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** What’s up with F/TAF for PrEP: Webinars on safety, trial design and $$$
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November 5, 2019

Dear Advocates,

Next week, on November 11^th, 13^th and 15^th, AVAC and partners will continue the webinar series addressing key issues related to the US FDA’s October approval of F/TAF as PrEP ([link removed]) and its supplemental approval directing drug maker Gilead to conduct a trial among cisgender women ([link removed]) . See below for webinar details and registration links, and check out the first webinar in this series ([link removed]) from last month for more background.

Dubbed Descovy by its maker Gilead, F/TAF has prompted heated discussion on several critical fronts. The recent FDA approval excluded “those who have receptive vaginal sex” due to insufficient data about safety and efficacy among cisgender women. Following this decision, Gilead is going forward with a new trial among cisgender women that will involve innovations to trial design. In addition, advocates have posed important questions about how the safety data compare between F/TAF (Descovy) and TDF/FTC (Truvada) and the implications for marketing and access. To explore these and related questions, AVAC ([link removed]) ,IRMA ([link removed]) , TAG ([link removed]) , WRI ([link removed]) and The Well Project ([link removed]) are hosting a series of webinars.

It’s Complicated- Implementation questions regarding price, programming and policies for Descovy as PrEP
November 11, 10:00 – 11:15am EST
Register here. ([link removed])
We’ll probe what Descovy’s market presence will mean and discuss the advocacy priorities to meet the challenges and opportunities. These questions are informed by the fact that Truvada (aka TDF/FTC) is set to go off patent next year, several generic options are waiting in the wings, and funding PrEP-related services in the US rely on key programs. The presentations will be moderated by Kathie Hiers, CEO of AIDS Alabama ([link removed]) , and include Amy Killelea (NASTAD ([link removed]) ), Tim Horn (NASTAD ([link removed]) ), David Hardy (HIVMA ([link removed]) and Johns Hopkins University ([link removed]) ), and James Krellenstein (PrEP4All ([link removed]) ).

Trial Design Takes a Step in the Post PrEP Era: What will Gilead’s study of F/TAF among cisgender women tell us about next gen PrEP and next gen trial design
November 13, at 10:00 – 11:15am EST
Register here. ([link removed])
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 ([link removed]) Jeff Murray will present how an innovative design will enable a relatively smaller trial, and the questions it raises.

PK, PD and F/TAF: What does an advocate need to know about the pharmacology of safety and efficacy and today’s PrEP drugs
November 15, 1-2pm EST
Register here. ([link removed])
Leading pharmacologists including Angela Kashuba (UNC ([link removed]) ), Craig Hendrix (Johns Hopkins ([link removed]) ) and Pete Anderson (University of Colorado ([link removed]) ) will join in a discussion on the important pharmacokinetic and pharmacodynamic questions related to F/TAF and TDF/FTC. We’ll explore questions about what drug levels matter, and where in the body drug needs to be to protect against HIV.

Check out the first webinar in this series ([link removed]) from last month where we explored the background science of F/TAF vs TDF/FTC as PrEP.

As always, the webinars will be recorded and posted on the AVAC website ([link removed]) . And we welcome any questions in advance ([link removed]) !

Best,
AVAC


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