Doctors tell US FDA: 'HIV prevention pill' - Gilead's Truvada - not ready for approval

Last week, a group of 55 US physicians sent a letter to the Food and Drug Administration urging the agency not to approve the use of Gilead Sciences’ HIV/AIDS treatment drug Truvada (emtricitabine and tenofovir disoproxil fumarate)for use as an HIV prevention pill – also known as “pre-exposure prophylaxis” (PrEP).

In the letter, spearheaded by AIDS Healthcare Foundation (AHF), the physicians detail a number of concerns raised by first-in humans efficacy data emerging from the iPrEX study of Truvada to prevent HIV transmission. Ultimately, the doctors are concerned that widespread use of PrEP, based on the available data, will unwittingly lead to more risky behavior, and more HIV infections.

The study of 2,499 high-risk men who have sex with men (MSM) found that the once-daily pill could decrease the likelihood of HIV infection by 44%. However, the physicians conclude that this very low result is insufficient to support approval as a prevention tool at this time. The group urges the FDA to not consider approval of the drug as an HIV prevention pill until the final results of all studies are available – still a number of years away.