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 is due to begin arriving in countries in late 2025 with service delivery planned to start in early 2026.
Source of Lenacapavir for PrEP Supply to Early Adopter Countries
Lenacapavir Regulatory Approval
Regulatory approvals, pending decisions, and appeals as of December 2025. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.
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.
And for the latest on lenacapavir, visit here.
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.
Preparing for LEN
Learning Lessons, Accelerating Access, Reducing Time to Impact
In the first year since efficacy results were reported, LEN for PrEP has achieved critical milestones in record time compared to oral PrEP, the dapivirine vaginal ring, and injectable cabotegravir. Speed, scale, and equity are still needed to deliver impact.
View the interactive version on our comprehensive page on all things lenacapavir. And the animated GIF version is available for download.
Source of Programmatic Cabotegravir for PrEP Supply
The first supplies of injectable cabotegravir for programmatic use (as opposed to use in implementation studies) began to arrive in countries in 2024. Currently, 16 countries are rolling out CAB for programmatic use, with the majority of supply provided by PEPFAR, and some additional quantities procured by the Global Fund.
HIV Prevention R&D at Risk
Tracking the Impact of US Funding Cuts
The US presidential administration is actively working to dismantle HIV research and demolish the architecture of global health. The entire HIV response — from basic research and clinical development to policy, programs, and global access to life-saving treatment and prevention — is now under attack, and the world runs the risk of reversing the strides made to end HIV.
AVAC has put together this report, highlighting the impact of US cuts on the pipeline of HIV prevention research and development. AVAC will continue to track these cuts and their impact, to amplify the damage they will cause, and to fight for their reversal.
STIWatch Quarterly Newsletter
Q4 Newsletter: November 2025
As many global health fields reassess their reliance on US government funding for research and development, the STI field—already underfunded and reliant on alternate donors—now faces even greater uncertainty. In this newsletter, we share a new STI resource for advocates and highlight the top issues we’re monitoring as events continue to unfold.
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.