FDA approves Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus in children ages 12 to 17- Gilead Sciences

The FDA has approved supplemental application for Harvoni (ledipasvir and sofosbuvir), from Gilead Sciences, to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni was previously approved to treat HCV in adults. Along with Sovaldi, Harvoni is 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. The approval provides pediatric treatment options for six major genotypes, or strains, of HCV. Harvoni is indicated for the treatment of pediatric patients 12 years of age and older or weighing at least 77 pounds (35 kilograms) with HCV genotype 1, 4, 5 or 6 infection without cirrhosis (liver disease) or with mild cirrhosis.

The safety, pharmacokinetics (how the body absorbs, distributes and rids itself of a drug) and efficacy of Harvoni for the treatment of HCV genotype 1 infection were established in an open-label, multicenter clinical trial that included 100 pediatric patients 12 years of age and older. The results were comparable to those observed in adults and demonstrated that 98 percent of patients had no virus detected in the blood 12 weeks after finishing treatment, suggesting the patients' infections were cured. The safety and efficacy of Harvoni for treatment of HCV genotypes 4, 5 or 6 infection in pediatric patients 12 years of age and older is based on data showing similar exposures (amount of drug in the body) to Harvoni in adults and adolescents with HCV genotype 1 infection, as well as similar efficacy and exposures to Harvoni across HCV genotypes 1, 4, 5 and 6 in adults. The most common adverse reactions observed with treatment with Harvoni were fatigue and headache.