×
ADVERTISEMENT

JUNE 16, 2021

FDA Approves New Formulation of Epclusa; Expands HCV Indication for Children as Young as 3

By SPC News Staff

The FDA approved an expanded indication for sofosbuvir-velpatasvir (Epclusa, Gilead Sciences) to treat chronic hepatitis C virus (HCV) in children as young as 3 years of age, regardless of HCV genotype or liver disease severity. 

The approval of sofosbuvir-velpatasvir for children as young as 3 years of age is based on data from a phase 2, open-label clinical trial that enrolled 41 children 3 to less than 6 years of age to be treated with the drug for 12 weeks. At 12 weeks