Press Release

AVAC, Access Bridge Call for Accelerated Ambition to Reach at Least Three Million People with Lenacapavir for HIV Prevention by the End of 2027 

New, more ambitious target will accelerate impact, drive affordability, and build momentum toward ending the HIV epidemic

NEW YORK and NAIROBI, October 21, 2026 – AVAC and Access Bridge today issued a global call to action urging governments, donors, manufacturers, implementers, and advocates to work toward a bold but achievable goal: reaching at least three million people with injectable lenacapavir (LEN) for HIV prevention by the end of 2027. 

“Scientific breakthroughs only matter if they reach the people who need them,” said Mitchell Warren, Executive Director of AVAC. “LEN has the potential to transform HIV prevention and the overall epidemic response, but realizing that potential will require more urgency, more ambition, and more investment. Three million people reached by the end of 2027 is entirely feasible and an essential step toward ending new HIV infections. The field must commit to this: no less and no slower, with a push for more and faster.” 

Since results of efficacy trials were announced in 2024, injectable lenacapavir for PrEP (LEN) has generated enormous excitement. By the end of 2024, Gilead Sciences provided voluntary licenses to generic manufacturers and submitted multiple regulatory filings, and the Global Fund and PEPFAR initially committed to reach two million people over three years with LEN, and then increased it to three million in three years. As of October 2026, LEN is recommended by WHO; has 19 regulatory approvals, and counting; is being introduced in 36 implementation science projects; and is being introduced as part of public health programs in 29 countries, with support from the Global Fund and PEPFAR. 

“LEN represents one of the most promising advances in HIV prevention in decades. There is no time to waste. If we are to have any hope of ending AIDS as a public health threat by 2030, the global community must move beyond incremental implementation and seize the opportunity to rapidly scale access to a highly effective, long-acting prevention option, alongside treatment for all people living with HIV,” said Warren. 

Recent progress has demonstrated both the feasibility and demand for long-acting HIV prevention. Rapid regulatory approvals and national introduction efforts have laid the groundwork for broader access. At the same time, community demand for long-acting prevention options continues to grow, particularly among populations that face barriers to daily oral PrEP use. If stakeholders fumble the moment, demand risks outpacing supply by large margins, which will harm public trust in prevention efforts. 

The coming year represents a critical window for action. AVAC’s newly updated publication, Now What with Injectable LEN for PrEP: How to Translate Ambition into Accelerated Delivery and Impact outlines how to reach at least three million people with LEN by the end of 2027, including two potential scenarios for LEN market development, and where advocates can demand action. 

AVAC and Access Bridge have called for a LEN market development strategy that builds the market faster, secures lower product pricing, and achieves greater impact by 2030. The faster the market grows, the more transmission can be averted, more quickly the PrEP market can expand, and the greater the potential impact with LEN. This market development will also help build the programmatic infrastructure to expand choice and prepare for the possible introduction in 2028 of monthly oral alimatravir, if it is also shown to be safe and effective next year. 

“Three million people by the end of 2027 is a starting point, not an endpoint,” said Wawira Nyagah, Executive Director of Access Bridge. “We have a historic opportunity to reshape the trajectory of the HIV epidemic, and we are just getting started. The question is not whether the field can move quickly enough; it’s whether we choose to.” 

To reach at least three million people with LEN by the end of 2027 and 20 million by 2030, AVAC and Access Bridge are calling on:  

  1. Countries to provide ambitious forecasts based on actual demand and need and programmatic opportunity, not based on budget. 
 
  1. Global Fund and PEPFAR/GHSD to place orders now for enough doses for at least 2.4 million people in 2027 (given that 600,000 per years of LEN was ordered for 2026). In addition, advocacy needs to mobilize domestic resources and other new donors to increase volumes further. 
  1. National regulators to ensure rapid approval and/or regulatory waivers of generic LEN so that there are no delays in transitioning from Gilead to lower-priced generics, which should begin happening early next year, and that there is adequate and consistent access to product in-country. 
  1. Gilead and the approved generic manufacturers to commit the supplies to make this delivery schedule in 2027 and ensure commodity security.  
  1. Countries and communities to develop the programmatic infrastructure and robust demand creation to deliver that quantity as part of comprehensive prevention choice programs, so that product reaches people who need and want it and that no product is wasted. 

