FDA Expands Harvoni, Sovaldi Hep C Treatments to include Children over 12

The FDA expanded the approvals of hepatitis C treatments Sovaldi and Harvoni to include children ages 12 to 17. Both antivirals, developed by Gilead Sciences, had previously been approved for adults.

Harvoni (ledipasvir and sofosbuvir) is indicated for the treatment of pediatric patients 12 years of age and older or weighing at least 35 kilograms with HCV genotype 1, 4, 5 or 6 infection without or with mild liver disease. Sovaldi (sofosbuvir), in combination with ribavirin, is indicated for patients 12 years of age and older or weighing at least 35 kilograms with genotype 2 or 3 HCV infection.

The approval was based in part on safety, pharmacokinetics and efficacy of Harvoni against genotype 1 infections in an open-label, multicenter clinical trial that included 100 pediatric patients over 12. The results were comparable to those observed in adults and demonstrated that 98 percent of patients had no virus detected in the blood 12 weeks after finishing treatment.

Treatment for genotypes 4, 5 or 6 was 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.