At AIDS 2026, researchers reported on results from phase 3 trials of a once-weekly combination of islatravir-lenacapavir for HIV treatment. Mitchell Warren, AVAC Executive Director, spoke to Managed Healthcare Executive about what the shift to less frequent oral dosing could mean for HIV treatment programs operating with shrinking budgets. “If we can move people to weekly oral, and then eventually monthly dosing, or even bi-monthly or every six-month dosing, we may be able to do more with less. We can have more impact, get more people on treatment when the drugs cost less and when they go to the clinic less often,” Warren said.
Mitchell Warren on weekly islatravir-lenacapavir for HIV treatment | AIDS 2026
Merck Secures Early Generic Deals to Fast-Track Monthly HIV Prevention Pill
Merck has announced early licensing agreements for its once-monthly HIV prevention pill, aiming to guarantee access for 129 developing nations.
AVAC and Access Bridge Applaud Monthly PrEP Pill Access Announcement; Call for Speed, Scale and Equity in Future Monthly Oral Alimatravir Introduction
AVAC and Access Bridge applaud Merck’s announcement today that it has granted seven direct licenses to generic manufacturers to produce their investigational monthly pill for HIV prevention, known as MK-8527, or alimatravir, while Phase 3 clinical trials are still enrolling.
The announcement from Merck/MSD reflects responsiveness to advocates’ longstanding calls to accelerate access to PrEP options. Since 2012, each successive PrEP introduction has gone faster than the previous one yet the time to market and to public health impact remains too slow.
In advance of the AIDS 2026 conference, Merck, known as MSD outside the US and Canada, today announced voluntary licensing agreements with seven manufacturers, including three in East and Southern Africa, to produce and market alimatravir for PrEP in 129 countries.
“Today’s news reflects truly positive momentum in future access to alimatravir for PrEP, if proven safe and effective,” said Mitchell Warren, AVAC’s executive director. “Granting licensing agreements to generic manufacturers while clinical trials are still enrolling, before it is known if the product is effective, should significantly reduce the time to market for the product. The timeline announced today gives us ample opportunity to work with ministries of health, donors, communities, and Merck to plan for broad access to the monthly PrEP pill. This option lends itself to innovative delivery models – from pharmacies to community-based distribution approaches. While trials are still enrolling, we have the time to collectively ensure models are well-conceived and planned, adequately funded, and set up for success. With this timeline in hand, there’s no excuse for getting it wrong.”
“Merck’s early access announcement represents significant potential time-savings, compared to the experience with cabotegravir (CAB) and lenacapavir (LEN) in both timeline for licensing, and inclusion of those with greatest need. With three generic manufacturers in Kenya, Uganda, and South Africa included, these agreements go beyond those put in place for CAB and LEN and help to ensure that countries with some of the highest HIV burdens and largest PrEP markets will be able to make the product locally, should alimatravir prove safe and effective in phase 3 trials,” Warren added. “But while these voluntary licenses are essential, they are not sufficient on their own to translate exciting science into public health impact. Ultimately, access is about far more than licensure alone.”
Merck has worked with communities and advocates throughout the development of alimatravir, as exemplified by community representatives helping conceptualize the design of the phase 3 trials, even before Merck spoke to regulators. “We’ve appreciated the partnership between Merck and advocates in the research process. We’re seeing that commitment to community priorities translate into product introduction and access steps. As advocates, we will continue to watchdog this space, ensure communities remain at the center of access planning as it moves forward, and ensure accountability among all stakeholders,” said Stacey Hannah, AVAC’s Director of Research Engagement.
Every step in the process of moving a product to market can and should go faster with alimatravir than it went with CAB and LEN. To ensure the monthly PrEP pill is introduced and broadly accessible with speed, scale, and equity, AVAC and Access Bridge call on the broad range of stakeholders ensure these critical actions take place:
- Merck/MSD, governments, and donors to commit to reach at least two million people with alimatravir within the first year of product launch and five million people within the first two years.
