The timeline for generic LEN for PrEP to come to market is expected to be significantly shorter than for CAB for PrEP. Bioequivalence (BE) testing for LEN, which demonstrates a generic product works in the body in the same way as the originator product, is likely to be six months, vs. the 18 months for CAB for PrEP, because of differences in the drug formulation. The rapid granting of voluntary licensing by Gilead also contributes to this shorter timeline. For the latest on LEN, visit here.
Going Faster with LEN Generics
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.
“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.”
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.
“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.”
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.
From Research to Access: The Community Statement from the Global Community Advisory Group (GCAG) on the Future of Alima (Alimatravir) for HIV Prevention
The EXPrESSIVE-10 Global Community Advisory Group (GCAG) released a statement on the future of alimatravir and HIV prevention. The statement reflects community perspectives and priorities around prevention choice, meaningful community engagement, equitable access, and ensuring that communities have a voice as research progresses toward potential introduction. As the GCAG writes, “The test is now whether early planning can translate into faster, more equitable action. An access plan is valuable not because it is announced, but because it creates a pathway that can be tracked, challenged, and delivered.”
SA and Zambia’s HIV shot dilemma: Demand versus supply
Early data shows South Africa and Zambia have high demand for lenacapavir (LEN), the twice-yearly HIV prevention injection. But clinics don’t yet have enough doses for everyone who wants it. In Bhekisisa, AVAC’s Executive Director Mitchell Warren weighs in on the excitement surrounding LEN and what a successful rollout will require.
Anxiety in Paradise: Highlights From the 26th International AIDS Conference in Rio de Janeiro
Following AIDS 2026 in Rio de Janeiro, TheBody reflected on the stark disparities on display. “There were all of these tensions there,” AVAC’s Executive Director Mitchell Warren said. “Between the amazing science and the difficult political and economic time we’re in. Between the opportunity of new, long-acting prevention tools and the fact that we were in a region of the world where access to them doesn’t exist. And between what could be and what currently is.”
Merck’s alimatravir licensing deal receives mixed response
In July, Merck announced licensing agreements with seven manufacturers for generic production of its HIV drug alimatravir, though access and equity concerns remain. As AVAC’s Executive Director Mitchell Warren explained, AVAC hopes to see Merck pledge to reach at least 2 million people with alimatravir within the first year of product launch and 5 million within the first 2 years, and guarantee it will be available in LMICs within 3 months of first approval. “These targets are a bare minimum and entirely feasible. We need this to jump-start the scale of the market, drive down prices and, most importantly, deliver impact”, Warren said.
Aids is no longer exceptional. What happens now?
Following AIDS 2026, Bhekisisa’s Mia Malan reflects on the annual conference that took place amid an unprecedented funding crisis and the dwindling political will to address HIV. As AVAC Executive Director Mitchell Warren said, “What comes out of a conference [or movement] is more important than what happened at the conference. Three to six months from now, we need to ask: are we working differently because we gathered in Rio? …I hope the answer will be clear: coming together and planning together strengthened our Aids response. That’s the measure of success.”
The Second Injection
In her Substack, Skye Grove unpacks the distance that still lies between products and services and the people who need them. Reflecting on AIDS 2026 conversations and sessions, she shares insights from AVAC’s Executive Director Mitchell Warren, Access Bridge’s Executive Director Wawira Nyagah, and AVAC partners like Yvette Raphael and Adaobi Lisa Olisa.
Accelerating policy approval and uptake of the dual prevention pill in Zambia through early stakeholder engagement
The Dual Prevention Pill (DPP), a combination of PrEP and combined oral contraception (COC), offers a novel, female-controlled option for HIV and unintended pregnancy prevention. However, new technologies like the DPP often face delays in regulatory approval and uptake due to limited stakeholder involvement early in the introduction process. This article in AIDS Care, authored by AVAC Fellow Rhoda Msiska, AVAC staff members Kate Segal and Cindra Feuer, and Newton Donkola, demonstrates how early, multisectoral stakeholder engagement could accelerate DPP approval and adoption in Zambia.