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[link removed] June 18, 2025


** FDA Approves Injectable LEN for PrEP
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A Historic Milestone Must Now Be Matched by Urgent Action

Dear Advocate,

AVAC welcomes the U.S. Food and Drug Administration (FDA) approval of injectable lenacapavir (LEN ([link removed]) ) as pre-exposure prophylaxis (PrEP). Developed by Gilead Sciences, LEN is a twice-yearly injectable PrEP option ([link removed]) that showed nearly complete protection against HIV in the landmark PURPOSE 1 and 2 trials ([link removed]) . Science Magazine named LEN the “Breakthrough of the Year ([link removed]) ” in 2024, a recognition that reflects its enormous potential. But that promise will only be realized if it is rolled out with speed, scale, and equity.

In our statement issued earlier today ([link removed]) , we outline what’s needed from every stakeholder in the HIV response to meet this moment—and not squander yet another PrEP option.
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As outlined in our Gears of Lenacapavir for PrEP Rollout ([link removed]) , this moment demands unprecedented ambition, commitment, and leadership from governments, funders, implementers, policymakers, and civil society.
Advocacy Tools and Resources

Please check out all of AVAC’s advocacy tools and resources ([link removed]) to support our collective work in advancing equitable LEN rollout as part of comprehensive, integrated and sustained HIV programs.
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** Getting PrEP Rollout Right This Time ([link removed])
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Our new report examines key insights from the rollout of oral PrEP and early introduction of injectable cabotegravir and the dapivirine vaginal ring to inform a faster, smarter and more equitable introduction of future HIV prevention tools, including long-acting injectable PrEP, such as lenacapavir.


** Gears of Lenacapavir for PrEP Rollout ([link removed])
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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.
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** From Clinical Trial Efficacy to Public Health Impact: A Plan for Accelerating Access to Injectable Lenacapavir for PrEP ([link removed])
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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.
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** The Lens on LEN: The Basics on Injectable Lenacapavir as PrEP ([link removed])
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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.
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** Podcast — Lenacapavir: The case for investing in delivering HIV prevention ([link removed]) :
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This episode of PxPulse goes deep on LEN for PrEP laying out recent 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.

Media Coverage
• Regulators Approve a Twice-Yearly Shot to Prevent H.I.V. Infection ([link removed]) , The New York Times
• FDA approves powerful HIV drug that nearly eliminated spread in clinical trials ([link removed]) , NBC News

This is the moment for all stakeholders to build on the momentum science. LEN has moved faster through regulatory review than any prevention product to date. Now it’s up to all of us to make sure that that progress translates into real, sustained impact on the epidemic, led by communities around the world.

Let’s get to work.

Best,

AVAC
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AVAC Global Advocacy for HIV Prevention
+1 212 796 6423 [email protected] (mailto:[email protected]) www.avac.org ([link removed])
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