HIV Prevention Product Overview

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

Global Health Watch: A generic price for LEN, Future of UNAIDS, UNGA 80, AI for Health, Issue 35

The stakes are high as the US approaches the start of a new fiscal year (FY26) on October 1, currently mired in stalled White House negotiations and a looming government shutdown; the Supreme Court’s pending decision on AVAC’s lawsuit; and the new US “America First” strategy to reshape foreign aid. This issue highlights major global health developments at the UN General Assembly, from debate over the future of UNAIDS to commitments from the Gates Foundation and Unitaid to accelerate access to injectable lenacapavir for PrEP (LEN), alongside new discussions on AI ethics and health. 

Gates Foundation and Unitaid Commit to Accelerate Market Development for Lenacapavir for PrEP 

The Gates Foundation and Unitaid announced new strategic investments to accelerate the development of, access to and price reduction for generic versions of injectable lenacapavir (LEN), the highly effective six-monthly injection for HIV PrEP. As AVAC’s Mitchell Warren said in its statement, “this could be a transformational moment in HIV prevention if political will, coordination, and further procurement investment meet this moment to deliver LEN with speed, scale and equity to all communities and populations who need and want prevention options.”  

IMPLICATIONS: While this progress is encouraging, it is only meaningful if momentum leads to real access. These agreements get LEN closer to the $40 per person per year price of daily oral PrEP for many, but not all, low and middle-income countries, and hopefully will accelerate large scale programs by 2027. AVAC’s publication, Now What with Injectable LEN for PrEP How to Translate Ambition into Accelerated Delivery and Impact, includes forecasts demonstrating that instead of 2 million people in three years that is currently being planned by the Global Fund and PEPFAR with initial supplies from Gilead, the world could reach at least 1.5 million people in just one year, rising to at least five million people per year by 2030. These numbers suggest what is possible and what is necessary to accelerate access, achieve real impact, build a sustainable market, and drive prices down even further.  

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UN General Assembly Updates

The UN General Assembly (UNGA 80) kicked off this week in New York with global health taking center stage. The US began the rollout of its new “America First Global Health Strategy,” which shifts toward bilateral aid models. Meanwhile, HIV innovation and access, especially for lenacapavir, are being debated in side events as delegates push for clarity on price, procurement, and equity. The WHO is accelerating its health agenda on noncommunicable diseases (NCDs) and mental health and will help lead discussions on a new global declaration.  

In its annual Goalkeepers event, the Gates Foundation announced its $912 million commitment in the current round of replenishment to the Global Fund for AIDS, TB and Malaria. The Foundation also recognized ten champions in global health, including AVAC’s partner Jerop Limo, a leading HIV and sexual and reproductive rights activist from Kenya. 

Next week, a new topic will take center stage at the UNGA’s high-level meetings: inclusive and accountable governance of artificial intelligence (AI). Ethics and equity will be central to deploying responsible AI for health, with advocates emphasizing that progress must be measured not only by rollout speed but by how well it protects patient privacy and addresses real-life challenges and needs. Development of AI governance to shape how digital tools are designed, regulated, and financed is a key part of the next generation of HIV and health programming. 

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United Nations Secretary-General Proposes to “Sunset” UNAIDS 

The UN Secretary-General shared a proposal in his new UN80 progress report to “sunset” UNAIDS by the end of 2026 and fold its mandate into broader UN structures in the face of funding cuts. The NGO delegation to the UNAIDS Programme Coordinating Board (PCB) strongly opposes this move, and was joined by nearly 800 civil society organizations warning that dismantling UNAIDS now would undermine leadership, coordination and accountability at a time of escalating funding cuts, growing inequalities, and service disruptions. UNAIDS was originally created to bring coherence across 11 UN agencies, avoid duplication, and ensure that communities most affected by HIV had a formal voice at the table. The plan endorsed by the UNAIDS PCB would downsize the Secretariat, embed staff in select UN Resident Coordinator offices and relocate programmatic expertise to regional hubs to align with the UN80 “Shifting Paradigms” vision of a more integrated, coherent UN system. As UNAIDS reminded all stakeholders in its statement, it is member states and governing bodies who should determine the way forward on how UN80 reforms are implemented.  

IMPLICATIONS: Achieving the UNAIDS goal of ending AIDS by 2030 depends on many factors, including clear accountability; knowing which UN agencies retain their strengths; ensuring they have the resources to deliver; and safeguarding coordination. Sustaining trusted partnerships with civil society and continuing to prioritize equitable rights-based programs, which have been central to UNAIDS’s role for two decades, will also be essential, and all of this risks being undermined if UNAIDS’ functions are dispersed without a coherent strategy. This debate marks a critical inflection point for how the global community organizes and funds the HIV response going forward. 

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Africa CDC Announces Grant to Support Local Drug and Vaccine Manufacturers 

The Africa CDC plans to invest approximately $3.2 billion dollars to support the development of local drug and vaccine manufacturing across the continent. The initiative includes funding and grant support for African manufacturers. This grant aims to reduce dependence on imported pharmaceuticals by strengthening domestic production and establishing a pooled procurement mechanism to guarantee market demand. 

