Discontinuation of the FEM-PrEP Trial - a quick round-up

This week saw a major development in the HIV prevention field: the Independent Data Monitoring Committee (IDMC) for the FEM-PrEP trial  concluded that it would be unlikely to prove the effectiveness of Truvada in preventing HIV infection among the study population, i.e., HIV-negative women who are at risk of infection through sexual transmission. As a result, Family Health Iinternational (FHI) – which is implementing the trial with research centers in Africa – has decided to discontinue the study.

Get the details as well as FHI’s perspective on the FHI website.

The CAPRISA group thanked FHI for carrying out the study and providing extremely significant interim results, and the iPrEx team stated that they look forward to working with the FEM-PrEP team to understand the results better. NIAID (National Institute of Allergy and Infectious Diseases) released a statement expressing disappointment at the halt of the trial, emphasizing the need for continuing research, and confirming that it will continue with the VOICE (Vaginal and Oral Interventions to Control the Epidemic) study while informing all current  VOICE participants about the FEM-PrEP results as early as possible.

The Microbicide Trials Network, the group conducting the VOICE study, issued a statement saying, "While it is disappointing that FEM-PrEP will not be able to provide information about Truvada for preventing HIV in women, the decision to stop the study should have no immediate impact on the VOICE study. VOICE is an ongoing trial involving women in Uganda, South Africa and Zimbabwe testing Truvada as well as the ARV tablet tenofovir and a vaginal microbicide containing tenofovir in gel form. VOICE will help determine which approach – daily use of the gel or tablet – is safe, effective and preferred by women for preventing HIV."

In The Wall Street Journal, Mark Schoofs outlined various possible explanations for the disappointing results, including potential adherence issues, as well as the physiological differences between men and women (essentially, these differences could mean a pill like Truvada may work better at preventing HIV infection among gay men or women with rectal exposure to HIV, than heterosexual women exposed vaginally.)  The New York Times deemed the termination of the trial “an unexpected setback” while the Washington Post discussed preliminary data.

South Africa’s Mail & Guardian presented the views of Dr. Khatija Ahmed of the Setshaba Research Centre in Pretoria. Dr. Ahmed led the research at one of the FEM-PrEP trial sites, and she points out that the halt of the trial “shows that you can't extrapolate that what happens in one population group will give you the same results in another population group.” She also stresses the need for ongoing research into HIV prevention options, given the high prevalence of HIV in sub-Saharan Africa.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]