Lenacapavir is an investigational antiretroviral drug that is being studied as a potential PrEP product. One key difference from injectable cabotegravir for PrEP (CAB for PrEP), injectable lencapavir (injectable LEN) is being studied as a subcutaneous injection making it eligible for self-injection. In contrast, CAB for PrEP is an intermuscular injection in the buttocks and requires privacy. Two Phase III trials are underway, conducted by Gilead, to determine the efficacy of lenacapavir as a six-month injection.
Lenacapavir is the second injectable ARV to be tested in late phase efficacy trials for PrEP. The first, CAB for PrEP, was approved by the FDA in December 2021. Learn more about CAB for PrEP here.
Lenacapavir’s introduction is being supported by the Coalition to Accelerate Access to Long-Acting PrEP, which brings together leading donors, agencies, and advocates aimed at a practical goal: jointly develop strategies and take coordinated action to identify and overcome access challenges to just-approved and future PrEP options. AVAC serves as the Secretariat. Find more on the Coalition and its work on the Coalition’s project page on AVAC.org.
This trial is being conducted among approximately 5,000 cisgender women in South Africa and Uganda. Purpose 1 is designed to test the efficacy of both injectable lenacapavir, given as an injection every six months, and emtricitabine/tenofovir alafenamide (F/TAF), given as a daily pill, in preventing HIV acquisition. Purpose 1 is scheduled to run until July 2027. More details here.
Conducted among 3,000 men who have sex with men, gay men, transgender men and transgender women, and gender non-binary people in Argentina, Brazil, Mexico, Peru, Puerto Rico, South Africa, Thailand, the USA, and Vietnam. This study is testing the efficacy of lenacapavir as PrEP given as an injection every 6 months. Purpose 2 is scheduled to run until April 2027. More details here.
Visit the Integrated Study Dashboard to stay up to date on all currently known activities relating to implementation research, modelling, clinical trials, open label extensions, and landscaping for new late stage biomedical HIV PrEP options, including lenacapavir.
The FDA placed a hold on both studies in December 2021 due to concerns about compatibility of the glass vials with the lenacapavir solution. The FDA lifted that hold in May 2022 and the trials are ongoing.