Once-Daily Doravirine in HIV-1-Infected, Antiretroviral-Naive Adults: An Integrated Efficacy Analysis.

Abstract

BACKGROUND\nDoravirine (DOR) demonstrated noninferior efficacy to darunavir plus ritonavir (DRV+r) and efavirenz (EFV) in 2 ongoing phase 3 trials: DRIVE-FORWARD (NCT02275780) and DRIVE-AHEAD (NCT02403674).\n\n\nMETHODS\nThis prespecified analysis pooled efficacy data through the first 48 weeks of DRIVE-FORWARD and DRIVE-AHEAD from the DOR groups (DOR/lamivudine [3TC]/tenofovir disoproxil fumarate [TDF] or DOR [100 mg QD] with emtricitabine [FTC]/TDF or abacavir [ABC]/3TC [n=747]), compared with DRV+r (800/100 mg QD) with FTC/TDF or ABC/3TC (n=383), or EFV/FTC/TDF (600/200/300 mg QD; n=364). Efficacy assessments included the proportion of participants with human immunodeficiency virus type 1 (HIV-1) RNA <50 copies/mL and change in CD4+ T-cell count.\n\n\nRESULTS\nAt week 48, 84.1% of DOR-treated participants achieved HIV-1 RNA <50 copies/mL versus 79.9% of the DRV+r-treated group and 80.8% of the EFV/FTC/TDF-treated group; results were similar across demographic/prognostic subpopulations, including baseline plasma HIV-1 RNA, gender, race, and HIV-1 subtype. Mean increases from baseline in CD4+ T-cell count through 48 weeks were 195.5 cells/mm3 for DOR, 185.6 cells/mm3 for DRV+r, and 188.4 cells/mm3 for EFV/FTC/TDF.\n\n\nCONCLUSIONS\nDOR, as a single entity (in combination with other antiretroviral agents) and as a fixed-dose combination (DOR/3TC/TDF), demonstrated noninferior efficacy to DRV+r and EFV as assessed by the proportion of HIV-1-infected, treatment-naïve adults with HIV-1 RNA <50 copies/mL.