Avac Event

What Does the Future Hold for Long Acting Injectable PrEP?

With long-acting injectable PrEP coming to market, how can we mitigate barriers and adopt the intervention widely in high-risk settings? On Wednesday, November 10, Evidence to Action, the webinar series hosted by the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), heard from experts at Johns Hopkins University, United States Agency for International Development (USAID), AVAC, Asia Pacific Coalition on Male Sexual Health (APCOM), and EGPAF on what’s new in PrEP, the present and future of long-acting injectables, what actions to take for optimal implementation and how we can better enable access in key populations.

Speakers to Include:

  • Opening Remarks: Anja Giphart, EGPAF

  • An overview of long-acting technologies and strategies in development for PrEP: Charles Flexner, Johns Hopkins University of Medicine

  • Reflecting on implementation of biomedical prevention interventions to date in the context of implementation of long-acting injectables and new products: Robyn Eakle, USAID

  • Priority actions to enable uptake of new products: Mitchell Warren, AVAC

  • How this will effect key populations and how we work alongside key pops to drive awareness around technical and practical aspects: Midnight Poonkasetwatana, APCOM

  • Concerns about making long term decisions on medication in the postpartum period: Dee Mphafi, EGPAF Youth Advocate

  • Moderated Discussion: Natella Rakhmanina, EGPAF

Downloads:

Avac Event

Webinar: Oral PrEP Implementation and Implications for Next Generation PrEP

This webinar discussed insights from oral PrEP programs and how these experiences can inform faster, smarter and more affordable rollout of next-generation HIV prevention products. It featured:

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  • AVAC’s Jessica Rodrigues opened the meeting with background on PrEP uptake globally and regionally, noting that due to rapid scale-up, approximately 69 percent of cumulative PrEP initiations have now occurred in Sub-Saharan Africa. (View the slides.)
  • Saiqa Mullick of Wits RHI shared lessons from South Africa’s experience scaling up oral PrEP from 2016, when PrEP was offered only to sex workers at a handful of clinics, to 2021, with PrEP broadly available in more than 2,000 public health facilities. (View slides.)
  • Daniel Were of Jhpiego described the Jilinde Project’s successful efforts to increase demand and dismantle stigma surrounding PrEP. (View slides.)
  • Joseph Murungu of Pangaea Zimbabwe AIDS Trust (PZAT) shared a dynamic, client-centered approach to ensure that PrEP programs respond to the needs of young people. (View slides.)

Watch the recording / Read the summary

Avac Event

Are We PrEPared this Time? Ensuring a Swift Translation of Research into Community Impact

First approved in 2012, roll out of oral PrEP has been slow, uneven, and marked by troubling and unacceptable uptake disparities across race/ethnicity, gender and geography. In 2019, less than 25 percent of people eligible for PrEP in the US received a prescription. Late last year, the US FDA approved a new PrEP agent called Apretude, an injectable, longer-acting PrEP option. While hopes are high for this intervention, it is replete with challenges from both the user as well as the delivery sides of the equation.

The AIDS Foundation Chicago, AVAC and an array of speakers spoke on what must happen to ensure swift translation of positive research results into community impact. What follows are a set of resources from the webinar.

Resources

Recording / Slides

Sign On Letter
Requesting that the Biden administration include in his upcoming budget request $400 million to create a National PrEP Grant Program. Organizations can sign here.

Resources Shared

Avac Event

HPTN 084 Primary Study Results Webinar

The HIV Prevention Trials Network (HPTN) hosted a community webinar to discuss the primary results of HPTN 084, a randomized, double-blind controlled trial designed to evaluate the efficacy and safety of long-acting injectable cabotegravir (CAB LA) to prevent the sexual acquisition of HIV in cisgender women in sub-Saharan Africa.

Participants

  • Sinead Delany-Moretlwe, MBBCh, Ph.D., DTM&H
    HPTN 084 Protocol Chair
    Wits Reproductive Health and HIV Insitute,
    University of the Witswatersrand
  • Mina Hosseinipour, MD, MPH
    HPTN 084 Protocol Co-Chair
    University of North Carolina at Chapel Hill School of Medicine,
    UNC Project-Malawi

View the recording.

Avac Event

Developments in the HIV Prevention Pipeline: PrEP, vaccines and more

On April 12, 2021, AVAC, EATG, PrEP in Europe, and PrEPster invited community educators and advocates involved in HIV biomedical prevention service delivery to participate in an e-meeting.

New PrEP modalities and service delivery models are on the horizon, with promising findings from recent clinical trials. Current and potential PrEP-users could soon have access to options beyond, but in addition to, oral PrEP; such as cabotegravir long-acting injectables and the islatravir monthly pill, among other ARV formulations and delivery mechanisms such as implants that are in earlier phases. There is also an entirely new class of HIV treatment, broadly neutralising antibodies (bNAbs), that have recently undergone their first efficacy trial as PrEP.

