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 began arriving in countries in late 2025 with service delivery starting in early 2026.

The Future of the HIV Response: Sustaining Progress in an era of Political Uncertainty and Scientific Opportunity

Significant progress has been made in expanding access to HIV treatment and prevention, but major gaps in coverage and equity were further exacerbated and destabilized by changes in US government support in January 2025. This commentary by AVAC’s Executive Director Mitchell Warren examines the implications of this divergence and argues that the future of the HIV response depends less on new biomedical discoveries than on the capacity to deliver existing and emerging options sustainably and with speed, scale and equity.

Read the article.

HIV Vaccine Clinical Trials Pipeline

This graphic summarizes the state of HIV vaccine research, detailing the different immunological approaches in clinical trials, the specific candidates being studied, and the collaborative networks of funders and developers working toward an effective vaccine.

Global Health Watch: Latest on White House OMB Federal Rx Grant Proposal, Global Fund Gains Stability, New Model for GH Partnerships

Issue 76

As the comment period to oppose the White House Office of Management and Budget’s (OMB) proposal to give political appointees greater authority over federal research grants closes next Monday, the Global Fund avoided new ideological restrictions on US funding even as it prepares for a new Executive Director. And new articles and analyses of US bilateral health agreements under the “America First Global Health Strategy” suggest the Administration’s vision for global health is shifting from supporting epidemic control to managing country transitions.

The Latest on the White House OMB’s Proposal Politicizing Federal Grants

The last day to submit comments opposing the OMB’s proposal to give political appointees greater authority over federal research grant decisions is Monday, July 13. The proposal has drawn major and widespread opposition from scientists, advocates, universities, associations, former government officials, the biotechnology industry and members of Congress, all calling out the weakening of a long-standing scientific peer-review process and injection of political considerations into federal funding. The proposal has already drawn more than 93,000 public comments and submissions opposing the rule. See AVAC’s submission. The US Administration aims to finalize the rule by October 1.

IMPLICATIONS: These rules, if adopted, would mandate that federally-funded science align with a politically motivated “America First” agenda aimed at dismantling decades of transformative global collaboration. These rules have the potential to dramatically reshape how federal dollars are spent and who decides, replacing evidence-based decision-making with political priorities. Notably, the published proposed rule specifically and falsely references PEPFAR as justification for increased political scrutiny of federal grants, linking HIV and global health programs to a broader debate over federal spending, oversight and executive authority. For the HIV field, these changes could affect the entire research-to-rollout continuum and global partnerships, at a time when scientific collaboration is necessary to achieving 2030 HIV targets and advancing global health equity.

TAKE ACTION: The proposed rule is still open for public comment through July 13. Click here to comment or see  AVAC’s Action Alert for more instructions. Submitted comments could slow implementation of any changes to the process because the OMB must reply to them all. The outpouring of comments could also persuade Congress, which has repeatedly rejected the Administration’s previous proposals to gut research funding, to use its power to stop these changes. Comments also put into the public record that are not adequately addressed, could be raised again in lawsuits to stop the changes.

READ:

Global Fund Gains Stability Amid Leadership Transition

The US government will continue funding the Global Fund without imposing its expanded global gag rule or other ideological funding conditions to US contributions. This will allow US funding to continue without restrictions related to abortion, diversity, equity and inclusion policies. At its Board meeting this week, the Global Fund also confirmed that its search for a new Executive Director will proceed as planned despite reports that the confidential nomination process might be restarted following media leaks. The Board is expected to appoint its next Executive Director in October.

IMPLICATIONS: While the decision not to impose the expanded global gag rule removes one immediate challenge, the Fund still faces significant financial uncertainty. Its next Executive Director will inherit an organization facing the major challenges of constrained resources, evolving donor expectations and increasing pressure to sustain impact in a changing global health landscape.  

READ: 

The New Model for US Global Health Partnerships 

PEPFAR and US bilateral health agreements continue to evolve. This week, Think Global Health expanded its tracker of the US Administration’s bilateral health agreements, showing that 31 countries have now signed five-year agreements that increasingly shift financing and implementation responsibilities to national governments through co-investment and country ownership models. Andrew Green focuses on one country, South Sudan, in a Devex piece that looks at the country’s new three-year, $166 million MoU with the US, noting that while it preserves support for HIV and disease surveillance, funding may be insufficient to offset recent aid reductions and the country may struggle to meet its own financial commitments. 

