On April 24, Project Inform submitted a written testimony to the U.S. Food and Drug Administration’s (FDA) Antiviral Advisory Committee in support of FDA approval of the antiviral drugs TDF/FTC (Truvada) to be offered to prevent HIV transmission among HIV-negative people.
Though some groups have tried to drum up controversy about pre-exposure prophylaxis (PrEP), Project Inform feels strongly that the data from clinical trials are sufficient to allow a committee of experts, who will be judging the evidence, to recommend extending the indication for TDF/FTC for use as PrEP.
The reason for our support of this indication is based on three critical pillars: 1) new prevention tools are desperately needed, particularly among men who have sex with men (MSM); 2) The data overwhelmingly support the conclusion that the drugs can be up to 90 percent effective in blocking transmission in those who take it properly; and 3) the drugs thus far look reasonably safe.
We do have concerns about how to best support adherence in those who are prescribed PrEP and how to track long-term side effects and have suggested a number of measures to address those concerns. To read our letter and learn more about our viewpoint, click here.