Dovato is the first FDA-approved complete, two-drug regimen for treatment- naïve HIV-1 patients. Credit: NIAID.

ViiV Healthcare has received US Food and Drug Administration (FDA) approval for its single-tablet, two-drug regimen Dovato to treat human immunodeficiency virus type 1 (HIV-1) infection in adults.

Dovato is a combination of 50mg dolutegravir (DTG) and 300mg lamivudine (3TC). Dolutegravir is an integrase strand transfer inhibitor (INSTI), while lamivudine inhibits nucleoside analogue reverse transcriptase.

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The medication is the first FDA-approved complete, two-drug regimen for HIV-1 patients who are treatment-naïve for antiretroviral therapy (ARV). It is intended to minimise exposure to the number of ARVs.

ViiV Healthcare CEO Deborah Waterhouse said: “With Dovato, the first complete, single-tablet, two-drug regimen for treatment-naïve adults, ViiV Healthcare is delivering what patients are requesting, a chance to treat their HIV-1 infection with as few drugs as possible, marking a significant step in HIV treatment.”

“ViiV Healthcare is delivering what patients are requesting, a chance to treat their HIV-1 infection with as few drugs as possible.”

The FDA approval is based on data from the ongoing Phase III GEMINI 1 and 2 clinical trials meant to evaluate the safety and efficacy of once-daily Dovato in a total of more than 1,400 patients.

According to the trial results, Dovato showed non-inferiority in HIV-1 control at week 48, compared to a three-drug regimen comprising DTG, tenofovir disoproxil fumarate and emtricitabine.

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The safety profile of the two-drug regimen was observed to be consistent with the product labelling for DTG and 3TC. The most common adverse reactions were headache, diarrhoea, nausea, insomnia and fatigue.

GEMINI study programme principal investigator Pedro Cahn said: “The approval of the fixed dose combination of dolutegravir and lamivudine, a complete, single-tablet, two-drug regimen, marks a pivotal moment in the treatment of HIV-1.

“Treatment-naïve people living with the virus have a powerful option that delivers non-inferior efficacy to a dolutegravir-based three-drug regimen, allowing them to take fewer ARVs and get and remain suppressed.”

Dovato is currently being reviewed by regulators in the European Union, Canada, Australia, Switzerland and South Africa.

ViiV plans to file applications in additional markets over the coming months.