Japan welcomes approval of ViiV’s Dovato for HIV-1
pharmafile | January 17, 2020 | News story | Medical Communications, Sales and Marketing | Dovato, Japan, ViiV Healthcare, pharma
Japan’s Ministry of Health, Labour and Welfare (MHLW) has awarded marketing approval to ViiV Healthcare, a subsidiary of GSK, for its once-daily pill Dovato (dolutegravir 50 mg/lamivudine 300 mg) for the treatment-naïve HIV-1 infection in patients of at least 12 years old who weigh at least 40kg.
Data drawn from over 1,400 HIV-1 patients and submitted to the MHLW showed that Dovato proved non-inferior compared to the combination of dolutegravir and two NRTIs, tenofovir disoproxil fumarate/emtricitabine, in plasinma HIV-1 RNA <50 copies per millilitre (c/mL) at 48 weeks of treatment. .
“In Japan, the standard of care for treatment-naïve people living with HIV has been for many years with a three-drug regimen,” remarked Dustin Haines, President at ViiV Healthcare Japan. “The data from our dolutegravir-based 2-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, 2-drug regimen with the knowledge that efficacy is non-inferior to a three-drug regimen.”
Dr Ichiro Koga, Director Medical Affairs, ViiV Healthcare Japan, also commented: “The authorisation of Dovato in Japan marks a significant development for people living with HIV. This treatment allows individuals to take a 2-drug regimen in a once-daily, single-pill with dolutegravir at its core. 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.”
Matt Fellows
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