CONRAD Commends FHI and FEM-PrEP Study Team

April 18, 2011

ARLINGTON, VA-- April 18, 2010 - - Today, our colleagues at FHI announced that the FEM-PrEP study of oral Truvada for HIV prevention in women is ending prior to the completion of the trial.   A scheduled interim analysis conducted by an independent data monitoring board showed that there was no difference in the number of HIV infections between the women in the placebo group, and in the Truvada group. FHI concluded that it is highly unlikely that daily doses of oral Truvada will prove effective at preventing HIV in this study group, and will begin an orderly closure of the study. While final analyses won’t be available for several months, CONRAD commends the FHI study team for conducting a highly professional trial that will provide important data to the field. 

Truvada is an antiretroviral that is currently used as a treatment for HIV-positive people and has been proven to be safe and effective.  There is strong evidence that antiretrovirals used prophylactically can prevent HIV infection.  Last year’s results of the iPrEX study of oral tenofovir in men who have sex with men showed a reduction of 44% in HIV infection in men who have sex with men.  It is a therapy that has been used successfully by HIV-infected mothers during childbirth to reduce an infant’s chance of contracting the virus by about 75%.  Treatment with anti-HIV drugs can also significantly reduce the risk of infection when taken immediately after exposure to the virus.

The FEM-PrEP trial enrolled 1951 HIV negative women at four sites in three countries: Bondo (Kenya), Arusha/Moshi (Tanzania), Pretoria (South Africa) and Bloemfontein (South Africa).  The trial compared Truvada plus standard HIV prevention services to a placebo pill plus standard prevention services.  Other pre-exposure prophylaxis trials are being conducted in Asia, South America, the United States, and other parts of Africa.

While it is unknown at this time why Truvada was not effective in the FEM-PrEP study group, its effectiveness in other studies remains to be seen.  These preliminary findings highlight the challenges scientists face in finding effective HIV prevention methods for women  - who are most at risk for contracting HIV, and who are more vulnerable socio-economically.  Additionally, with each trial, the field gathers more data that can be applied to ongoing and future trials - continued research and funding support is more crucial now than ever before.

For more information on the FEM-PrEP study, please go to:

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