F/TAF Background and Webinar Series

In October 2019, the US FDA approved a new daily oral PrEP strategy using F/TAF (brand name Descovy). This next generation of oral PrEP is garnering criticism, prompting innovation in trial design and raising questions.

• FDA approval excluded “those who have receptive vaginal sex” due to insufficient data about safety and efficacy among cisgender women.
• Gilead’s approach, which neglected gathering this data from cisgender women, has drawn heated criticism from global advocates who point to decades HIV biomedical research that has left women by the wayside.
• The FDA simultaneously issued a supplemental approval directing drug maker Gilead to conduct a trial among cisgender women to gather the necessary data. The proposed trial will include important innovations, allowing for a smaller trial with implications for next generation trial design in the era of PrEP.
• F/TAF and TDF/FTC (brand name Truvada) have different side effects or safety profile, but claims that one set of side effects are more significant or less safe are not backed up by the evidence.
• Generics are poised to offer TDF/FTC in the US, where Gilead’s patent on Truvada is expiring. Advocates are raising concerns that Gilead will mislead would-be PrEP users and providers, and profiteer off their anxieties, by portraying Descovy as the better PrEP.

Table of Contents

• Overview
• Webinar Series
• Background Information

AVAC’s Overview of F/TAF and Related Issues

AVAC’s blog, "A New Oral PrEP Strategy is on the Horizon, But Who is Going to Get it provides a comprehensive overview of issues surrounding F/TAF and the approval process.

Webinar Series

On November 11, 13 and 15, AVAC and partners will continue the webinar series addressing key issues related to the US FDA’s approval of F/TAF as PrEP and its supplemental approval directing drug maker Gilead to conduct a trial among cisgender women. See below for webinar details and registration links, and details of the first webinar in this series.

• PK, PD and F/TAF: What does an advocate need to know about the pharmacology of safety and efficacy and today’s PrEP drugs
  Rescheduled! Details to come.
  Leading pharmacologists Angela Kashuba (UNC), Craig Hendrix (Johns Hopkins) and Pete Anderson (University of Colorado) discuss the important pharmacokinetic and pharmacodynamic questions related to F/TAF and TDF/FTC. Learn about what drug levels matter, and where in the body drug needs to be to protect against HIV.

• 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
  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? On Wednesday, November 13, the FDA’s Jeff Murray presented how an innovative design will enable a relatively smaller trial, and the questions it raises.
  
  Recording and Slides: YouTube / Jeff Murray's Slides

• It’s Complicated—Implementation questions regarding price, programming and policies for Descovy as PrEP
  November 11
  Advocates, policy makers, funders and other stakeholders have surfaced a number of questions regarding Descovy (F/TAF) for PrEP – recently approved by the FDA to prevent HIV during anal sex. With Truvada (TDF/FTC) set to go off patent next year, several generic options waiting in the wings, and our community’s reliance on the 340B program for funding PrEP-related services, many have raised concerns about price, policy and programming related to Descovy. Added to the complicated mix of issues are the presence of numerous lawsuits calling into question the safety of Truvada for both treatment and prevention and different PrEP indications for Descovy and Truvada, including different safety profiles. On Monday, November 11, an array of experts helped us sift through the questions – none of which have easy answers, all of which have significant implications for PrEP implementation in the United States.
  
  Recording and Slides: YouTube / David Hardy and Craig Hendrix's Slides / Amy Killelea and Tim Horn's Slides

• Advocates’ Debrief on the Science of Daily F/TAF vs. TDF/FTC as PrEP
  October 7, 2019
  Researchers Andrew Hill from the Pharmacology Department at Liverpool University and Monica Gandhi from Global Medicine at UCSF/San Francisco General Hospital explored the research to date on F/TAF as PrEP, especially as it relates to its safety profile compared to TDF/FTC and the lack of robust data in cisgender women. This webinar was co-convened by AVAC, the Treatment Action Group (TAG), The Well Project and the Women's Research Initiative.
  
  Recording and Slides: YouTube / Andrew Hill's slides / Monica Gandhi's slides

Background Information

• AVAC's factsheet for Gilead’s Phase III DISCOVER trial of daily F/TAF.
• Gilead's application to license F/TAF as a daily oral PrEP strategy for HIV prevention.
• Gilead’s presentation to the Antimicrobial Drugs Advisory Committee and FDA. It showed that daily F/TAF is as safe and effective as daily TDF/FTC for HIV prevention among MSM and transgender populations.
• AVAC’s comments to the advisory committee and FDA, challenging claims that F/TAF if "better PrEP".
• Briefing document of the Antimicrobial Drugs Advisory Committee — this advisory committee voted 16-2 in favor of approving F/TAF as PrEP for men and transgender women, and 10-8 against for cisgender women.
• Presentation by the FDA’s Deputy Director of the Division of Antiviral Products, Office of Antimicrobial Products Center for Drug Evaluation and Research.
• The FDA's October announcement of its approval of F/TAF as PrEP except those who have “receptive vaginal sex.”
• The FDA's October supplemental approval directing Gilead to conduct a trial among cisgender women provides details and dates on the proposed trial.