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Source of Lenacapavir for PrEP Supply to Early Adopter Countries
November 2026
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 in Africa
November 2026
Lenacapavir for PrEP has now reached seventeen countries in Africa. This map offers more detail on the LEN rollout.
Global Health Watch: A New Congress and a New Cadre of Scientific Leadership, US FDA Approves Generic LEN, Future of Global Fund
November 2026
The US midterm elections this week brought significant changes to Congress, creating both new opportunities and uncertainties for the future of science, global health and HIV. This is a moment that is both “celebratory and scary,” with much to unpack about what a new Congress will mean for US policies and investments. With potentially more than 100 new members taking office in January, the need for education, engagement and advocacy will be critical to securing supportive policies and sustainable funding for US-led global health programs and research. This issue examines what the election results mean for science and global health, the US FDA regulatory approval of generic lenacapavir for HIV PrEP (LEN), and Mark Dybul’s vision for the Global Fund amid shrinking resources and shifting priorities.
Preparing for LEN
November 2026
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.
Now What with Injectable LEN for PrEP
November 2026
Since results of the PURPOSE efficacy trials were announced in 2024, injectable lenacapavir for PrEP (LEN) has generated enormous excitement and opportunity – and frustration. By the end of 2024, Gilead Sciences provided six voluntary licenses to generic manufacturers and submitted multiple regulatory filings, and the Global Fund and PEPFAR committed to an ambition to reach two million people over three years, pending regulatory approvals and WHO guidelines. It seemed like bold ambition – and it was, compared to the previous launches of oral PrEP, vaginal ring and CAB.
But this ambition was always defined as a floor, not a ceiling. In April 2026, the collaboration increased the goal to reach three million people over three years with LEN for PrEP. In July 2025, AVAC published a first edition of Now What with Injectable LEN for PrEP, outlining priorities to ensure introduction moved swiftly. Now, in this update, AVAC is calling for a new minimum floor: reach three million in two years (2026-2027). No less and no slower, with a push for more and faster.
HIV Prevention Product Overview
November 2026
The graphic provides an overview of PrEP products currently available and in late-stage clinical trials.
Moving a Product to the Real World
November 2026
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 cabotegravir.
Going Faster with LEN Generics
November 2026
The timeline for generic LEN for PrEP to come to market is expected to be significantly shorter than for CAB for PrEP. Bioequivalence (BE) testing for LEN, which demonstrates a generic product works in the body in the same way as the originator product, is likely to be six months, vs. the 18 months for CAB for PrEP, because of differences in the drug formulation.
Years Ahead in HIV Prevention Research: Time to Market
November 2026
This timeline shows the potential time points when the next-generation of HIV prevention options might find their way into new programs.
Where We Are Now with LEN for PrEP
November 2026
This timeline tracks the regulatory approval process for lenacapavir (LEN) for HIV prevention from late 2024 through late 2026. Key milestones include FDA Priority Review status, FDA approval in June 2025, expected subsequent approvals from European regulators and WHO, and Global Fund and PEPFAR commitment to roll out LEN to three million people over the next three years.
showing 1-10 of 2334