As we look ahead to 2024 and the vital work AVAC and partners will be carrying forward, the conversations from 2023 offer guidance and insights. Px Pulse, AVAC’s podcast on critical issues facing HIV prevention research, hosted several not-be-missed conversations in 2023 that will reverberate into the year ahead.
From a stalled PEPFAR reauthorization to LGBTQIA+ voices fighting persecution in Uganda; from efforts to bring equity to a new global architecture for pandemic readiness to advances in HIV vaccine science and advocacy to include pregnant people in research—we hope that all of these conversations can inform our advocacy in 2024. Click on the episode for both recordings and resources.
Considered one of the greatest US foreign policy and global development achievements of the century, the program has saved upwards of 25 million lives since it launched in 2003. But PEPFAR is marking its 20th anniversary while fighting for its future. LISTEN HERE.
In March 2023, the Ugandan Parliament moved forward broad-reaching legislation to further criminalize LGBTQIA+ people. This podcast features Ugandan advocates and AVAC partners discussing the specifics of how these attacks have gained momentum and their ties to US-based religious extremists. The advocates discuss what needs to happen next. LISTEN HERE.
Health leaders around the world are in the midst of creating a new architecture to deal with pandemics. Chris Collins, the CEO and President at Friends of the Global Fight Against AIDS, Tuberculosis and Malaria, talks about what’s at stake, which policymakers get it already, why this year matters so much, and what advocates can do about it. LISTEN HERE.
Over the coming months, global leaders will make key decisions about several initiatives to prepare for the next pandemic. This podcast explores what they commit to, how much they will spend and how well these plans safeguard equity. LISTEN HERE.
AVAC’s Manju Chatani-Gada takes us through conversations with a trial participant who became pregnant, researchers, policymakers and donors to understand why this population gets excluded, the impact it has and what to do about it. LISTEN HERE.
Evolving Strategies for an HIV Vaccine: One researcher explains where the field is going and why? Dr. Katy Stephenson explores the implications of recent trial results, the big questions driving next generation vaccine development, and new strategies underway in early phase research. LISTEN HERE.
Happy listening—and let us know what topics you want to hear more about in 2024!
PxWire Volume 13, Issue No. 4
PxWire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research and development, implementation and advocacy. Each issue includes updates, emerging issues and upcoming events. Also available as a PDF.
From Research to Rollout: A look at where we are in HIV prevention
As we look back on 2023, powerful crosscurrents confront HIV prevention and global health equity. More options than ever before could be available, but many forces threaten to undermine access to proven prevention options that exist today and the development of additional options that are still needed. Threats to PEPFAR and hate laws targeting LBGTQI+ people are just a sample.
Upstream research and development is dynamic, but robust stakeholder engagement and sustainable funding must still be secured and integrated into a people-centered research agenda. These commitments are the compass that will ultimately lead to impact in the real world. The highlights below provide a snapshot of key updates in Q3 of 2023 and resources to inform advocacy on these critical questions.
Progress in PrEP Uptake
These updates from AVAC’s Global PrEP Tracker explore trends in 2023 and highlight new data as of September 2023.
PEPFAR and PrEP
PEPFAR’s role has been instrumental to accelerating global uptake of PrEP to date. This year, four countries started providing PrEP for the first time, and seven countries exceeded 70,000 new PrEP initiations, most of which are attributable to PEPFAR. This lifesaving, uniquely effective, program must see continued full funding and a 5-year reauthorization to carry on this work and help to put the world on track to control the epidemic.
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Cumulative PrEP Initiation Milestones
Global Milestones
The world surpassed 5.6 million cumulative PrEP initiations as of September 2023. Initiations increased by 700,000+ since Q2 2023. Though comparable to previous quarterly increases, it is the highest ever recorded quarterly increase by the Global PrEP Tracker.
At the same time last year the world had reached 3.3 million cumulative PrEP initiations, representing a doubling of initiations since then.
Country Level Milestones
Early adopting African countries continue to show the most rapid increases in PrEP uptake. South Africa has shattered 1 million cumulative initiations. Nigeria, Uganda, and Zambia have all surpassed 500,000 initiations, Kenya has surpassed 400,000, and Zimbabwe has surpassed 200,000.
Malawi and Brazil saw jumps of approximately 20,000 initiations over this quarter, while Lesotho had more modest increases of 10,000 initiations.
Dozens of countries continue to grow their programs. For example, El Salvador, Honduras, and South Sudan all surpassed 1,000 cumulative initiations.
Cyprus and Malta recorded their first oral PrEP initiations, at 29 and 579 respectively.
Spotlight on West Africa
As of Q3 2023, the top five West and Central African countries for PrEP initiation have surpassed 10,000 initiations; Cameroon, Cote d’Ivoire, Democratic Republic of the Congo (DRC), Ghana and Nigeria. Nigeria has marked almost 550,000 cumulative initiations as of this quarter, ranking it second, behind South Africa, worldwide. These milestones can be credited to targeted PEPFAR investments. But despite these successes, West and Central Africa make up only 14 percent of PrEP initiations recorded in Africa, compared to 85 percent reported by East and Southern Africa. These same countries are home to two thirds of all people living with HIV in West Africa. There is vital work to be done to close the gap.
West and Central Africa can and must continue to leverage this recent growth in oral PrEP by making additional HIV prevention options available. In September, Nigeria’s regulators approved injectable cabotegravir (CAB for PrEP)—approving the first new biomedical HIV prevention option in a West and Central African country since oral PrEP. But at this time, only one other CAB for PrEP application has been submitted in the region, in Côte d’Ivoire, and none for the dapivirine vaginal ring (DVR). Only one CAB for PrEP implementation study is planned for the region.
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PrEParing for New Products
Current HIV prevention options aren’t reaching all who need them. Access to a range of options that meet the needs of diverse people, especially those most at risk, will be essential to meeting global targets for ending the HIV epidemic.
CAB for PrEP Supply: In October 2023, ViiV, the developer and sole manufacturer of CAB for PrEP for now, announced a 40 percent increase in forecasted doses that could be available for non-commercial use in low- and middle-income countries through 2025, an increase to 1.2 million potential doses. Of these, 116,000 have been allocated to post-trial access for HPTN 083 and 084 participants; 129,000 for an initial set of eight implementation studies; 326,000 to PEPFAR programs in Malawi, Ukraine, Vietnam, Zambia and Zimbabwe; leaving at least 629,000 doses available for procurement by PEPFAR, Global Fund and national governments. See more details in our Country Planning Matrix. Three generic manufacturers could begin to deliver doses in 2026 or 2027.
Implementation Science (IS): As DVR and CAB for PrEP supplies arrive in countries, dozens of implementation science studies are underway in 22 different countries. Check out AVAC’s Integrated Study Dashboard for more details and stay tuned for updates.
PrEParing for Choice: For the first time since oral PrEP was introduced in 2012, PrEP users will have a range of methods to choose from—but only if they have access to them. Policy makers, donors, governments and implementers must commit to making these methods available, accessible and affordable. The HIV Prevention Choice Manifesto, launched in September by the African Women’s HIV Prevention Community Accountability Board, outlines what needs to happen to make choice a reality.
Approval Information
Malaysia, Nigeria, Peru, Zambia, and the European Medicines Agency have approved CAB for PrEP; ViiV also made submissions in Canada, Colombia, and the United Kingdom. There are now 13 regulatory approvals and 15 additional submissions that are pending.
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The HIV Prevention Pipeline: The latest in research, development and more
The HIV prevention pipeline has evolved: Few products are in late stage or efficacy trials, newly proven products are rolling out, and early phase clinical trials are exploring innovative strategies. R&D is focused on ARV and non-ARV based prevention products and HIV vaccines that build on new knowledge about the virus. The late-stage trials of recent years and basic science have brought deepening insights that are being applied today to a diversity of ‘upstream’ interventions.
