Source of Lenacapavir for PrEP Supply to Early Adopter Countries

The Global Fund, with support from CIFF, and PEPFAR have jointly committed to reaching up to two million people with injectable lenacapavir for PrEP over three years. Supply of LEN is due to begin arriving in countries in late 2025 with service delivery planned to start in early 2026.

This graphic appears in PxWire.

Lenacapavir Regulatory Approval

Regulatory approvals, pending decisions, and appeals as of December 2025. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.

Moving a Product to the Real World

The rollout of oral PrEP demonstrates that people don’t take PrEP simply because it’s available—there needs to be a demand for it, and it needs to be accessible, acceptable and used effectively by those who need and want it. These are the lessons the field is applying to the rollout of the dapivirine vaginal ring (DVR), and injectable cabotegravir (CAB) and lenacapavir (LEN) for PrEP. To reach the UNAIDS target of 10 million PrEP users by 2025, initiations of oral PrEP alone will not be enough—and this graphic shows that the field is beginning to apply past lessons to accelerate introduction of injectable PrEP options.

And for the latest on lenacapavir, visit here.

Where We Are Now with LEN for PrEP

The chaos in foreign assistance programs (including discontinuation of major PrEP programs), cuts in staffing and new demands on donor commitments will make decisions on the procurement of LEN for PrEP more complex and uncertain.

In December 2024, the Global Fund and PEPFAR announced a plan to reach 2 million people with LEN for PrEP over three years. Exactly how funding to support this unprecedented introduction program will move forward is far from certain. The other stakeholders, including Global Fund, Gilead, CIFF and the Gates Foundation expressed commitments to the deal and are making progress, but major questions remain.

Global Health Watch: PEPFAR negotiations leave communities behind, Global Fund replenishment falls short, continued chaos at CDC and NIH

Issue 44

UNAIDS World AIDS Day report: Overcoming disruption, transforming the AIDS response

Decisions and actions this week further weaken the global HIV response — from the exclusion of communities in the new PEPFAR US global health strategy negotiations to a Global Fund replenishment that falls short of what’s needed to deliver emerging HIV, TB, and malaria innovations at scale. Major disruptions at the US CDC and NIH – including halted non-human primate research, politicized vaccine messaging, leadership changes that jeopardize HIV research, and “skipping” World AIDS Day — continue the erosion of accountability, trust, and the integrity of the public health system. 

US Global Health Strategy Negotiations Leaving Communities Behind 

African advocacy partners including Eastern Africa National Networks of AIDS and Health Service Organizations (EANNASO) and the Coalition to build Momentum, Power, Activism, Strategy & Solidarity in Africa (COMPASS) have been taking stock of the ongoing country negotiations around the US government’s Memorandums of Understanding (MoUs) as part of its new “America First” global health strategy. They are finding that communities are being systematically excluded from the “government-to-government” negotiations for new 5-year PEPFAR MoUs, a direct reversal of the community engagement that has defined decades of the HIV response. Efforts to ensure program effectiveness, implementer accountability, programs for key populations, and commodity security are all at stake. The new framework would also require partner countries to share pathogens and patient data, potentially with US commercial interests, without privacy safeguards or assured access to resulting products — for decades longer than the life of the actual MOUs. With an MoU signing deadline of December 12, there is a great need to mobilize to demand transparency, inclusion and fair terms for all parties. 

IMPLICATIONS: The exclusion of communities from the new MoU negotiations is an abrupt shift away from the community-centered model that has been at the center of PEPFAR’s success for decades. These closed-door, government-to-government negotiations undermine the hard-won progress on reaching key populations, protecting data privacy, and delivering services that are responsive to the real-life needs of communities. Sidelining communities threatens the effectiveness, and legitimacy of the next phase of the HIV response and without immediate transparency and meaningful engagement, these MoUs risk weakening impact and trust. 