IMPLICATIONS: This move could be a turning point for health sovereignty in Africa, offering the promise of more reliable supply chains, lower costs, and greater independence from external donor trends. But it also presents real challenges: scaling production to meet global standards, navigating regulatory harmonization, and maintaining quality assurance and sustainability will be essential. If successful, it could shift power in global health — giving African countries more leverage in pricing and access negotiations for prevention tools such as ARVs and vaccines, while reducing vulnerability during global supply disruptions. 

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What We’re Reading

Press Release

AVAC Applauds Agreements to Accelerate Market Development for Lenacapavir for PrEP

New York, NY, September 24, 2025 — AVAC welcomes parallel announcements from the Gates Foundation and Unitaid on strategic investments to accelerate the development of, access to and price reduction for generic versions of injectable lenacapavir (LEN), the highly effective six-monthly injection for HIV PrEP.   

“These investments are a vitally important step in translating the remarkable science of LEN into public health impact,” said Mitchell Warren, executive director of AVAC. “With these agreements, injectable LEN for PrEP gets closer to the price of daily oral PrEP, $40 per person per year, for low and middle-income national governments. This means national programs in many, but not all, countries can begin planning for 2027, at which time ongoing oral PrEP and LEN use will be available at similar prices, meaning many countries will be truly able to offer people who need prevention choice  when it comes to the PrEP method that best meets their needs. This could be a transformational moment in HIV prevention if political will, coordination, and further procurement investment meet this moment to deliver LEN with speed, scale and equity to all communities and populations who need and want prevention options. Many questions remain, but in this current environment, we need to seize opportunities and good news when we can.”   

These new commitments to accelerate access to generic versions of LEN come on the heels of the Global Fund and PEPFAR re-committing to their December 2024 announcement of reaching two million people with LEN for PrEP within three years, with drug supplies coming from the originator company, Gilead Sciences. Among the outstanding questions from these new commitments is the price of the required oral loading dose for LEN, which is needed to achieve high efficacy. While the cost of ongoing use of LEN for PrEP would be similar to the cost of a year of daily oral PrEP, anyone initiating or restarting LEN for PrEP needs an oral loading dose of LEN. This oral loading dose is not included in the $40 price mentioned in the Gates and Unitaid deals and will add between $15-$17 in the first year of anyone initiating or re-starting LEN, and supply chains and purchasers need to include this extra cost in their calculations.

“The ‘two million in three years’ ambition from Global Fund and PEPFAR must be seen as a floor and not a ceiling,” said Warren. “The global PrEP data that AVAC tracks show a more ambitious goal, getting LEN to at least 1.5 million next year alone, is achievable and necessary. Ultimately, LEN must reach more than five million people per year to have real impact, build a sustainable market, and drive prices down even further. This means we must act faster and think bigger.” 

AVAC calls on all stakeholders to do their part. Next steps require coordinated action and further investment to ensure the creation of a viable and sustained market. 

“This is the moment to ensure that LEN for PrEP lives up to its full potential, and to hold each other accountable for what must happen next,” said Wawira Nyagah, AVAC’s director of product introduction & access.  “Demand creation and program design for LEN must be fully resourced, evidence-based and community-centered. Volume commitments, manufacturing, and supply chains must be sustained and stable. But to make a difference at a global level, the HIV response must go beyond these essential, but minimum, steps with a bold vision to accelerate the entry of generics and trigger a virtuous cycle of price drops, which further drive-up PrEP use.”  

LEN, developed by Gilead Sciences, is a twice-yearly injectable PrEP option that showed nearly complete protection against HIV in the landmark PURPOSE 1 and 2 trials. Science Magazine named LEN the “Breakthrough of the Year” in 2024, a recognition that reflects its enormous potential. But fulfilling this potential is far from certain, and all stakeholders have critical work to do, as detailed in AVAC’s 2024 publication, Gears of Lenacapavir for PrEP Rollout. 

AVAC’s publication, Now What with Injectable LEN for PrEP How to Translate Ambition into Accelerated Delivery and Impact, includes forecasts demonstrating that instead of 2 million people in three years, the world could reach at least 1.5 million people in just one year. Gilead has confirmed that they can manufacture enough injectable LEN to reach in excess of 5 million LEN users over the next three years. These numbers suggest what is possible and this is no time to think small. 

“To achieve true impact against HIV requires early commitments from additional donors to procure large volumes of LEN, which will enable a bigger rollout, exceeding targets, and reaching more people who need PrEP in more places, which in turn secures the kind of market scale that accelerates further prices reductions,” said Nyagah. “It requires country regulators, ministries of health, implementers, advocates and communities where HIV prevention is needed to prepare with policies and programs that will succeed in connecting people with products that work in the context of their lives. The field has learned these lessons before. Technology alone gets you nowhere; it’s delivering the product with speed, scale and equity that gets the job done.” 

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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 Bluesky and Instagram. Find more at www.avac.org and www.prepwatch.org. 

Avac Event

South African AIDS Conference (SAAIDS)

The 12th SAAIDS Conference 2025, under the theme: Unite for Change – Empower Communities and Redefine Priorities for HIV/AIDS will be held in Johannesburg 8-11 September.

