Specialist HIV company ViiV Healthcare has secured Japanese approval for Dovato (dolutegravir 50mg/lamivudine 300mg) two-drug regimen to treat of HIV-1 infection.
The Japan Ministry of Health, Labour and Welfare (MHLW) has approved Dovato to treat HIV-1 infection in adults and adolescents above12 years of age with a minimum of around 40kg.
Dovato is a once-daily and single-pill, which combines dolutegravir integrase inhibitor (INI) with lamivudine nucleoside reverse transcriptase inhibitor (NRTI).
The approval was based on data from the global GEMINI 1 and 2 trials, which recruited over 1,400 HIV-1 infected adults.
According to the company, dolutegravir and lamivudine showed non-inferior efficacy based on plasma HIV-1 RNA <50 copies per millilitre (c/mL) 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 in the trials.
HIV-1 affects human immune cells known as CD4 T lymphocytes, a type of white blood cell that plays a significant role in the human immune system.
ViiV Healthcare Japan president Dustin Haines 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. 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.”
Dovato was already approved in the European Union (EU) to treat HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40kg.
The US Food and Drug Administration (FDA) approved Dovato once-daily and single-tablet regimen of dolutegravir 50mg and lamivudine 300mg to treat HIV-1 infection in adults with no antiretroviral (ARV) treatment history, as well as no known resistance to either dolutegravir or lamivudine.
In December 2019, ViiV Healthcare announced that it is seeking approval from the FDA for its fostemsavir to treat HIV-1 infection.