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Trial Design Takes a Step in the Post PrEP Era: What will Gilead’s F/TAF among Cisgender women tell us about next gen PrEP and next gen trial design
The FDA’s October approval excluded F/TAF as PrEP “for those who have receptive vaginal sex.” Many voices have expressed outrage that Gilead’s strategy for F/TAF regulatory approval left women by the wayside. Gilead had previously claimed finding a relevant cohort of women would not be feasible. Gilead is designing a novel trial, planned to begin in Africa in 2020, to gather missing data about the safety and efficacy of F/TAF among cisgender women. What are the implications of this trial? In this webinar, the FDA’s Jeff Murray will present how an innovative design will enable a relatively smaller trial, and the questions it raises.

Nov 13, 2019 10:00 AM in Eastern Time (US and Canada)

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