FDA approves HIV two-drug combo Dovato

The US Food and Drug Administration on Monday approved the investigational two-drug single-tablet regimen (STR) Dovato (dolutegravir/lamivudine) for the treatment for HIV-1 infection in adults who have not previously been treated with antiretroviral drugs.

Dovato, from ViiV Healthcare, which is majority owned by UK pharma major GlaxoSmithKline (LSE: GSK), reduces exposure to the number of ARVs from the start of treatment, while still maintaining the efficacy and high barrier to resistance of a traditional DTG-based three-drug regimen, according to ViiV Healthcare.

“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,” commented Deborah Waterhouse, chief executive of ViiV Healthcare.