ViiV’s Dovato approved in Europe as treatment option for HIV-1

pharmafile | July 3, 2019 | News story | Research and Development, Sales and Marketing Dovato, GSK, HIV, ViiV Healthcare, pharma 

ViiV Healthcare, the specialist HIV firm majority owned by GSK, is celebrating the news that the European Commission has chosen to approve Dovato (dolutegravir/lamivudine) as a treatment for HIV-1 infection.

The marketing authorisation applies to patients over the age of 12 who also weigh at least 40kg and have no known or suspected resistance to the integrase inhibitor class, or lamivudine.

“The Marketing Authorisation of Dovato in Europe marks a significant development for people living with HIV. 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,” commented Dr John C Pottage Jr, Chief Scientific and Medical Officer at ViiV. “ViiV Healthcare’s ambition and innovative R&D programme aims to reduce the number of HIV drugs people living with HIV take over a lifetime and Dovato is an important addition to our portfolio of medicines to support this aim.”

The drug has already secured approval in the US, having been authorised by the FDA back in April this year. Europe sees around 25,000 new cases of HIV each year, and the need for those living with the condition to take antiretroviral treatments for life highlights the need for the introduction of alternative therapies.

Deborah Waterhouse, CEO at ViiV, commented: “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 strengthens ViiV Healthcare’s industry-leading portfolio of innovative treatment approaches for people living with HIV.”

Matt Fellows

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