Doravirine vs ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 96-week results of a randomized, double-blind, non-inferiority, phase 3 trial
The Lancet HIV Jan 12, 2020
Molina JM, Squires K, Sax PE, et al. - Researchers reported 96-week data from the phase 3 DRIVE-FORWARD trial, in which doravirine was identified as non-inferior to ritonavir-boosted darunavir regarding efficacy, with a superior lipid profile, in HIV-positive adults who were treatment-naive at week 48. This phase 3 study was performed at 125 clinical centers in 15 countries. From December 1, 2014, to October 20, 2015, 1,027 individuals were screened. Of these, 769 participants received either doravirine (n = 385) or ritonavir-boosted darunavir (n = 384). Furthermore, at least one dose of the allocated treatment was given to 383 participants in both groups. At week 96, an HIV-1 RNA concentration of < 50 copies per mL was achieved in a higher proportion of the doravirine group (73%) than the darunavir group (66%). Treatment groups showed significant differences in mean changes from baseline in LDL cholesterol and non-HDL cholesterol. Outcomes at 96 weeks supported previous reports of efficacy and safety for doravirine at 48 weeks. These findings thus support the use of doravirine for the long-term treatment of adults with previously untreated HIV-1 infection.
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