MK-8527 Announced: Merck announced a new Phase 2a trial to evaluate the safety, tolerability, and pharmacokinetics of a monthly oral pill, MK-8527. The trial began in November 2023 in participants at low-risk for HIV acquisition. If successful, Phase 3 trials could start in 2025.
PURPOSE Program: A new Phase 2 study, PURPOSE 5, will evaluate lenacapavir as a twice-yearly prevention option in France and the United Kingdom, as part of the larger PURPOSE program. Purpose 5 is recruiting participants who are disproportionally affected and often underrepresented in HIV clinical trials. PURPOSE 1 and 2 are Phase 3 efficacy studies in Argentina, Brazil, Mexico South Africa, Thailand, Uganda and the United States. PURPOSE 3 & 4 are smaller studies focused on populations facing disproportionate risk.
The Dual Prevention Pill (DPP): In September, the DPP, which would protect against pregnancy and HIV, moved to the next stage in R&D. A pilot bioequivalence study has shown the pill’s combined drugs—an antiretroviral and a contraceptive—are absorbed at an equivalent rate as taking them separately. The DPP now moves to a larger bioequivalence study needed for a regulatory submission. Check out the updated DPP Market Preparation and Introduction Strategy for highlights. The Population Council and Medicines360 are also developing a second-generation DPP with F/TAF.
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Prevention Playlist
The most effective advocacy is based on smart analysis and accurate information. AVAC develops a wide range of materials and resources to inform decision making and action. Check out these essential resources to the global conversation on HIV prevention and global health equity.
JOIN
ICASA: The biennial International Conference on AIDS and Sexually Transmitted Infections in Africa. Dec 4-9. Register
How Our Environment Impacts Cure, webinar, Dec 13. Register
STI Watch Newsletter, a curated resource on the latest STI vaccines, diagnostics and other prevention strategies.
The STI Clinical Trials Dashboard, tracking trials on vaccines, doxycycline as post-exposure prophylaxis (DoxyPEP) and diagnostics against chlamydia, gonorrhea, hepatitis B, herpes simplex virus(HSV), human papillomavirus, syphilis and trichomoniasis infections.
Spotlight on New PrEP Tools and Data: From R&D to access
Tuesday, November 28
Between the recent accelerated growth in global PrEP initiations, and the introduction of new PrEP products like cabotegravir and the dapivirine vaginal ring, the field of PrEP data has never been more exciting or more complex. Staying on top of the latest advances is key for advocates, researchers, funders, and others working in HIV prevention to do their job effectively—but how can you navigate the vast amount of PrEP data online? AVAC, the Medicines Patent Pool (MPP), and Unitaid presented information on three important online PrEP resources and understand how they can support and enhance your work:
PrEPWatch.org: the one stop shop for PrEP resources to support introduction and scale-up, including the PrEPTracker, the only place to find information on global PrEP initiations online
Access to Medicines Tracker: the go-to place for quarterly-updated insights on regulatory filings, regulatory approvals, and product supplies of MPP-licensed generic medicines at the country level.
As of Q3 2023, the top five West and Central African countries for PrEP initiation have surpassed 10,000 initiations; Cameroon, Cote d’Ivoire, Democratic Republic of the Congo (DRC), Ghana and Nigeria. Nigeria has marked almost 550,000 cumulative initiations as of this quarter, ranking it second, behind South Africa, worldwide. These milestones can be credited to targeted PEPFAR investments. But despite these successes, West and Central Africa make up only 14 percent of PrEP initiations recorded in Africa, compared to 85 percent reported by East and Southern Africa. These same countries are home to two thirds of all people living with HIV in West Africa. There is vital work to be done to close the gap.
West and Central Africa can and must continue to leverage this recent growth in oral PrEP by making additional HIV prevention options available. In September, Nigeria’s regulators approved injectable cabotegravir (CAB for PrEP)—approving the first new biomedical HIV prevention option in a West and Central African country since oral PrEP. But at this time, only one other CAB for PrEP application has been submitted in the region, in Côte d’Ivoire, and none for the dapivirine vaginal ring (DVR). Only one CAB for PrEP implementation study is planned for the region.
