Title

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

Authors

Stefan Wirth, Witten/Herdecke University
Carmen Ribes-Koninckx, Hospital Infantil La Fe
Maria Angeles Calzado, Hospital Infantil La Fe
Flavia Bortolotti, Azienda Ospedaliera di Padova
Lucia Zancan, Azienda Ospedaliera di Padova
Paloma Jara, Hospital Universitario Infantil La Paz
Mark Shelton, Cook Children's Medical Center
Nanda Kerkar, Mount Sinai Medical Center
Marcela Galoppo, Hospital General de Ninos Dr. Ricardo Gutierrez
Alejandra Pedreira, Hospital General de Ninos Dr. Ricardo Gutierrez
Norberto Rodriguez-Baez, Children’s Medical Center of Dallas
Mirta Ciocca, Hospital Aleman
Alain Lachaux, Hopital Edouard Herriot
Florence Lacaille, Hopital Necker Enfants Malades
Thomas Lang, Klinikum Starnberg
Ulrike Kullmer, Universitaet Mainz
Wolf Deitrich Huber, University Clinic for Pediatrics
Teresita Gonzalez, Hospital de Ninos Sor Maria Ludovica de La Plata
Henry Pollack, New York University
Estella Alonso, Children’s Memorial Hospital
Pierre Broue, Hopital des Enfants
Jyoti P. Ramakrishna, University of Massachusetts Medical School
Deborah Neigut, Christus Santa Rosa Children’s Hospital
Antonio Del Valle-Segarra, University Pediatric Hospital
Bessie Hunter, Hospital Luis Calvo Mackenna
Zachery Goodman, Armed Forces Institute of Pathology
Christine R. Xu, Schering-Plough Research Institute
Hanzhe Zheng, Schering-Plough Research Institute
Stephanie Noviello, Schering-Plough Research Institute
Vilma Sniukiene, Schering-Plough Research Institute
Clifford Brass, Schering-Plough Research Institute
Janice K. Albrecht, Schering-Plough Research Institute

UMMS Affiliation

Department of Pediatrics

Date

4-2-2010

Document Type

Article

Medical Subject Headings

Adolescent; Antiviral Agents; Body Height; Body Weight; Child; Child Development; Child, Preschool; Drug Resistance, Viral; Drug Therapy, Combination; Female; Genotype; Hepacivirus; Hepatitis C, Chronic; Humans; Interferon Alfa-2b; effects; Male; Polyethylene Glycols; effects; Ribavirin; Treatment Outcome; Viral Load

Disciplines

Gastroenterology | Pediatrics

Abstract

BACKGROUND and 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 (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.

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.

Rights and Permissions

Citation: J Hepatol. 2010 Apr;52(4):501-7. Epub 2010 Feb 4. Link to article on publisher's site

Related Resources

Link to Article in PubMed

PubMed ID

20189674