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.
This trial is being conducted among approximately 5,000 cisgender women in South Africa. 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 June 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 Puerto Rico, South Africa and the USA. 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.
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.