Dovato gets EMA approval for HIV-1 infection

ViiV Healthcare with Pfizer Inc. and Shionogi Limited as shareholders, announced that the European Commission has granted Marketing Authorisation for Dovato (dolutegravir/lamivudine) 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.

Marketing Authorisation for Dovato is supported by data from the landmark global GEMINI 1 and 2 studies that included more than 1,400 HIV-1 infected adults. In these studies, dolutegravir and 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 and lamivudine seen in GEMINI 1 and 2 were consistent with the product labelling for dolutegravir and lamivudine. Four patients (1%) in both the dolutegravir and lamivudine, and the dolutegravir and TDF/FTC, study arms experienced drug-related serious adverse events, and 15 patients (2%) in the dolutegravir and lamivudine arm and 16 patients (2%) in the dolutegravir and TDF/FTC arm had adverse events that led to discontinuation. The most common adverse reactions included headache, diarrhoea, nausea, insomnia, and fatigue. No patient who experienced virologic failure in either treatment arm developed treatment-emergent resistance also up to week 48.

Comment: This treatment allows individuals to take a two-drug regimen in a single pill with dolutegravir at the core, building on the established potency and safety profiles of dolutegravir and lamivudine.