LONDON (Alliance News) - GlaxoSmithKline PLC on Monday said Dovato has been approved in the US as a treatment for HIV-1 infection in adults who have not previously been treated with antiretroviral drugs.
Dovato is a two-drug regimen of dolutegravir and lamivudine and is taken once per day as a single tablet. It is approved as a complete regimen to treat HIV-1 in adults who have not taken antiretrovirals before and have no known resistance to either dolutegravir or lamivudine.
The US Food & Drug Administration approved Dovato on the basis of the Gemini 1 and 2 studies, which included more than 1,400 patients infected with HIV-1. These studies showed Dovato to be as effective as the standard three-drug regimen.
Dovato was developed by ViiV Healthcare, a specialist HIV company that was founded by Glaxo and Pfizer Inc in 2009. Shionogi & Co Ltd, a Japanese pharma company, joined ViiV Healthcare in 2012.
ViiV Healthcare Chief Executive Deborah Waterhouse said: "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."