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Vaginas Deserve Better: Responding to recent F/TAF as PrEP approval

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AVAC
Friday, October 4, 2019

Yesterday, the US Food and Drug Administration (FDA) announced its approval of Gilead’s drug Descovy (also known as F/TAF) as daily oral PrEP for adults and adolescents, except those who have “receptive vaginal sex.”

 

AVAC and allies immediately decried the announcement, which lacked an acknowledgement of the gap in data on those at risk of HIV via vaginal sex. The announcement also failed to include any information about a funded plan and timeline for gathering the data necessary to understand if this drug prevents HIV infection among cisgender women.

 

The FDA has since posted its approval letter, which outlines a post-marketing commitment ON GILEAD to conduct a trial in cisgender women, with data expected in mid-2025. As Gilead plans and conducts this long-overdue trial, there’s vital work to be done around early and integrated Good Participatory Practice and community engagement starting now, not after the protocol is approved, and sustained throughout the life of the trial.

 

Join us and other advocates for the first of a two-part webinar series on F/TAF as PrEP. We’ll explore the science and research—and the community response to these developments.

 

Advocates’ Debrief on the Science of Daily F/TAF vs. TDF/FTC as PrEP

 

As always, please send any comments or questions.