- Merck/MSD to agree to sell the product to any public health procurer or donor at a price no more than the price of generic daily oral PrEP and injectable lenacapavir.
- Merck/MSD to guarantee that alimatravir will be available in low and middle-income countries within three months of first approval; halving the timeline it took for LEN to become available.
- Merck/MSD to articulate a transparent and robust plan for ensuring affordable, equitable access to alimatravir in Latin America, with a specific priority on countries hosting the EXPrESSIVE 11 trial, and direct work with advocates to navigate country specifics where voluntary licenses are not in place.
- WHO to accelerate the guidelines development process.Merck/MSD to clarify its regulatory strategy and prioritize broad regulatory submissions in parallel with its FDA submission, working with the WHO’s Collaborative Registration Procedure, the EMA’s Medicine4All program, and the African Medicines Agency.
- Donors working with WHO and ministries of health to design and embed a robust implementation science agenda within programmatic rollout to answer critical questions, particularly about adherence, for this new, monthly method of prevention, as part of introduction.
- All stakeholders to create and plan now for innovative service delivery that continues to simplify PrEP, working with private pharmacies, community-based organizations, and other innovative service delivery efforts.
- National governments start to prepare ambitious and costed implementation plans, guidelines, and comprehensive programs to integrate alimatravir into existing HIV prevention programs.
“Today’s announcement shows that the HIV prevention field can learn and apply lessons in real time. LEN for PrEP is now in limited distribution in ten African countries within two years of proven efficacy; this was a huge step forward, but we as a field can still do better,” said Wawira Nyagah, executive director of Access Bridge. “Now is the time to plan for even speedier and wider access if alimatravir works. This must include pricing transparency from Merck and their generic licensees, accelerated investments by donors to design and implement integrated programs that offer the monthly pill as part of choice of product and service delivery models that actually reach people who need and can benefit from it, everywhere, based on public health imperatives, and not on World Bank country classifications or geographical location. Anywhere the HIV epidemic is increasing must be included, full stop.”
For more than a decade, AVAC has mapped the roadmap and timelines for moving PrEP products from earliest research stages to market. With each successive option, AVAC has flagged what is failing, where the global community is watching, where things are improving, and where there’s room to do better still. As a result of this work, the global community is executing better, faster, more inclusively, and more equitably with every new option. Learn more about AVAC’s work on alimatravir. AVAC and Access Bridge will continue to monitor the research, approval processes and product implementation of PrEP options at https://avac.org/prevention-option/prep/ and www.prepwatch.org.
Press Release
AVAC and Access Bridge Applaud Monthly PrEP Pill Access Announcement; Call for Speed, Scale and Equity in Future Monthly Oral Alimatravir Introduction
Contact: [email protected]
Rio de Janeiro, Brazil, 24 July 2026 — AVAC and Access Bridge applaud Merck’s announcement today that it has granted seven direct licenses to generic manufacturers to produce their investigational monthly pill for HIV prevention, known as MK-8527, or alimatravir, while Phase 3 clinical trials are still enrolling.
The announcement from Merck/MSD reflects responsiveness to advocates’ longstanding calls to accelerate access to PrEP options. Since 2012, each successive PrEP introduction has gone faster than the previous one, yet the time to market and to public health impact remains too slow.
In advance of the AIDS 2026 conference, Merck, known as MSD outside the US and Canada, today announced voluntary licensing agreements with seven manufacturers, including three in East and Southern Africa, to produce and market alimatravir for PrEP in 129 countries.