AVAC and Access Bridge emphasize that scaling LEN must be part of a broader commitment to prevention choice. The HIV prevention landscape is entering a new era: beyond LEN is the potential inclusion of new methods like the investigational monthly PrEP pill alimatravir (AMI), which is undergoing clinical trials now. The PrEP market from 2028 could be far more complex and competitive. 

No single product will meet everyone’s needs, but expanding access to a diverse range of prevention options is essential to ensuring that all individuals can find methods that work for them. AVAC and Access Bridge urge partners across sectors to align around a common objective now: turning the promise of LEN into measurable public health impact for millions of people around the world. 

Read the full Now What with Injectable LEN for PrEP: How to Translate Ambition into Accelerated Delivery and Impact here. 

No Time to Lose: Reaching At Least Three Million with LEN for PrEP by 2027

AVAC and Access Bridge today issued a global call to action and new publication urging governments, donors, manufacturers, implementers, and advocates to work toward a bold but achievable goal: reaching at least three million people with injectable lenacapavir (LEN) for HIV prevention by the end of 2027. This new, more ambitious target will drive affordability, build a sustainable PrEP market, and accelerate impact.

Read Now

“Scientific breakthroughs only matter if they reach the people who need them. LEN has the potential to transform HIV prevention and the overall epidemic response, but realizing that potential will require more urgency, more ambition, and more investment. Three million people reached by the end of 2027 is entirely feasible and an essential step toward ending new HIV infections. The field must commit to this: no less and no slower, with a push for more and faster.”

Mitchell Warren
Executive Director, AVAC

Since results of efficacy trials were announced in 2024, injectable lenacapavir for PrEP (LEN) has generated enormous excitement. By the end of 2024, Gilead Sciences provided voluntary licenses to generic manufacturers and submitted multiple regulatory filings, and the Global Fund and PEPFAR initially committed to reach two million people over three years with LEN, and then increased it to three million in three years. As of October 2026, LEN is recommended by WHO; has 19 regulatory approvals, and counting; is being introduced in 36 implementation science projects; and is being introduced as part of public health programs in 29 countries, with support from the Global Fund and PEPFAR. 

Recent progress has demonstrated both the feasibility and demand for long-acting HIV prevention. Rapid regulatory approvals and national introduction efforts have laid the groundwork for broader access. At the same time, community demand for long-acting prevention options continues to grow, particularly among populations that face barriers to daily oral PrEP use. If stakeholders fumble the moment, demand risks outpacing supply by large margins, which will harm public trust in prevention efforts. 

The coming year represents a critical window for action. Our publication, Now What with Injectable LEN for PrEP: How to Translate Ambition into Accelerated Delivery and Impact outlines how to reach at least three million people with LEN by the end of 2027, including two potential scenarios for LEN market development, and where advocates can demand action. 

To reach at least three million people with LEN by the end of 2027 and 20 million by 2030, AVAC and Access Bridge are calling on:

  1. Countries to provide ambitious forecasts based on actual demand and need and programmatic opportunity, not based on budget.
  2. Global Fund and PEPFAR/GHSD to place orders now for enough doses for at least 2.4 million people in 2027 (given that 600,000 per years of LEN was ordered for 2026). In addition, advocacy needs to mobilize domestic resources and other new donors to increase volumes further.
  3. National regulators to ensure rapid approval and/or regulatory waivers of generic LEN so that there are no delays in transitioning from Gilead to lower-priced generics, which should begin happening early next year, and that there is adequate and consistent access to product in-country. 
  4. Gilead and the approved generic manufacturers to commit the supplies to make this delivery schedule in 2027 and ensure commodity security.
  5. Countries and communities to develop the programmatic infrastructure and robust demand creation to deliver that quantity as part of comprehensive prevention choice programs, so that product reaches people who need and want it and that no product is wasted.

“Three million people by the end of 2027 is a starting point, not an endpoint. We have a historic opportunity to reshape the trajectory of the HIV epidemic, and we are just getting started. The question is not whether the field can move quickly enough; it’s whether we choose to.”

