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January 15, 2020

Japan approves ViiV’s two drug regimen Dovato for HIV

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).

By Allie Nawrat

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).

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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.”

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.

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What is the Global Healthcare and Pharma Market Q2 Outlook?

Given the background of high inflation, re-emerging supply chain issues, and the widespread macro-economic implications of the Ukraine conflict, the global pharmaceutical industry is facing an entirely new set of challenges following the turbulence of the COVID-19 pandemic. GlobalData’s World Markets Healthcare (WMH) service has released its latest Q2 forecast. This report incorporates the latest thinking on the opportunities and risks this new environment presents for pharma companies. However, the pharma sector is proving resilient, and we are projecting 4.4% global growth for the year ahead. Yet it remains that the current economic picture is inverting some baseline assumptions from previous quarterly forecasts and altering which markets we expect the key growth levers to derive from. Download our latest executive summary for a snapshot view of what our clients use to formulate winning strategies.
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