Independent monitoring bodies of two PrEP trials recommend offering antiretroviral therapy to all study participants
GENEVA, 29 October 2014—UNAIDS warmly welcomes strong indications from two ongoing trials of the effectiveness of antiretroviral therapy in preventing new HIV infections among men who have sex with men.
The IPERGAY trial, conducted by the ANRS, the French National Agency for Research on AIDS and Viral Hepatitis, enrolled 400 men who have sex with men in France to establish the efficacy of taking the antiretroviral combination of tenofovir/emtricitabine as pre-exposure prophylaxis (PrEP) before and after sex rather than daily. The data safety and monitoring board for the IPERGAY trial reviewed data for the study and found a “very significant” reduction in the risk of HIV infection in the group of participants using tenofovir/emtricitabine as PrEP compared to the placebo group. The monitoring board subsequently recommended that the placebo group be stopped and that all trial participants should be offered tenofovir/emtricitabine as PrEP.
This announcement follows a recent decision to amend the PROUD study in the United Kingdom. In the PROUD study, the participants were initially placed at random into two groups—one group that used PrEP from the start of the study and another group that was due to receive PrEP after 12 months. However, the independent data monitoring committee found that the effectiveness seen in the trial exceeded the threshold set for trial continuation and recommended that the researchers offer daily PrEP to all study participants immediately.
Neither study is ready to present the full data for review. However, both independent monitoring bodies were clear that the results were so convincing that it would be unethical to allow the participants to continue without receiving PrEP. The final results of the IPERGAY and PROUD trials are expected to be presented in early 2015. Once the results are confirmed, antiretroviral therapy taken as PrEP before and after sex could become an additional HIV prevention option for men who have sex with men.
UNAIDS underlines that no single intervention is completely protective in preventing HIV transmission, which is why UNAIDS advocates strongly for combination HIV prevention. This includes correct and consistent use of condoms, delaying sexual debut, having fewer sexual partners, male circumcision, access to antiretroviral therapy, reducing stigma and discrimination, and the removal of punitive laws.
UNAIDS
The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org and connect with us on Facebook, Twitter, Instagram and YouTube.
