Gilead, US FDA Ponder Innovative Designs For Descovy HIV Prevention Study In Women

Despite a close vote recommending against approval of Gilead Sciences Inc.’s Descovy (emtricitabine/tenofovir alafenamide) for HIV pre-exposure prophylaxis in cisgender women, a US Food and Drug Administration advisory committee sent Gilead and the agency a clear message: the sponsor needs to perform prevention efficacy studies in this population.

What is less clear, however, is what those studies might look like, and whether the FDA will try to hold Gilead to its voluntary commitment to conduct such studies through public pressure or some