High sustained virologic response rates in children with chronic hepatitis C receiving peginterferon alfa-2b plus ribavirin.
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.
Wirth
Stefan
S
Children's Hospital, HELIOS Klinikum Wuppertal, Witten/Herdecke University, Heusnerstrasse 40, Wuppertal, Germany. stefan.wirth@helios-kliniken.de
Ribes-Koninckx
Carmen
C
Calzado
Maria Angeles
MA
Bortolotti
Flavia
F
Zancan
Lucia
L
Jara
Paloma
P
Shelton
Mark
M
Kerkar
Nanda
N
Galoppo
Marcela
M
Pedreira
Alejandra
A
Rodriguez-Baez
Norberto
N
Ciocca
Mirta
M
Lachaux
Alain
A
Lacaille
Florence
F
Lang
Thomas
T
Kullmer
Ulrike
U
Huber
Wolf Dietrich
WD
Gonzalez
Teresita
T
Pollack
Henry
H
Alonso
Estella
E
Broue
Pierre
P
Ramakrishna
Jyoti
J
Neigut
Deborah
D
Valle-Segarra
Antonio Del
AD
Hunter
Bessie
B
Goodman
Zachery
Z
Xu
Christine R
CR
Zheng
Hanzhe
H
Noviello
Stephanie
S
Sniukiene
Vilma
V
Brass
Clifford
C
Albrecht
Janice K
JK
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
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b