ViiV Wins Adolescent HIV Use for Dovato

FDA has approved ViiV Healthcare’s Dovato (dolutegravir/lamivudine) for treating HIV-1 infection in adolescents 12 years of age and older with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed. Approval is based on data from the DANCE study which evaluated the therapy in treatment-naïve adolescents, as well as evidence from well-controlled trials in adults living with HIV (GEMINI-1 and GEMINI-2 (treatment-naïve adults) and TANGO (treatment-experienced adults), according to the company. “The safety and efficacy data in adolescents from the DANCE study were comparable to those observed in adults,” it says. Dovato is described as a once-daily, single-tablet that combines the integrase strand transfer inhibitor dolutegravir (50 mg) with the nucleoside reverse transcriptase inhibitor lamivudine (300 mg).