Resources

If you’re attending, don’t miss a keynote plenary where AVAC’s Mitchell Warren will share perspectives on the future of HIV prevention, and an important satellite on Wednesday, Bridging the Gap and Identifying Opportunities: Innovative Strategies to Accelerate HIV Prevention, Treatment, and Care for Key and Vulnerable Populations in South Africa.  

Press Release

AVAC Condemns US Administration’s ‘Pocket Rescission’ Request to Withhold Billions in Foreign Aid 

AVAC calls on Congress to reassert its constitutional power

Contact: [email protected]

New York, NY, September 2, 2025 – AVAC condemns the US Administration’s intent to withhold billions of dollars in federal foreign assistance through the proposed ‘pocket rescission’ request sent to Congress last Friday. AVAC calls on Congress to reassert its constitutional power in appropriating federal spending and counteracting this executive overreach by the Administration. The Administration is seeking to cancel any Congressionally-appropriated funding at its discretion, with zero oversight or accountability from a co-equal branch of government. 

“This is a true constitutional crisis, advancing the Administration’s assault on Congress’ ‘power of the purse’ and putting millions of lives at risk,” said Mitchell Warren, executive director of AVAC, lead plaintiff in AVAC v. State Department. “We have already seen the devastating consequences of the foreign aid freeze: interrupted treatment, shuttered clinics, prevention efforts stalled, and lives lost. Now, by attempting to usurp Congress of its constitutional role and granting the President unilateral authority to decide which appropriations to honor and which to ignore, the Administration is setting a dangerous precedent—one that, if unless prevented, will reverberate globally, jeopardize lives, and undermine the very foundations of US governance.” 

The Administration continues to attempt to use questionable budgetary maneuvers to “run out the clock” on the fiscal year and avoid disbursing nearly $4.2 billion of Congressionally-appropriated foreign assistance. These maneuvers are illegal, and represent another step in the Administration’s reckless efforts to pull back billions in unspent foreign assistance funds which were already approved by Congress.   

“This crisis has been building since January 20, when the Administration froze foreign assistance funding and forced AVAC and partners to turn to the courts,” said Warren. This past week marked one of the worst yet. On August 28, the D.C. Circuit Court of Appeals denied AVAC’s petition to rehear its case en banc and vacated the District Court’s preliminary injunction that had required the Administration to release billions in Congressionally-appropriated foreign assistance funds. That decision came only two days after the Administration filed an emergency petition to the Supreme Court of the United States seeking permission to continue withholding the funds. While last week’s ruling was a setback, the Court did significantly modify a prior opinion from August 13, paving the way for AVAC, the Global Health Council (GHC), and co-plaintiffs to return to the District Court to pursue relief. Lawyers representing AVAC and GHC have already filed motions for a renewed preliminary injunction. 

“AVAC and GHC have gone back to the District Court to seek a new injunction. And our fight doesn’t stop there,” Warren said. “We will continue to press our case in courtrooms, in Congress, and alongside communities to defend global health and the rule of law. The courts must act swiftly to send a strong message against this executive overreach, and Congress must defend democracy by reasserting its constitutional role as the arbiter of how funds are appropriated and spent.” 

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About AVAC: Founded in 1995, 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 Bluesky and Instagram. Find more at www.avac.org and www.prepwatch.org.

Press Release

AVAC Responds to Government’s Emergency Appeal to SCOTUS

In response to the US government’s August 26 emergency application to the US Supreme Court seeking to stay the preliminary injunction in the AVAC v Department of State legal case against the foreign aid freeze, AVAC’s Executive Director, Mitchell Warren wrote:

“It is no surprise that the administration has taken our case directly to the Supreme Court, especially after the District Court’s very clear and firm denial of their request yesterday to suspend the requirement to obligate Congressionally appropriated funding for foreign assistance. Time and again, this administration has shown their disdain for foreign assistance and a disregard for people’s lives in the United States and around the world. But even more broadly and dangerously, this administration’s actions further erode Congress’s role and responsibility as an equal branch of government. The question being put to SCOTUS is whether they will be complicit in further eroding the constitutional commitment to checks and balance.”

EXPrESSIVE Phase 3 Trials

Seventeen countries are hosting sites for Merck’s trials of a monthly pill for PrEP. Launch is expected in Q3 2025. This graphic shows where these trials are taking place.

This file is also available to download as a PowerPoint file.

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.

Download this as a PowerPoint file. And for the latest on lenacapavir, visit here.

HIV Research on Pause

Impacts of US government cuts on HIV R&D

This presentation, delivered by AVAC’s Executive Director, Mitchell Warren at IAS 2025, shares a sobering picture of the sweeping changes to science, global health and particularly, HIV R&D since January 20, 2025. It outlines the impact of foreign aid cuts, NIH grant terminations, and policy shifts and shares a vision for the future.

Years Ahead in HIV Prevention Research: Time to Market

This timeline shows the potential time points when the next-generation of HIV prevention options might find their way into new programs.

This file is also available to download as a PowerPoint file.