In 2024, Gilead Sciences released findings from the PURPOSE 1 and PURPOSE 2 trials testing lenacapavir (LEN) as HIV prevention. The PURPOSE 1 trial found 100% efficacy in preventing HIV in 5,300 cisgender women in Uganda and South Africa, and the PURPOSE 2 trial showed a 96% reduction in HIV incidence among cisgender men, trans, and non-binary individuals across multiple countries. Both trials demonstrated LEN’s safety and effectiveness in reducing HIV transmission. In June 2025, the FDA approved injectable LEN for PrEP.
In September 2025, the Gates Foundation and Unitaid committed to accelerate access to generic versions of LEN on the heels of the Global Fund and PEPFAR re-committing to their December 2024 announcement of reaching two million people with LEN for PrEP within three years, with drug supplies coming from the originator company, Gilead Sciences.
The field is moving faster than the first decade of oral PrEP and the rollout of injectable cabotegravir, propelled by exemplary advocacy and improved coordination among stakeholders. But making lenacapavir, and new prevention options, available to all who need it requires even greater speed, scale, and equity. Ongoing community-led strategic action must continue and accelerate.
Explore AVAC’s key LEN resources to inform your advocacy
Infographics
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This framework for lenacapavir scale-up outlines the key actions, stakeholders and milestones needed to support the rapid, equitable and sustainable introduction of lenacapavir (LEN) for HIV prevention.
This graphic shows the latest status of all five LEN clinical trials including the groundbreaking results of PURPOSE 1 and PURPOSE 2.
This graphic illustrates how the field is applying lessons from past product introductions to accelerate introduction of new prevention options.
This graphic lays out the development timelines for LEN and injectable cabotegravir (CAB), showing how earlier licensing, technology transfer and shorter bioequivalence timelines could accelerate the availability of LEN.
This timeline tracks the regulatory approval process for LEN from late 2024 through early 2026.
This graphic compares the annual price of PrEP options in LMICs.
The graphic provides an overview of PrEP products currently available and in late-stage clinical trials.
This graphic estimates the potential demand for LEN across the top 16 PrEP markets, showing how many people could choose LEN based on current oral PrEP use and projected preferences for long-acting HIV prevention.
Using the current oral PrEP market as a baseline, this graphic estimates what demand for LEN could look like through 2028 and shows how current donor commitments stack up against that opportunity.
This graphic tracks the global regulatory status of LEN, showing where the product has been approved, where decisions are pending or under review, and where regulatory appeals are underway. Visit our dashboard on PrEPWatch.org.
This infographic tracks ongoing and planned implementation studies of LEN, showing where countries are generating the evidence needed to guide rollout, delivery models and equitable scale-up, visit our dashboard on PrEPWatch.org.
This graphic illustrates how LEN supply is expected to expand over time, from initial rollout to generic availability.
This timeline compares the introduction of LEN with previous PrEP products, showing how the field is applying lessons from earlier rollouts to accelerate equitable access and avoid repeating past delays.
Read
- Getting PrEP Rollout Right This Time
This report examines key insights from the rollout of oral PrEP and early introduction of injectable cabotegravir (CAB) and the dapivirine vaginal ring (DVR) to inform a faster, smarter and more equitable introduction of future HIV prevention tools, including long-acting injectable PrEP, such as lenacapavir. - Now What With Injectable LEN For PrEP?
This fact sheet is intended to help outline what is actually known – and not – and what needs to happen next.
- Gears of Lenacapavir for PrEP Rollout
This document outlines a focused plan for LEN for PrEP rollout over the next few years, specifying priorities by stakeholder and evaluating volume and pricing strategies. The report as a whole details a coordinated response to this historic opportunity to ensure rapid implementation, equitable access, and sustainable impact.
- From Clinical Trial Efficacy to Public Health Impact: A Plan for Accelerating Access to Injectable Lenacapavir for PrEP
This plan provides a broad view of all the moving parts and identifies actions and actors responsible for ensuring time is not wasted and opportunity not squandered.
- The Lens on LEN: The Basics on Injectable Lenacapavir as PrEP
This advocates’ primer provides background on lenacapavir for PrEP and its trials; a summary of the early findings of PURPOSE 1 & 2; key questions and next steps.
- Advocates’ Guide to Lenacapavir
This wide-ranging slide deck gives a complete overview of lenacapavir — showing the overall prevention product pipeline, describes lenacapavir, compares it to other options, discusses the trials testing the product, next steps, and links to advocacy resources.
In the News
- AVAC Applauds Agreements to Accelerate Market Development for Lenacapavir for PrEP.
Read AVAC’s statement on what the Gates Foundation and Unitaid’s commitments to accelerate the development of, access to and price reduction for generic versions of LEN mean for the field and what needs to happen next. - Opinion: The world has a new HIV prevention drug. Let’s use it.
There is hope for a new 5 by 3 global target of getting 5 million people on long-acting PrEP to prevent HIV by 2030.
- Access Questions Hang Over Gilead’s HIV Shot
“For all of the wonders of product development, PrEP has not even begun to have the impact we need it to,” said Mitchell Warren, AVAC’s executive director in this Axios news story. - AVAC Calls on Gilead and Global Stakeholders to Accelerate Access to Generic Lenacapavir Following License Agreements
Read AVAC’s statement welcoming Gilead Sciences’ announcement in granting multiple, non-exclusive licenses to generic manufacturers to produce lenacapavir, their investigational twice-a-year injectable for PrEP, while it is still in clinical trials.
Listen
Podcast: Lenacapavir: The case for investing in delivering HIV prevention
This episode of PxPulse goes deep on LEN for PrEP. Recorded just days before Gilead’s announcement that PURPOSE 2 also found very high efficacy, Dr. Flavia Kiweewa, a principal investigator of PURPOSE 1, the first trial to announce efficacy, lays out the research findings and what they mean. And Chilufya Kasanda Hampongo of Zambia’s Treatment Advocacy and Literacy Campaign and Mitchell Warren of AVAC talk about how to change a long history of squandered opportunities to get rollout right.
Watch
- The Scientific Journey of Lenacapavir: From basic science to clinical development to impact
Hosted by AVAC, this webinar explored how US support from NIH for basic science and South Africa’s clinical research infrastructure made possible the development of lenacapavir for PrEP (LEN), a discovery in HIV prevention that went on to be named Science magazine’s 2024 Breakthrough of the Year. - Update on Injectable Lenacapavir for PrEP
AVAC hosted a webinar focused on updates for the PURPOSE trials for injectable lenacapavir for PrEP. Gilead provided an overview of the PURPOSE 1 and 2 trial results and insight into the status of PURPOSE 3, 4, and 5. This was be an opportunity for civil society to hear from Gilead directly. - Breaking Ground: Expanding Access to Lenacapavir
This webinar hosted by Unitaid Advocates Network brought together global health experts, community advocates, and civil society organizations to discuss the challenges and opportunities in ensuring equitable access to Lenacapavir. - AVAC Welcomes FDA Approval of LEN
AVAC’s executive director, Mitchell Warren explains this historic milestone and what’s needed to ensure it’s rolled out with speed, scale, and equity.