EU Panel Backs Dolutegravir/Lamivudine Combo Pill for HIV

Megan Brooks

April 26, 2019

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of 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 substitutions associated with resistance to the integrase inhibitor class or lamivudine.

"Advances in HIV treatment mean that people living with HIV are living longer, and are taking daily medication over a longer period of time. Today's CHMP positive opinion for Dovato is an important step towards providing treatment-naïve people living with HIV in Europe the first once-daily, single-pill, complete 2-drug regimen for the treatment of HIV," John C. Pottage, Jr, MD, chief scientific medical officer, ViiV Healthcare, said in a news release.

The US Food and Drug Administration approved Dovato earlier this month, as reported by Medscape Medical News .

The efficacy and safety of Dovato were shown in two identical, randomized, double-blind, controlled clinical trials (GEMINI 1 and 2) that included more than 1400 HIV-1-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 consistent 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.

A final decision on marketing authorization by the European Commission is expected in the next several months, the company said.

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