ViiV Healthcare’s human immunodeficiency virus (HIV) drug Dovato (dolutegravir 50mg/lamivudine 300mg) has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW).
Dovato is a once-daily, single pill, two-drug regimen approved to treat adults and adolescents aged over 12 with HIV type 1 (HIV-1) infection who weigh more than 40kg.
The drug is composed of Tivicay (dolutegravir), which is an integrase inhibitor (INI), and Epivir (lamivudine), which is a nucleoside reverse transcriptase inhibitor (NRTI). This dual mechanism of action means the drug inhibits the viral cycle of HIV at two sites.
ViiV Healthcare Japan president Dustin Haines commented: “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.”
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The MHLW’s decision to approve Dovato based upon data from the global GEMINI 1 and 2 studies of more than 1,400 HIV-1 infected adults.
In these studies, Dovato demonstrated non-inferiority at week 48 in treatment-naïve patients, compared to the three-drug regimen standard of care of dolutegravir and two NRTIs. This non-inferiority was measured by HIV-1 RNA having less than 50 copies per millilitre, which is the standard measure of HIV control.
The company’s director of medical affairs in Japan Dr Ichiro Koga added: “The authorisation of Dovato in Japan marks a significant development for people living with HIV.
“ViiV Healthcare’s ambition and innovative R&D programme aim to reduce the number of HIV medicines people living with HIV take over a lifetime and Dovato is an important addition to our portfolio of medicines to help support this aim.”
In addition, the safety profile of Dovato in the GEMINI 1 and 2 studies was consistent with its existing product labelling. This drug has already been approved in the European Union and the US for certain groups of HIV patients.