Gilead Sciences Inc.'s once-daily HIV-1 regimen Biktarvy has been approved for use by Japan's Ministry of Health, Labour and Welfare.
Foster City, Calif.-based Gilead's Biktarvy tablet combines bictegravir and two additional HIV medicines, emtricitabine and tenofovir alafenamide, or Descovy, also manufactured by Gilead.
The Japanese approval was based on data from four phase 3 studies that included 2,415 patients. Two of these studies, dubbed 1489 and 1490, were carried out in HIV-1 infected adults who had never undergone treatment, while the other two studies, known as 1844 and 1878, included virologically suppressed adults. After 48 weeks of treatment, Biktarvy met the main goal of showing non-inferiority to standard therapy in all four studies.
The once-daily single tablet regimen was approved in the U.S. in February 2018 to treat HIV-1 infection.