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Global Fund Replenishment Support, But Falls Short of Target 

Last Friday, donors pledged just over $11 billion at the Global Fund’s 8th Replenishment in Johannesburg. This was an important show of support, especially given the challenging political and economic climate, but well short of the $18 billion target needed to fully harness today’s unprecedented scientific advances against HIV, TB and malaria. The US pledged $4.6 billion, a decrease from the previous cycle, even as it reaffirms the 1:2 matching commitment, placing renewed pressure on Congress to fully appropriate funds, and on other donors to step up.  

IMPLICATIONS: As long-acting HIV prevention, new malaria tools and improved TB treatments enter the market, this shortfall threatens the speed, scale and equity of their rollout. And with communities already facing service disruptions, this shortfall could cost millions of lives and squander a historic opportunity to turn innovation into impact. 

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Big Disruptions at US CDC and NIH – and World AIDS Day

In the last week, decisions and actions at the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health’s (NIH) Division of AIDS (DAIDS) further jeopardize the future of HIV research and confidence in vaccines. The CDC abruptly ordered an end to all non-human primate research, including critical macaque studies that have long supported HIV prevention science. The agency also altered language on its website implying a link to vaccines and autism and contradicting established scientific consensus. At the NIH, long-time DAIDS Director, Carl Dieffenbach, was reassigned to the Fogarty International Center, a move that removes a trusted leader who played a central role in guiding HIV research. See AVAC’s resource, HIV Prevention R&D at Risk, which tracks the impact of all this and more. Also, just ahead of December 1, the US administration announced that it will no longer commemorate World AIDS Day. 

IMPLICATIONS: Together, these actions continue the decline in US global health leadership, unraveling decades of scientific progress and trust in vaccines and public health institutions. Halting essential preclinical research in macaques, politicizing vaccine messaging and sidelining experienced leadership weakens the pipeline of innovation and threatens the integrity of HIV science at a moment when sustained investment and credibility are most needed. As for World AIDS Day, Congressman Mark Pocan, who leads the Congressional HIV/AIDS Caucus, said the administration’s refusal was “shameful and dangerous.” But it’s important to remember that World AIDS Day is not decided by the US government; it belongs to everyone – and the new UNAIDS report provides the theme: Overcoming disruption, transforming the AIDS response. Or as the International AIDS Society says: Rethink. Rebuild. Rise

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What We’re Reading

UNAIDS World AIDS Day report: Overcoming disruption, transforming the AIDS response

UNAIDS’ new report shows that we were closer than in decades to ending AIDS by 2030, yet new HIV infections stayed flat in 2024, even before funding cuts, and resources were not enough to drive them down. We must double down with bolder, more strategic action to drive real decline.

Read the Report

Source of Programmatic Cabotegravir for PrEP Supply

The first supplies of injectable cabotegravir 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.

This graphic appears in PxWire.

Global Health Watch Timeline

43 Weeks of Crisis, Context & Resources to Respond

During these challenging times, Global Health Watch has been the go-to source for tracking and analyzing attacks on global health and the HIV response, pandemic preparedness, and human rights: from the US government’s foreign aid freeze and subsequent funding collapses to the politicization of science and erosion of public health infrastructure.

This timeline tracks selected milestone events in 2025, both massive disruptions in global health along with advocacy responses and wins in the midst of madness.

HIV Prevention R&D at Risk

Tracking the Impact of US Funding Cuts

The US presidential administration is actively working to dismantle HIV research and demolish the architecture of global health. The entire HIV response — from basic research and clinical development to policy, programs, and global access to life-saving treatment and prevention — is now under attack, and the world runs the risk of reversing the strides made to end HIV.

AVAC has put together this report, highlighting the impact of US cuts on the pipeline of HIV prevention research and development. AVAC will continue to track these cuts and their impact, to amplify the damage they will cause, and to fight for their reversal.

Avac Event

The Quest For An HIV Cure — Will It Be Discovered in Africa?

We will explore what has been happening in terms of HIV cure research in Africa, and discuss 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. 

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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. 

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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. 

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What We’re Reading

Resources