After HIV prevention trial closes, advocates call for continued research

Family Health International (FHI) recently announced its decision to discontinue the FEM-PrEP study, which aimed to determine if daily antiretroviral drugs could safely and effectively prevent HIV infection in women in Africa through a method called pre-exposure prophylaxis (PrEP). FHI’s decision follows a recommendation from the study’s Independent Data Monitoring Committee, which determined that the study would be highly unlikely to be able to demonstrate the effectiveness of the antiretroviral Truvada in preventing HIV infection in the study population, even if it continued to its originally planned conclusion. A statistical interim analysis showed that the same number of HIV infections took place in participants given the antiretrovirals compared to those taking a placebo. The committee concluded that even if the trial were to continue, the number of trial participants would be too small to determine a conclusive outcome on the effectiveness of oral daily Truvada.

FHI subsequently concurred and decided to initiate an orderly closure of the study over the next few months. The final analyses have not yet been conducted. At this time, it cannot be determined whether Truvada works to prevent HIV infection in women.

“Today’s announcement about the FEM-PrEP study is disappointing,” said Mitchell Warren, AIDS Vaccine Advocacy Coalition (AVAC) executive director. “However, it must be seen as what it is—the closure of a single trial in a field that has generated exciting results in the recent past. Even with this finding, there is still a strong rationale for continuing other trials, including those in women, in hopes of obtaining better results in the future.”

The study received support from the President’s Emergency Plan for AIDS Relief (PEPFAR) through the US Agency for International Development (USAID). US Global AIDS Coordinator Eric Goosby and USAID Administrator Rajiv Shah said in a statement, “While we are disappointed in the news from the FEM-PreP study, funded by PEPFAR through USAID, other research on pre-exposure prophylaxis is underway. This is the nature of scientific research; some failures lead to other successes. We will continue to work with our colleagues in the scientific community to monitor the results of these and other research studies, in the hope that they will produce new tools for HIV/AIDS prevention.”

FEM-PrEP was one of a number of important studies that seeks to understand whether tenofovir-based oral prevention can help prevent HIV infection in different populations. Three other studies are currently underway that will help to answer if oral Truvada or tenofovir can reduce HIV transmission in those at greatest risk of infection, including:

• Injecting drug users.
• Women at high risk.
• Couples in which one partner is HIV-positive and the other HIV-negative.

Sponsors of these trials do not expect any immediate impact on their ongoing studies and stress the even greater importance to continue research to answer critical questions about what works, in which communities, and where. “What is important is that we learn lessons from FEM-PrEP—and continue in our search for prevention tools that women can use to help protect themselves from HIV,” said Yasmin Halima, director of the Global Campaign for Microbicides (GCM). “The field has promised, and delivered, some exciting results. This is a setback certainly, but additional studies are already underway, testing Truvada and newer agents with different dosing and delivery mechanisms. As advocates, we have to keep fighting for women and for communities who today still remain biologically, culturally, and economically vulnerable to HIV.” See the links below for more details.

Additional resources:

AVAC release

Goosby and Shah statement

FHI release

GCM release


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