ViiV Healthcare has picked up European marketing authorisation for Dovato for treating HIV-1 in adults and adolescents over 12.
Dovato (dolutegravir/lamivudine) is a new once-daily single pill two-drug regiment for treating HIV-1 infection.
The authorisation is supported by data from the landmark global GEMINI 1 & 2 studies that included more than 1,400 HIV-1 infected adults.
“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,” said John C. Pottage, Jr, Chief Scientific and Medical Officer at ViiV Healthcare.”
CEO Deborah Waterhouse added: “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.”
Dovato was authorised by the US FDA in April 2019.