A pill to prevent HIV?
The FDA is currently reviewing an application from Gilead Sciences to expand the labeling indication of Truvada, a combination antiretroviral drug, for HIV prevention. While the drug is currently used in many regimens for HIV therapy, clinical trials have demonstrated its ability to prevent HIV acquisition among HIV negative people, when taken correctly. (If you take the pill every day, your risk of acquiring HIV appears to be greatly reduced: in the iPrEx study, participants who took the drug regularly (as confirmed by blood samples, not the less reliable self-reports) had 90% fewer infections than a control group.)
Despite its clear potential, there remain concerns about the drug's cost (at least $10k/yr for daily use), safety (associated with kidney injury and bone mineral density loss), appropriateness for different populations (especially heterosexual women, among whom the efficacy data are mixed), drug resistance (if a person who's already HIV positive uses Truvada instead of a full 3- or 4- drug combination regimen) and patients' ability to take it regularly (adherence was found to be so low in the FEM-PrEP trial that it was impossible to draw any conclusions about the drug's efficacy).
Most researchers, clinicians and HIV advocates seem to be taking a cautious but optimistic stance towards incorporating this intervention into clinical practice. CDC has issued interim guidance and a limited number of providers have already been prescribing Truvada off-label. One group opposing FDA approval of the new indication, however, is the AIDS Healthcare Foundation. Here, you can see me discuss this topic on the TV show Biocentury This Week along with Tom Myers of AHF and Owen Ryan of amfAR:
![BioCentury 04.29.12 - [1] What's at Stake](http://www.biocenturytv.com/images/marquees/marq_042912_play.png)
More content on this topic to come. For now, enjoy the video!
The FDA is currently reviewing an application from Gilead Sciences to expand the labeling indication of Truvada, a combination antiretroviral drug, for HIV prevention. While the drug is currently used in many regimens for HIV therapy, clinical trials have demonstrated its ability to prevent HIV acquisition among HIV negative people, when taken correctly. (If you take the pill every day, your risk of acquiring HIV appears to be greatly reduced: in the iPrEx study, participants who took the drug regularly (as confirmed by blood samples, not the less reliable self-reports) had 90% fewer infections than a control group.)
Despite its clear potential, there remain concerns about the drug's cost (at least $10k/yr for daily use), safety (associated with kidney injury and bone mineral density loss), appropriateness for different populations (especially heterosexual women, among whom the efficacy data are mixed), drug resistance (if a person who's already HIV positive uses Truvada instead of a full 3- or 4- drug combination regimen) and patients' ability to take it regularly (adherence was found to be so low in the FEM-PrEP trial that it was impossible to draw any conclusions about the drug's efficacy).
Most researchers, clinicians and HIV advocates seem to be taking a cautious but optimistic stance towards incorporating this intervention into clinical practice. CDC has issued interim guidance and a limited number of providers have already been prescribing Truvada off-label. One group opposing FDA approval of the new indication, however, is the AIDS Healthcare Foundation. Here, you can see me discuss this topic on the TV show Biocentury This Week along with Tom Myers of AHF and Owen Ryan of amfAR:
More content on this topic to come. For now, enjoy the video!
