November 28th, 2011

Tenofovir Gel Disappointing in VOICE Trial

From the Microbicide Trials Network:

VOICE, an HIV prevention trial that has been evaluating two antiretroviral (ARV)-based approaches for preventing the sexual transmission of HIV in women – daily use of one of two different ARV tablets or of a vaginal gel – will be dropping the vaginal gel from the study … The DSMB recommended that VOICE discontinue the tenofovir gel and placebo gel arms, because there was no difference in effect between them in preventing HIV infection.

This leaves only the TDF/FTC intervention arm still open in VOICE, as the TDF alone arm was stopped for futility by a similar DSMB action in September.

We’ll be covering these new data in greater detail in Journal Watch AIDS Clinical Care (including some speculation on why tenofovir gel here failed), but on first pass, this news comes as a big disappointment — especially in light of the CAPRISA 004 study, results of which triggered a standing ovation at the International AIDS Conference in Vienna in 2010.

In fact, HIV prevention research has been on quite a roll the past few years, so much so that maybe we’re unrealistically expecting the data equivalent of a home run with each study.

If it were that easy, however, we wouldn’t have to do the research — in other words (to continue the metaphor), that’s why they play the games on the field.

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HIV Information: Author Paul Sax, M.D.

Paul E. Sax, MD

Contributing Editor

NEJM Journal Watch
Infectious Diseases

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