The China National Medical Products Administration has approved Gilead’s fixed-dose combination HIV treatment Descovy (emtricitabine and tenofovir alafenamide).
Descovy is indicated in China for treating, in combination with other antiretroviral agents, HIV-1 patients aged 12 and older that weigh at least 77 lbs. Its approval stems from results of two Phase 3 studies that met their primary objectives of non-inferiority compared to a Stribild regimen.
Descovy comes with a boxed warning in the U.S. regarding the risks of post treatment acute exacerbation of hepatitis B. It received FDA and European Commission marketing approval in 2016.