Dual therapy based on co-formulated darunavir/ritonavir plus lamivudine for initial therapy of HIV infection: The ANDES randomized controlled trial

•The dual therapy strategy was based on co-formulated protease inhibitors plus lamivudine in treatment-naïve people living with human immunodeficiency virus.•This randomized trial shows the non-inferiority of a fixed dose co-formulation of darunavir/ritonavir (DRV/r) combined with lamivudine (3TC) compared with a three-drug regimen based on these drugs plus tenofovir.•The combination was well tolerated.•Co-formulated DRV/r plus 3TC is an effective and safe option as initial antiretroviral therapy. Tenofovir-containing antiretroviral therapy regimens may have long-term toxicity-related side effects. This study aimed to compare the virological efficacy of co-formulated darunavir/ritonavir plus lamivudine with darunavir/ritonavir plus tenofovir and emtricitabine or lamivudine. The ANDES study was a 48-week, phase 4, randomized, open-label, non-inferiority trial in treatment-naïve adults living with human immunodeficiency virus (HIV). Patients were randomized on a 1:1 basis to receive a daily oral regimen of either dual therapy based on a generic co-formulation of darunavir/ritonavir (800/100 mg) plus a generic lamivudine 300 mg pill, or triple therapy with darunavir/ritonavir plus tenofovir/emtricitabine (300/200 mg) or tenofovir/lamivudine (300/300 mg). The primary endpoint was the proportion of patients with a viral load of