“Today’s news reflects truly positive momentum in future access to alimatravir for PrEP, if proven safe and effective,” said Mitchell Warren, AVAC’s executive director. “Granting licensing agreements to generic manufacturers while clinical trials are still enrolling, before it is known if the product is effective, should significantly reduce the time to market for the product. The timeline announced today gives us ample opportunity to work with ministries of health, donors, communities, and Merck to plan for broad access to the monthly PrEP pill. This option lends itself to innovative delivery models – from pharmacies to community-based distribution approaches. While trials are still enrolling, we have the time to collectively ensure models are well-conceived and planned, adequately funded, and set up for success. With this timeline in hand, there’s no excuse for getting it wrong.”
“Merck’s early access announcement represents significant potential time-savings, compared to the experience with cabotegravir (CAB) and lenacapavir (LEN) in both timeline for licensing, and inclusion of those with greatest need. With three generic manufacturers in Kenya, Uganda, and South Africa included, these agreements go beyond those put in place for CAB and LEN and help to ensure that countries with some of the highest HIV burdens and largest PrEP markets will be able to make the product locally, should alimatravir prove safe and effective in phase 3 trials,” Warren added. “But while these voluntary licenses are essential, they are not sufficient on their own to translate exciting science into public health impact. Ultimately, access is about far more than licensure alone.”
Merck has worked with communities and advocates throughout the development of alimatravir, as exemplified by community representatives helping conceptualize the design of the phase 3 trials, even before Merck spoke to regulators. “We’ve appreciated the partnership between Merck and advocates in the research process. We’re seeing that commitment to community priorities translate into product introduction and access steps. As advocates, we will continue to watchdog this space, ensure communities remain at the center of access planning as it moves forward, and ensure accountability among all stakeholders,” said Stacey Hannah, AVAC’s Director of Research Engagement.
Every step in the process of moving a product to market can and should go faster with alimatravir than it went with CAB and LEN. To ensure the monthly PrEP pill is introduced and broadly accessible with speed, scale, and equity, AVAC and Access Bridge call on the broad range of stakeholders ensure these critical actions take place:
- Merck/MSD, governments, and donors to commit to reach at least two million people with alimatravir within the first year of product launch and five million people within the first two years.
- Merck/MSD to agree to sell the product to any public health procurer or donor at a price no more than the price of generic daily oral PrEP and injectable lenacapavir.
- Merck/MSD to guarantee that alimatravir will be available in low and middle-income countries within three months of first approval; halving the timeline it took for LEN to become available.
- Merck/MSD to articulate a transparent and robust plan for ensuring affordable, equitable access to alimatravir in Latin America, with a specific priority on countries hosting the EXPrESSIVE 11 trial, and direct work with advocates to navigate country specifics where voluntary licenses are not in place.
- WHO to accelerate the guidelines development process. Merck/MSD to clarify its regulatory strategy and prioritize broad regulatory submissions in parallel with its FDA submission, working with the WHO’s Collaborative Registration Procedure, the EMA’s Medicine4All program, and the African Medicines Agency.
- Donors working with WHO and ministries of health to design and embed a robust implementation science agenda within programmatic rollout to answer critical questions, particularly about adherence, for this new, monthly method of prevention, as part of introduction.
- All stakeholders to create and plan now for innovative service delivery that continues to simplify PrEP, working with private pharmacies, community-based organizations, and other innovative service delivery efforts.
- National governments start to prepare ambitious and costed implementation plans, guidelines, and comprehensive programs to integrate alimatravir into existing HIV prevention programs.
“Today’s announcement shows that the HIV prevention field can learn and apply lessons in real time. LEN for PrEP is now in limited distribution in ten African countries within two years of proven efficacy; this was a huge step forward, but we as a field can still do better,” said Wawira Nyagah, executive director of Access Bridge. “Now is the time to plan for even speedier and wider access if alimatravir works. This must include pricing transparency from Merck and their generic licensees, accelerated investments by donors to design and implement integrated programs that offer the monthly pill as part of choice of product and service delivery models that actually reach people who need and can benefit from it, everywhere, based on public health imperatives, and not on World Bank country classifications or geographical location. Anywhere the HIV epidemic is increasing must be included, full stop.”