This e-meeting provided community educators and advocates with a concise summary of existing and future PrEP formulations, and a community-level perspective on strategic advocacy within regulatory frameworks to increase community PrEP access and uptake.

Webinar Agenda

  • 13:00-13:05 Welcome and introduction (Gus Cairns, PiE)
  • 13:05-13:20 The PrEP pipeline: beyond daily oral TDF/FTC PrEP (Cindra Feuer, AVAC)
  • 13:20-13:35 Antibodies and vaccines (Penny Moore, University of the Witwatersrand)
  • 13:35-13:50 Community level advocacy and access (Michael Meullbroek & Ferran Pujol, BCN Checkpoint)
  • 13:50-14:05 Q&A (Moderated by Will Nutland, PrEPster)
  • 14:05-14:25 Moderated discussion (Moderated by Will Nutland, PrEPster)
  • 14:25-14:30 Meeting wrap-up (Gus Cairns, PiE)

Recording and Slides: YouTube / PrEP in Europe Initiative’s Slides

Avac Event

Long-Acting Injectable Cabotegravir for PrEP: Understanding Results of HPTN 083 & 084 and key areas for advocacy

[UPDATE]: In December of 2021, the FDA approved CAB-LA as PrEP, making it the first injectable PrEP to be added to the toolbox of proven prevention methods. The other methods are male and female condoms, daily oral PrEP, voluntary medical male circumcision and the Dapivirine Vaginal Ring.

On May 3, AVAC held a webinar where you can listen to the researchers who led the studies about long-acting injectable PrEP strategy and advocates who are leading essential advocacy efforts around the introduction of CAB-LA.

On the call, lead trial investigators Sinead Delany-Moretlwe from HPTN 084 and Raphy Landovitz from HPTN 083 provided updates, and we were joined by AVAC’s Emily Bass, Chiluyfa Kasanda from TALC in Zambia, Richard Lusimbo from Pan Africa ILGA, and Sibongile Maseko who is an independent consultant and women’s health advocate based in Eswatini.

Recording and Slides: YouTube / Civil Society Advocates’ Slides / Sinead Delaney-Moretlwe’s Slides / Raphy Landovitz’s Slides

Avac Event

HPTN 083 Preliminary Study Results Webinar

On Friday, May 22, the HIV Prevention Trials Network (HPTN) held a community webinar to discuss the preliminary results of HPTN 083, a global randomized, controlled, double-blinded study that compared the safety and efficacy of long-acting injectable cabotegravir (CAB LA) to daily oral tenofovir/emtricitabine (TDF/FTC) (Truvada) for pre-exposure prophylaxis (PrEP). The study showed that CAB LA lowered HIV incidence among cisgender men and transgender women who have sex with men. The sister study, HPTN 084 is the first study to compare the safety and efficacy of CAB LA to daily oral TDF/FTC for HIV PrEP among cisgender women. A panel discussion on HPTN 084’s importance to HIV prevention for cisgender women followed.

Moderator:

Panelists:

Click here to watch the recording.

Avac Event

Webinar: HPTN 083 Primary Study Results

The HIV Prevention Trials Network (HPTN) held a community webinar, on July 16, to present the primary results of HPTN 083, a global randomized, controlled, double-blinded study that compared the safety and efficacy of long-acting injectable cabotegravir (CAB LA) to daily oral tenofovir/emtricitabine (TDF/FTC) (Truvada) for pre-exposure prophylaxis (PrEP). The study showed that a PrEP regimen containing CAB LA was superior to oral TDF/FTC for the prevention of HIV acquisition among cisgender men and transgender women who have sex with men.

Host: Melissa Turner, HPTN Community Working Group Chair

Moderator: Mitchell Warren, Executive Director, AVAC

Panelists:

  • HPTN 083 Protocol Chair – Dr. Raphael Landovitz, UCLA Center for Clinical AIDS Research and Education (CARE)
  • HPTN 083 Protocol Co-Chair – Dr. Beatriz Grinsztejn, National Institute of Infectious Diseases Evandro Chagas-

Additional panelists avialbe for questions and answer session:

  • HPTN 084 Protocol Chair – Dr. Sinead Delany-Moretlwe, Wits RHI, University of Witwatersrand
  • HPTN 084 Protocol Co-Chair – Dr. Mina Hosseinipour, UNC Project Lilongwe
  • Head of Research & Development, ViiV Healthcare – Dr. Kimberly Smith
  • Senior Director, Global HIV Prevention Strategy, ViiV Healthcare – Dr. Alex Rinehart

Watch the recording here.

Avac Event

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

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

Avac Event

It’s Complicated: Implementation questions regarding price, programming and policies for Descovy as PrEP

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:

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