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.

Excerpted from Grant, D. and K. Marshall. "Next steps for PrEP: Getting a proven prevention option to the people who need it". Treatment Issues. June 2013.

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.

Published Data

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.

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