Visualizing Multisectoral Prevention: The DREAMS program theory of change

This is PEPFAR’s own visualization of how its AGYW programs can effect change. It’s notable for the definition of a care package that touches on the individual and her community, and for the way it defines a range of outcomes. There isn’t anything comparable for PEPFAR’s Key Population Investment Fund, which is infusing resources into a range of countries. Some of that funding is going for ART; for primary prevention, a theory of change linked to incidence is a must. AVAC is working with allies in KPIF countries to make this demand.

Excerpted from AVAC Report 2019: Now What?

Monitoring Primary Prevention: What to look at and why it matters – for oral PrEP and more

A look at four major factors relevant to primary prevention and correlated interventions to support their impact.

Excerpted from AVAC Report 2019: Now What?

What Gets Measured Matters

There is enormous variability in country and funder/normative approaches to tracking PrEP program rollout. Assessments of progress require common, comprehensive measures against and estimates of the parameters seen here.

Excerpted from AVAC Report 2019: Now What?

AVAC Report 2019: With 2020 targets sure to be missed, we ask Now What?

Report cover

Today, AVAC released Now What?, our 2019 annual report on the state of the HIV prevention field. Each year, the AVAC Report frames the most pressing advocacy issues facing the HIV response. At the threshold of 2020, it’s clear that global goals for HIV prevention will miss the mark by a long shot.

Though important progress has been made, the crisis UNAIDS called out in 2016 persists today with new infections around 1.7 million annually, a far cry from the 2020 target of fewer than 500,000.

So, we asked ourselves, Now What?, and answered with cross-cutting analysis and an advocacy agenda to match.

FIRST, we call for leadership that is bold, visible and activist, from the new head of UNAIDS, to houses of parliament to civil society coalitions: take uncompromising stances, demand accountability, speak out for intersectional issues of race, gender, class and climate. This work needs to be funded, full-throttle and fearless.

SECOND, we call for the use of today’s most recent evidence to guide new prevention targets that will pave the way for epidemic control. Clear milestones for the prevention research pipeline must be set. Investments over the past decades have provided us with the prevention options we have today, and much-needed new strategies are under now investigation. The field needs targets for prevention research that people can understand and influence.

THIRD, we call for multilayered prevention approaches that are centered around the person, not the virus. Since last World AIDS Day, we’ve learned again, perhaps most strikingly from the ECHO trial, about the dynamic needs of women for HIV and pregnancy prevention. The complexity of translating results into policy, bring renewed urgency to the need for comprehensive HIV prevention and reproductive health approaches. Multilayered prevention incorporates multipurpose strategies (i.e., products that prevent both pregnancy and HIV) within programs designed to address structural barriers (i.e., policy reform, transforming community norms, facilitating educational empowerment).

2020 will be a pivotal year—join us in calling on leaders, from the grassroots to global capitals, to make 2020 a turning point, when siloes come down, crises are transformed by innovation, and prevention is center stage in the fight against HIV.

Happy reading, and we’d love to hear how you answer Now What?

POSTPONED: Nov 15 webinar on PK/PD & F/TAF

Due to last-minute scheduling conflicts, we must postpone Friday’s (Nov 15) webinar—PK, PD and F/TAF: What does an advocate need to know about the pharmacology of safety and efficacy and today’s PrEP drugs. We apologize for the inconvenience but stay tuned for details on its rescheduling!

And, in case you missed it, download and view the rest of the webinar series via the links below:

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 [Nov 13]

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? 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 [Nov 11]

An array of experts helped us sift through the questions on pricing, policy and programming related to Descovy, 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 [Oct 7]

This webinar was the first the 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.
Recording and Slides: YouTube / Andrew Hill’s slides / Monica Gandhi’s slides

For additional background visit our F/TAF page on our website at www.avac.org/ftaf.

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

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

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

Next week, on November 11th, 13th and 15th, AVAC and partners will continue the webinar series addressing key issues related to the US FDA’s October 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 check out the first webinar in this series 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, IRMA, TAG, WRI and The Well Project 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.
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, and include Amy Killelea (NASTAD), Tim Horn (NASTAD), David Hardy (HIVMA and Johns Hopkins University), and James Krellenstein (PrEP4All).

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.
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.

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.
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.

Check out the first webinar in this series 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. And we welcome any questions in advance!

The Dapivirine Ring: Key learnings from like-product introductions

Vaginal insertion and partial efficacy are two challenges that could affect the uptake and continued use of the dapivirine ring. Analyses of the introductions of other products that share similar characteristics provide useful lessons to inform planning for rollout of the dapivirine ring. This paper provides information for planners, implementers, funders, researchers, trainers, providers of technical assistance and others to build an agenda for introducing the dapivirine ring that addresses these two challenges.

Vaginas Deserve Better: Responding to recent F/TAF as PrEP approval

Yesterday, the US Food and Drug Administration (FDA) announced its approval of Gilead’s drug Descovy (also known as F/TAF) as daily oral PrEP for adults and adolescents, except those who have “receptive vaginal sex.”

 

AVAC and allies immediately decried the announcement, which lacked an acknowledgement of the gap in data on those at risk of HIV via vaginal sex. The announcement also failed to include any information about a funded plan and timeline for gathering the data necessary to understand if this drug prevents HIV infection among cisgender women.

 

The FDA has since posted its approval letter, which outlines a post-marketing commitment ON GILEAD to conduct a trial in cisgender women, with data expected in mid-2025. As Gilead plans and conducts this long-overdue trial, there’s vital work to be done around early and integrated Good Participatory Practice and community engagement starting now, not after the protocol is approved, and sustained throughout the life of the trial.

 

Join us and other advocates for the first of a two-part webinar series on F/TAF as PrEP. We’ll explore the science and research—and the community response to these developments.

 

Advocates’ Debrief on the Science of Daily F/TAF vs. TDF/FTC as PrEP

 

As always, please send any comments or questions.

Advocates’ Debrief on the Science of Daily F/TAF vs. TDF/FTC as PrEP

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

REGISTER HERE.

This webinar is 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 will be 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 will share their take on the latest research, contextualize the August 7 discussion, and help 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.

The webinar will be recorded and posted online shortly after its conclusion.

Have a question or comment? Please be in touch!