In a separate analysis, Jirair Ratevosian broke down what five reports from the US Department of State to Congress reveal about the Administration’s vision for global health. He writes, “Read together, these excerpts are overwhelmingly about the mechanics of transition: MOUs, implementation plans, co-investment, funding adjustments, corrective actions, benchmarks, workforce transfer, and reductions in US assistance. There is much less discussion of incidence, viral suppression, advanced disease management, prevention gaps, community systems, or epidemic control… It suggests they are no longer the organizing principle.”  

IMPLICATIONS: These pieces reflect a move toward implementation of the new global health agreements. As implementation continues, we’ll be watching whether the financing assumptions, implementation systems and country commitments that are the foundation of these agreements are sufficient enough to sustain HIV and broader health gains. As Ratevosian notes, “Every Administration has its own priorities. But organizing principles matter because they determine what leaders measure, what they reward, and ultimately what they protect. When transition becomes the primary frame, there is a risk that epidemic control becomes something assumed rather than something actively managed.” 

In a separate analysis, Jirair Ratevosian broke down what five reports from the US Department of State to Congress reveal about the Administration’s vision for global health. He writes, “Read together, these excerpts are overwhelmingly about the mechanics of transition: MOUs, implementation plans, co-investment, funding adjustments, corrective actions, benchmarks, workforce transfer, and reductions in US assistance. There is much less discussion of incidence, viral suppression, advanced disease management, prevention gaps, community systems, or epidemic control… It suggests they are no longer the organizing principle.”

READ: 

What We’re Reading

Presenting at AIDS2026?

Access AVAC’s latest infographics on the research and development pipeline, prevention options, and the impact of US funding cuts.

Access the Graphics

Best of AVAC’s Advocacy Guides

The AIDS 2026 conference is fast approaching. To help advocates stay informed and engaged, AVAC has curated a collection of its Advocates’ Guides covering the science, policy, implementation and advocacy conversations shaping the future of the HIV/AIDS response. Developed with partners across the field, these guides help translate complex science and policy to help inform advocacy before, during and after the conference.

For those presenting at AIDS 2026, please check out AVAC’s slide deck containing the latest infographics on the research & development pipelines, the delivery of new prevention options and the impact of US funding cuts on foreign assistance and on research and science. We will be continuously updating it, so be sure to check back for updates as the conference approaches.

The introduction of injectable lenacapavir for HIV PrEP (LEN) is underway–in some places at least. To ensure communities remain at the center of LEN rollout, this new Advocates’ Checklist for Lenacapavir for PrEP Introduction is an immediate, actionable blueprint. And read more in this blog by the co-chairs of the Civil Society Caucus of the Coalition to Accelerate Access to Long-Acting PrEP and AVAC staff.

Access the Checklist
Access the Guide

Planning For MK-8527

Expanding prevention choice means investing in a diverse pipeline of HIV prevention options. MK-8527 is an investigational antiretroviral (ARV) once-monthly oral PrEP pill that is currently in Phase III clinical trials. If proven safe and effective, it could offer another important PrEP option. This resource provides advocates with an overview of the MK-8527, the science behind it and the latest on its clinical development.  

Learn More

Podcast: The Future of PrEP

AVAC’s Executive Director Mitchell Warren joined ITPC’s Make Medicines Affordable podcast to discuss the future of PrEP. While Lenacapavir is a transformative option for HIV prevention, Warren shares what it will take to ensure it reaches the people who need it most.

Listen Now

Download the Latest Infographics from AVAC

Presenting at AIDS 2026?

These graphics are updated regularly, so be sure to check back.  

Access the Graphics

Additional Resources

  • People’s Research Agenda: This people-centered framework guides equitable and accelerated HIV prevention research, development and product introduction. It tracks scientific progress, assesses whether investments align with community-defined priorities, and identifies critical gaps in the prevention pipeline needed to meet the diverse needs and preferences of all populations 
  • HIV Prevention Product Overview: The graphic provides an overview of PrEP products currently available and in late-stage clinical trials. 
  • Lenacapavir Resource Hub: Your one-stop resource for all things lenacapavir, this page brings together the latest news, advocacy resources, scientific updates, implementation tools and infographics to help advocates stay informed and ensure LEN rolls out with speed, scale and equity. 

