July 29, 2025
Momentum continues to build for injectable lenacapavir (LEN) for PrEP as what could be one of the most transformational moments in HIV prevention ever. Just weeks after the US Food and Drug Administration approved LEN for PrEP, the WHO issued new global recommendations for offering LEN, and last week the European Medicines Agency recommended its approval in the EU and globally (even earlier than anticipated).
But getting LEN to those who need and want it depends on addressing an array of complex factors beyond regulatory approvals, including action, coordination and transparency on funding, price and volume agreements, supply chains, health worker training, demand creation, and community engagement. We outlined all of the moving parts in December in Gears of Lenacapavir for PrEP Rollout, and now’s the time to ensure all of the gears actually begin to turn even faster.
The recent advances, of course, arrive amid a cruel irony: just as prevention breakthroughs gain traction, US political decisions are unraveling the systems needed to deliver them. Still, the prevention pipeline continues to grow. In addition to the movement on LEN for PrEP, Merck’s once-monthly oral PrEP pill just entered Phase III trials, another step toward real choice and expanded options in HIV prevention.
Check out AVAC’s resources below (all newly updated) to help advocates track, explain, and take action to meet the moment. And read our insights from the International AIDS Society meeting in Kigali.
Updated Resources
Long-Acting PrEP Status Update
A quarterly update featuring graphic tools for tracking regulatory approvals, implementation science, price and volume agreements, and pipeline overviews. Visit here.
Lenacapavir Regulatory Approval
Regulatory approvals and pending decisions as of July 2025. Download the graphic.
Where We Are Now With LEN for PrEP
A timeline of essential milestones to scaling up LEN for PrEP. View here.
Moving a Product to the Real World
The field is beginning to apply past lessons to accelerate introduction of injectable PrEP options. Download here.
Getting PrEP Rollout Right This Time
Qualitative landscape analysis to identify actionable lessons and recommendations from past PrEP introduction and implications for LEN for PrEP. Read the report.
Now What with Injectable LEN for PrEP?
Outline of what is actually known – and not – and what needs to happen next. Read it here.
All of the LEN for PrEP documents are at avac.org/lenacapavir and be sure to check out PrEPWatch for all of these resources and more.