In continuation of my update on lenacapavir
lenacapavir
Bictegravir
Bictegravir plus lenacapavir (BIC/LEN) is an integrase strand transfer inhibitor (INSTI) and a capsid inhibitor combination in development for the treatment of HIV-1 infection.
Bictegravir was first FDA-approved as one of the ingredients in Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) for the treatment of HIV-1 infection in 2018.
Lenacapavir was first FDA-approved under the brand name Sunlenca for treatment of HIV-1 infection 2022, and Yeztugo for pre‑exposure prophylaxis (PrEP) in 2025.
Bictegravir plus lenacapavir is a once-daily, single-tablet regimen designed to provide sustained virologic suppression with a high barrier to resistance.
A New Drug Application (NDA) has been submitted to the U.S. FDA for the treatment of HIV in adults who are virologically suppressed. The NDA submission was supported by positive Phase 3 data from the ARTISTRY-1 (NCT05502341) and ARTISTRY-2 (NCT06333808) trials, which evaluated BIC/LEN in adults with HIV with virological suppression, including those who switched from complex multi-tablet regimens or from Biktarvy. In both trials, BIC/LEN demonstrated comparable efficacy in maintaining virological suppression at Week 48 and was generally well tolerated, with no significant or new safety concerns identified.
- ARTISTRY-1 enrolled the oldest study population in a Phase 3 HIV treatment registrational trial to date. The Week 48 data presented at CROI 2026 showed the treatment switch to BIC/LEN from complex regimens was also associated with improvements in certain fasting lipid parameters and patient-reported treatment satisfaction. Detailed ARTISTRY-1 results were published in The Lancet on March 28, 2026.
- ARTISTRY-2 showed that switching to BIC/LEN had no significant impact on weight.
The FDA has granted priority review of the NDA and has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 27, 2026
https://en.wikipedia.org/wiki/Lenacapavir
https://en.wikipedia.org/wiki/Bictegravir
