Japanese approval for Biktarvy for HIV-1

26 March 2019

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection.

US biotech major Gilead Sciences’ (Nasdaq: GILD) HIV triplet Biktarvy combines the novel, unboosted integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of the Descovy (emtricitabine 200mg/tenofovir alafenamide 25mg; FTC/TAF) dual nucleoside reverse transcriptase inhibitor (NRTI) backbone, and is the smallest INSTI-based triple-therapy STR available. Biktarvy is the first HIV product that Gilead will launch and commercialize in Japan directly through its local subsidiary, Gilead Sciences KK. Gilead’s shares moved up 1.26% to $64.60 by early afternoon trading in New York.

In the USA, Biktarvy has a Boxed Warning in its product label regarding the risk of post-treatment acute exacerbation of hepatitis B.

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