Shots:

• The US FDA has approved the NDA of an oral pellet formulation of Epclusa (sofosbuvir 200 mg/velpatasvir 50 mg and sofosbuvir 150 mg/velpatasvir 37.5 mg) for children aged 3 yrs. who cannot swallow tablets
• The approval is based on a P-II trial evaluating Epclusa in 41 children with HCV for 12 wks. The study showed 83% SVR rate- 88% in HCV genotype 1- 50% in HCV genotype 2- and 100% in HCV genotype 3 & 4- discontinued treatment within one to 20 days of starting treatment who did not achieve cure
• The expanded approval and oral pellet formulation of Epclusa will help children living with HCV- regardless of HCV genotype or liver disease severity

  | Ref: Business Wire | Image:Gilead