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FDA approves label changes for Sovaldi, Harvoni in children with HCV

The FDA approved changes to the labeling of direct-acting antivirals Sovaldi and Harvoni to include information on dosage and administration in pediatric patients with hepatitis C aged 3 years to younger than 12 years.

Sovaldi (sofosbuvir, Gilead Sciences) is indicated for the treatment of chronic HCV genotype 2 or genotype 3 in patients aged 3 years or older without cirrhosis or with compensated cirrhosis regardless of treatment experience.

Sofosbuvir should be administered with ribavirin for 12 weeks in patients with genotype 2 and for 24 weeks in those with genotype 3. The DAA can be administered as tablets or oral pellets with or without food based on the patient’s weight.

Adverse events to sofosbuvir with ribavirin were consistent with those observed in clinical studies of adult patients. Decreased appetite occurred in 13% of patients.

Harvoni (sofosbuvir/ledipasvir, Gilead Sciences) is indicated for the treatment of chronic HCV in pediatric patients aged 3 years and older with genotype 1, 4, 5 or 6 without cirrhosis or with compensated cirrhosis; in those with genotype 1 with decompensated cirrhosis; and with combination ribavirin in liver transplant recipients with genotype 1 or 4 without cirrhosis or with compensated cirrhosis.

Administration of sofosbuvir/ledipasvir should continue for 12 weeks in most patients and for 24 weeks in treatment-experienced patients with compensated cirrhosis. Patients can receive either tablets or oral pellets.

Adverse events to sofosbuvir/ledipasvir were also consistent with those observed in adults with no grade 3 or grade 4 adverse reactions or discontinuation due to adverse events.

Reference: www.fda.gov