TY - JOUR
T1 - High sustained virologic response rates in children with chronic hepatitis C receiving peginterferon alfa-2b plus ribavirin
AU - Wirth, Stefan
AU - Ribes-Koninckx, Carmen
AU - Calzado, Maria Angeles
AU - Bortolotti, Flavia
AU - Zancan, Lucia
AU - Jara, Paloma
AU - Shelton, Mark
AU - Kerkar, Nanda
AU - Galoppo, Marcela
AU - Pedreira, Alejandra
AU - Rodriguez-Baez, Norberto
AU - Ciocca, Mirta
AU - Lachaux, Alain
AU - Lacaille, Florence
AU - Lang, Thomas
AU - Kullmer, Ulrike
AU - Huber, Wolf Dietrich
AU - Gonzalez, Teresita
AU - Pollack, Henry
AU - Alonso, Estella
AU - Broue, Pierre
AU - Ramakrishna, Jyoti
AU - Neigut, Deborah
AU - Valle-Segarra, Antonio del
AU - Hunter, Bessie
AU - Goodman, Zachery
AU - Xu, Christine R.
AU - Zheng, Hanzhe
AU - Noviello, Stephanie
AU - Sniukiene, Vilma
AU - Brass, Clifford
AU - Albrecht, Janice K.
N1 - Funding Information:
ClinicalTrials.gov registration numbers: NCT00104052 and NCT00761735 . J.K.A., C.B., V.S., C.R.X., H.Z. are employed by Schering-Plough Research Institute, Kenilworth, New Jersey, USA. S.N. was employed during this study in Schering-Plough Research Institute, Kenilworth, New Jersey, USA and now is a consultant to the company. L.Z. declared that she does not have anything to disclose regarding funding or conflict of interest with respect to this manuscript. All the other authors have declared that they received funding from the drug company involved in order to carry out their research in this manuscript. The authors are grateful to Aimee Shephard, Gary Spivak, Mital Modi, and Eric Manuel for managing the study; Becky Liou, Lydia Li, and Michael Salman for programming; Joann Harvey for study efficacy statistical analysis; Samir Gupta for statistical analysis of pharmacokinetic; Stefanie Alfano, Kathleen Giordano, Julian Squadano, Soledad Medina, and Patricia Loderstedt for clinical data management; Yuntao Wan and Debra Post for processing pharmacokinetic samples; all subinvestigators, study coordinators, and monitors for conducting this study; and Tim Ibbotson, Ph.D., and Claudette Knight, PharmD, for writing assistance. This assistance was funded by Schering-Plough.
PY - 2010/4
Y1 - 2010/4
N2 - 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.
AB - 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.
KW - Efficacy
KW - Hepatitis C virus genotype
KW - Pediatric
KW - Safety
KW - Viral load
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U2 - 10.1016/j.jhep.2010.01.016
DO - 10.1016/j.jhep.2010.01.016
M3 - Article
C2 - 20189674
AN - SCOPUS:77949657688
SN - 0168-8278
VL - 52
SP - 501
EP - 507
JO - Journal of Hepatology
JF - Journal of Hepatology
IS - 4
ER -
