What’s All the Fuss About F/TAF? A Call for Action in 2020

December 20, 2019

What’s all the fuss about F/TAF for oral PrEP? The US Food and Drug Administration (FDA) approved drug maker Gilead’s Descovy (also known as F/TAF) as daily oral PrEP in October 2019, with one notable caveat: the label excluded those who are at risk from “receptive vaginal sex”, indicating that more data is needed for the drug to be approved as HIV prevention for cisgender women. The FDA’s supplemental approval requires Gilead to conduct safety and efficacy trial in cisgender women on a timeline that aims for data by 2025.

In the aftermath of this approval, there are questions about the differences between these two forms of PrEP, what contribution F/TAF might make to the pipeline of prevention, and the vital role of stakeholder engagement as Gilead drafts the study protocol for a trial of F/TAF in women. We explore all this and more in this episode of Px Pulse.

AVAC be following the progress of F/TAF and the trial design as it takes shape in the months to come. Engagement with Gilead is an essential for advocates and we want to hear from you at avac@avac.org.

Listen

• Listen to the full podcast (13:54)

Highlights

• What’s different, what’s the same between F/TAF and TDF/FTC?
• What role is there for F/TAF in HIV prevention?
• What the FDA did not approve F/TAF for cisgender women?
• What happens next?
• Now comes a new trial, what makes it different.

Transcript

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Additional Resources

• F/TAF page on AVAC.org with background information and webinar recordings on safety, trial design and price of F/TAF for PrEP – AVAC
• The FDA’s supplemental approval of F/TAF for PrEP: Details on the proposed F/TAF trial in cisgender women – FDA
• Where Were the Women? Gender Parity in Clinical Trials – The New England Journal of Medicine
• Next-generation trial design in HIV prevention symposium – IAS 2019 conference
• Good Participatory Practice (GPP) Guidelines – AVAC and UNAIDS