TY - JOUR
T1 - The combination of ribavirin and peginterferon is superior to peginterferon and placebo for children and adolescents with chronic hepatitis C
AU - Schwarz, Kathleen B.
AU - Gonzalezperalta, Regino P.
AU - Murray, Karen F.
AU - Molleston, Jean P.
AU - Haber, Barbara A.
AU - Jonas, Maureen M.
AU - Rosenthal, Philip
AU - Mohan, Parvathi
AU - Balistreri, William F.
AU - Narkewicz, Michael R.
AU - Smith, Lesley
AU - Lobritto, Steven J.
AU - Rossi, Stephen
AU - Valsamakis, Alexandra
AU - Goodman, Zachary
AU - Robuck, Patricia R.
AU - Barton, Bruce A.
N1 - Funding Information:
PEDS-C was funded in part by the National Institute of Diabetes and Digestive and Kidney Diseases in collaboration with the Food and Drug Administration Office of Orphan Products Development and under a contract between Johns Hopkins and Hoffman LaRoche (Nutley, NJ). Roche supplied drugs and the costs of the data coordinating center and the central laboratory. Roche Molecular Systems (Alameda, CA) supported the quantitative viral testing. An external data and safety monitoring board appointed by the National Institute of Diabetes and Digestive and Kidney Diseases reviewed and approved the study design and monitored its conduct. Roche had no role in study design, oversight, analysis, or interpretation and was not represented on the data and safety monitoring board. Investigators interpreted study results and prepared manuscripts independently.
PY - 2011/2
Y1 - 2011/2
N2 - Background & 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 RNApositive children from 11 university medical centers were randomly assigned to receive either PEG alfa-2a (PEG-2a; 180 μg/1.73 m2 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 log10 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.
AB - Background & 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 RNApositive children from 11 university medical centers were randomly assigned to receive either PEG alfa-2a (PEG-2a; 180 μg/1.73 m2 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 log10 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.
KW - Antiviral Therapy
KW - Multicenter Pediatric Trial
KW - Pediatric Liver Disease
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U2 - 10.1053/j.gastro.2010.10.047
DO - 10.1053/j.gastro.2010.10.047
M3 - Article
C2 - 21036173
AN - SCOPUS:79251541488
SN - 0016-5085
VL - 140
SP - 450-458.e1
JO - Gastroenterology
JF - Gastroenterology
IS - 2
ER -