This randomized trial compared two antiretroviral regimens in 447 therapy-naive adults with advanced HIV disease across seven European countries. Participants received either bictegravir, emtricitabine, and tenofovir alafenamide or darunavir, cobicistat, emtricitabine, and tenofovir alafenamide. The study followed patients for 48 weeks to see who experienced virological or clinical events first.
The results showed that the integrase inhibitor group had a lower rate of the composite primary outcome. Specifically, 22% of patients in the integrase inhibitor group experienced an event compared to 32% in the boosted protease inhibitor group. Drug-related adverse events of grade 2 or higher also occurred less often in the integrase inhibitor group at 7% versus 14%.
Serious adverse events and discontinuations did not differ between the two groups. Deaths were not related to the study drugs. The trial was underpowered to determine which specific antiretrovirals perform best in people with advanced HIV disease. Funding came from Gilead Sciences and Janssen Pharmaceuticals. These findings support using the integrase inhibitor regimen as a preferred first-line option for this patient group.