P.S. On Tuesday, July 14 AVAC and partners will share the impact stories of ten years of the Coalition to Accelerate and Support Prevention Research (CASPR). We hope you’ll join us. 

HIV Prevention Product Overview

The graphic provides an overview of PrEP products currently available and in late-stage clinical trials.

What Does It Take to Conduct HIV Cure Research?

Progress towards an HIV cure depends on strengthening four critical systems: lab equipment, sustainable funding, policy & programs, and training.

Long-Acting HIV Treatment Pipeline

AVAC has begun to track the research pipeline for long-acting HIV treatment (LA-ART). A rapidly expanding pipeline for LA-ART has the potential to introduce new regimens with dosing frequencies that range from weeks to months to, eventually, years. The benefits of LA-ART include reduced drug dosing, frequency, and number of drugs, with the potential for associated decreases in the cost of medications and the burden on health systems. New drug classes could close treatment gaps in children, adolescents, and those with high viremia, comorbidities and resistance. Ongoing clinical research will hopefully further demonstrate whether there are trade-offs (treatment failures or resistance) between LA-ART and highly effective daily oral ART. In addition to the new long-acting products, simplified single-tablet daily regimens are also in development.

From Anticipation to Action: The Civil Society Advocates’ Checklist for Lenacapavir for PrEP 

By Co-Chairs of the Civil Society Caucus of the Coalition to Accelerate Access to Long-Acting PrEP Chilufya Kasanda, Kenneth Mwehonge, Numan Afifi and AVAC staff supporting the Caucus Navita Jain & Bridget Jjuuko

The landscape of HIV prevention is shifting beneath our feet. We have officially moved from the anticipation of long-acting options to the gritty, urgent work of early implementation, and translating biomedical options into actual choices for people.

The most recent new option is injectable lenacapavir (LEN) for PrEP – a six-monthly subcutaneous injection that offers near perfect protection from HIV. With LEN implementation ongoing in nine African countries as part of Global Fund and PEPFAR support to 24 “Early Adopter” countries, the question is no longer if LEN will arrive, but how fast we can get it to the communities who need it most and build a sustainable, scalable market.

To ensure community leadership sits at the center of this rollout, the Advocates’ Checklist for Lenacapavir for PrEP Introduction was designed as an immediate, actionable blueprint to help civil society organizations (CSOs) and global health advocates pressure-test government commitments, map implementation bottlenecks and demand equitable access. Whether your country is currently on the early adopter list or you are fiercely campaigning for its inclusion, this checklist outlines the essential questions we all need to be asking our Ministries of Health, technical partners and funders.

Why This Checklist? Why Now?

While the field eagerly prepares for the entry of generic LEN supplies into the market in 2027, we cannot afford to simply wait for that eventuality. The demand and need for LEN is immediate – and the sooner we create demand, the sooner generics will make larger volumes at lower prices. Advancing LEN rollout now, as quickly and as large as possible, translates directly into preventable HIV infections and signals strong demand to generic manufacturers as they prepare to enter the market and to donors as they plan for larger-scale procurement. Advocates need to push for speedy and equitable access to LEN right now, while simultaneously preparing national systems for a multi-producer generic market tomorrow.

The checklist breaks down advocacy targets into five critical pillars:

  • Regulatory & Policy Alignment: Moving LEN from regulatory approval to formal integration into National HIV Prevention Guidelines alongside oral PrEP, long-acting injectable cabotegravir (CAB-LA) and the Dapivirine Vaginal Ring (DVR).
  • Financing & Procurement: Holding funders accountable to the “3 Million in 3 Years” target for providing access to LEN for prevention, and treating that commitment as a floor, not a ceiling. Ensuring robust demand forecasts are developed and financing plans reflect both procurement and program needs.
  • Supply Chain & Site Readiness: Using technical tools to track whether orders sitting at the Global Fund are actually reaching central warehouses and frontline clinics.
  • Demand Generation & Community Leadership: Fighting back against the “slow rollout” narrative and embedding LEN into comprehensive, integrated choice campaigns rather than letting it be siloed.
  • Accountability & Monitoring: Securing dedicated civil society seats on National Technical Working Groups and deploying Community-Led Monitoring (CLM) to track stock-outs and document real-world access barriers.

