FDA approved supplemental applications for 2 primary hepatitis C medications to be used in children for the first time.
The agency said sofosbuvir (Sovaldi) and ledipasvir/ sofosbuvir (Harvoni), both marketed by Gilead Sciences, can now treat hepatitis C virus (HCV) in children aged 12 to 17 years.
“These approvals will help change the landscape for HCV treatment by addressing an unmet need in children and adolescents,” said Edward Cox, MD, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research, in a FDA statement.
It is estimated that there are 23,000 to 46,000 children in the US with HCV infection, FDA said.
Harvoni is indicated for the treatment of pediatric patients aged 12 years and older or weighing at least 77 pounds with HCV genotype 1, 4, 5 or 6 infection without cirrhosis (liver disease) or with mild cirrhosis. Sovaldi in combination with ribavirin is indicated for the treatment of pediatric patients 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 safety, pharmacokinetics, 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 aged 12 years and older. The results were comparable to those observed in adults and demonstrated that 98% 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 aged 12 years and older is based on data showing similar exposures 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.
Sovaldi in combination with ribavirin was evaluated in an open-label clinical trial that included 50 pediatric patients aged 12 years and older. The results were comparable to those observed in adults and 100% of patients with HCV genotype 2, and 97% 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.
Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected adult patients who were undergoing or had completed treatment with HCV direct-acting antivirals, and who were not receiving HBV antiviral therapy.
“HBV reactivation in patients treated with direct-acting antiviral medicines resulted in serious liver problems or death. Health care professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with Harvoni or Sovaldi,” FDA said.