The Quest For An HIV Cure — Will It Be Discovered in Africa?
We explored what has been happening in terms of HIV cure research in Africa, and discussed opportunities to support more Africa-focused HIV cure research.
Moderator: Anna Miti, The Choice Agenda
Speakers:
Dr. Thumbi Ndung’u, Africa Health Research Institute
Dr. Gabriela Cromhout, University of KwaZulu-Natal
Adaobi Lisa Olisa, Root to Rise, IAS HIV Vaccine & Cure Advocacy Fellow
Global Health Watch: Global Fund replenishment, LEN for PrEP arrives, HIV funding uncertain post gov’t shutdown
Issue 43
This week’s newsletter publishes just as the Global Fund’s 8th Replenishment Summit in South Africa is taking place. The Global Fund represents one of the strongest symbols of global solidarity in the fight against HIV, TB, and malaria, but, despite early pledges from several European Union member states and private partners, key donors (including the UK, Germany and France) appear to be stepping back, with smaller or uncertain pledges at this critical moment, and it is not yet clear what the US will do. A budget-constrained Global Fund raises serious concerns about losing ground against all three diseases and failing to seize opportunities to scale up new innovations in all three, including long-acting injectable PrEP for HIV. This Global Fund Advocates Network (GFAN) tracker tallies pledges, and this resource for scenario building shows how potential donor pledges could impact the funds available for health programs. Be sure to watch AVAC’s channels for the latest on the pledges.
Read on for more including the arrival of injectable lenacapavir for PrEP in Eswatini and Zambia, the uncertain future of US health funding post-shutdown, and new research exposing the impact of NIH clinical trial cuts.
Lenacapavir Arrives in Eswatini and Zambia
The first doses of injectable lenacapavir for PrEP (LEN) arrived in Eswatini and Zambia. These initial deliveries mark a historic acceleration in PrEP access, moving faster than we’ve seen with past introductions (see AVAC’s new graphic comparing the rollout of LEN to past PrEP products) and signaling momentum and an ability to apply lessons from past delays. With additional regulatory reviews underway across the region, this early action represents a promising step forward.
IMPLICATIONS: While these first shipments are worth celebrating, they’re just a down payment on what’s needed to deliver LEN at scale with equity. The joint Global Fund and PEPFAR commitment to reach two million people in the first three years is far more ambitious than past introductions, but falls short of delivering the impact that is needed. For LEN to have maximum impact, global donors and governments must align on transparent volume commitments, prioritize high-need markets and ensure that rollout strategies are rooted in community-led approaches. While South Africa is slated to receive LEN with Global Fund support, the fact that they are excluded from PEPFAR’s program is a huge, missed opportunity. If we really want to build a sustainable market as quickly as possible, one that will drive volume up and prices down and deliver real impact, South Africa must be THE center of the market and needs PEPFAR and Global Fund both to work with the South Africa government. AVAC’s full LEN resource library, including infographics on supply and demand, is designed to support advocates working to make that vision real.
US Government Reopens, Health Funding Remains Uncertain
The US Congress officially reopened the federal government after the longest shutdown (43 days) in the country’s history. Funding for most agencies is now extended until January 30, and three appropriations bills were passed to cover several departments through all of fiscal year 2026 which ends next September. However, key health initiatives remain vulnerable: the deal keeps major health programs, including the nation’s HIV response, on a short-term continuing resolution only through January, and does not address spiking US health insurance costs.
IMPLICATIONS: HIV prevention, treatment, and care programs will continue at last year’s levels through January 30, which avoid devastating cuts for the time being, with the fight to increase investments ongoing. The broader budget agreement also sidesteps major reforms demanded by lawmakers that threaten to gut these programs. It’s not clear if or when future disruptions might further impact public health programs and US global health engagement.
Clinical Trials Affected by NIH Research Grant Terminations
A new study published in the Journal of the American Medical Association (JAMA) shows that more than 74,000 clinical trial participants were affected when 383 clinical trials lost funding from the National Institutes of Health (NIH) between February 28 and August 15, 2025. These cuts disrupted research across a range of diseases, but most of the targeted trials were outside of the US and were testing preventive or behavioral interventions, primarily in infectious diseases. “Those findings suggest that there’s a bias towards termination of grants that have nothing to do with the quality of research being conducted,” the authors wrote.
IMPLICATIONS: This is one of the first studies to officially document the impact of the Presidential Administrations’ hostile policies and funding cuts to science. The political willingness to gut science without warning erodes trust in public health institutions and undercuts the foundation of long-term innovation. The impact is being seen across geographies, industries, communities, and diseases.
Sexually Transmitted Infections: ‘Self-testing’ versus ‘self-collection’: the critical role of consistent language in the field of STI diagnostics
This editorial from AVAC’s Alison Footman and colleagues makes the case for precise and consistent language around self-testing and self-collection. because clarity impacts policy, expectations, and access.
