Virologically-suppressed adults with HIV may be one step closer to having another option for treatment now that Gilead's single-tablet regimen of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) has met its primary endpoint in a phase 3 trial.
Bictegravir is an integrase strand transfer inhibitor with a high barrier to resistance that is recommended for treatment of HIV in global guidelines. It is approved as a key component in the HIV treatment Biktarvy, a regimen first approved by the U.S. FDA in 2018. Lenacapvir is a first-in-class capsid inhibitor with no overlapping resistance to other existing drug classes. It is approved in multiple countries as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV.
The BIC/LEN combination is not currently approved anywhere in the world.
The Artistry-2 trial switched patients from Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to BIC/LEN. Results showed that BIC/LEN was statistically non-inferior to Biktarvy, with the percentage of patients with HIV-1 RNA levels ≥50 copies/mL at Week 48 meeting the primary efficacy endpoint.
Gilead will be combining these results with those from the Artistry-1 phase-3 trial to from the basis of its regulatory submissions.