INTERFERON-ALPHA TREATMENT OF CHRONIC HEPATITIS-C VIRUS-INFECTION IN CHILDREN

Objectives. To determine the safety and efficacy of interferon-alpha t herapy of chronic hepatitis C virus (HCV) infection in children. Study design. This was an open-labeled prospective trial of interferon-alph a-2a (IFN-alpha) in children with evidence of HCV infection for at lea st 6 months, Twenty-three children were enrolled and treated with IFN- alpha at a dosage of 3 million units/m(2) three times weekly. Beginnin g in 1995 patients defined as complete or partial responders after 6 m onths 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 nonresponde rs for age, gender, duration of infection, pretreatment alanine aminot ransferase and hepatitis C viral ribonucleic acid levels, saturation o f serum iron-binding capacity, histologic score of chronic hepatitis a nd viral genotype. Statistical methods used for these comparisons incl uded 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 par tial response and 9 (43%) had no response. Three of the 4 complete res ponders had prolonged treatment; in 2 the response was maintained. One responder re lapsed but responded to a second, longer course of treat ment. Four of the 8 partial responders had prolonged therapy and 3 of them became complete responders. One child who was originally a nonres ponder lost HCV RNA within the first year after therapy. Thus eventual ly 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 o bserved. No differences in any of the variables tested could be demons trated between responders and nonresponders, but small sample size lim its power. IFN-alpha was discontinued in only one child because of sid e effects, and temporary dosage adjustments were needed in 4 children. Conclusions. IFN-alpha is of some efficacy in the treatment of chroni c HCV infection in children. Complete or partial responders at 6 month s should undergo prolonged treatment.