Researchers reported today at the 20 th Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta that none of three interventions tested in a large scale trial among African women, known as VOICE (Vaginal and Oral Interventions to Control the Epidemic) - daily oral tenofovir, daily oral TDF/FTC and daily 1% vaginal tenofovir gel - provided additional protection against HIV, likely because of low adherence in across all three interventions.
PrEP trials in Africa have provided key data about women in different populations and life circumstances. Trials have shown high rates of effectiveness among African women in stable relationships in which one partner is HIV-positive and low or flat rates of effectiveness among young women who were less likely to be in stable relationships. In all of these trials, including the VOICE trial, higher rates of effectiveness were linked with higher rates of adherence.
"The VOICE results were disappointing. The fact that few women in a trial which had very high rates of HIV incidence chose to, or were able to, use the products daily shows that we have much work to do to understand what social, cultural and other factors affect adherence to the prescribed dose and how we can support women in effectively using new prevention tools. But PrEP remains a valuable option for many women who will want to and can use it as prescribed," said Manju Chatani-Gada, Senior Program Manager at AVAC and co-convener of the Working Group. "Well-designed demonstration projects will help us understand adherence and other real-world issues for women who choose to use PrEP."
The Working Group calls for a coordinated, timely and adequately funded U.S. government response to PrEP for women that involves the full participation and leadership of individuals and communities most in need of effective, comprehensive HIV prevention. The federal coordinating group must look to answer critical questions not answered by current data about daily Truvada for PrEP, including:
- How will daily PrEP be used for HIV prevention by women in the United States?
- What data are needed regarding daily PrEP's acceptability and effectiveness among those women?
- How will daily PrEP be promoted, made accessible and financed for use by U.S. women?