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 (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.
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 (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.
Authors: Kathleen B Schwarz; Regino P Gonzalez-Peralta; Karen F Murray; Jean P Molleston; Barbara A Haber; Maureen M Jonas; Philip Rosenthal; Parvathi Mohan; William F Balistreri; Michael R Narkewicz; Lesley Smith; Steven J Lobritto; Stephen Rossi; Alexandra Valsamakis; Zachary Goodman; Patricia R Robuck; Bruce A Barton Journal: Gastroenterology Date: 2010-10-28 Impact factor: 22.682
Authors: C Xu; S Gupta; G Krishna; D Cutler; S Wirth; C Galoppo; M Ciocca; K Kolz; S Noviello; V Sniukiene Journal: Eur J Clin Pharmacol Date: 2013-08-24 Impact factor: 2.953
Authors: A Bamford; A Turkova; H Lyall; C Foster; N Klein; D Bastiaans; D Burger; S Bernadi; K Butler; E Chiappini; P Clayden; M Della Negra; V Giacomet; C Giaquinto; D Gibb; L Galli; M Hainaut; M Koros; L Marques; E Nastouli; T Niehues; A Noguera-Julian; P Rojo; C Rudin; H J Scherpbier; G Tudor-Williams; S B Welch Journal: HIV Med Date: 2015-02-03 Impact factor: 3.180
Authors: Jean P Molleston; William Mellman; Michael R Narkewicz; William F Balistreri; Regino P Gonzalez-Peralta; Maureen M Jonas; Steven J Lobritto; Parvathi Mohan; Karen F Murray; Dolores Njoku; Philip Rosenthal; Bruce A Barton; Monica V Talor; Irene Cheng; Kathleen B Schwarz; Barbara A Haber Journal: J Pediatr Gastroenterol Nutr Date: 2013-03 Impact factor: 2.839
Authors: Maureen M Jonas; William Balistreri; Regino P Gonzalez-Peralta; Barbara Haber; Steven Lobritto; Parvathi Mohan; Jean P Molleston; Karen F Murray; Michael R Narkewicz; Philip Rosenthal; Kathleen B Schwarz; Bruce A Barton; John A Shepherd; Paul D Mitchell; Christopher Duggan Journal: Hepatology Date: 2012-07-06 Impact factor: 17.425
Authors: Anna Mania; Mariusz Kaczmarek; Paweł Kemnitz; Katarzyna Mazur-Melewska; Magdalena Figlerowicz; Jan Sikora; Wojciech Służewski; Jan Żeromski Journal: Med Microbiol Immunol Date: 2017-11-08 Impact factor: 3.402