For more than a decade, AVAC has mapped the roadmap and timelines for moving PrEP products from earliest research stages to market. With each successive option, AVAC has flagged what is failing, where the global community is watching, where things are improving, and where there’s room to do better still. As a result of this work, the global community is executing better, faster, more inclusively, and more equitably with every new option. Learn more about AVAC’s work on alimatravir. AVAC and Access Bridge will continue to monitor the research, approval processes and product implementation of PrEP options at https://avac.org/prevention-option/prep/ and www.prepwatch.org.
***
About AVAC
AVAC is an international non-profit organization that provides an independent voice and leverages global partnerships to accelerate ethical development and delivery of effective HIV prevention options, as part of a comprehensive and integrated pathway to global health equity. Follow AVAC on BlueSky and LinkedIn and find more at avac.org and prepwatch.org.
About Access Bridge
Access Bridge is an independent, Africa-anchored organization advancing timely, sustainable, and equitable introduction of and access to HIV prevention and related health products. Incubated at AVAC and rooted in African leadership and global collaboration, Access Bridge leads a globally recognized portfolio of product introduction and access projects. Follow Access Bridge on LinkedIn and find more at healthaccessbridge.org and prepwatch.org.
Lenacapavir Implementation Studies
Ongoing and planned implementation studies for the lenacapavir as of July 2026. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.
Potential Lenacapavir Supply, 2026-28
Lenacapavir has the potential to reach millions — and the momentum is building. Using the current oral PrEP market as a baseline, this graphic estimates what demand for LEN could look like through 2028 and shows how current donor commitments stack up against that opportunity.
Advancing the inclusion of pregnant and lactating populations in HIV PrEP research: ethical, regulatory, and surveillance recommendations from a multisectoral working group
Approximately one-quarter of vertical HIV transmissions are linked to infections during pregnancy and lactation, yet data on PrEP use in these populations remains generally limited due to their exclusion from clinical trials. A multisectoral working group, including AVAC’s Executive Director Mitchell Warren and former AVACer Manju Chitani Gada collaborated to develop evidence-based strategies to improve the inclusion of pregnant and lactating women in PrEP trials. The group recommended reframing pregnant and lactating women as needing protection through research, alongside standardized data systems, stronger incentives, global collaboration, and digital innovation to ensure equitable inclusion in HIV prevention efforts.
Advancing the inclusion of pregnant and lactating populations in HIV PrEP research: ethical, regulatory, and surveillance recommendations from a multisectoral working group
Approximately one-quarter of vertical HIV transmissions are linked to infections during pregnancy and lactation, yet data on PrEP use in these populations remains generally limited due to their exclusion from clinical trials. A multisectoral working group, including AVAC’s executive director Mitchell Warren, held meetings and a scientific symposium to inform evidence-based strategies for improving the inclusion of pregnant and lactating women in PrEP trials. They recommend reframing pregnant and lactating women as needing protection through research, alongside standardized data systems, stronger incentives, global collaboration, and digital innovation to ensure equitable inclusion in HIV prevention efforts.
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.”
“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.”
“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.”
Avac Event
Future-Proofing the AIDS Response
Harnessing the Power of Innovation and Communities
The UN high-level side-event “Future-proofing the AIDS Response: Harnessing the power of innovation and communities,” will be held on the margins of the UN High Level Meeting on HIV. The event will be organized by UNDP, UNFPA, WHO, UNODC, UNICEF, UN Women, UNHCR — in collaboration with civil society partners: GNP+, AVAC, women’s organizations, and key population networks.
AVAC’s Executive Director Mitchell Warren and AVAC Board member and ITPC Executive Director Solange Baptiste will be speaking at the event, and are joined by AVAC Board member Jeff O’Malley of UNDP who are organizing the event.
Find out more about side events and panels here: https://www.unaids.org/en/2026-high-level-meeting-aids.