On August 22 the Fellows team held the 2020 AVAC Fellows Global Info Session. AVAC’s Advocacy Fellows Program launched in 2009 to expand the capacity of advocates and organizations to accelerate, shape and monitor biomedical HIV prevention research and implementation worldwide. Since the start, seventy Fellows have moved through the program in its first 10 years, many of whom have gone on to become leaders in the HIV movement in their communities, countries and globally. This global informational call was for prospective applicants to learn more about the program and ask questions directly to current Fellows, Alumni, Supervisors and the AVAC team. You can learn more about the application process here and download the application materials here.
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2020 AVAC Fellows Global Info Session
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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
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Improving Access to Innovative HIV Technology
Two things need to happen to achieve greater success in the global fight against HIV: dramatically reduce new infections and achieve viral suppression in those already living with the virus. In order to meet these goals, new infections must come down from an annual rate of 1.7-2 million that has been stagnant for a decade, viral suppression must be sustained and ensured for the more than 23 million people living with HIV (PLHIV) on anti-retroviral treatment (ART), and treatment must be provided to the more than 14 million PLHIV not on ART.
New technology offers the potential to facilitate these efforts if they can be utilized effectively. The July 2019 International AIDS Society science conference in Mexico City highlighted several important technological innovations either already on the market or that will be available in the coming years including long-acting injectable treatment, pre-exposure prophylaxis (PrEP), implants, and broadly neutralizing antibodies as a vaccine. However, the ongoing experience of starting oral PrEP programs has demonstrated that taking new products to scale for impact is complex and that there are significant obstacles to ensuring access to those in need.
On Tuesday, October 22nd, 2:30-5:00 pm, the CSIS Global Health Policy Center hosted a public event to explore recent developments in HIV prevention and treatment technology, examine successes and challenges in integrating those products into existing service delivery, and discuss how global programs, such as PEPFAR and the Global Fund, need to adapt to ensure access and uptake.
Fireside Chat
- Deborah Waterhouse – CEO, ViiV Healthcare
Moderated by:
J. Stephen Morrison – Senior Vice President and Director, CSIS Global Health Policy Center
Panel Discussion
- Ambassador Deborah L. Birx – Coordinator of the United States Government Activities to Combat HIV/AIDS and U.S. Special Representative for Global Health Diplomacy, PEPFAR
- Charles Lyons – President and CEO, Elizabeth Glaser Pediatric AIDS Foundation
- Mitchell Warren – Executive Director, AVAC
Moderated by:
Sara M. Allinder – Executive Director and Senior Fellow, CSIS Global Health Policy Center
Watch a recording of the event here.
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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:
- Kathie Hiers, CEO of AIDS Alabama
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
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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
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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.
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Webinar: Are we there yet? The long and winding rectal road…
IRMA’s Marc-Andre LeBlanc and Craig Hendrix of Johns Hopkins and the Microbicide Trials Network provide a rollicking rectal recap. From the rectal dawn of research and advocacy til today, scientists and advocates have worked together tirelessly (and fiercely) to advance safe, effective, acceptable and accessible rectal microbicides for the men, women, and transgender individuals who want and need them.
With threats to the microbicide field at large coming from multiple angles, this webinar takes stock of where we have been and where we are now in terms of rectal microbicide research and advocacy to help us chart our collective course forward. We seek to ensure adequate, sustainted resources for the development of user-desired, user-initiated, short-term, non-systemic, pleasure-enancing HIV prevention options – including rectal microbicides.
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Webinar: Informing the Research Enterprise
On September 5, there was a conversation with Dr. Carl Dieffenbach, the Director of the Division of AIDS (DAIDS) at the NIH’s National Institute of Allergy and Infectious Diseases, about the future of investments in the US National Institutes of Health’s (NIH) HIV clinical trial research networks in the US and internationally.
Every seven years, the NIH reviews the structure and funding of its HIV clinical research networks. This “network recompetition” process involves decisions will help determine the focus and priorities of its HIV clinical trial networks through 2027, as well as the number and structures of the various networks that undertake this research. These are critical questions for advocates to weigh in on—whether you are in the US or not. Learn more with our factsheet.
The webinar included a brief introductory presentation from Dr. Carl Dieffenbach followed by a Q&A session. NIAID is also currently accepting public comments and questions online, so now is your chance!
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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.
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Webinar: Informing the Research Enterprise: Dr. Carl Dieffenbach on future priorities for HIV research networks
On Friday, October 27, there was the second webinar in a series with Dr. Carl Dieffenbach, the Director of the Division of AIDS (DAIDS) at the NIH’s National Institute of Allergy and Infectious Diseases, about the future of investments in the US National Institutes of Health’s (NIH) HIV clinical trial research networks in the US and internationally. A recording of the first webinar is available here.
As background, every seven years, the NIH reviews the structure and funding of its HIV clinical research networks. This “network recompetition” process involves decisions that will help determine the focus and priorities of its HIV clinical trial networks through 2027, as well as the number and structures of the various networks that undertake this research. These are critical questions for advocates to weigh in on—whether you are in the US or not. Learn more with our factsheet.
The webinar included a brief introductory presentation from Dr. Carl Dieffenbach followed by a Q&A session. NIAID is also accepting public comments and questions online until November 30, 2017, so now is your chance!