title: High sustained virologic response rates in children with chronic hepatitis C receiving peginterferon alfa-2b plus ribavirin.
abstract: OBJECTIVE
  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 (60microg/m(2)/week) plus RBV (15mg/kg/day). The duration of therapy was 24 weeks for genotype (G) 2 and G3 patients with low viral load (<600,000IU/ml) and 48 weeks for G1, G4, and G3 with high viral load (>or=600,000IU/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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Children's Hospital, HELIOS Klinikum Wuppertal, Witten/Herdecke University, Heusnerstrasse 40, Wuppertal, Germany. stefan.wirth@helios-kliniken.de
authors.forename: Stefan
authors.initials: S
authors.lastname: Wirth
authors.forename: Carmen
authors.initials: C
authors.lastname: Ribes-Koninckx
authors.forename: Maria Angeles
authors.initials: MA
authors.lastname: Calzado
authors.forename: Flavia
authors.initials: F
authors.lastname: Bortolotti
authors.forename: Lucia
authors.initials: L
authors.lastname: Zancan
authors.forename: Paloma
authors.initials: P
authors.lastname: Jara
authors.forename: Mark
authors.initials: M
authors.lastname: Shelton
authors.forename: Nanda
authors.initials: N
authors.lastname: Kerkar
authors.forename: Marcela
authors.initials: M
authors.lastname: Galoppo
authors.forename: Alejandra
authors.initials: A
authors.lastname: Pedreira
authors.forename: Norberto
authors.initials: N
authors.lastname: Rodriguez-Baez
authors.forename: Mirta
authors.initials: M
authors.lastname: Ciocca
authors.forename: Alain
authors.initials: A
authors.lastname: Lachaux
authors.forename: Florence
authors.initials: F
authors.lastname: Lacaille
authors.forename: Thomas
authors.initials: T
authors.lastname: Lang
authors.forename: Ulrike
authors.initials: U
authors.lastname: Kullmer
authors.forename: Wolf Dietrich
authors.initials: WD
authors.lastname: Huber
authors.forename: Teresita
authors.initials: T
authors.lastname: Gonzalez
authors.forename: Henry
authors.initials: H
authors.lastname: Pollack
authors.forename: Estella
authors.initials: E
authors.lastname: Alonso
authors.forename: Pierre
authors.initials: P
authors.lastname: Broue
authors.forename: Jyoti
authors.initials: J
authors.lastname: Ramakrishna
authors.forename: Deborah
authors.initials: D
authors.lastname: Neigut
authors.forename: Antonio Del
authors.initials: AD
authors.lastname: Valle-Segarra
authors.forename: Bessie
authors.initials: B
authors.lastname: Hunter
authors.forename: Zachery
authors.initials: Z
authors.lastname: Goodman
authors.forename: Christine R
authors.initials: CR
authors.lastname: Xu
authors.forename: Hanzhe
authors.initials: H
authors.lastname: Zheng
authors.forename: Stephanie
authors.initials: S
authors.lastname: Noviello
authors.forename: Vilma
authors.initials: V
authors.lastname: Sniukiene
authors.forename: Clifford
authors.initials: C
authors.lastname: Brass
authors.forename: Janice K
authors.initials: JK
authors.lastname: Albrecht
mesh_terms: D000293:Adolescent; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D001827:Body Height; D001835:Body Weight; D002648:Child; D002657:Child Development; D002675:Child, Preschool; D024882:Drug Resistance, Viral / Q000235:genetics; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects* / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D008297:Male; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b