FDA approves two hepatitis C drugs for pediatric patients

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The U.S. Food and Drug Administration (FDA) has approved Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) for the treatment of hepatitis C in pediatric patients, ages 12 to 17.

According to the Centers for Disease Control and Prevention (CDC), about 46,000 children in the United States have hepatitis C. If left untreated, hepatitis C leads to the inflammation of the liver, reducing liver function, but these antiviral treatments are able to prevent the virus from advancing and in some cases even curing it.

“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 the FDA’s Center for Drug Evaluation and Research. 

Both approved for use in pediatric patients 12 years of age and older and over 77 pounds, these treatments address the six major strains of HCV. Harvoni, responsible for treating hepatitis C strains 1, 4, 5 and 6, has been tested on 100 pediatric patients and shown to eliminate 98 percent of the virus after 12 weeks of treatment. Sovaldi in combination with ribavirin, responsible of treating hepatitis C strains 2 and 3, has been tested in 50 pediatric patents and shown to eliminate the virus in 100 percent of patients with strain 1 and 97 percent of patients with strain 3 after 12 weeks of treatment.