The U.S. Food and Drug Administration approved supplemental applications for Sovaldi (sofosbuvir)
and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17.
Harvoni and Sovaldi were previously approved to treat HCV in adults.
These are the first direct-acting antiviral treatments approved for children and adolescents with HCV.
Direct-acting antiviral drugs reduce the amount of HCV in the body by preventing the virus from
multiplying, and in most cases, they cure HCV.
“These approvals will help change the landscape for HCV treatment by addressing an unmet need in
children and adolescents,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in
the FDA’s Center for Drug Evaluation and Research.
Today’s approvals provide pediatric treatment options for six major genotypes, or strains, of HCV.