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Tenofovir gel dropped from HIV prevention trial in women because it was not effective
Date:11/28/2011

tudy results are expected to be available in late 2012 or early 2013.

The VOICE team acknowledges with extreme gratitude the women who have participated in the trial, who have helped in providing the answers to key scientific questions, first about oral tenofovir tablets, and now about tenofovir gel. The goal now is to complete the study so that we can determine whether Truvada used daily is safe and effective in preventing HIV in women.

VOICE is especially relevant for understanding the potential for Truvada to prevent HIV in different groups of women. While two studies Partners PrEP and TDF2 showed that daily use of Truvada was very effective in both the men and women in those studies, it is not certain how generalizable the data from these two studies are to all women. Partners PrEP found Truvada was 73 percent more effective than placebo among men and women in committed relationships with an HIV-infected partner, in which both partners knew each other's HIV status and both consented to enroll in the study. As such, the results may not represent single women, women with multiple partners or those who, though married, may not know whether or not her husband has HIV. And while the results of TDF2 suggest that Truvada was effective in both men and women, few conclusions can be drawn from the results concerning the effectiveness of Truvada specifically in women due to the small numbers of women who became infected during follow-up.

The one trial besides VOICE that involved only women, a study called FEM-PrEP, was not able to demonstrate that daily use of Truvada was effective in that study population of women who were considered higher-risk, including women who engaged in frequent sexual intercourse or had more than one sex partner. A full analysis of FEM-PrEP data is expected to be available at the end of 2011 or early 2012, at which time there will be greater understanding why the study could not find Truvada effective.

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Contact: Lisa Rossi
rossil@upmc.edu
412-916-3315
Microbicide Trials Network
Source:Eurekalert

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