This graphic shows currently available options for HIV prevention, newly approved and recommended treatment, and those in development.
The HIV Prevention Pipeline
SRH + HIV integration advocacy, Pandemic Accord, GPP and more!
AVAC’s round-up of resources, updates and insights this week includes a new roadmap for sexual and reproductive health (SRH) and HIV integration, resources to support an equitable Pandemic Accord, innovations in Good Participatory Practices (GPP) and more!
The power of choice in contraception, sexual health and HIV prevention this World Contraception Day
Roadmap: Sexual and Reproductive Health (SRH) Integration Roadmap
Copper Rose Zambia, as a part of CASPR and AVAC launched a new resource addressing the critical need for integrated SRH and HIV services. This roadmap provides key steps for success, focusing on collaboration, strategic mapping and targeted advocacy.
Advocate’s Guide: Advocates’ Guide to Multipurpose Prevention Technologies (MPTs)
MPTs are products designed to simultaneously address more than one sexual and reproductive health concern. This advocates’ guide shows the pipeline of products in development, discusses why MPTs are needed, investment, and what advocates can do to push for MPT development and introduction.
What will it take for an equitable Pandemic Accord?
Call to Action: Pandemic Accord Priorities from the Coalition of Advocates for Global Health and Pandemic Preparedness
A group of organizations advocating for an integrated and holistic approach to preparedness that emphasizes equity, inclusion, and synergies of multiple global health programs in advancing preparedness, shares five priorities in Pandemic Accord negotiations.
UNGA Side Event: Restrategizing Civil Society Engagement for Pandemic and Global Governance
AVAC’s Sam Rick moderated CISDI’s event alongside Nina Schwalbe, Lawrence Gostin, Eloise Todd and others, reminding the audience that for pandemic prevention, preparedness and response (PPPR) to succeed, lessons from the HIV response must be integrated into the architecture being built for PPPR.
Good Participatory Practices in action
Call for Applications: Now Accepting Applications for the 2024 Good Participatory Practice Online Course
The 2024 Good Participatory Practice Online Course is now accepting applications for 30 spots! This course offering will run 14 October – 20 December 2024. The application deadline is 9 October.
Recording: Innovations in GPP
Recording / Clever Chilende Slides / Sarah Read Slides / Ntando Yola Slides
Avac Event
Integrating HIV and PrEP Services in US Correctional Facilities
This webinar explored the integration of HIV prevention and PrEP services in diverse US correctional settings and during the critical period following release. It also highlighted innovative HIV status-neutral approaches, fostering holistic and comprehensive HIV care, treatment, and prevention services in these settings.
Presenters:
- Jeannette Webb, BS, University of Chicago
- Russell Brewer, DrPH, University of Chicago
- Chad Zawitz, MD, Cook County Health, Chicago
- Gjvar Payne, Capitol Area Reentry Program, Baton Rouge
- Louise Bienvenu, JD, Frontline Legal Services, New Orleans
Recording / Slides / Resources
Brand-new PxPulse Podcast on LEN’s Impact on HIV Prevention
The promise of long-acting PrEP has been super-charged this year by studies showing the powerful efficacy of an injectable antiretroviral known as lenacapavir (LEN).
PxPulse’s new episode, Lenacapavir: The case for investing in delivering HIV prevention, goes deep on LEN. Recorded just days before Gilead’s announcement that PURPOSE 2, its second major trial of LEN as injectable PrEP, also found very high efficacy, Dr. Flavia Kiweewa, a principal investigator of PURPOSE 1, the first trial to announce efficacy, lays out the research findings and what they mean. And Chilufya Kasanda Hampongo of Zambia’s Treatment Advocacy and Literacy Campaign and Mitchell Warren of AVAC talk about how to change a long history of squandered opportunities to get rollout right.
The PURPOSE 1 trial announced findings in June that a twice-yearly injection of LEN was 100% effective among cisgender women, with zero new cases of HIV. And the PURPOSE 2 trial among cisgender men, and trans and non-binary people, was shown to reduce the risk of HIV by 96%.
