ViiV Healthcare's Dovato gains EU approval as two-drug, single-tablet regimen for patients with HIV

ViiV Healthcare announced Wednesday that the European Commission approved 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. The two-drug, single-tablet regimen gained clearance in the US in April.

Commenting on the latest approval, Deborah Waterhouse, chief executive of ViiV, which is majority owned by GlaxoSmithKline, with Pfizer and Shionogi as shareholders, noted that "for many years, the standard of care for treatment-naïve people living with HIV in Europe has been a three-drug regimen." Waterhouse added "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."

The approval of Dovato, which follows a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use in April, is supported by data from the GEMINI 1 and 2 studies. Results from the trials showed that Dovato was non-inferior in terms of efficacy to a three-drug regimen of ViiV's Tivicay (dolutegravir) and Gilead Sciences' Truvada (tenofovir disoproxil fumarate/emtricitabine) in treatment-naïve adults with HIV-1.

Dovato combines the integrase strand transfer inhibitor Tivicay with the nucleoside analogue reverse transcriptase inhibitor lamivudine. For related analysis, see Physician Views snap-poll results - More patients would prefer two-drug HIV regimens but threat of resistance will slow ViiV’s strategy, and KOL Views Results: Resistance fears will weigh on Dovato but TANGO switching study could be big boost, says leading HIV expert.

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