Gilead’s Vosevi (sofosbuvir, velpatasvir and voxilaprevir) Receives NMPA’s Approval for Chronic Hepatitis C Infection Who Require Re-Treatment

Gilead’s Biktarvy (Bictegravir, Emtricitabine and Tenofovir Alafenamide) Receives MHLW’s Approval for HIV-1 Infection in Japan


  • The approval is based on two P-III studies POLARIS-1 and POLARIS-4 assessing Vosevi in patients with HCV genotype 1-6 with or without compensated cirrhosis who had failed prior DAA treatment with or without an NS5A inhibitor
  • The study resulted in 97% of patients achieved 1EP @SVR12 to determine cure rate, defined as HCV RNA undetectable 12 weeks after completing therapy
  • Vosevi is a combination of (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg) administered once daily and has a boxed warning of the risk of Hepatitis B virus reactivation in HCV/HBV coinfected, also received the US FDA’s and EMA’s marketing approval in 2017

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