FEM-PrEP Study Closes Early, Implications Yet to be Determined

By Rob Banaszak on April 19, 2011 in Policy/Advocacy

julia_chengBy Julia Cheng, Zamora Fellow, AIDS United

On Monday April 18th Family Health International (FHI), the organizers of a clinical trial testing the combination antiretroviral (ARV) drug Truvada as an oral Pre-Exposure Prophylaxis (PrEP), announced that the FEM-PrEP study would begin to close.   FHI released a statement after a scheduled review by an Independent Data Monitoring Committee advised that the study of the effectiveness of using the drug to prevent HIV among African women at high risk for contracting the virus would be unlikely to come to conclusive results.

For many in the HIV community, the closure of this study is disappointing.  Previous studies of Truvada and tenofovir (one of the ARVs contained in Truvada) had shown promising implications and advocates had hoped they were nearing a breakthrough in preventing HIV.  The CAPRISA trial released results in July 2010 showing that a microbicidal vaginal gel containing 1% tenofovir had an overall 39% effectiveness rate in preventing HIV and a 54% effectiveness rate for women who used the gel for the majority of their sexual encounters.  The iPrEX study, which used the same drug as the FEM-PrEP study, released its results in November 2010 showing a 43.8%  average reduced risk for men who have sex with men (MSM) and transgender women who have sex with men but a 72.8% reduced risk for those with high adherence to the drug regimen. PrEP and vaginal microbicides both have delivery methods that are helpful because they do not need to be applied or used during sexual intercourse and can be used without having to negotiate with a partner.  Since social inequities play a large role in determining those most affected by HIV, giving greater tools to people may have less power over their HIV exposure, particularly women, can play a huge role in reducing infection.

Upon the announcement of the FEM-PrEP trial closure, both CAPRISA and iPrEx researchers released statements commending the researchers and participants of the trial, while urging caution at making conclusions from the still preliminary data.  They noted that this news needs to be studied further and that the study may have large implications for the use of PrEP and Truvada or conversely may have no significant impact on the existing science.  In the meantime, the Centers for Disease Control and Prevention (CDC) released a letter reiterating that its interim guidelines for PrEP only apply to MSM.  For now, little will change until more details of the study come to light as the researchers close the study and analyze their data.  Whatever the case, the closing of the FEM-PrEP trial at this point continues to show that communities and people at risk of HIV need more tools to prevent HIV that are supported by science.

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