The PURPOSE trials evaluate the safety and efficacy of injectable lenacapavir (LEN), an investigational antiretroviral (ARV) drug being studied as a potential PrEP product. This graphic shows the latest status of all five trials including the groundbreaking results of PURPOSE 1 and PURPOSE 2.
The HIV Prevention Pipeline
This graphic shows currently available options for HIV prevention, newly approved and recommended treatment, and those in development.
Avac Event
Innovative HIV Prevention and Treatment Keynote and Panel Discussion
An in-depth discussion on lenacapavir, this session will examine its potential to transform HIV prevention on a global scale, looking at the latest clinical evidence, regulatory pathways, and the access barriers that may shape its rollout, especially in low-resource settings. The program will feature a special keynote address followed by a panel discussion with leading experts in HIV prevention and global health, exploring how innovation, policy, and equity intersect in the next frontier of HIV response.
Keynote Session
Moupali Das, MD, MPH, Gilead Sciences
Keynote Moderator: Dr. Charles B. Holmes, Director, Georgetown University Center for Innovation in Global Health; Distinguished Scholar and Program Director·O’Neill Institute for National and Global Health Law at Georgetown University Law Center
Panel Discussion
Moderator: Martha Sichone Cameron, PhD Candidate, Global Infectious Disease, Georgetown University
Micheal Ighodaro, Executive Director, Global Black Gay Men Connect (GBGMC)
Rupa Patel, MD, MPH, Clinical Researcher, Whitman Walker Institute
The first supplies of CAB for programmatic use (as opposed to use in implementation studies) began to arrive in countries in 2024.
Currently, 16 countries are rolling out CAB for programmatic use, with the majority of supply provided by PEPFAR, and some additional quantities procured by the Global Fund.
Stop work orders for PEPFAR programming, issued in January 2025 by the new US administration, led to the cancellation of planned programs to offer CAB before they could start in Namibia and South Africa. Ethiopia’s CAB program was able to move forward with supplies supported by Global Fund.
The future of PEPFAR and Global Fund supported CAB programs remains uncertain in the context of multiple forms of injectable PrEP entering the market. But lessons and insights being gathered now on delivery of injectable PrEP via these programs can be leveraged to help countries prepare for the introduction of LEN.
In addition, Unitaid, the Gates Foundation, and Gilead are supporting LEN implementation research:
Two Unitaid-funded PrEP implementation projects – ImPrEP in Brazil (led by Fiocruz) and Project PrEP in South Africa (led by Wits RHI) – will be adding LEN.
Gates is providing support to the Desmond Tutu Health Foundation for a new LEN implementation study, ALIGN, in South Africa.
Gilead is funding a Phase 4 study, PROPEL, in the United States that will assess real world implementation of LEN and effectiveness outcomes.
The supply for LEN for these projects is being provided by Gilead.
Seventeen countries are hosting sites for the Phase 3 efficacy trials of a monthly PrEP pill, MK-8527, being developed by Merck (also known as MSD outside of the US and Canada). Merck announced the launch of the Phase 3 trials at IAS 2025 in Kigali. MK-8527 was found to be safe and well-tolerated in Phase 2 clinical trials.
A long-acting PrEP pill would offer a unique new option to the existing range of PrEP options and could significantly expand use of HIV prevention, especially among young women, key populations, those facing stigma or access barriers, and those that prefer an oral PrEP option over an injectable.
EXPrESSIVE-10, with funding from the Gates Foundation, is expected to launch in Q4. It will enroll about 4,600 cisgender adolescent girls, young women, and other women who could benefit from PrEP across three countries in Eastern and Southern Africa.
EXPrESSIVE-11 launched in August 2025, and will enroll about 4,400 cisgender men, MSM, transgender men and women, and gender non-binary persons who could benefit from PrEP in 16 countries. So far, EXPrESSIVE-11 has launched at sites in Dominican Republic, Guatemala, Switzerland, and the US.
Merck’s commitment to stakeholder engagement to date contributes an important model of Good Participatory Practice (GPP) to the field, by putting global advocates at the forefront of planning for the program and trial design. Merck has expressed a commitment to sustain this vital engagement throughout the program and next steps.
Join ISSTDR, IUSTI, the STI & HIV 2025 World Congress, and AVAC for a special webinar spotlighting speakers who were not about to join the congress due to financial and political barriers. Presenters will share their findings, debate their results, and discuss the work still ahead for the STI field. Don’t miss this opportunity to engage directly with cutting-edge research and the people driving it forward.
Cabotegravir Implementation
Implementation studies completed, ongoing, or planned for cabotegravir as of October 2025. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.
Dapivirine Vaginal Ring Implementation
Ongoing and planned implementation studies for the dapivirine vaginal ring as of October 2025. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.