HIV combo drug Dovato gets Japan approval

HIV specialist company ViiV Healthcare, which is majority-owned by UK pharma major GlaxoSmithKline (LSE: GSK), says it has obtained approval of Dovato (dolutegravir 50mg/lamivudine 300mg) from the Japan Ministry of Health, Labor and Welfare (MHLW) for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40kg, to be administered orally, with or without food.

Dovato is a once-daily, single-pill, 2-drug regimen (2DR) for treatment-naïve HIV infection that combines dolutegravir, an integrase inhibitor (INI), with the nucleoside reverse transcriptase inhibitor (NRTI) 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,” commented Dustin Haines, president of ViiV Healthcare Japan.