PEPFAR’s role has been instrumental to accelerating global uptake of PrEP to date. In 2023, four countries started providing PrEP for the first time, and seven countries exceeded 70,000 new PrEP initiations, most of which are attributable to PEPFAR. This lifesaving, uniquely effective, program must see continued full funding and a 5-year reauthorization to carry on this work and help to put the world on track to control the epidemic.
This dynamic, workshop-style showcase was the first of a series that featured multimedia presentations that took participants through key PrEP resources including: A toolkit to ensure programs related to sexual and reproductive health (SRH) and HIV prevention are well designed to reach and support adolescent girls and young women. Comprehensive databases for tracking PrEP uptake, Implementation research and other critical data by product, country, and population.
Small groups had opportunities to take deep dives into each of the above resources, and explore how they might use these in their work. Additionally, participants provided input on what resources are still needed, collaborate on how to improve and disseminate what exists, and support the development of evidence and networks to advance HIV prevention.
This graphic shows currently available options for HIV prevention, newly approved and recommended treatment, and those in development.
HPTN 096: Building Equity Through Advocacy – An Integrated, Status-Neutral Approach for Ending the Epidemic Among Black Gay Men in the South
November 15, 10:00 to 11:30 AM ET
The Choice Agenda and partners hosted a fascinating discussion about a novel, much-needed HIV prevention research study – HPTN 096 on November 15. Currently in the field, the study addresses social, structural, institutional, and behavioral barriers to HIV prevention and care. Visit the study website here.
Speakers (list in formation):
Prof. LaRon E. Nelson. Yale School of Nursing; HPTN 096 Protocol Co-Chair Christopher Hucks-Ortiz, HPTN Black Caucus Chair Dr. Cedric Pulliam, HPTN 096 Community Strategy Group Abraham Johnson, HPTN 096 Research Advisor
Moderators: Riko Boone, Treatment Action Group John Meade, AVAC
Co-sponsored by PrEP in Black America and Federal AIDS Policy Partnership Research Working Group
People who are pregnant or lactating (PLP) have historically been excluded from research because of concerns for the developing fetus. But this has led to a dearth of data on new interventions against health threats for this population. In the case of HIV, pregnancy raises the risk of acquiring HIV by up to three times, but providers often do not have the data to know whether a new intervention is safe or how it will work for pregnant patients. As a result, PLP and their physicians are left to make difficult decisions around the use of proven HIV prevention products as they await more data specific to pregnancy and lactation.
But change is in the air. Champions for the inclusion of PLP in research are paving the way for a paradigm shift— one that will redefine this population from needing protection from research to being better protected through research. In this episode of Px Pulse, AVAC’s Manju Chatani-Gada takes us through conversations with a trial participant who became pregnant, researchers, policy-makers and donors to understand why this population gets excluded, the impact it has, and what to do about it.
Tune in to hear
Dr. Anne Drapkin Lyerly, Principal Investigator of the PHASES Project to advance equitable inclusion of pregnant women in HIV research and its follow-on project, PREPARE, focused on ethical HIV research in adolescents who are pregnant.
Elisia Madende, Trial participant in the HPTN 084 trial in Zimbabwe
Dr. Ashley Lima, Health Science Specialist and Lead Technical Advisor for Socio-behavioral Research – USAID Office of HIV/AIDS Research Division
Dr. Takunda Sola, HIV Prevention and Key Populations Medical Officer- Zimbabwe MoH AIDS/TB Unit
This dynamic, workshop-style showcase was the first of a series that featured multimedia presentations that took participants through key PrEP resources including: A toolkit to ensure programs related to sexual and reproductive health (SRH) and HIV prevention are well designed to reach and support adolescent girls and young women. Comprehensive databases for tracking PrEP uptake, Implementation research and other critical data by product, country, and population.
Small groups had opportunities to take deep dives into each of the above resources, and explore how they might use these in their work. Additionally, participants provided input on what resources are still needed, collaborate on how to improve and disseminate what exists, and support the development of evidence and networks to advance HIV prevention.