LEN now enters a select category, one of five ARV-based options for PrEP that all protect against HIV if you take them. But many of the people applauding the results from PURPOSE 1 and 2 will tell you that breakthrough science like this, as hard as it is, is still the easy part. Breaking the back of the HIV epidemic demands overcoming an altogether different challenge — coordinating and accelerating every step in rolling out new products so that everyone who needs HIV prevention can get it.
Listen to this podcast to learn what must be done to finally deliver on the promise of highly effective HIV prevention, from pills to rings to injectable PrEP and beyond.
Avac Event
Breaking New Ground: Expanding Access to Lenacapavir—Lessons from Dolutegravir and the Future of HIV Prevention
This UAN Call, titled Breaking New Ground: Expanding Access to Lenacapavir—Lessons from Dolutegravir and the Future of HIV Prevention, brought together global health experts, community advocates, and civil society organizations to discuss the challenges and opportunities in ensuring equitable access to Lenacapavir.
This webinar was hosted by Unitaid.
Lenacapavir: The case for investing in delivering HIV prevention
The promise of long-acting PrEP has been super-charged this year by studies showing the powerful efficacy of an antiretroviral known as lenacapavir (LEN).
This episode of PxPulse goes deep on LEN for PrEP. Recorded just days before Gilead’s announcement that PURPOSE 2 also found very high efficacy, Dr. Flavia Kiweewa, a principal investigator of PURPOSE 1, the first trial to announce efficacy, lays out the research findings and what they mean. And Chilufya Kasanda Hampongo of Zambia’s Treatment Advocacy and Literacy Campaign and Mitchell Warren of AVAC talk about how to change a long history of squandered opportunities to get rollout right.
The PURPOSE1 trials announced findings in June that a twice-yearly injection of LEN was 100% effective among cisgender women, with zero new cases of HIV. And the PURPOSE 2 trial among cisgender men, and trans and non-binary people, was shown to reduce the risk of HIV by 96%.
LEN now enters a select category, one of five ARV-based options for PrEP that all protect against HIV if you take them. But many of the people applauding the results from PURPOSE 1 and 2 will tell you that breakthrough science like this is, as hard as it is, is still the easy part. To break the back of the HIV epidemic demands overcoming an altogether different challenge—coordinating and accelerating every step in rolling out new products so that everyone who needs HIV prevention can get it.
Listen to this podcast to learn what must be done to finally deliver on the promise of highly effective HIV prevention, from pills to rings to injectable PrEP and beyond.
Listen
Resources
- Second Pivotal Trial of Twice-Yearly HIV Prevention Injection Safe and Highly Effective: PURPOSE 2 Trial Among Gay Men, Trans and Nonbinary People, AVAC Press Release
- The Lens on LEN: The basics on injectable lenacapavir as PrEP, AVAC
- Country planning matrix, PrEPWatch
- Moving a Product to the Real World, AVAC
- The long wait for long-acting HIV prevention and treatment formulations, Lancet
- A game-changer for PrEP if access is adequate, Lancet
- Allocation of Non-Commercial CAB for PrEP Supply in Low- and Middle-Income Countries, 2023-2025, AVAC
- Generic Cabotegravir Timelines, AVAC
- UNAIDS Exec Summary, UNAIDS
- Lenacapavir: What it would it take to get the 6-monthly anti-HIV jab to SA, Bhekisisa
Second Pivotal Trial of Twice-Yearly HIV Prevention Injection Safe and Highly Effective
AVAC welcomes the groundbreaking results of the PURPOSE 2 HIV prevention study of twice-yearly injectable lenacapavir for PrEP among 3,200 cisgender men, transgender men, transgender women, and nonbinary individuals who have sex with partners assigned male at birth. Among more than 2,000 people in the trial who received lenacapavir, there were only two HIV infections.
