Objectives: To determine the safety and efficacy of interferon-alpha therapy of chronic hepatitis C virus (HCV) infection in children.
Study design: This was an open-labeled prospective trial of interferon-alpha-2a (IFN-alpha) in children with evidence of HCV infection for at least 6 months. Twenty-three children were enrolled and treated with IFN-alpha at a dosage of 3 million units/m2 three times weekly. Beginning in 1995 patients defined as complete or partial responders after 6 months were offered an additional 6 months of treatment. Endpoints were alanine aminotransferase normalization and loss of hepatitis C viral ribonucleic acid from serum. Responders were compared with nonresponders for age, gender, duration of infection, pretreatment alanine aminotransferase and hepatitis C viral ribonucleic acid levels, saturation of serum iron-binding capacity, histologic score of chronic hepatitis and viral genotype. Statistical methods used for these comparisons included the Kruskal-Wallis test, the Mann-Whitney two-sample test and the Fisher exact test.
Results: Of the 21 children who completed at least 6 months of treatment, 4 (19%) had complete response, 8 (38%) had partial response and 9 (43%) had no response. Three of the 4 complete responders had prolonged treatment; in 2 the response was maintained. One responder relapsed but responded to a second, longer course of treatment. Four of the 8 partial responders had prolonged therapy and 3 of them became complete responders. One child who was originally a nonresponder lost HCV RNA within the first year after therapy. Thus eventually 7 (33%) of 21 patients were complete responders. After at least 12 months of follow-up on most of these children, no relapses have been observed. No differences in any of the variables tested could be demonstrated between responders and nonresponders, but small sample size limits power. IFN-alpha was discontinued in only one child because of side effects, and temporary dosage adjustments were needed in 4 children.
Conclusions: IFN-alpha is of some efficacy in the treatment of chronic HCV infection in children. Complete or partial responders at 6 months should undergo prolonged treatment.