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.
Source of Lenacapavir for PrEP Supply to Early Adopter Countries
Years Ahead in HIV Prevention Research: Time to Market
This timeline shows the potential time points when the next-generation of HIV prevention options might find their way into new programs.
Speeding Up Access to PrEP
Time from efficacy results to key milestones
The timeline for hitting key milestones in product introduction is moving faster for injectable LEN than for any previous PrEP products, starting from the announcement of efficacy results in Phase III trials. LEN’s accelerated timeline compared to oral PrEP, DVR, and CAB reflects a field-wide effort to learn lessons from previous PrEP rollout and not repeat the mistakes of the past.
Advocates’ Primer: Understanding Bioequivalence and Pharmacokinetic Studies in Next-Generation HIV Prevention Products
As more next-generation PrEP options become available, HIV prevention research is shifting away from large, multi-year efficacy trials toward pharmacokinetic (PK) and bioequivalence (BE) studies — which test whether a new formulation behaves in the body like a product already proven to work. This primer explains the shift and what it means for advocates.
An Advocates’ Checklist for Lenacapavir for PrEP Introduction
The Civil Society Caucus of the Coalition to Accelerate Access to Long-Acting HIV PrEP developed a new resource that offers practical guidance to help civil society, advocates and implementers accelerate equitable access to LEN for PrEP. The checklist is designed to support faster, community-centered rollout ahead of broader generic availability in 2027.
Lenacapavir Regulatory Approval
Regulatory approvals, pending decisions, and appeals as of May 2026. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.
EXPrESSIVE Phase III Program Countries of MK-8527
Seventeen countries are hosting sites for the Phase III efficacy trials of a monthly PrEP pill, MK-8527, 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. MK-8527 was found to be safe and well-tolerated in Phase II clinical trials.
Analytical Treatment Interruption (ATI)
In this video, from the Series of Jojo, viewers are introduced to a methodology used to assess the efficacy of cure strategies — Analytical Treatment Interruption (ATI). Watch to learn more.
AVAC Infographics for HIV Vaccine Awareness Day
For HIV Vaccine Awareness Day, AVAC’s latest infographics — covering preventive vaccines, bNAbs, the HIV prevention research pipeline, and the impact of US funding cuts — are available as easy-to-use slides.
CROI Cure Reflections Video Series
Produced by PAVE (Pediatric Adolescent Virus Elimination), this weekly series of four videos provides HIV cure-related takeaways from CROI 2026.
More videos forthcoming!