CDC Responds To End Of African PrEP

The CDC writes us this morning to note their response to the early halting of an African HIV PrEP study, which I mentioned yesterday. Pre-exposure prophylaxis (PrEP) involves taking an HIV medication as a preventive to infection. The CDC expresses disappointment with the cessation of the African study, as "this approach has already been shown to be effective in reducing HIV infection among men who have sex with men."

While PrEP with FTC/TDF was not shown to be effective in preliminary analyses of these study results, it cannot yet be definitely determined whether this drug combination works, or does not work, to prevent HIV among women. FEM-PrEP study investigators will be conducting additional analyses in the coming months to better assess potential reasons for the results in this study – including examining factors such as adherence and differential risk behavior between the two trial arms -- that may account for the lack of demonstrated efficacy in this trial. Investigators from other PrEP trials, including CDC, will be working closely with FHI to review all available data and determine any implications for ongoing research. Given today's results, CDC cautions against women using PrEP for HIV prevention at this time. We will not know if PrEP is effective for women, couples, or injection drug users until the conclusive results of this and other trials are reported.

African HIV PrEP Study Halted

Citing poor early results, researchers have halted an African study in which women were given the HIV medication Truvada as a preventive to infection. Pre-exposure prophylaxis (PrEP) has been considered one of the more promising advances against AIDS.

Women taking Truvada, made by Gilead Sciences Inc., are just as likely to get HIV as other women who have been given dummy pills, an interim analysis of the study found. Even if the study were to continue, it would not be able to determine whether the pills help prevent infection, since the results are even this far along, researchers said. The finding is disappointing because another study last fall concluded that Truvada did help prevent infections in gay and bisexual men when given with condoms, counseling and other prevention services. Many AIDS experts view that as a breakthrough that might help slow the epidemic.

Last month the U.S.-based AIDS Healthcare Foundation denounced a similar study for gay men, saying, "There is no magic pill." Truvada costs as much as $14,000/year in the United States, but is available in generic form overseas for as little as $140/year.

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