Preliminary data from the FEM-PrEP trial show equal numbers of HIV infection in women taking Truvada as oral pre-exposure prophylaxis and those taking placebo.
A large trial of HIV pre-exposure prophylaxis (PrEP) has been stopped early, because it is “highly unlikely” to demonstrate that Truvada (tenofovir disoproxil fumarate/FTC) protects women against HIV infection.
In this phase III trial (called FEM-PrEP), 1951 HIV-negative, high-risk women in Africa were randomized to take Truvada or placebo orally once daily. All the women received monthly risk-reduction counseling, free condoms, and free treatment for sexually transmitted infections; they were also tested monthly for HIV infection and pregnancy.
Preliminary data from approximately 1100 person-years of follow-up indicate that 56 infections occurred during the trial, with exactly half in the Truvada group and half in the placebo group. This fin…
Author
DisclosuresConsultant/Advisory BoardUNAIDS; WHO; Bill and Melinda Gates Foundation, Population Council
Grant/Research SupportNIH; National Institute of Allergy and Infectious Diseases; Tides Foundation/MAC AIDS Fund; USAID; South African National Research Foundation; European Union; South African Medical Research Council
Editorial BoardsNew England Journal of Medicine; AIDS Reviews; AIDS Research and Human Retroviruses; mBio; Indian Journal of Medical Research; JAIDS: Journal of Acquired Immune Deficiency Syndromes
DisclosuresConsultant/Advisory BoardUNAIDS; WHO; Bill and Melinda Gates Foundation, Population Council
Grant/Research SupportNIH; National Institute of Allergy and Infectious Diseases; Tides Foundation/MAC AIDS Fund; USAID; South African National Research Foundation; European Union; South African Medical Research Council
Editorial BoardsNew England Journal of Medicine; AIDS Reviews; AIDS Research and Human Retroviruses; mBio; Indian Journal of Medical Research; JAIDS: Journal of Acquired Immune Deficiency Syndromes