FDA approves Sovaldi, Harvoni for pediatric patients with HCV
The FDA has approved Sovaldi and Harvoni as supplemental applications for the treatment of hepatitis C in children aged 12 to 17 years, according to an FDA news release.
“These approvals will help change the landscape for HCV treatment by addressing an unmet need in children and adolescents,” Edward Cox, MD, director of the office of antimicrobial products in the FDA’s Center for Drug Evaluation and Research, said in the release.
Sovaldi (sofosbuvir, Gilead) in combination with ribavirin is indicated for the treatment of pediatric patients 12 years and older or at least 77 lb with HCV genotype 2 or 3 without cirrhosis or with mild cirrhosis.
The safety and efficacy of sofosbuvir in combination with ribavirin for pediatric patients was evaluated in an open-label clinical trial of 50 patients 12 years or older. Results were comparable to those observed in adults. At 12 weeks, all patients with genotype 2 and 97% of patients with genotype 3 had no virus detection. The most common adverse events were fatigue and headache.
Harvoni (ledipasvir/sofosbuvir, Gilead) is indicated for the treatment of pediatric patients 12 years and older or at least 77 lb with HCV genotypes 1, 4, 5 or 6 without cirrhosis or with mild cirrhosis.
The safety and efficacy of ledipasvir/sofosbuvir for pediatric patients with genotype 1 was evaluated in an open-label clinical trial of 100 patients 12 years and older. Results were comparable to those observed in adults. At 12 weeks, 98% of patients had no virus detection. Treatment for genotypes 4, 5 and 6 showed similar safety and efficacy profiles.
According to the FDA, because hepatitis B reactivation has been reported in HCV/HBV coinfected adult patients who underwent or had completed treatment with direct-acting antivirals, all patients, including pediatric patients, should be screened for evidence of current or prior HBV.