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Results of FEM-PrEP Clinical Trial Examining Pre-Exposure Prophylaxis (PrEP) for HIV Prevention Among Heterosexual Women

April 18, 2011

Dear Colleague,

Today, FHI announced that it will stop the FEM-PrEP study of pre-exposure prophylaxis (PrEP) for HIV prevention among heterosexual women. The decision was made after a regularly scheduled interim review of data by the trial's independent data monitoring committee determined that the trial could not demonstrate efficacy even if it continued to its originally-planned conclusion.

These preliminary results are disappointing, especially given that this approach has already been shown to be effective in reducing HIV infection among men who have sex with men (MSM). The well-conducted study included nearly 2,000 women at high risk for HIV infection in three African nations and sought to determine if a once-daily pill containing oral

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Visit the CDC's website to find out more about their activities, publications and services.
See Also
PrEP Ineffective for Women? Study on Truvada for HIV Prevention Is Unexpectedly Cut Short
Global Campaign for Microbicides Statement on the Discontinuation of the FEM-PrEP Trial
The FEM-PrEP HIV Prevention Study and Its Implications for NIAID Research
More News and Research on HIV Medications for HIV Prevention

Reader Comments:

Comment by: michael w (los angeles) Sun., Apr. 24, 2011 at 4:35 pm UTC
The CDC is misleading people when it says that PrEP is effective in reducing HIV infection among gay men. Based on the one study that was done there was only a 44% reduction in new infections which is a poor result.
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Comment by: John E (St. Louis, MO) Wed., Apr. 27, 2011 at 11:43 am UTC
Sorry, Michael, you are mistaken. But it isn't your fault - the reporting on these stories has been misleading and disappointing. One wonders whether the reporters simply don't understand the science or whether they are deliberately distorting the facts in order to lower expectations or to block further studies. In fact the problem in all PrEP studies to date has been poor adherence (people not taking the medicine as directed). When you look only at the results obtained from people who actually took the meds, the results are striking: effectiveness in the >90% range. In other words, when people actually take the drugs, they are protected from HIV infection. The FemPrEP study was halted not because the drug didn't work, but because the women weren't taking it. The study was stopped because it would not have proved anything (except maybe that people can be pretty damn stupid).

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