Published by John Wiley & Sons, Inc., Hepatology is available online via Wiley InterScience at http://www.interscience.wiley.com/journal/hepatology.
HCV is usually asymptomatic in children though it can lead to serious liver damage. Treatment with interferon is standard and induces lasting remission in more than a third of infected children. The addition of ribavirin to treatment with interferon has been shown to markedly improve outcomes for adults with HCV, but the combination has not been extensively studied in children. Led by Regino Gonzlez-Peralta, M.D. of the Division of Pediatric Gastroenterology, Hepatology, and Nutrition at the University of Florida, researchers addressed combination therapy for children with a twofold program.
The first part searched for the optimal dose of ribavirin for children with HCV while testing the drug's safety and efficacy. Fifty-six children, ages five to 16, were randomly assigned to take interferon along with ribavirin in varying doses for 48 weeks. They were evaluated for efficacy and side effects at regular intervals, and followed-up for an additional 24 weeks. By the end of the follow-up period, 35 percent of children taking 8 mg/kg/day of ribavirin, 37 percent taking 12 mg/kg/day, and 47 percent of 15/mg/kg/day had undetectable levels of HCV in their blood. Side effects were similar among all doses. Based on this data, the researchers selected the dosage 15 mg/kg/day for further study.