China approval for Biktarvy

9 August 2019

The China National Medical Products Administration (NMPA) 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.

Developed by US biotech major Gilead Sciences (Nasdaq: GILD), 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.

In China, Biktarvy is indicated for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.

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