HIV treatment Dovato (dolutegravir/lamivudine) approved in Japan

The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted marketing approval for Dovato, a treatment for HIV-1 infection.

The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Dovato (dolutegravir/lamivudine) for the treatment of HIV-1 infection. The oral drug is available for adults and adolescents above 12 years of age weighing at least 40kg.

The marketing authorisation for the once-daily, single-pill, two-drug regimen was granted to ViiV Healthcare. The tablet is formed of 50mg of dolutegravir which is an integrase inhibitor and 300mg of lamivudine, a nucleoside reverse transcriptase inhibitor.

Dovato inhibits the HIV cycle at two different sites. Dolutegravir inhibits HIV replication by preventing the viral DNA from integrating into the genetic material of T cells. This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Lamivudine works by interfering with the conversion of viral RNA into DNA which prevents the virus from multiplying.

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 two-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, two-drug regimen with the knowledge that efficacy is non-inferior to a three-drug regimen.”

The marketing authorisation is based upon data from global clinical trials that included more than 1,400 HIV-1 infected adults.

Dovato is also authorised by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of HIV-1 infection.