FDA OKs applications for hepatitis C treatment in children

The medications' effectiveness would be based on their ability to minimize the amount of HCV in the prescribed individual.
The medications' effectiveness would be based on their ability to minimize the amount of HCV in the prescribed individual. | File photo

The U.S. Food and Drug Administration has approved two applications for treatments of hepatitis C in children.

The applications submitted were for the medications Harvoni and Sovaldi, and each is suitable for children 12-17. The medications would be the first of this type of antiviral treatment for children.

"These approvals will help change the landscape for HCV treatment by addressing an unmet need in children and adolescents," Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said.

The medications' effectiveness would be based on their ability to minimize the amount of HCV in the prescribed individual, making contracting the disease less likely. Both medications have been tested for safety, and the side effects of Sovaldi when combined with ribavirin are fatigue and headache. The same side effects are true of Harvoni.

Between 2.7 million and 3.9 million people in the U.S. have chronic HCV, according to the CDC, and children whose mothers had HCV are more likely to contract the disease.

Both Sovaldi and Harvoni are marketed by Gilead Sciences Inc.