Dovato EMA approval : The European Commission (EC) has approved ViiV Healthcare’s once-daily, single-pill, two-drug regimen Dovato (dolutegravir/lamivudine) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

Dovato EMA approval

The European approval for Dovato is for adults and adolescents aged over 12 years, weighing more than 40 kg, with no known or suspected resistance to lamivudine or integrase inhibitor class.

Dovato is the combination of dolutegravir (Tivicay, 50mg), an integrase strand transfer inhibitor (INSTI), and lamivudine (Epivir, 300mg), a nucleoside analogue reverse transcriptase inhibitor (NRTI).

Dovato EMA approval was driven by the findings of the Gemini 1 and 2 clinical trials, which was done on 1,400 adults infected with HIV-1.

The two-drug regimen, at week 48, demonstrated non-inferior efficacy based on plasma HIV-1 RNS <50 copies per ml, in the two studies. This was in comparison to the three-drug regimen of dolutegravir and two nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in HIV-1 infected adults, who were treatment-naïve.

In April 2019, ViiV Healthcare secured Dovato FDA approval in the US for the treatment of HIV-1 in adults without an antiretroviral (ARV) treatment history and with no known resistance to its constituent drugs – dolutegravir and lamivudine.

Commenting on Dovato EMA approval, Deborah Waterhouse – CEO of ViiV Healthcare, said: “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.”

ViiV Healthcare is a specialist HIV company, which was formed in 2009 by GlaxoSmithKline (GSK) and Pfizer, who were joined by Japanese pharma company Shionogi in 2012.

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  Deborah Waterhouse, dolutegravir, Dovato, Epivir, Europe, European Commission, GlaxoSmithKline, HIV, HIV-1, lamivudine, Tivicay, ViiV Healthcare