on Monday, October 7 at 9-10am ET, AVAC, the Treatment Action Group (TAG), The Well Project and the Women’s Research Initiative (WRI) co-convened the webinar Advocates’ Debrief on the Science of Daily F/TAF vs. TDF/FTC as PrEP.

This webinar was the first in a two-part series, responding to advocates’ desire to better understand 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 issue came into greater focus during an August 7 FDA advisory committee meeting at which Gilead’s regulatory submission of F/TAF for PrEP was discussed and debated.

On the webinar, AVAC, TAG, The Well Project and WRI representatives were joined by researchers Andrew Hill (Senior Visiting Research Fellow in the Pharmacology Department at Liverpool University) and Monica Gandhi (Professor of Medicine and Associate Division Chief of the Division of HIV, Infectious Diseases, and Global Medicine at UCSF/San Francisco General Hospital). They shared their take on the latest research, contextualized the August 7 discussion, and helped to inform an advocacy agenda for next steps.

For background, check out AVAC’s blog for a recap of the advisory committee proceedings, as well as TAG and PrEP4All’s joint comment to the FDA.

Recording and Slides: YouTube / Andrew Hill’s slides / Monica Gandhi’s slides

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.

Moderator:

• Kathie Hiers, CEO of AIDS Alabama

Speakers:

• Amy Killelea, Senior Director, Health Systems & Policy – National Association of State and Territorial AIDS Directors (NASTAD)
• Tim Horn, Director, Medication Access and Pricing – NASTAD
• David Hardy, Immediate-Past Chair, HIV Medicine Association (HIVMA), Adjunct Professor of Medicine, Johns Hopkins University School of Medicine
• Craig Hendrix, Professor of Medicine, Pharmacology, and Epidemiology, Johns Hopkins University School of Medicine.

Recording and Slides: YouTube / David Hardy and Craig Hendrix’s Slides / Amy Killelea and Tim Horn’s Slides

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

On Friday, November 15, from 1-2pm ET, leading pharmacologists including Angela Kashuba (UNC), Craig Hendrix (Johns Hopkins) and Pete Anderson (University of Colorado) 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.

Register here.

At CROI 2018 we heard stories, saw new data, and had lots of questions about early PrEP rollout. On Wednesday, April 18th, AVAC and partners from Jilinde in Kenya and PZAT in Zimbabwe explored valuable resources for people working to deliver oral PrEP. See below for some of the tools and resources we will explored and discussed during the webinar.

• Country Updates and the Global PrEP Tracker provide the status of PrEP.
• A Framework For Scaling Up PrEP provides step-by-step guidance for introducing PrEP into new settings.
• PrEP Resources aims to be a central repository for materials currently being used by programs—in areas such as global guidance; national policies and guidelines; M&E; training curricula; advocacy; implementation; and demand creation.

All of these materials (and many more) can be found on PrEPWatch.org, the clearinghouse for oral PrEP efforts across the globe.

Recording: YouTube / Audio / Slides

Hundreds of people tuned in to hear researchers discuss the available data on “time to protection” required for effective oral PrEP with TDF/FTC—i.e., how many doses must be taken to build up protective levels of the drug in the blood? The answer is—it varies. Not surprisingly then, so do the guidelines for PrEP use.

As webinar participants learned, the data are varied and subject to interpretation. The World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC) recommend different time frames to reach protection in their respective guidelines for oral PrEP use. Both of these recommendations are based on measurements of the amount of drug that accumulates in blood and/or tissue over a specific period of time. The studies of how drugs are taken into the body and how they leave the body is called “pharmacokinetics” and “pharmacodynamics” or “PK” and “PD” for short, as explained in our primer for advocates. There isn’t a single PK measurement that is associated with PrEP protection—so both WHO and CDC guidelines are based on inference.

AVAC hosted a follow-on webinar presentation where representatives from both the CDC and WHO reviewed their respective guidance development processes and the role, use, contexts and audience for guidance documents.

Watch the recording on YouTube, listen to an mp3 version or download the slides. Q&A starts approximately 55 minutes in.