The combination of ribavirin and peginterferon is superior to peginterferon and placebo for children and adolescents with chronic hepatitis C

Gastroenterology

Volumn 140, Issue 2, 2011, Pages 450-458.e1

  Schwarz, Kathleen B ^a   Gonzalezperalta, Regino P ^b   Murray, Karen F ^c   Molleston, Jean P ^d   Haber, Barbara A ^e   Jonas, Maureen M ^f   Rosenthal, Philip ^g   Mohan, Parvathi ^h   Balistreri, William F ⁱ   Narkewicz, Michael R ^j   Smith, Lesley ^k   Lobritto, Steven J ^k   Rossi, Stephen ^l   Valsamakis, Alexandra ^a   Goodman, Zachary ^m   Robuck, Patricia R ⁿ   Barton, Bruce A ^o  

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b University of Florida and UF Health Shands Children s Hospital   (United States)

^c SEATTLE CHILDREN S HOSPITAL   (United States)

^d INDIANA UNIVERSITY   (United States)

^e UNIVERSITY OF PENNSYLVANIA   (United States)

^f BOSTON CHILDREN S HOSPITAL   (United States)

^g UNIVERSITY OF CALIFORNIA   (United States)

^h CHILDREN'S NATIONAL MEDICAL CENTER   (United States)

ⁱ CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER   (United States)

^j Children's Hospital Colorado   (United States)

^k Och Spine at New York Presbyterian Hospitals   (United States)

^l ROCHE MOLECULAR SYSTEMS   (United States)

^m ARMED FORCES INSTITUTE OF PATHOLOGY   (United States)

ⁿ NATIONAL INSTITUTES OF HEALTH   (United States)

^o MARYLAND MEDICAL RESEARCH INSTITUTE   (United States)

more..

Author keywords

Antiviral Therapy; Multicenter Pediatric Trial; Pediatric Liver Disease

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; PEGINTERFERON ALPHA2A; PLACEBO; RIBAVIRIN; THYROXINE; VIRUS RNA;

ADOLESCENT; AGGRESSION; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BLINDNESS; BODY MASS; CHILD; COMBINATION CHEMOTHERAPY; DEPRESSION; DISEASE DURATION; DISEASE SEVERITY; DISEASE TRANSMISSION; DOUBLE BLIND PROCEDURE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FATTY LIVER; FEMALE; FLU LIKE SYNDROME; FOLLOW UP; GASTROINTESTINAL SYMPTOM; GENOTYPE; HEADACHE; HEMOGLOBIN BLOOD LEVEL; HEPATITIS C; HEPATITIS C VIRUS; HUMAN; HYPOTHYROIDISM; INSULIN DEPENDENT DIABETES MELLITUS; LEUKOCYTE COUNT; LIVER FIBROSIS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEUTROPENIA; NEUTROPHIL COUNT; PATIENT COMPLIANCE; PREDICTIVE VALIDITY; PRIORITY JOURNAL; RACE; RANDOMIZED CONTROLLED TRIAL; RETINA EXUDATE; SIDE EFFECT; SUICIDAL IDEATION; TREATMENT DURATION; TREATMENT RESPONSE;

EID: 79251541488     PISSN: 00165085     EISSN: None     Source Type: Journal    
DOI: 10.1053/j.gastro.2010.10.047     Document Type: Article

References (35)

