Dovato is a once-daily, single-pill, 2-drug regimen that combines integrase inhibitor (INI) dolutegravir, and the nucleoside reverse transcriptase inhibitor (NRTI) lamivudine
ViiV Healthcare secures regulatory approval for Dovato regimen in Japan. (Credit: GlaxoSmithKline plc.)
ViiV Healthcare, a majority-owned company of GlaxoSmithKline (GSK), has received the Japan Ministry of Health, Labour and Welfare (MHLW) marketing approval of Dovato regimen for the treatment of HIV-1 infection in adults.
Dovato is a once-daily, single-pill, 2-drug regimen that combines integrase inhibitor (INI) dolutegravir, and the nucleoside reverse transcriptase inhibitor (NRTI) lamivudine, indicated for HIV-1 infection in adults and adolescents aged 12 years or more, weighing 40kg or more.
The regimen works by inhibiting the viral cycle at two different sites, where INIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells, and NRTI interferes with the conversion of viral ribonucleic acid (RNA) into deoxyribonucleic acid (DNA).
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 regimen is a combination of dolutegravir and lamivudine for HIV infected patients
The company said that the marketing authorisation of Dovato is based on the data from GEMINI 1 & 2 studies, conducted on more than 1,400 HIV-1 infected adults.
The Dovato regimen has shown positive results for efficacy compared to a three-drug regimen of dolutegravir and two NRTIs, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC).
The safety results for Dovato regimen in GEMINI 1 & 2 trials were consistent with the product labelling. Headache, diarrhoea, nausea, insomnia, and fatigue include the most common adverse reactions.
Dovato regimen has received the EU authorisation and the US Food and Drug Administration (FDA) authorisation for the treatment of HIV-1 infection in adults and adolescents.
ViiV Healthcare Japan medical affairs director Ichiro Koga said: “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.”