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.
The field is moving faster than the first decade of oral PrEP and the beginning 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.
Find critical resources to inform your advocacy below.
Read
From Clinical Trial Efficacy to Public Health Impact: A Plan for Accelerating Access to Injectable Lenacapavir for PrEP
This plan provides a comprehensive view of all the moving parts and identifies priority 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.
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.
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.
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
Breaking Ground: Expanding Access to Lenacapavir
This webinar hosted by UNITAID brought together global health experts, community advocates, and civil society organizations to discuss the challenges and opportunities in ensuring equitable access to Lenacapavir.
Infographics
The PURPOSE trials evaluate the safety and efficacy of injectable lenacapavir (LEN), an investigational antiretroviral (ARV) drug being studied as a potential PrEP product. This graphic shows the latest status of all five trials including the groundbreaking results of PURPOSE 1 and PURPOSE 2.
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.
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.