PrEP Data To-Date
Clinical Research Results
PrEP using a daily oral TDF/FTC tablet reduces risk of HIV in women and men.
Data from the iPrEx, Partners PrEP and TDF2 studies shows that daily oral TDF/FTC (marketed as Truvada) is safe and effective to reduce risk of infection in heterosexual men and women, gay men and other men who have sex with men, and transgender women (see links to published research below).
Data from these studies formed the basis of Gilead’s application to the US Food and Drug Administration for approval of TDF/FTC as PrEP [cross link to area of site that deals with this] (Gilead is the manufacturer and patent holder for TDF/FTC). Trial data show that TDF/FTC reduces HIV risk in women and men who are able to take it correctly and consistently.
The estimates of effectiveness vary in each trial but across the studies adherence—or whether participants took the tablet daily as instructed—was predictive of protection. Two trials of daily TDF/FTC in women, the FEM-PrEP and VOICE trials, found no effect of daily oral TDF/FTC. Further analysis of the data from these studies showed that the participants weren’t able to adhere well to the daily PrEP regimen. Adherence was too low for the trial to ultimately determine whether the intervention provided any protection. Daily TDF alone was tested for effectiveness in reducing risk of HIV via needle exposure. Results from a study in injecting drug users in Thailand showed that daily TDF was effective at reducing HIV risk in people who inject drugs.
Bottom line: Daily TDF/FTC as PrEP works when taken correctly and consistently.
Below are links to the abstracts and full publications (where available) from the major trials to-date. For information regarding ongoing research, visit our PrEP pipeline page.
- [iPrEx] "Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men", NEJM 2010; 363:2587-2599
- [FEM-PrEP] "Preexposure Prophylaxis for HIV Infection among African Women", NEJM 2012; 367:411-22
- [Partners PrEP] "Antiretroviral Prophylaxis for HIV Prevention in Heterosexual Men and Women", NEJM 2012; 367:399-410
- [TDF2] "Antiretroviral Preexposure Prophylaxis for Heterosexual HIV Transmission in Botswana", NEJM 2012; 367:423-434
- [VOICE] "Understanding the Results of VOICE- Fact Sheet" Fact Sheet of the VOICE trial results
- [Bangkok Tenofovir Study] "Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomized, double-blind, placebo-controlled phase 3 trial", Lancet 2013 June 15; 381:2083-90