European Commission Greenlights Drug-Sparing Dovato for HIV

Megan Brooks

July 03, 2019

The European Commission has approved the fixed-dose combination of dolutegravir and lamivudine (Dovato, ViiV Healthcare) for HIV-1 infection.

Dovato contains 50 mg dolutegravir, an integrase inhibitor, and 300 mg lamivudine, a nucleoside analogue. It is indicated for treatment-naïve adults and children older than 12 years weighing at least 40 kg with no known or suspected resistance to the integrase inhibitor class or lamivudine.

The European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval in April, as reported by Medscape Medical News.

"For many years, the standard of care for treatment-naïve people living with HIV in Europe has been a 3-drug regimen," ViiV Healthcare chief executive officer Deborah Waterhouse commented in a news release.

"The data from our dolutegravir-based 2-drug regimen development program challenges this, and with the authorization of Dovato, people living with HIV can for the first time start treatment on a once-daily, single-pill, 2-drug regimen with the knowledge that efficacy is non-inferior to a 3-drug regimen whilst containing fewer antiretrovirals," Waterhouse said.

The efficacy and safety of Dovato were demonstrated in two identical, randomized, double-blind, controlled clinical trials (GEMINI 1 and 2) that included more than 1400 HIV-infected adults with no prior antiretroviral treatment history.

In these studies, Dovato was noninferior based on plasma HIV-1 RNA < 50 copies/mL, a standard measure of HIV-1 control, at week 48 when compared with a three-drug regimen of dolutegravir and two nucleoside reverse transcriptase inhibitors (tenofovir disoproxil fumarate/emtricitabine).

The safety results for Dovato were in line with the product labeling for both drugs separately. The most common adverse reactions with Dovato were headache, diarrhea, nausea, insomnia, and fatigue. No patient who experienced virologic failure in either treatment group developed treatment-emergent resistance.

The US Food and Drug Administration approved Dovato in April, as reported by Medscape Medical News.

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