The European Commission has granted marketing authorisation for dolutegravir/lamivudine (Dovato) for the treatment of HIV-1 infection, announced ViiV Healthcare.
The combo pill is indicated for 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.
“For many years, the standard of care for treatment-naïve people living with HIV in Europe has been a three-drug regimen. The data from our dolutegravir-based two-drug regimen development programme challenges this, and with the authorisation of Dovato, people living with HIV can for the first time start treatment on a once-daily, single-pill, two-drug regimen with the knowledge that efficacy is non-inferior to a three-drug regimen whilst containing fewer antiretrovirals,” said Deborah Waterhouse, CEO, ViiV Healthcare in a statement.
Marketing authorisation for dolutegravir/lamivudine is supported by data from the 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 <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.
Dolutegravir 50 mg/ lamivudine 300 mg tablets was authorised by the US FDA in April 2019.
ViiV Healthcare, the specialist HIV company, is majority-owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders.