The FDA advisory panel has voted in favour of approving Gilead Sciences’ Truvada (tenofovir/emtricitabine), the first regimen indicated for pre-exposure prophylaxis of HIV-1 infection among uninfected adults – men who have sex with men, HIV uninfected partners in serodiscordant couples, and other individuals at high risk for acquiring HIV through sexual activity.
As expressed by one of the committee members, Nancy Padian, “this matters so much.” Still, some FDA committee members have expressed concern about the potential for drug resistance without cautious restrictions on the availability of this regimen; others suggested that the data does not yet justify its use in the wider, high-risk population.
But perhaps one of the most concerning arguments relates to patient perceptions/attitudes – something less easily managed with restrictions and guidelines. At a time when patient education and adherence to antiretrovirals are often a challenge, an “easy” option could foster a false sense of security and encourage risky behaviour. The question is: how do we ensure proper use of this medicine and what happens if we can’t?