CHMP recommends approval of Dovato in HIV

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending marketing authorisation for Dovato (dolutegravir + lamivudine), from ViiV Healthcare, 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.

The Marketing Authorisation Application for the once-daily, single-pill, 2-drug regimen of Dovato is supported by data from the landmark global GEMINI 1 & 2 studies that included more than 1,400 HIV-1 infected adults. In these studies, dolutegravir + lamivudine demonstrated non-inferior efficacy based on plasma HIV-1 RNA less than 50 copies per millilitre (c/mL), a standard measure of HIV control, at Week 48 when compared to a three-drug regimen of dolutegravir and two nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), in treatment-naïve, HIV-1 infected adults. The safety results for dolutegravir + lamivudine seen in GEMINI 1 & 2 were consistent with the product labelling for dolutegravir and lamivudine. No patient who experienced virologic failure in either treatment arm developed treatment-emergent resistance.