The Food and Drug Administration has approved the use of Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) for the treatment of hepatitis C virus (HCV) in children aged 12 years and older.
The drugs – the first direct-acting, potentially curative antiviral treatments approved for children and adolescents with HCV – previously were approved for adults. The supplemental applications submitted by Gilead Sciences, which markets the drugs, were approved by the FDA on April 7 and expand the use of these drugs to pediatric patients aged 12 and up who weigh at least 77 pounds, and who have either mild or no cirrhosis; Sovaldi is indicated for those with HCV genotypes 2 or 3, and Harvoni is indicated for those with HCV genotypes 1, 4, 5, or 6.
“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 a press statement .
The safety, pharmacokinetics, and efficacy of the drugs as established in trials leading to their approval for adults were confirmed in open-label trials in the pediatric population. Adverse effects with Sovaldi, which was studied in combination with ribavirin, included headache and fatigue.
Of note, hepatitis B virus (HBV) reactivation has been reported in adults with HCV/HBV coinfection who were treated with these drugs, but who were not receiving HBV antiviral therapy; therefore, all patients should be screened for evidence of current or prior HBV infection before starting treatment with Harvoni or Sovaldi, according to the FDA statement.