ViiV Healthcare has secured approval from the US Food and Drug Administration (FDA) for its Dovato (dolutegravir/lamivudine) for treatment-naïve HIV-1 adults.
The approval has been granted for a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50mg and lamivudine (3TC) 300mg to treat HIV-1 infection in adults with no antiretroviral (ARV) treatment history and with no known resistance to either DTG or 3TC.
Dovato is a two-drug regimen (2DR) developed to reduce exposure to the number of ARVs from the start of treatment and maintain the efficacy and high barrier to resistance of a traditional DTG-based three-drug regimen.
ViiV Healthcare CEO Deborah Waterhouse said: “Building on our innovative portfolio of medicines, Dovato is powered by dolutegravir, an antiretroviral included in multiple combination therapies and the most prescribed integrase inhibitor in the world, coupled with the established profile of lamivudine.
“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.”
The approval was based on data from the Gemini 1 and 2 studies, which recruited over 1,400 HIV-1 infected adults.
The studies showed that DTG + 3TC exhibited non-inferiority based on plasma HIV-1 RNA <50 copies per milliliter (c/mL) at week 48 when compared to a three-drug regimen of DTG and two nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), in treatment-naïve HIV-1 infected adults.
Gemini 1 and Gemini 2 are duplicate, phase III, randomized, double-blind, multicenter, parallel group and non-inferiority studies designed to assess the efficacy and safety of once-daily dolutegravir and lamivudine compared to once-daily dolutegravir and the fixed-dose combination of TDF/FTC at 48 weeks in HIV-1-infected, ART-naïve adult participants.
Gemini study program 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.”
DTG/3TC as a complete, once-daily, single-tablet, two-drug regimen for HIV-1 therapy is currently under assessment by the European Medicines Agency (EMA) and regulatory authorities in Canada, Australia, Switzerland, and South Africa. The company is also planning several additional submissions during this year.