Working together, partners from Ascend Futures Foundation, APCOM, HEPS Uganda and AVAC, representing members of the Civil Society Caucus of the Coalition to Accelerate Access to Long-Acting PrEP, lent their expertise and localized insights to create this tool for the global community. It is the newest in a suite of resources available on PrEPWatch to support LEN rollout, including the LEN Resource Toolkit and the Long-Acting PrEP Status Dashboard.

With this tool in hand, now is the time to turn high-level commitments into real choices at the clinic level. For questions or comments about the checklist, contact us at [email protected].

Get Involved: Download and Share the Checklist: Access the full PDF tool to start auditing your country’s readiness. 

Track Progress Live: Keep an eye on global efforts and view continuously updated, country-specific progress trackers on PrEPWatch.

“Lenacapavir has the potential to transform HIV prevention, but its true impact will depend on whether it expands choice rather than replaces it. No single prevention method will work for everyone. Ending new HIV infections requires a prevention ecosystem where every individual can choose the option that best fits their needs, preferences and circumstances.”

Chilufya Hampongo
Executive Director of Ascend Futures Foundation and co-chair of the CS Caucus

“Asia and the Pacific account for nearly one in six people living with HIV globally. For us, global access is about ensuring that new prevention tools do not remain available only in a handful of countries but can reach the millions of people across our region who could benefit from them. That’s how scientific innovation translates into public health impact.”

Numan Afifi
Senior Policy and Research Officer at APCOM and co-chair of the CS Caucus

“Lenacapavir has the potential to transform HIV prevention in high-burden countries. For governments, it is more than a new product—it is an opportunity to prevent infections more effectively, expand choice, reach underserved populations, and reduce the long-term social and economic costs of HIV. If introduced equitably and at scale, LEN could become one of the most important tools in accelerating progress towards ending AIDS as a public health threat.”

Kenneth Mwehonge
Executive Director of HEPS Uganda and co-chair of the CS Caucus

Global Health Watch: New Political Declaration on HIV/AIDS, End of US PEPFAR Support for South Africa + Treatment Declines

Issue 74

UN member states adopted a new Political Declaration on HIV/AIDS reaffirming global commitments to end AIDS by 2030, but for the first time since 2001, the declaration was not adopted by consensus – and with the US notably voting against it. At the same time, last week’s news that the US Department of State is assuming greater control over PEPFAR is followed this week by the phase-out of US PEPFAR support for South Africa and new analyses showing PEPFAR-supported HIV treatment declined in 2025, following the US Administration’s foreign aid freeze. Also, for organizations in the US, please consider signing Partners in Health’s Letter to Protect CDC PEPFAR Programs.

UN HIV Declaration Adopted Amid Deep Political Divisions

The UN General Assembly adopted a new Political Declaration on HIV/AIDS this week reaffirming global commitments to end AIDS as a public health threat by 2030. However, for the first time since political declarations on HIV began in 2001, the declaration was not adopted by consensus. And importantly, the US delegation voted against the declaration. Deputy US Representative to the UN, Tammy Bruce, said in a comment rejecting the declaration that it strayed too far from the targets for ending AIDS “by including divisive topics”. The declaration acknowledges that progress toward the 2030 goal is off track, highlighting widening funding gaps, disruptions to HIV services, and persistent barriers faced by populations at high risk of HIV. Advocates and civil society played an important role in ensuring the declaration included commitments to evidence-based, rights-based HIV responses and renewed calls for sustained investment in prevention, treatment and community-led services.

IMPLICATIONS: The divided vote underscores how geopolitical tensions and domestic politics in the US are shaping global health policy at a moment when the HIV response faces its greatest financing crisis. While the declaration provides an important political framework for countries and advocates, it carries no binding obligations and offers few concrete answers to address the growing funding shortfall as nationalism rises and development assistance falls. The US government’s opposition marks an insular, ideologically driven retreat from longstanding consensus for rights-based HIV programming, particularly for key populations who continue to bear a disproportionate burden of HIV. This is consistent with the harmful policies and positions the US Administration has taken against communities vulnerable to HIV including the Promoting Human Flourishing in Foreign Assistance (PHFFA) and the invisibility of vulnerable populations in the most recent PEPFAR data.

