The FDA has approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir) to treat hepatitis C virus (HCV) infection in children 12 to 17 years of age. Harvoni and Sovaldi were previously approved to treat HCV infection in adults. Both products are marketed by Gilead Sciences.
Harvoni and Sovaldi are now the first direct-acting antiviral treatments approved for children and adolescents infected by HCV. Direct-acting antiviral drugs reduce the amount of HCV in the body by preventing the virus from multiplying, and in most cases they cure the disease.
The new approvals provide pediatric treatment options for six major genotypes (strains) of HCV. Harvoni is indicated for the treatment of pediatric patients 12 years of age and older or weighing at least 77 pounds (35 kg) with HCV genotype 1, 4, 5, or 6 infection without cirrhosis or with mild cirrhosis. Sovaldi in combination with ribavirin is indicated for the treatment of pediatric patients 12 years of age and older or weighing at least 77 pounds (35 kg) 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 trial that included 100 pediatric patients 12 years of age and older. The results were comparable with those observed in adults and demonstrated that 98% of patients had no virus detected in the blood 12 weeks after finishing treatment, suggesting that the patients’ infections were cured.
The safety and efficacy of Harvoni for the treatment of HCV genotype 4, 5, or 6 infection in pediatric patients 12 years of age and older were demonstrated by 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.
Fatigue and headache were the most common adverse events associated with treatment with Harvoni.
The combination of Sovaldi and ribavirin was evaluated in an open-label clinical trial that included 50 pediatric patients 12 years of age and older. The results in this group were comparable with those observed in adults. All of the patients with HCV genotype 2 and 97% of those with HCV genotype 3 had no virus detected in the blood 12 weeks after completing treatment.
Fatigue and headache were the most common adverse events associated with Sovaldi in combination with ribavirin. All contraindications to ribavirin also apply to Sovaldi combination therapy.
Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected adults 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 medications has 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.
Source: FDA; April 7, 2017.