ViiV Healthcare secures Japanese approval for Dovato to treat HIV-1 infection

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.

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