Dovato, the two-drug regimen treating HIV developed by ViiV Healthcare, has been approved in Japan.
Dovato combines dolutegravir, an integrase inhibitor (INI), with the nucleoside reverse transcriptase inhibitor (NRTI) lamivudine.
The approval is supported by data from the landmark global GEMINI 1 & 2 studies that included more than 1,400 HIV-1 infected adults.
In these studies, dolutegravir and lamivudine demonstrated non-inferior efficacy based on plasma HIV-1 RNA <50 copies per millilitre (c/mL) – a standard measure of HIV control – at week 48 when compared to a three-drug regimen of dolutegravir and two NRTIs, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), in treatment-naïve, HIV-1 infected adults. The safety results for dolutegravir and lamivudine seen in GEMINI 1 & 2 were consistent with the product labelling for dolutegravir and lamivudine. Dustin Haines, President of ViiV Healthcare Japan, said: “In Japan, the standard of care for treatment-naïve people living with HIV has been for many years with a three-drug regimen. “The data from our dolutegravir-based 2-drug regimen development programme has, however, challenged this, and with the authorisation of Dovato, people living with HIV in Japan can, for the first time, start treatment on a once-daily, single-pill, 2-drug regimen with the knowledge that efficacy is non-inferior to a three-drug regimen.”