In response, global civil society groups led by Health GAP have elevated the People’s Declaration on HIV/AIDS as a counter to the resulting Political Declaration. Over 400 organizations signed onto the People’s Declaration, illustrating a major show of power and call for action by governments to reaffirm commitments, rights, and investments to end HIV for everyone, everywhere.

READ:

US Ending PEPFAR in South Africa

The US Administration abruptly announced its intention to end PEPFAR support in South Africa, with funding expected to terminate by early 2027. The decision is part of the Administration’s broader retrenchment from foreign assistance and is related to political disagreements with the South African government. South Africa receives more than $400 million annually through PEPFAR, which supports health workers, prevention programs and service delivery. This decision marks one of the most consequential changes to PEPFAR since its creation in 2003, with significant implications in envisioning an end to the HIV epidemic – in South Africa and globally. This news follows the Administration’s Executive Order in February 2025, which made baseless claims about South Africa, and the March 2025 decision to “hold all research awards” for South Africa after designating it a “country of concern”. At the time, AVAC told Bhekisisa, “It is very clear that the President is using budgets and terminations of previously agreed to programmes to redefine agendas… that defy science and are clearly political and ideological.”

IMPLICATIONS: The PEPFAR withdrawal from South Africa reinforces the shift away from evidence to ideology, moving from long-term global health partnerships toward a more transactional foreign policy model. These short-sighted decisions come despite the historical South Africa-USA partnership that has catalyzed scientific research and program impact for HIV prevention and treatment, where the country plays a vital role in clinical research, development of cutting-edge prevention technologies, and implementing models for treatment, care and prevention. Although South Africa finances its own antiretroviral medicines, PEPFAR supports important aspects of the health workforce, community-based prevention and services for key populations. A rapid withdrawal will disrupt testing, prevention and services, placing additional strain on the country battling the largest HIV epidemic. Furthermore, the end to PEPFAR funding along with the severance of National Institutes of Health (NIH) research partnerships, cuts off a country that is central to ending the global epidemic and one that continues to inform the science of HIV and tuberculosis treatment and prevention.

READ:

New Analysis Shows Decline in PEPFAR-Supported HIV Treatment

A new analysis published in Nature Health finds that PEPFAR-supported HIV treatment declined in 2025 following the US Administration’s foreign aid freeze, with approximately 2 million fewer people reported as receiving PEPFAR-supported antiretroviral therapy than in 2024 (a 10% decrease). Of the 26 countries examined, treatment support fell across all, though some of the decline reflects changes in how PEPFAR classifies and reports treatment support rather than patients losing access to care. South Africa was called out in the analyses, accounting for most of the treatment declines—individuals previously counted as receiving direct PEPFAR support were reclassified as benefiting from broader health system investments, resulting in a net treatment decline of about 95,000 people (1.8%). The authors conclude a “decline of ∼1.73 million individuals on direct PEPFAR-supported treatment and an increase of ∼1.64 million individuals on treatment benefitting solely from the programme’s broader support to health systems, yielding a net treatment loss of 94,881 (−1.8%)”.

IMPLICATIONS: As the authors conclude, “while the analysis cannot determine whether and to what extent declines will translate into reduced individual- or population-level treatment outcomes, a reduction in PEPFAR-supported treatment of this scale within a single fiscal year raises concerns.” The data underscore the significant disruptions caused by funding uncertainty and restructuring across the program.

READ:

Add Your Voice to Stop OMB’s Attack on American Science

Proposed new regulations by the White House Office of Management and Budget (OMB) would use budgetary and regulatory tools to bypass longstanding scientific peer-review and congressional processes, including withholding appropriated funds, restructuring federal agencies, and proposing rules that would give political appointees greater influence over research funding decisions. Public comments are due by July 13th – please consider taking action and visit Stand Up for Science’s STOP OMB portal now.


What We’re Reading