Now what with F/TAF for PrEP? A call for action in 2020

A new episode of our Px Pulse podcast is ready for download!

What’s all the fuss about F/TAF? Listen to this episode for a snapshot of the issue and a preview of what will take much of AVAC’s – and our partners’ – attention in 2020. The US Food and Drug Administration (FDA) approved F/TAF (Descovy) as daily oral PrEP in October 2019. But there’s was one notable caveat: the label excluded those who are at risk from “receptive vaginal sex”, indicating that more data is needed for the drug to be approved as HIV prevention for cisgender women. The FDA’s supplemental approval requires Gilead to conduct a safety and efficacy trial in cisgender women to produce the lacking data by 2025, with a draft trial protocol before the end of this year.

As Gilead drafts the protocol, civil society, advocates, communities and all stakeholders must engage with planning for this trial from A-Z. In this episode, we look at what’s different and what’s the same between F/TDF (Truvada) and F/TAF, what’s driving innovation in the proposed trial design, why it’s so essential for advocates to engage and more.

For the full podcast episode, highlights and resources, visit avac.org/px-pulse. And subscribe on Apple Podcasts, Spotify or wherever you get your podcasts!

The Challenges for Young Nigeria

In AVAC Report 2019: Now What?, we called out to these advocates, members of “Generation Now”, encouraging them to sustain their bold efforts in the fight against HIV. Below is one response and more are available here.

The author, David Ita, is a community HIV prevention advocate from Nigeria and 2019 AVAC Advocacy Fellow with New Vaccine and Microbicide Advocacy Society (NHVMAS).

Dear AVAC,

Reading your letter to Generation Now, made me think of my own work in HIV advocacy and the particular challenges young people in Nigeria face accessing both sexual and reproductive health services and HIV prevention options. These barriers have a particularly negative affect on young women. Adolescent girls and young women contract HIV earlier in life and have higher incidence of HIV infection than their male peers.

As an AVAC Advocacy Fellow, I promote the integration of sexual and reproductive health (SRH) services and HIV prevention for young people in Nigeria and I’m working to increase young people’s capacity to serve as HIV prevention advocates in their community. This work makes connections that simply must be made if we want to succeed in defeating HIV. For example, I have worked with civil society, the Ministry of Health and the Ministry of Education to address reducing the age of consent for HIV testing and treatment. I want to equip young people with the knowledge necessary to make informed choices regarding their health. This means integrating SRH curriculum in schools and disseminating information regarding PrEP amongst youth. Sharing knowledge is essential amongst this population. Imagine, a 2017 National Health Survey showed that only 29 percent of young women and 27.9 percent of young men in Nigeria were able to name accurate prevention methodologies! We all must awaken to how important this work is, now imperative it is to change numbers like those. It’s also important to be very serious about incorporating a range of perspectives into the work I do. I have surveyed young people throughout Nigeria on their experiences, and opinions regarding SRH and HIV prevention. These perspectives continue to inform my work with young people.

I have learned much from what they have shared with me. As the youth in my community work together to respond to serious structural obstacles and demand access to necessary services, I see their passion and dedication. To look to the future with optimism, I have made a dedication of my own, putting the younger generation in the center of my advocacy. We all must awaken to how important this work is.

David Ita

AVAC’s “3D” View of the World: 2019 and beyond

This infographic lays out AVAC’s top-line recommendations from AVAC Report 2019: Now What? The recommendations fall into three categories: deliver — prevention programs whose impact is well-measured and -defined; demonstrate — next-generation engagement for next-generation trials; develop — new targets for the post-2020 world.

UNAIDS Fast-Track Targets: The plan and the progress

The most widely-known UNAIDS Fast-Track goals were the 90-90-90 targets focused on diagnosing people with HIV, linking them to ART and supporting them to achieve virologic suppression. But these were only part of what the UNAIDS modelers said was needed to reduce new HIV diagnoses to 500,000 per year; the model also included significant scaling up of primary prevention including the targets listed below. There are gaps across the board, which helps explain how the world fell short of the hoped-for reduction in new HIV diagnoses.

Excerpted from AVAC Report 2019: Now What?

A Generic and Unifying HIV Prevention Cascade Framework

What get’s measured matters if and only if that measurement is linked to impact. The most common approaches to evaluating primary prevention don’t measure up. They measure commodities but not use. A count of the condoms or PrEP bottles handed to people does not tell you whether the condoms were used, the pills were taken—or even, often, whether the people receiving the commodities were at high risk of HIV. A simple, universal prevention cascade could help change that. This one, which presumes that HIV testing has happened and is focused on people at risk of HIV, suggests four stages (see A) and then shows how solutions could be tailored to fix the cascade (see B).

Excerpted from AVAC Report 2019: Now What?

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.