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On August 30, 2018, the FDA approved doravirine (DOR) in combination with NRTIs for initial therapy of adults with HIV. DOR, a new non-nucleoside reverse transcriptase inhibitor (NNRTI), is active against HIV that carries mutations conferring resistance to other drugs in this class (Clin Infect Dis 2018; [e-pub]). A coformulation of this drug with tenofovir disoproxil fumarate (TDF) and lamivudine (3TC) has also been approved for the same indication.
DOR was approved based on the results of two phase 3 randomized clinical trials in treatment-naive adults with HIV. In the DRIVE-AHEAD study, 728 participants received DOR/TDF/3TC or efavirenz/TDF/FTC. At week 48, DOR was noninferior to efavirenz in terms of virologic suppression (84% and 81%, r…