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Peginterferon alfa‐2b plus ribavirin treatment in children and adolescents with chronic hepatitis C
Author(s) -
Wirth Stefan,
PieperBoustani Heidrun,
Lang Thomas,
Ballauff Antje,
Kullmer Ulrike,
Gerner Patrick,
Wintermeyer Philip,
Jenke Andreas
Publication year - 2005
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.20661
Subject(s) - ribavirin , medicine , tolerability , gastroenterology , dosing , hepatitis c , peginterferon alfa 2a , adverse effect , chronic hepatitis , immunology , virus
Peginterferon plus ribavirin is standard therapy for adults with chronic hepatitis C. As no data are available for children, the aim of the study was to evaluate the efficacy and tolerability of peginterferon alfa‐2b in combination with ribavirin in chronically infected children. Genotypes, alanine aminotransferase levels, and different routes of viral transmission were considered. In an open‐labeled, uncontrolled pilot study, 62 children and adolescents (range, 2–17 years) were treated with subcutaneous peginterferon alfa‐2b at a dose of 1.5 μg/kg body weight once per week plus oral ribavirin (15 mg/kg × day) for 48 weeks. Sixty‐one patients completed the study. Twenty‐three children discontinued therapy after 6 months according to study protocol. Sustained viral response was documented in 22 (47.8%)of 46 patients with genotype 1, in 13 (100%) of 13 with genotype 2 or 3, in 1 of 2 with genotype 4, in 19 (70.4%) of 27 children with parenteral, in 12 (48%) of 25 with vertical, and in 5 of 9 with unknown route of infection. Overall, treatment was well tolerated. Nevertheless, some side effects were present in all treated patients. Eighty‐three percent had leucopenia, but only 3 individuals required dose reduction and 10.3% developed thyroid autoantibodies and thyroid dysfunction. In conclusion , combination treatment of peginterferon alfa‐2b with ribavirin showed encouraging results and was well tolerated in children and adolescents with chronic hepatitis C. Weekly dosing of peginterferon alfa‐2b is a considerable advance for this age group. The treatment is not approved for children. Further controlled trials are needed. (H EPATOLOGY 2005.)