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[link removed] September 16, 2026


**
All things alimatravir (AMI)
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Dear Advocate,

Alimatravir ([link removed]) (AMI, known as MK-8527) is an investigational monthly pill being studied for PrEP in the EXPrESSIVE program ([link removed]) . The addition of a monthly PrEP pill, if proven safe and effective in the EXPrESSIVE trials, will expand the number of prevention options and open the door to new and innovative delivery models.

AVAC and partners have been engaging with Merck/MSD since the very start of the Alimatravir product development program and helped conceptualize the EXPrESSIVE efficacy trial design. Building on this foundation of community-centricity (#community) , advocates can now push for AMI to be rolled out with speed, scale and equity. Since 2012, each successive PrEP introduction has gone faster than the previous one ([link removed]) , yet the time to market ([link removed])  and to public health impact for PrEP remains too slow. Read on for AVAC’s insights on AMI, from accelerated licensing and affordability to community priorities and meaningful engagement.
Update
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** The Latest on AMI
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Just before the AIDS 2026 conference ([link removed]) in July, AMI developer Merck/MSD granted seven direct licenses ([link removed]) to generic manufacturers to produce and market the drug in 129 low- and middle-income countries, including all of Africa and much of Asia, while the trials are still enrolling. These agreements are in place 18 months before a possible efficacy result, and substantially earlier than for lenacapavir ([link removed]) or cabotegravir ([link removed]) . If AMI is found safe and effective, these agreements could greatly accelerate the introduction process ([link removed]) . AVAC and Access Bridge ([link removed]) welcomed the
announcement, highlighting the challenges that remain to ensure future access is equitable and widespread among the populations that need it most.

While overall good news, several countries ([link removed]) that are hosting the EXPrESSIVE 11 trial ([link removed]) are left out of the voluntary license territory, reflecting a broader trend of excluding Latin American countries ([link removed]) and some Asian countries from voluntary licenses. Merck/MSD did subsequently sign a memorandum of understanding with Fiocruz ([link removed]) , a Brazilian manufacturer, to supply AMI for Brazil and the region, but the terms, timing and next steps remain unclear. Furthermore, key populations in high-income countries also face access disparities.

Find all the latest updates on AVAC’s alimatravir page ([link removed]) .
Resource
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** PxWire Explores AMI Generic Licensing Agreements
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AVAC’s latest edition of PxWire ([link removed]) features an analysis of generic licensing for AMI ([link removed]) and what it means for the field, and an explainer on generic licensing agreements and current coverage across long-acting prevention products. The explainer examines the promise of generics for advancing affordable, equitable access ([link removed]) and raises questions about the persistent and worrying gaps in these agreements.

Read the latest edition of ([link removed]) PxWire ([link removed]) .
Pricing estimate
Photo credit: aidsmap


** AMI Could Be the Cheapest HIV Prevention Option Yet, But Does Affordable Mean Accessible?
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A new academic analysis presented at AIDS 2026 ([link removed]) suggests that AMI could be manufactured at large scale by generic companies and sold for as low as $3 per person per year, and a separate New York Times report ([link removed]) highlighted estimates that generic AMI could be sold to national health systems for as little as $5 per person per year. But an affordable product is only impactful if people can access it. As the Gates Foundation's ([link removed]) Max Lataillade ([link removed]) said in an AVAC satellite session at AIDS 2026 ([link removed]) , "Innovation without global access or implementation does not create the impact that we want. Science creates the possibility, collaboration creates the impact, but
communities create the future."

Read AVAC’s coverage of the AMI modeling data presented at AIDS2026 ([link removed]) .
Community perspective
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** From Research to Access: Community Statement from the Global Community Advisory Group (GCAG) on the Future of Alimatravir for HIV Prevention
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Following Merck/MSD’s generic licensing announcement for AMI, the EXPrESSIVE-10 Global Community Advisory Group (GCAG) released a statement on community perspectives and priorities around prevention choice ([link removed]) , 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.”

Read the EXPrESSIVE-10 GCAG statement ([link removed]) .
Impact Story
Examples of demand generation materials for EXPrESSIVE-11 in 8 trial countries
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** Putting Communities at the Center of EXPrESSIVE
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The EXPrESSIVE program ([link removed]) includes two phase 3 efficacy trials studying AMI for HIV prevention—EXPrESSIVE-10 among cisgender women and EXPrESSIVE-11 among cisgender men who have sex with men, transgender men, transgender women and gender non-binary individuals. The trials are anticipated to have results in the latter half of 2027. With support from the Gates Foundation, AVAC is supporting strong, consistent community engagement ([link removed]) across the program. As a part of this work, AVAC partnered with community-based organizations in Argentina, Brazil, Kenya, Peru, the Philippines, South Africa, Thailand and Vietnam to develop educational materials for EXPrESSIVE-11 ([link removed]) through a participatory human-centered design (HCD) process. Luciana Kamel ([link removed]) , the Community Education Team Lead for HIV studies at Fiocruz
([link removed]) , AVAC’s partner in Brazil for this work, described how this approach changed what was possible: “The trust, openness and respect for our work with the community made it possible to move beyond simply producing recruitment materials and instead build something that reflected the people and contexts the study was intended to engage.”

Learn more about community-led design in EXPrESSIVE-11 ([link removed]) .

Check out all the communications materials here ([link removed]) .

ADDITIONAL AMI RESOURCES
• Video: AVAC’s Recap of AMI from AIDS 2026 ([link removed])
• Blog: Grace Kumwenda’s AIDS 2026 Reflections, including on AMI ([link removed])
• Press Release: AVAC and Access Bridge Applaud Monthly PrEP Pill Access Announcement; Call for Speed, Scale and Equity in Future Monthly Oral Alimatravir Introduction ([link removed])
• Podcast: PxPulse – Next Up: A monthly pill for PrEP? ([link removed])
• Article: Merck's alimatravir licensing deal receives mixed response ([link removed](26)00439-1/abstract)
• Past analyses of real-time lessons learned about PrEP introductions: Getting PrEP Rollout Right This Time ([link removed]) and Getting Rollout Right: Lessons from Oral PrEP ([link removed]) .

In solidarity,

AVAC
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AVAC Global Advocacy for HIV Prevention
+1 212 796 6423 [email protected] (mailto:[email protected]) www.avac.org ([link removed])
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