ViiV Healthcare announced that it received the approval of Dovato (dolutegravir 50 mg/lamivudine 300 mg) from the Japan Ministry of Health, Labour, and Welfare (MHLW). The drug indicated in adults and adolescents above 12 years of age suffering from HIV-1.
The drug is a two-day regimen with an integrase inhibitor (dolutegravir) with nucleoside reverse transcriptase inhibitor (lamivudine).
“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 program has, however, challenged this. With the authorization 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” said Dustin Haines, President, ViiV Healthcare Japan.
The approval of the drug was based on GEMINI 1 and 2 studies. These included more than 1,400 HIV-1 infected adults. The primary endpoint was HIV-1 RNA <50 copies per millilitre (c/mL) at week 48. The drug showed non-inferiority compared to a three-drug regimen of dolutegravir and two NRTIs, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), in treatment-naïve, HIV-1 infected adults.
Dovato is approved in Europe and the United States. The drug acts by preventing the integration of viral DNA with the genetic material of human T cells.