $10-12,000 a year to maintain this kind of treatment to prevent HIV infection. But if you’re targeting correctly --  high-risk populations where the risk of HIV is more than one percent a year, which may not sound like a lot to your listeners but that’s a high risk population -- then it actually has been shown to be cost effective because you are preventing HIV infections and as we know, treating HIV is an expensive proposition as well.
JOHNSON: And briefly in the time we have left, what about the concerns about prevention and safe sex efforts? There were some organizations like the AIDS Health Care Foundation who were very concerned that people would start thinking, oh we’ve got a pill to stop HIV, I can stop using condoms and stop my safe-sex practices.
ZOLOPA: Well I think that’s why also this has to be done in the context of medical care so that can be monitored and those kinds of behaviors can continue to be reduced.
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