Where We Are Now with LEN for PrEP

The chaos in foreign assistance programs (including discontinuation of major PrEP programs), cuts in staffing and new demands on donor commitments will make decisions on the procurement of LEN for PrEP more complex and uncertain.

In December 2024, the Global Fund and PEPFAR announced a plan to reach 2 million people with LEN for PrEP over three years. Exactly how funding to support this unprecedented introduction program will move forward is far from certain. The other stakeholders, including Global Fund, Gilead, CIFF and the Gates Foundation expressed commitments to the deal and are making progress, but major questions remain.

AVAC Input for Recompetition of the NIAID HIV/AIDS Clinical Trials Networks

AVAC’s formal input submitted on the re-competition of the NIAID HIV/AIDS Clinical Trials Networks. The recommendations were informed by the People’s Research Agenda (PRA), a comprehensive framework developed through consultations with over 130 community representatives across 23 countries.

Download

HIV Prevention Product Overview

The graphic provides an overview of PrEP products currently available and in late-stage clinical trials.

PrEP Price Comparison

Comparing the annual price of oral TDF/FTC vs. the dapivirine vaginal ring and injectable cabotegravir. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.

Lenacapavir Regulatory Approval

Regulatory approvals, pending decisions, and appeals as of September 2025, including US Food and Drug Administration approval. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.

Cabotegravir Regulatory Approval

Regulatory approvals and those pending for cabotegravir as of September 2025. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.

Dapivirine Vaginal Ring Regulatory Approval

Regulatory approvals, pending decisions, and appeals as of September 2025. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.

Addressing Transgender Erasure in HIV Clinical Trials

The scorecard for transgender and gender-diverse inclusion

Scorecard indicators reveal a dearth of HIV research responsive to the needs of transgender and gender-diverse (TGD) communities. The lack of TGD representation in HIV clinical trials indicates a historical erasure of TGD communities with potential public health consequences. The scorecard might guide future HIV research to be more responsive to the needs of TGD people. Published in the American Journal of Public Health.

Download

EXPrESSIVE Phase 3 Trials

Seventeen countries are hosting sites for Merck’s trials of a monthly pill for PrEP. Launch is expected in Q3 2025. This graphic shows where these trials are taking place.

This file is also available to download as a PowerPoint file.

Moving a Product to the Real World

The rollout of oral PrEP demonstrates that people don’t take PrEP simply because it’s available—there needs to be a demand for it, and it needs to be accessible, acceptable and used effectively by those who need and want it. These are the lessons the field is applying to the rollout of the dapivirine vaginal ring (DVR), and injectable cabotegravir (CAB) and lenacapavir (LEN) for PrEP. To reach the UNAIDS target of 10 million PrEP users by 2025, initiations of oral PrEP alone will not be enough—and this graphic shows that the field is beginning to apply past lessons to accelerate introduction of injectable PrEP options.

Download this as a PowerPoint file. And for the latest on lenacapavir, visit here.