Wawira Nyagah
Executive Director, Access Bridge

Scaling LEN must be part of a broader commitment to prevention choice. The HIV prevention landscape is entering a new era: beyond LEN is the potential inclusion of new methods like the investigational monthly PrEP pill alimatravir (AMI), which is undergoing clinical trials now. The PrEP market from 2028 could be far more complex and competitive. 

No single product will meet everyone’s needs, but expanding access to a diverse range of prevention options is essential to ensuring that all individuals can find methods that work for them. AVAC and Access Bridge urge partners across sectors to align around a common objective now: turning the promise of LEN into measurable public health impact for millions of people around the world. 

Read the full Now What with Injectable LEN for PrEP: How to Translate Ambition into Accelerated Delivery and Impact here. 

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.

Now What with Injectable LEN for PrEP?

How to Translate Ambition into Accelerated Delivery and Impact

Since results of the PURPOSE efficacy trials were announced in 2024, injectable lenacapavir for PrEP (LEN) has generated enormous excitement and opportunity – and frustration. By the end of 2024, Gilead Sciences provided six voluntary licenses to generic manufacturers and submitted multiple regulatory filings, and the Global Fund and PEPFAR committed to an ambition to reach two million people over three years, pending regulatory approvals and WHO guidelines. It seemed like bold ambition – and it was, compared to the previous launches of oral PrEP, vaginal ring and CAB.

But this ambition was always defined as a floor, not a ceiling. In April 2026, the collaboration increased the goal to reach three million people over three years with LEN for PrEP.

In July 2025, AVAC published a first edition of Now What with Injectable LEN for PrEP, outlining priorities to ensure introduction moved swiftly. Now, in this update, AVAC is calling for a new minimum floor: reach three million in two years (2026-2027). No less and no slower, with a push for more and faster.

Without speed, scale and equity, LEN is simply exciting science; but, with them, LEN can be a transformational moment in the HIV/AIDS response.

Download

Re: Imminent Threats to HIV Research: Organizational Sign-On Letter to Congress

AVAC joined dozens of other organizations in urging Congress to address imminent threats to HIV research from the Administration. These threats are part of a broader political effort to undermine the National Institutes of Health (NIH) and congressionally appropriated taxpayer-funded science grants. There are three interwoven and impending threats to the ground-breaking scientific research conducted by the NIH and the HIV clinical trial networks it supports through the National Institute of Allergy and Infectious Diseases (NIAID). If not immediately addressed, these threats – individually and together – would have grave, long-lasting impact on decades of HIV and infectious diseases research, reducing access to effective, cost-efficient HIV prevention, care and treatment and undermining innovative efforts to end the HIV epidemic, including vital ongoing work to develop an accessible cure.

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Press Release

MEDIA ALERT: 139 Organizations Urge Congress to Act on Three Imminent Threats to HIV Research Ahead of Midterms

WASHINGTON, D.C. — October 20, 2026 — Just two weeks before the midterm elections, 138 organizations have signed an urgent letter to congressional appropriations leaders, calling for immediate action to protect federal HIV research from three threats that could disrupt clinical trials, undermine scientific independence, and jeopardize billions in taxpayer-funded research investments.

The letter, coordinated by the Save HIV Funding campaign, was delivered to 90 U.S. senators and 402 U.S. representatives — including Senators Susan Collins and Patty Murray, and Representatives Tom Cole and Rosa DeLauro — and identifies three critical concerns:

  • Overdue clinical trial funding: An NIH funding opportunity originally forecast for August 25 has yet to be released, threatening the renewal of four major HIV clinical trial networks. The organizations urge HHS to approve the funding opportunity immediately and NIH/NIAID to publish it without further delay.
  • Political interference in scientific research: Signatories call on Congress to protect NIH’s established scientific peer-review process and block measures that would place political appointees in charge of federal research grant decisions.
  • Potential diversion of research funding: The letter raises concerns about an interagency agreement that could redirect potentially billions of dollars from NIAID to the Department of Defense, calling for transparency, congressional oversight, and protections in the FY2027 appropriations bill.

