26 Apri 2019 - Recommendation based on landmark GEMINI 1 & 2 studies which demonstrated non-inferior efficacy of dolutegravir + lamivudine compared to a traditional dolutegravir-based, three-drug regimen, in HIV-1 infected, treatment-naïve adults.
ViiV Healthcare today announced that the CHMP of the EMA has issued a positive opinion recommending marketing authorisation for Dovato, for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.