Genvoya first TAF-based regimen approved in China for adults and adolescents with HIV

6 August 2018

The China National Drug Administration (CNDA) has approved Genvoya(elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg or E/C/F/TAF) for the treatment of HIV-1 infection.

Developed and marketed by US biotech major Gilead Science (Nasdaq: GILD), Genvoya is the first TAF-based single tablet regimen for the treatment of HIV to be approved in China. The drug was approved in both the USA and Europe in 2015.

Genvoya is indicated in China as a complete regimen for the treatment of adults and adolescents (aged 12 years and older with a body weight of at least 35kg) infected with HIV-1 without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir. In the USA, Genvoya has a boxed warning in its product label regarding the risks of post treatment acute exacerbation of hepatitis B.

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