The consequences could extend far beyond HIV. The organizations warn that disrupted funding could remove participants from unfinished clinical trials, dismantle research teams and infrastructure, delay advances in HIV prevention and cure research, and compromise scientific work involving cancer, tuberculosis, viral hepatitis, and future infectious disease outbreaks.

The letter arrives as voters prepare to elect the next Congress, whose members will help determine the future of federal research funding and oversight.

Read the full letter here.

Global Health Watch: World Health Summit highlights, UN pandemic declaration, Guinea-Bissau vaccine trial, NIH peer-review changes

Issue 90

Challenges and scientific progress took center stage at the World Health Summit in Berlin, the UN adopted a new pandemic preparedness declaration, concerns continue over the proposed US-funded hepatitis B vaccine trial in Guinea-Bissau, and proposed changes to NIH’s scientific peer-review process raise new questions about transparency and political influence over research funding.

World Health Summit Highlights Challenges, Leadership and HIV Cure Progress

In Berlin, the World Health Summit (WHS) brought global health leaders together this week to discuss the future of global health financing, governance, scientific innovation and the growing impact of conflict on health systems. Jirair Ratevosian summarizes WHS and whether global health institutions are keeping pace with a changing world and highlights the featured public discussion with prospective candidates for WHO Director-General, which gave some insight into their priorities for the organization’s future. Sara Jerving of Devex covered the summit, as well, and concluded, “The global health sector can innovate, collaborate, and come up with all the clever solutions it can. But that will continue to fall drastically short when wars continue to rob millions of people of any chance of living healthy lives.” And at the opening of its new HIV cure research center, the Charité medical school and hospital in Berlin publicly named the “second Berlin patient” cured of HIV, Thomas Kahlert.

IMPLICATIONS: The WHS highlighted challenges facing global health institutions amid declining official development assistance (ODA), growing conflicts that are disrupting essential services and increasing calls from countries and communities for greater ownership and accountability. The news of the “second Berlin patient” shows what sustained investment in science can achieve, even as researchers work toward innovations that are effective, safe and accessible to all. 

READ:

UN Adopts Pandemic Preparedness Declaration 

The United Nations General Assembly adopted the Political Declaration on Pandemic Prevention, Preparedness and Response on Monday with 153 countries voting for the Declaration and three dissenting – Argentina, Isreal and the United States – and two countries, New Zealand and Paraguay, abstaining. Consensus on the text was not achieved at the September 25 Second High-Level Meeting on Pandemic Prevention, Preparedness and Response (PPPR), and negotiations continue over the Pathogen Access and Benefit-Sharing (PABS) annex to the separate WHO Pandemic Agreement, which would establish how countries sharing pathogens and genetic data benefit from the medical products developed using them.

IMPLICATIONS: The Declaration shows international support for pandemic preparedness, but as Friends of the High-Level Meeting on Pandemic Prevention, Preparedness and Response warn, the Declaration “contains few measurable or time-bound commitments,” and they challenge all Member States “to set ambitious, time-bound targets to ensure that we are truly able to prevent, prepare for, and respond to health emergencies and pandemic threats.” The disagreements over PABS speak to the division over access to vaccines, treatments and diagnostics, with many arguing over whether access should depend on voluntary arrangements or enforceable guarantees of equitable benefit-sharing. WHO and advocates are urging countries to reach an agreement over PABS by May, so the Pandemic Agreement can move forward. US government and other high-income country objections to PABS provisions, along with their failure to support the finalized Declaration, loomed over negotiations. The US government, in particular, used hardline rhetoric in expressing disagreement over the use of WTO waivers and uncompensated technology transfers. It also took divisive ideological positions, rejecting the Declaration’s references to climate change and sexual and reproductive health and rights. Moreover, the US government sought to ban international support for “gain-of-function” research. Overall, the experience illustrates the US government’s preference for entering into bilateral agreements rather than multilateral accords, while maintaining domestic oversight of biomedical research and intellectual property. 

