A week-48 randomized phase-3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients.

ABSTRACT:

Objectives

To investigate efficacy and safety of a single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg vs. darunavir/cobicistat plus emtricitabine/tenofovir disoproxyl fumarate (TDF) (control) in antiretroviral-treatment-naive, HIV-1-infected adults.

Design

Phase-3, randomized, active-controlled, double-blind, international, multicenter, noninferiority study (NCT02431247).

Methods

Seven hundred and twenty-five participants were randomized (1 : 1) to D/C/F/TAF (362) or control (363). The primary objective was to demonstrate noninferiority of D/C/F/TAF vs. control for percentage viral load less than 50 copies/ml (FDA-snapshot analysis) at 48 weeks (10% margin).

Results

At week 48, D/C/F/TAF was noninferi

SUBMITTER: Eron JJ 

PROVIDER: S-EPMC6039393 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature