Clinical trial results were similar to those of the drug in adults.
FDA approved a supplemental application for a popular hepatitis C drug for adults to be utilized in children.
FDA expanded the approval of sofosbuvir and velpatasvir (Epclusa, Gilead Sciences) from adults only to treat hepatitis C virus (HCV) in children ages 6 years and older or weighing at least 37 pounds with any of the six HCV genotypes-or strains-without cirrhosis (liver disease) or with mild cirrhosis.
“This approval will provide additional treatment options for children and adolescents with HCV,” says Debra Birnkrant, MD, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, in a press release. “This approval will also be important in settings where there is limited ability for health care professionals to conduct HCV genotype testing.”
The safety and efficacy of Epclusa for children was established in an open-label, multicenter clinical trial that included a total of 173 treatment-naÃ¯ve and treatment-experienced pediatric patients ages 6 years and older without cirrhosis or with mild cirrhosis.
“No meaningful differences in pharmacokinetics were seen in pediatric patients compared to adults. The safety and efficacy results were comparable to those observed in adults,” according to the FDA.
Epclusa includes a boxed warning that hepatitis B virus (HBV) reactivation has been reported in patients infected with both HCV and HBV who were taking or had completed treatment with HCV antivirals and were not taking HBV antivirals.
The most common adverse reactions observed with treatment with Epclusa were fatigue and headache-consistent with those observed in clinical trials of Epclusa in adults.