The FDA approved supplemental applications for Sovaldi (sofosubuvir) and Harvoni (ledipasvir and sofosbuvir), marketed by Gilead Sciences Inc., to treat hepatitis C virus (HCV) in pediatric patients. Both drugs were previously approved to treat HCV in adults, but the latest approval expands use to include children aged 12 to 17 years old.
Harvoni is indicated to treat pediatric patients aged 12 years and older or weighing at least 77 pounds with HCV genotypes 1, 4, 5, or 6 infection without cirrhosis or with mild cirrhosis. Sovaldi, in combination with ribavirin, is indicated to treat children aged 12 years and older or weighing at least 77 pounds with genotype 2 or 3 HCV infection without cirrhosis or with mild cirrhosis.
The approval marks the first direct-acting antiviral treatments approved for children and adolescents with HCV.
The approval is based on data from clinical trials establishing the safety, pharmacokinetics, and efficacy of Harvoni and Sovaldi. An open-label, multicenter study including 100 pediatric patients aged 12 years and older showed no detection of virus 12 weeks after taking Harvoni in 98% of patients with HCV genotype 1. Harvoni treatment for HCV genotypes 4, 5, or 6 infection showed similar results in adults and adolescents. The most common adverse reactions observed were fatigue and headache.
Sovaldi, in combination with ribavirin, was evaluated in a study that included 50 pediatric patients aged 12 years and older, and the results were comparable to those observed in adults and 100% of patients with HCV genotype 2, and 97% of patients with genotype 3 had no virus detected in the blood 12 weeks after finishing treatment. The most common adverse events observed were fatigue and headache.
FDA approves two hepatitis C drugs for pediatric patients [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm551407.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
. Accessed April 7, 2017.