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.

The US CDC estimates that nearly 500,000 women in the US could benefit from using PrEP. But women’s uptake of PrEP is small compared to men’s because most women who might want it have never even heard of it. One of the most effective ways to raise most women’s awareness of PrEP is to get their health care providers (usually family planning clinics) talking to them about PrEP.

In this webinar we explored the education that needs to be done among those health care providers to make this happen and what is being done to be prioritize it, especially by federal agencies, state and local health departments.

Surveys and focus groups conducted with women demonstrate few women know about PrEP as an effective HIV prevention method and women are interested in learning more about PrEP as a potential option for themselves.

Join HIVE for a 1-hour discussion via Google Hangouts.

Participants learned about:

• Health care access
• PrEP guidelines
• Who is falling through the gaps?
• Bias/stigma from provider and/or community
• Engaging in a conversation about PrEP
• Assessing risk
• Community mobilization around PrEP and prevention
• Shifting community norms around PrEP and queer sexuality

For more information, contact [email protected]. The flyer is available for download below.

The PrEP Access & Engagement Training was hosted by BTAN Bay Area and the Black AIDS Institute. Health care access, PrEP guidelines, how to engage in a conversation about PrEP, community mobilizing around PrEP and prevention and much more were discussed.