1. M.J. Alter, D. Kruszon-Moran, and O.V. Nainan The prevalence of hepatitis C virus infection in the United States, 1988 through 1994 N Engl J Med 341 1999 556 562
2. R. Jhaveri, W. Grant, and T.L. Kauf The burden of hepatitis C virus infection in children; estimated direct medical costs over a ten-year period J Pediatr 148 2006 353 358
3. European Paediatric Hepatitis C Virus Network Three broad modalities in the natural history of vertically acquired hepatitis C virus infection Clin Infect Dis 41 2005 45 51
4. K.F. Murray, L.S. Finn, and S.L. Taylor Liver histology and alanine amino transferase levels in children and adults with chronic hepatitis C infection J. Pediatr Gastroenterol Nutr 41 2005 634 638
5. F. Bortolotti, G. Verucchi, and C. Camma Long-term course of chronic hepatitis C in children: from viral clearance to end-stage liver disease Gastroenterology 134 2008 1900 1907
6. N.R. Barshes, I.W. Udell, and T.C. Lee The natural history of hepatitis C virus in pediatric liver transplant recipients Liver Transpl 12 2006 1042 1043
7. R. Gonzales-Peralta, M.R. Langham Jr, and J.M. Andres Hepatocellular carcinoma in two young adolescents with chronic hepatitis C J Pediatr Gastroenterol Nutr 48 2009 630 635
8. U.S. Department of Health and Human Services (DHHS) National Center for Health Statistics Third National Health and Nutrition Examination Survey, 19881994 1998 Centers for Disease Control and Prevention Hyattsville, MD
9. K.R. Jacobson, K. Murray, and A. Zellos An analysis of published trials of interferon in children with chronic hepatitis C J Pediatr Gastroenterol Nutr 34 2002 52 58
10. J.G. McHutchison, S.C. Gordon, and E.R. Schiff Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C N Engl J Med 339 1998 1485 1492
11. R.P. Gonzalez-Peralta, D.A. Kelly, and B. Haber Interferon alfa-2b in combination with ribavirin for the treatment of chronic hepatitis C in children: efficacy, safety, and pharmacokinetics Hepatology 42 2005 1010 1018
12. S. Wirth, T. Lang, and S. Gehring Recombinant alfa-interferon plus ribavirin therapy in children and adolescents with chronic hepatitis C Hepatology 36 2002 1280 1284
13. K.B. Schwarz, P. Mohan, and M.R. Narkewicz Safety, efficacy and pharmacokinetics of peginterferon α2a (40 kd) in children with chronic hepatitis C J Pediatr Gastroenterol Nutr 43 2006 499 505
14. S. Wirth, H. Pieper-Boustani, and T. Lang Peginterferon alfa-2b plus ribavirin treatment in children and adolescents with chronic hepatitis C Hepatology 41 2005 1013 1018
15. S. Wirth, C. Ribes-Koninckx, and F. Bortolotti High sustained virologic response rates in children with chronic hepatitis C receiving peginterferon alfa-2b plus ribavirin Hepatology 48 Suppl 2008 392A 393A
16. P. Jara, L. Hierro, and A. de la Vega Efficacy and safety of peginterferon-alpha2b and ribavirin combination therapy in children with chronic hepatitis C infection Pediatr Infect Dis J 27 2008 142 148
17. S. Wirth, C. Ribes-Koninckx, and M.A. Caizado High sustained virologic response rates in children with chronic hepatitis C receiving peginterferon alfa-2b plus ribavirin J Hepatol 52 2010 501 507
18. V.H. Ferm, C.C. Willhite, and L. Kilham Teratogenic effects of ribavirin on hamster and rat embryos Teratology 17 1978 93 102
19. D.M. Kochar, J.D. Penner, and T.B. Knudsen Embryotoxic, teratogenic, and metabolic effects of Ribavirin in mice Toxicol Appl Pharmacol 52 1980 99 112
20. Agnish MD. An oral gavage study for effects of RO 20-9963 (Ribavirin) on fertility and early embryonic development to implantation in Sprague Dawley rats. Covance Study No 6131-316, Roche Study No 07392. RR 1003508.
21. S.S. Roberts Assessing ribavirin exposure during pregnancy: the Ribavirin Pregnancy Registry Gastroenterol Nurs 6 2008 413 417
22. K.F. Murray, J.R. Rodrique, R.P. Gonzalez-Peralta PEDS-C Clinical Research Network Design of the PEDS-C trial: pegylated interferon ± ribavirin for children with chronic hepatitis C viral infection Clin Trials 4 2007 661 673
23. M.R. Narkewicz, P. Rosenthal, K.B. Schwarz PEDS C Study Group Ophthalmologic complications in children with chronic hepatitis C treated with pegylated interferon J Pediatr Gastroenterol Nutr 51 2010 183 186
24. Z.D. Goodman, H.R. Makhlouf, and L. Liu Pathology of chronic hepatitis C in children: liver biopsy findings in the Peds C Trial Hepatology 47 2008 836 843
25. J.R. Rodrigue, W. Balistreri, and B. Haber Impact of hepatitis C virus infection on children and their caregivers: quality of life, cognitive and emotional outcomes J Pediatr Gastroenterol Nutr 48 2009 341 347
26. Division of AIDS toxicity table for grading severity of pediatric (>3 months of age) adverse experiences www.niaid.nih.gov/dmid/clinresearch/ DMIDpedtox.doc
27. M.G. Ghany, D.B. Strader, and D.L. Thomas Diagnosis, management, and treatment of hepatitis C: an update Hepatology 49 2009 1335 1374
28. G.L. Davis, J.B. Wong, and J.G. McHutchison Early virologic response to treatment with peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C Hepatology 38 2003 645 652
29. M.W. Fried, M.L. Shiffman, and K.R. Reddy Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection N Engl J Med 347 2002 975 982
30. A.M. Bisceglie, and J.H. Hoofnagle Optimal therapy of hepatitis C Hepatology 36 2002 S121 S127
31. M.P. Manns, J.G. McHutchison, S.C. Gordon International Hepatitis Interventional Therapy Group Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomized trial Lancet 358 2001 958 965
32. J.G. McHutchison, E.J. Lawitz, M.L. Shiffman IDEAL Study Team Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection N Engl J Med 361 2009 580 593
33. H.S. Te, G. Randall, and D.M. Jensen Mechanism of action of ribavirin in the treatment of chronic hepatitis C Gastroenterol Hepatol 3 2007 218 226
34. P. Castellvi, R. Navins, and F. Gutierrez Pegylated interferon and ribavirin-induced depression in chronic hepatitis C: role of personality J Clin Psychiatry 70 2009 817 828
35. G. Grundy, and N. Beeching Understanding social stigma in women with hepatitis C Nurs Stand 19 2004 35 39