Press Release
Second Pivotal Trial of Twice-Yearly HIV Prevention Injection Safe and Highly Effective: PURPOSE 2 Trial Among Gay Men, Trans and Nonbinary People
AVAC Calls for Accelerated Regulatory Review and Ambitious, Equitable Access Plans
New York City, September 12, 2024 – AVAC welcomes the groundbreaking results of the PURPOSE 2 HIV prevention study of twice-yearly injectable lenacapavir for PrEP among 3,200 cisgender men, transgender men, transgender women, and nonbinary individuals who have sex with partners assigned male at birth. Among more than 2,000 people in the trial who received lenacapavir, there were only two HIV infections.
Preliminary safety and efficacy results were reported today by Gilead Sciences, the drug’s developer. An independent data and safety monitoring board (DSMB), at a scheduled review of the trial data, found the regimen to be safe and highly effective, with a 96% lower HIV rate compared with the expected background incidence of HIV infection and 89% lower compared with oral TDF/FTC. These results follow the results of PURPOSE 1, released earlier this year, that showed 100% efficacy of lenavcapavir among cisgender women in South Africa and Uganda.
“This is the second impressive result for this new HIV prevention option, opening up more possibilities for choice for even more people to find an option that is right for them,” said Mitchell Warren, AVAC’s executive director. “Beyond expanded choice, a twice-yearly injection has the potential to transform the way we deliver HIV prevention to people who need and want it most – from an easier to follow regimen for individuals to a decreased burden on healthcare systems that are stretched to the limit. But these data only matter if the field moves with speed, scale and equity.”
“Having results from a trial population that includes trans men and women, nonbinary people and gay men is an important milestone for community inclusion in HIV prevention studies,” said Kenyon Farrow, AVAC communications director and PrEP user since 2015. “I am excited that people who want to use PrEP or who fear stigma or discrimination, may soon have the possibility of another option that could be much easier to use and provide more discretion. It is imperative that we accelerate planning for rollout of lenacapavir. We know that even with the most ambitious timeline, it will take time for lenacapavir to be rolled out to all who need and want to use it.”
The study evaluated the safety and efficacy of twice-yearly injectable lenacapavir for PrEP compared to once-daily oral emtricitabine/tenofovir and background HIV incidence. All trial participants will now be offered lenacapavir. Additional studies in critical populations, including PURPOSE 3 among cisgender women in the US and PURPOSE 4 among people who inject drugs, are also underway. It will be imperative to understand how today’s results influence these trials. A schematic of the suite of studies is here.
“We applaud Gilead’s commitment to Good Participatory Practice in this and the other PURPOSE studies, especially through the inclusion of multiple populations in the PURPOSE studies and a commitment to including community voices in trial design and in access plans” said Stacey Hannah, AVAC director of research engagement. “Access and implementation plans must be shaped and informed by continuous, robust participatory engagement. AVAC and our partners look forward to continuing engagement with Gilead and other key stakeholders in this process.”
Importance of Access and Equity
Gilead said it is committed to making lenacapavir available for prevention in countries where it is needed most and to granting direct voluntary licenses for longer-term availability. Today’s results make it clear that Gilead, along with regulatory and normative agencies, funders and civil society, must work on an accelerated timeline to ensure broad and timely access to individuals and communities everywhere.
“In an updated access statement today, Gilead committed to beginning global regulatory filings by the end of 2024 and to facilitating faster access to target populations and countries,” Warren said. “This raises the stakes to accelerate speed, scale and equitable access. Gilead needs to urgently grant these licenses even before regulatory approval and name its prices, so that funders can prepare to accelerate product introduction. And WHO must urgently initiate its guideline review process so that lenacapavir, if approved by regulatory agencies, can be immediately added into the PrEP method mix. There is no time to waste if we are to translate these exciting clinical trial results into actual public health impact.”
“We now know that lenacapivir for PrEP is safe and highly effective among a range of populations,” Farrow added. “Even as we await regulatory submission and review, there is urgent work to be done now by communities, policy makers, funders and program implementers to design and build HIV prevention programs and prepare health systems to deliver the growing array of biomedical PrEP options, including the addition of twice-yearly injectable lenacapavir. The full range of PrEP products—including oral PrEP—must be made feasible choices for all people who need and want HIV prevention options.”
