Thirteen leading AIDS organizations are calling on Gilead Sciences and the U.S. Food and Drug Administration (FDA) to move more quickly on plans to evaluate the use of the HIV drug Truvada (tenofovir and emtricitabine) in HIV-negative men who have sex with men (MSM) and transgender females. The groups, which include Project Inform, are asking Gilead and the FDA to move forward now with review of Truvada for pre-exposure prophylaxis (PrEP) for MSMs and transgender females quickly, due to the raging epidemic in those groups, rather than waiting until a fuller set of data becomes available on PrEP in heterosexual men and women.
As made clear in the press release the groups issued and in their open letter to the FDA and Gilead (below), the study examining PrEP in MSM and transgender females gave an unambiguous answer about efficacy and safety. The same cannot yet be stated for PrEP use in heterosexuals. Though two studies showed strong efficacy, one for Truvada and one for Truvad compared with tenofovir alone, two other studies have had conflicting results.
Because the pace of new HIV infections is so high in MSM and female transgenders, particularly in young blacks and Latinos, and because roll-out of PrEP will be nearly impossible without FDA approval, the groups are asking Gilead to request that the FDA review Truvada for PrEP for MSM and transgender females now, rather than waiting until further details become available for heterosexual men and women and then reviewing PrEP for all groups at the same time.
For the press release click here.
For the letter to Gilead and the FDA click here.