FDA approves Sovaldi (sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17- Gilead Sciences

The FDA has approved supplemental applications for Sovaldi (sofosbuvir), from Gilead Sciences, to treat hepatitis C virus (HCV) in children ages 12 to 17. Sovaldi were previously approved to treat HCV in adults. Along with Harvoni, it is the first direct-acting antiviral treatment 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. The approval provides pediatric treatment options for six major genotypes, or strains, of HCV. Sovaldi in combination with ribavirin is indicated for the treatment of pediatric patients 12 years of age and older or weighing at least 77 pounds (35 kilograms) with genotype 2 or 3 HCV infection without cirrhosis or with mild cirrhosis.

Sovaldi in combination with ribavirin was evaluated in an open-label clinical trial that included 50 pediatric patients 12 years of age and older. The results were comparable to those observed in adults and 100 percent of patients with HCV genotype 2, and 97 percent of patients with HCV genotype 3 had no virus detected in the blood 12 weeks after finishing treatment. The most common adverse events observed with Sovaldi in combination with ribavirin were fatigue and headache. All contraindications to ribavirin also apply to Sovaldi combination therapy.