WASHINGTON — The Food and Drug Administration today approved supplemental applications for Gilead Sciences’ Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus in children ages 12 to 17.
According to the FDA, these are the first direct-acting antiviral treatments approved for children and adolescents with 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 HCV.
Harvoni and Sovaldi were previously approved to treat HCV in adults.
“These approvals will help change the landscape for HCV treatment by addressing an unmet need in children and adolescents,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
Friday’s approvals provide pediatric treatment options for six major genotypes, or strains, of HCV. Harvoni is indicated for the treatment of pediatric patients 12 years of age 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 12 years of age and older or weighing at least 77 pounds with genotype 2 or 3 HCV infection without cirrhosis or with mild cirrhosis.
HVC is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. According to the Centers for Disease Control and Prevention, an estimated 2.7 to 3.9 million people in the United States have chronic HCV, and children born to HCV-positive mothers are at risk for HCV infection. It is estimated that there are 23,000 to 46,000 children in the United States with HCV infection.
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 12 years of age and older. 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, suggesting the patients’ infections were cured.