The Combination of Ribavirin and Peginterferon Is Superior to Peginterferon and Placebo for Children and Adolescents With Chronic Hepatitis C
UMass Chan Affiliations
Department of Quantitative Health SciencesDocument Type
Journal ArticlePublication Date
2010-11-03Keywords
Hepatitis C, ChronicRibavirin
Interferon Alfa-2a
Interferon Alfa-2b
Child
Adolescent
Bioinformatics
Biostatistics
Epidemiology
Health Services Research
Metadata
Show full item recordAbstract
BACKGROUND and AIMS: Although randomized trials of adults infected with hepatitis C virus (HCV) have shown that ribavirin increases the efficacy of pegylated interferon (PEG), such trials have not been performed in children. We conducted a randomized controlled trial of PEG and ribavirin, compared with PEG and placebo, in children 5 to 17 years old with chronic hepatitis C. METHODS: HCV RNA-positive children from 11 university medical centers were randomly assigned to receive either PEG alfa-2a (PEG-2a; 180 mug/1.73 m(2) body surface area, subcutaneously each week; n = 55) and ribavirin (15 mg/kg orally in 2 doses daily) or PEG-2a and placebo (n = 59) for 48 weeks. The primary end point was sustained virologic response (SVR; lack of detectable HCV RNA at least 24 weeks after stopping therapy). RESULTS: SVR was achieved in 53% of children treated with PEG-2a and ribavirin, compared with 21% of children who received PEG-2a and placebo (P < .001). Early virologic response (HCV RNA reduction >2 log(10) IU at 12 weeks) had a negative predictive value of only 0.89 in children with genotype 1, indicating that these children might benefit from 24 weeks of therapy before stopping treatment. Side effects, especially neutropenia, led to dose modification in 40% of children. Eighty-two percent of the PEG/ribavirin and 86% of the PEG/placebo group were in compliance with the year 2 follow-up visit; the durability of virologic response was 100% in both groups. CONCLUSIONS: The combination of PEG and ribavirin is superior to PEG and placebo as therapy for chronic hepatitis C in children and adolescents. reserved.Source
Gastroenterology. 2010 Oct 28. Link to article on publisher's siteDOI
10.1053/j.gastro.2010.10.047Permanent Link to this Item
http://hdl.handle.net/20.500.14038/47831PubMed ID
21036173Notes
Bruce A. Barton is a member of the Peds-C Clinical Research Network.Related Resources
Link to Article in PubMedae974a485f413a2113503eed53cd6c53
10.1053/j.gastro.2010.10.047