Posted by Michael Wonder on 08 Apr 2019
FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment
8 April 2019 - The U.S. FDA today approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato.
This is the first FDA-approved two-drug, fixed-dose, complete regimen for HIV-infected adults who have never received treatment for HIV.
The efficacy and safety of Dovato, one tablet taken daily, were demonstrated in two identical, randomized, double-blind, controlled clinical trials in 1,433 HIV-infected adults with no prior antiretroviral treatment history.
