Lenacapavir for PrEP has now reached seventeen countries in Africa. This map offers more detail on the LEN rollout as of October 2026.
Source of Lenacapavir for PrEP Supply in Africa
Long-Acting PrEP Generic Manufacturers
Licenses have been granted to manufacturers across multiple low- and middle-income countries to produce generic long-acting PrEP products. Cabotegravir (CAB) and Lenacapavir (LEN) are approved and rolling out, while alimatravir (AMI) is in Phase 3 efficacy trials. Generic manufacturing can play an important role in expanding access to PrEP, and licensing to three African manufacturers for AMI is a notable step toward strengthening regional supply and affordability.
Funding for Prevention Rollout, Not Close-Out
AVAC’s new publication, Now What with Injectable LEN for PrEP: How to Translate Ambition into Accelerated Delivery and Impact, outlines pathways to reach at least three million people by the end of 2027, including two scenarios for LEN market development. It highlights necessary actions partners—such as the Global Fund, ministries of health, donors, communities, and suppliers—must take to make this aspiration a reality. The U.S. government’s critical diplomatic and global leadership is needed to move these partners to take on this ambitious target. This factsheet highlights what Congress do to accelerate access and protect more than 3 million people from HIV.
EXPrESSIVE Phase III Program Countries of Alimatravir
Seventeen countries are hosting sites for the Phase III efficacy trials of a monthly PrEP pill, called MK-8527, now known as alimatravir, being developed by Merck (also known as MSD outside of the US and Canada). Merck announced the launch of the Phase III trials at IAS 2025 in Kigali. Alimatravir (AMI) was found to be safe and well-tolerated in Phase II clinical trials.
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:
- Countries to provide ambitious forecasts based on actual demand and need and programmatic opportunity, not based on budget.
- 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.
- 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.
- Gilead and the approved generic manufacturers to commit the supplies to make this delivery schedule in 2027 and ensure commodity security.
- 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.
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:
- Countries to provide ambitious forecasts based on actual demand and need and programmatic opportunity, not based on budget.
- 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.
- 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.
- Gilead and the approved generic manufacturers to commit the supplies to make this delivery schedule in 2027 and ensure commodity security.
- 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.
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
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.
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.
HIV Prevention Pipeline: Products to Watch
From the People’s Research Agenda, this graphic tracks the pipeline of potential new HIV prevention options across broadly neutralizing antibodies, preventive vaccines, pre-exposure prophylaxis, and multipurpose technologies.

