Shots:

• The US FDA has approved sNDA for Epclusa (sofosbuvir 400mg/velpatasvir 100mg; sofosbuvir 200mg/velpatasvir 50 mg) to treat patients with HCV as young as 6 years of age or weighing at least 17 kg- regardless of HCV genotype or liver disease severity
• The approval is based on P-II Study 1143 assessing Epclusa in 175 patients for 12wks. The study showed SVR rate (93% in patients with genotype 1 HCV infection & 100% with genotype 2-3-4 & 6 HCV infection in children aged 12 to <18 yrs.) and a SVR rate (93% in genotype 1 HCV infection- 91 % in genotype 3 HCV infection- and 100% in genotype 2 & 4 HCV infection)
• The expanded approval of Epclusa will help eligible children living with HCV to combat life-threatening and debilitating disease and the therapy has received the FDA & EMA’s approval for treating adults in 2016

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