READ:

Guinea-Bissau Denies Approving Controversial hepatitis B US-Funded Vaccine Trial 

New reporting raises further concerns about a proposed US-funded hepatitis B vaccine trial in Guinea-Bissau, which has raised significant questions over African public health leadership, ethical research standards and sovereignty. As we reported previously, the proposed trial would delay birth-dose vaccination for thousands of newborns despite overwhelming evidence and WHO guidance that immediate vaccination saves lives. This week, The Guardian reports that Guinea-Bissau’s government denied approving the study, which contradicts claims that researchers had received authorization to proceed. Meanwhile, the US Centers for Disease Control and Prevention (CDC) is said to have begun efforts to allocate $1.6 million in global health security funding for the trial. 

IMPLICATIONS: The proposed study and questions surrounding its approval continue to raise fundamental concerns about research ethics, national sovereignty, the use of US global health funding and the continued anti-vaccine ideology of US Health and Human Services Secretary Robert F. Kennedy Jr. Delaying access to a proven, effective vaccine could expose newborns to preventable infections. Guinea-Bissau’s rejection of claims that it approved the trial reinforces the importance of country leadership, independent ethical review and protecting research participants, particularly vulnerable populations. 

READ:

NIH Peer Review Proposal Highlights Transparency and Scientific Independence Risks

The US National Institutes of Health (NIH) closed its public comment period on proposed changes to its scientific peer-review process, which informs research funding decisions. The Infectious Diseases Society of America (IDSA) and HIV Medicine Association (HIVMA) were among the organizations submitting a comment. The proposed process would replace numerical peer-review scores with three broad categories: “most competitive,” “competitive” and “not discussed.” NIH leadership argues the change would give the agency greater flexibility to consider factors beyond small differences in scores as part of its proposed Unified Funding Strategy. However, scientists and research organizations warn that removing numerical scores from subsequent funding decisions could weaken accountability and make it harder to determine whether grants are awarded based on scientific merit.  

IMPLICATIONS: This proposal is yet another development that raises concerns about transparency and political influence over which studies receive support. NIH’s peer-review system has long been a foundation of independent, merit-based scientific research. Replacing numerical scores with broader categories could give NIH officials greater discretion over funding decisions while reducing the information available to researchers and advisory councils. 

READ:

HIV advocates sound alarm as NIH hits ‘pause’ on new HIV clinical trials

Following last week’s New York Times report on the NIH’s directive that its four HIV clinical trials networks temporarily pause launching new HIV clinical trials amid delays in renewing funding for its HIV research networks, Positively Aware highlights advocates’ growing concerns about the future of HIV research.

Next Wednesday, October 21 at 12:15pm during IDWeek in Washington DC at the Convention Center, join the Save HIV Funding campaign for a rally demanding the US Congress to release federal HIV research funding and for an opportunity to experience the #CutsKill quilt panels.

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Investing in Biomedical Innovation for Health and Economic Growth

This Financial Times webinar will bring together policymakers, funders, researchers, philanthropies and industry leaders to explore how to keep medical innovation moving forward. The conversation will examine how to create the right conditions for future breakthroughs – and deliver clear benefits for patients, health systems, economies and society.

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Funding shifts leave HIV community-based organizations with less say

Shock waves rippled through the network of U.S. HIV/AIDS service organizations when the Centers for Disease Control and Prevention (CDC) announced in July that it would no longer directly fund nearly 100 community-based organizations (CBOs), as it had for many years, instead shifting funding to state and local health departments. Mitchell Warren, AVAC’s Executive Director, says that the shift away from involving communities is part of a larger effort to conceal PEPFAR’s activities and progress from outside observers and advocates. “The U.S. government has dramatically changed how it treats civil society, which has been tumultuous and leaves us with a lot of confusion.”

HIV advocates sound alarm as NIH hits ‘pause’ on new HIV clinical trials

The National Institutes of Health (NIH) notified four major research networks that they should “pause” new clinical studies that had not yet enrolled participants and that could not be completed by November 30, 2027, when their current funding expires. As AVAC’s Executive Director Mitchell Warren says, “This may be one of the most shortsighted, scientifically absurd and ideologically wrong decisions, and there have been a lot of those in the last 20 months.”

Injectable PrEP Regulatory Approvals

This graphic tracks regulatory approvals for injectable cabotegravir and lenacapavir for PrEP as of October 2026. For additional details on product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.