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News From the Food and Drug Administration
May 16, 2017

A First in HCV Drugs for Youths

JAMA. 2017;317(19):1942. doi:10.1001/jama.2017.5542

Children and teens aged 12 to 17 years who have hepatitis C virus (HCV) infection will have access to the same antiviral medications that are known to eliminate HCV infections in adults.

Sofosbuvir, marketed as Solvadi, and a combination of sofosbuvir and ledipasvir, marketed as Harvoni, are the first direct-acting antiviral treatments to gain FDA approval for pediatric patients with HCV infection. Direct-acting antivirals decrease HCV levels by preventing the virus from replicating. In most cases, FDA officials said, the drugs cure HCV infection.