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

Avac Event

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

Avac Event

PK, PD and F/TAF: What does an advocate need to know about the pharmacology of safety and efficacy and today’s PrEP drugs

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.

Avac Event

Webinar: HIV Research in the Era of PrEP: The implications of TDF/FTC for biomedical prevention trials

On Thursday, October 26, colleagues from the Treatment Action Group (TAG), along with advocates, researchers and GPP practitioners, discussed the recommendations from TAG’s recently released white paper, HIV Research in the Era of PrEP: The Implications of TDF/FTC for Biomedical Prevention Trials.

The effectiveness and increasing availability of oral PrEP raises questions about how it should be incorporated into clinical trial designs for next-generation HIV prevention options. This paper explores ethics, the scientific literature to date, and advocates’ views on the issue.

Recording: YouTube / Audio / Slides