Lessons learned from rollout of daily oral PrEP, and more recently the dapivirine vaginal ring and injectable cabotegravir, can help speed regulatory approval and guideline development in key countries, design of effective programs, and community understanding of and acceptance of lenacapavir for PrEP.
“For many years, AVAC and a coalition of international partners have been planning for successful, accelerated introduction of PrEP at scale and with equity. There can be no excuses, no delays, and no repeats of the failures of oral PrEP rollout. We must move with speed, scale, and equity to ensure lenacapavir has the impact we need to prevent new HIV infections,” said Warren.
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About AVAC
AVAC is an international non-profit organization that provides an independent voice and leverages global partnerships to accelerate ethical development and equitable delivery of effective HIV prevention options, as part of a comprehensive and integrated pathway to global health equity. Follow AVAC on Twitter @HIVpxresearch; find more at www.avac.org and www.prepwatch.org.
Avac Event
Do Vaginas Demand Perfection? Implications for Event-Driven PrEP
Dr. Jenell Stewart (University of Minnesota, Hennepin Healthcare) joined The Choice Agenda to discuss and analyze recent research on HIV PrEP and implications for event driven PrEP across sex and gender.
HIV leaders say it’s time to end the long wait for long acting products
Dear Advocate,
How do we translate recent scientific advances in long-acting HIV prevention and therapy into public health impact? Read answers in this new The Lancet HIV commentary from a distinguished group of authors including our Executive Director, Mitchell Warren, AVAC board members, Linda-Gail Bekker, Solange Baptiste Simon, with partners Francois Venter, Kenly Sikwese, and others: The long wait for long-acting HIV prevention and treatment formulations.
Major advances in long-acting HIV treatment and prevention, including the latest PURPOSE 1 results of lenacapavir for PrEP, hold great promise for achieving global targets. However, planning to coordinate among stakeholders, including pharmaceutical companies, governments, and multilateral organizations to deploy and ensure equitable access to these products, particularly in low- and middle-income countries, requires immediate action.
“Civil society organisations and HIV activists have been instrumental in holding pharmaceutical companies, financial donors, governments, and international organisations accountable for commitments to the international HIV treatment response for decades,” the authors write. “These organisations and activists are needed to promote transparency in pricing, challenge restrictive patent practices, advocate for affordable and widespread availability of drug innovations, prevent companies from restricting broad access to medications, and require funding to allow this work to be done independently.”
Key Messages
- Long-acting antiretrovirals are perhaps the greatest advance in HIV care in over a decade and provide great promise towards achieving global HIV prevention and control programme targets.
- Current long-acting agents are firmly under the control of originator pharmaceutical companies and remain unavailable or cost-prohibitive across much of the globe.
- If action from the broader HIV community is stagnant, the populations who are most in need of these long-acting agents are unlikely to receive any benefit until well into the 2030s, resulting in a large number of preventable HIV infections.
- Coordination by international agencies, with assistance from relevant financial donors and stakeholders, will be needed in the complex research and access programmes required to provide widescale use of these indispensable products to people living with HIV or affected by HIV.
Resources on Long-Acting HIV Prevention
The Lens on LEN: this primer for advocates shares the basics on injectable lenacapavir as PrEP.
Long-Acting PrEP Status Update: this webpage shares graphics and information synthesizing the current status of long-acting PrEP products. It’s updated quarterly.
PrEP Products Overview: this page on PrEPWatch shares the status of PrEP products in development and approved.
Injectable Cabotegravir Evidence Gap Tracker: this webpage summarizes the latest insights from the Biomedical Prevention Implementation Collaborative (BioPIC) on injectable CAB for PrEP, links to learn more, and information on where evidence is still needed, mapped against priority evidence gaps.
Years Ahead in HIV Prevention Research: Time to Market: this downloadable graphic shows the potential time points when the next-generation of HIV prevention options might find their way into new programs.