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

Kathleen B. Schwarz, Regino P. Gonzalezperalta, Karen F. Murray, Jean 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

Research output: Contribution to journalArticle

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Abstract

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.

Original languageEnglish
Pages (from-to)450-458
Number of pages9
JournalGastroenterology
Volume140
Issue number2
DOIs
StatePublished - Feb 2011

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Ribavirin
Chronic Hepatitis C
Interferons
Placebos
Hepacivirus
Body Surface Area
Therapeutics
Neutropenia
Randomized Controlled Trials
Genotype
RNA

Keywords

  • Antiviral Therapy
  • Multicenter Pediatric Trial
  • Pediatric Liver Disease

ASJC Scopus subject areas

  • Gastroenterology

Cite this

The combination of ribavirin and peginterferon is superior to peginterferon and placebo for children and adolescents with chronic hepatitis C. / Schwarz, Kathleen B.; Gonzalezperalta, Regino P.; Murray, Karen F.; Molleston, Jean; Haber, Barbara A.; Jonas, Maureen M.; Rosenthal, Philip; Mohan, Parvathi; Balistreri, William F.; Narkewicz, Michael R.; Smith, Lesley; Lobritto, Steven J.; Rossi, Stephen; Valsamakis, Alexandra; Goodman, Zachary; Robuck, Patricia R.; Barton, Bruce A.

In: Gastroenterology, Vol. 140, No. 2, 02.2011, p. 450-458.

Research output: Contribution to journalArticle

Schwarz, KB, Gonzalezperalta, RP, Murray, KF, Molleston, J, Haber, BA, Jonas, MM, Rosenthal, P, Mohan, P, Balistreri, WF, Narkewicz, MR, Smith, L, Lobritto, SJ, Rossi, S, Valsamakis, A, Goodman, Z, Robuck, PR & Barton, BA 2011, 'The combination of ribavirin and peginterferon is superior to peginterferon and placebo for children and adolescents with chronic hepatitis C', Gastroenterology, vol. 140, no. 2, pp. 450-458. https://doi.org/10.1053/j.gastro.2010.10.047
Schwarz, Kathleen B. ; Gonzalezperalta, Regino P. ; Murray, Karen F. ; Molleston, Jean ; Haber, Barbara A. ; Jonas, Maureen M. ; Rosenthal, Philip ; Mohan, Parvathi ; Balistreri, William F. ; Narkewicz, Michael R. ; Smith, Lesley ; Lobritto, Steven J. ; Rossi, Stephen ; Valsamakis, Alexandra ; Goodman, Zachary ; Robuck, Patricia R. ; Barton, Bruce A. / The combination of ribavirin and peginterferon is superior to peginterferon and placebo for children and adolescents with chronic hepatitis C. In: Gastroenterology. 2011 ; Vol. 140, No. 2. pp. 450-458.
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abstract = "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.",
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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

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.

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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.

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KW - Multicenter Pediatric Trial

KW - Pediatric Liver Disease

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