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Lenacapavir Regulatory Approval

Regulatory approvals, pending decisions, and appeals as of February 2026.

AVAC Infographics for CROI 2026

Going to CROI? AVAC’s up-to-date infographics — on the research & development pipeline, prevention options, and the impact of US funding cuts — are available here for use in conference presentations. We constantly update these graphics, so check back for updates. The latest version of the deck will be available here.

Source of Lenacapavir for PrEP Supply to Early Adopter Countries

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 planned to start in early 2026.

Lenacapavir Implementation Studies

Ongoing and planned implementation studies for the lenacapavir as of February 2026.

AVAC vs DoS Updated Page

Speeding Up Access to PrEP

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.

HIV Vaccine Clinical Trials Pipeline

This graphic summarizes the state of HIV vaccine research, detailing the different immunological approaches in clinical trials, the specific candidates being studied, and the collaborative networks of funders and developers working toward an effective vaccine.

Change in PrEP Initiations from 2024 to 2025 in Five Countries

Between the period January-September 2024 to January-September 2025, PrEP initiations fell between 13% and 66% in selected high-volume PrEP countries where ministries of health (MoH) were able to provide data. Among the five countries depicted, four saw significant decline in PrEP uptake. All four relied on PEPFAR PrEP programs and were disrupted by stop work orders (SWO).

PxWire Volume 16, Issue 1

This issue showcases the status of access to oral PrEP with the best data available since the US foreign aid freeze disrupted PEPFAR operations. Stakeholders are digging deep to meet the moment, which includes an unprecedented opportunity to drive down HIV incidence with the rollout of lenacapavir. Lastly, our update on the HIV vaccine R&D pipeline documents an evolving and diverse portfolio of products, which remains essential for a durable end to HIV as a global health threat.

EXPrESSIVE Phase III Program Countries of MK-8527

Seventeen countries are hosting sites for the Phase 3 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 3 trials at IAS 2025 in Kigali. MK-8527 was found to be safe and well-tolerated in Phase 2 clinical trials.