High sustained virologic response rates in children with chronic hepatitis C receiving peginterferon alfa-2b plus ribavirin

Stefan Wirth, Carmen Ribes-Koninckx, Maria Angeles Calzado, Flavia Bortolotti, Lucia Zancan, Paloma Jara, Mark Shelton, Nanda Kerkar, Marcela Galoppo, Alejandra Pedreira, Norberto Rodriguez-Baez, Mirta Ciocca, Alain Lachaux, Florence Lacaille, Thomas Lang, Ulrike Kullmer, Wolf Dietrich Huber, Teresita Gonzalez, Henry Pollack, Estella AlonsoPierre Broue, Jyoti Ramakrishna, Deborah Neigut, Antonio del Valle-Segarra, Bessie Hunter, Zachery Goodman, Christine R. Xu, Hanzhe Zheng, Stephanie Noviello, Vilma Sniukiene, Clifford Brass, Janice K. Albrecht

Research output: Contribution to journalArticle

107 Scopus citations

Abstract

Background & Aims: Pegylated interferon (PEG-IFN) alfa-2b plus ribavirin (RBV) is the standard of care for adults with chronic hepatitis C but was not approved for the treatment of children at the time of this study. The aim of this study was to evaluate the efficacy and safety of PEG-IFN alfa-2b plus RBV in children. Methods: Children and adolescents ages 3-17 years were treated with PEG-IFN alfa-2b (60 μg/m2/week) plus RBV (15 mg/kg/day). The duration of therapy was 24 weeks for genotype (G) 2 and G3 patients with low viral load (<600,000 IU/ml) and 48 weeks for G1, G4, and G3 with high viral load (≥600,000 IU/ml). The primary end point was sustained virologic response (SVR), defined as undetectable hepatitis C virus (HCV) RNA 24 weeks after completion of therapy. Results: SVR was attained by 70 (65%) children. Genotype was the main predictor of response: G1, 53%; G2/3, 93%; G4, 80%. SVRs were similar in younger and older children. Baseline viral load was the main predictor of response in the G1 cohort. No new safety signals were identified, and adverse events (AEs) were generally mild or moderate in severity. Dose was modified because of AEs in 25% of children; 1 child discontinued because of an AE (thrombocytopenia). No serious AEs related to study drugs were reported. Conclusion: Therapy with PEG-IFN alfa-2b plus RBV in children and adolescents with chronic hepatitis C offers favorable efficacy, reduced injection frequency, and an acceptable safety profile.

Original languageEnglish (US)
Pages (from-to)501-507
Number of pages7
JournalJournal of Hepatology
Volume52
Issue number4
DOIs
StatePublished - Apr 1 2010

Keywords

  • Efficacy
  • Hepatitis C virus genotype
  • Pediatric
  • Safety
  • Viral load

ASJC Scopus subject areas

  • Hepatology

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    Wirth, S., Ribes-Koninckx, C., Calzado, M. A., Bortolotti, F., Zancan, L., Jara, P., Shelton, M., Kerkar, N., Galoppo, M., Pedreira, A., Rodriguez-Baez, N., Ciocca, M., Lachaux, A., Lacaille, F., Lang, T., Kullmer, U., Huber, W. D., Gonzalez, T., Pollack, H., ... Albrecht, J. K. (2010). High sustained virologic response rates in children with chronic hepatitis C receiving peginterferon alfa-2b plus ribavirin. Journal of Hepatology, 52(4), 501-507. https://doi.org/10.1016/j.jhep.2010.01.016