Durability of sustained response shown in paediatric patients with chronic hepatitis C who were treated with interferon alfa-2b plus ribavirin

D. A. Kelly, B. Haber, R. P. González-Peralta, K. F. Murray, M. M. Jonas, Jean Molleston, M. R. Narkewicz, F. R. Sinatra, T. Lang, A. Lachaux, S. Wirth, M. Shelton, H. S. Te, H. Pollack, W. Deng, S. Noviello, J. K. Albrecht

Research output: Contribution to journalArticle

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Abstract

Summary. Long-term studies in adults indicate that sustained virologic response (SVR) after combination treatment for chronic hepatitis C (CHC) predicts long-term clearance. Although peginterferon plus ribavirin is now standard care for children with CHC, long-term follow-up studies are not yet available. This study evaluated durability of virologic response over 5 years in children previously treated with interferon alfa-2b plus ribavirin (IFN/R). Ninety-seven of 147 children with CHC, who were treated with IFN/R and completed the 6-month follow-up in two previous clinical trials, participated in this long-term follow-up study. All were assessed annually for up to 5 years; patients with SVR were assessed for durability of virologic response. Children with SVR (n = 56) and those with detectable hepatitis C virus (HCV) RNA 24-week post-treatment (n = 41) were followed for a median of 284 weeks. Overall, 70% (68/97) of patients completed the 5-year follow-up. One patient with genotype 1a CHC had SVR and relapsed at year 1 of follow-up with the same genotype. Kaplan-Meier estimate for sustained response at 5 years was 98% (95% CI: 95%, 100%). Six patients with low-positive HCV RNA levels (n = 4) or missing HCV RNA at the 24-week follow-up visit (n = 2) in the initial treatment studies had virologic response during this long-term follow-up study. Linear growth rate was impaired during treatment with rapid increases in the immediate 6 months post-treatment. Mean height percentile at the end of the 5-year follow-up was slightly less than the mean pretreatment height percentile. Five patients experienced serious adverse events; none related to study drug exposure. SVR after IFN/R predicts long-term clearance of HCV in paediatric patients; growth normalized in the majority of children during the long-term follow-up. Similar long-term results could be expected after peginterferon alfa-2b plus ribavirin treatment.

Original languageEnglish
Pages (from-to)263-270
Number of pages8
JournalJournal of Viral Hepatitis
Volume19
Issue number4
DOIs
StatePublished - Apr 2012

Fingerprint

interferon alfa-2b
Ribavirin
Chronic Hepatitis C
Pediatrics
Hepacivirus
RNA
Therapeutics
Genotype
Kaplan-Meier Estimate
Child Care
Growth
Sustained Virologic Response
Clinical Trials

Keywords

  • chronic hepatitis C
  • interferon and ribavirin
  • long-term virologic response
  • paediatric patients

ASJC Scopus subject areas

  • Hepatology
  • Infectious Diseases
  • Virology

Cite this

Durability of sustained response shown in paediatric patients with chronic hepatitis C who were treated with interferon alfa-2b plus ribavirin. / Kelly, D. A.; Haber, B.; González-Peralta, R. P.; Murray, K. F.; Jonas, M. M.; Molleston, Jean; Narkewicz, M. R.; Sinatra, F. R.; Lang, T.; Lachaux, A.; Wirth, S.; Shelton, M.; Te, H. S.; Pollack, H.; Deng, W.; Noviello, S.; Albrecht, J. K.

In: Journal of Viral Hepatitis, Vol. 19, No. 4, 04.2012, p. 263-270.

Research output: Contribution to journalArticle

Kelly, DA, Haber, B, González-Peralta, RP, Murray, KF, Jonas, MM, Molleston, J, Narkewicz, MR, Sinatra, FR, Lang, T, Lachaux, A, Wirth, S, Shelton, M, Te, HS, Pollack, H, Deng, W, Noviello, S & Albrecht, JK 2012, 'Durability of sustained response shown in paediatric patients with chronic hepatitis C who were treated with interferon alfa-2b plus ribavirin', Journal of Viral Hepatitis, vol. 19, no. 4, pp. 263-270. https://doi.org/10.1111/j.1365-2893.2011.01544.x
Kelly, D. A. ; Haber, B. ; González-Peralta, R. P. ; Murray, K. F. ; Jonas, M. M. ; Molleston, Jean ; Narkewicz, M. R. ; Sinatra, F. R. ; Lang, T. ; Lachaux, A. ; Wirth, S. ; Shelton, M. ; Te, H. S. ; Pollack, H. ; Deng, W. ; Noviello, S. ; Albrecht, J. K. / Durability of sustained response shown in paediatric patients with chronic hepatitis C who were treated with interferon alfa-2b plus ribavirin. In: Journal of Viral Hepatitis. 2012 ; Vol. 19, No. 4. pp. 263-270.
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N2 - Summary. Long-term studies in adults indicate that sustained virologic response (SVR) after combination treatment for chronic hepatitis C (CHC) predicts long-term clearance. Although peginterferon plus ribavirin is now standard care for children with CHC, long-term follow-up studies are not yet available. This study evaluated durability of virologic response over 5 years in children previously treated with interferon alfa-2b plus ribavirin (IFN/R). Ninety-seven of 147 children with CHC, who were treated with IFN/R and completed the 6-month follow-up in two previous clinical trials, participated in this long-term follow-up study. All were assessed annually for up to 5 years; patients with SVR were assessed for durability of virologic response. Children with SVR (n = 56) and those with detectable hepatitis C virus (HCV) RNA 24-week post-treatment (n = 41) were followed for a median of 284 weeks. Overall, 70% (68/97) of patients completed the 5-year follow-up. One patient with genotype 1a CHC had SVR and relapsed at year 1 of follow-up with the same genotype. Kaplan-Meier estimate for sustained response at 5 years was 98% (95% CI: 95%, 100%). Six patients with low-positive HCV RNA levels (n = 4) or missing HCV RNA at the 24-week follow-up visit (n = 2) in the initial treatment studies had virologic response during this long-term follow-up study. Linear growth rate was impaired during treatment with rapid increases in the immediate 6 months post-treatment. Mean height percentile at the end of the 5-year follow-up was slightly less than the mean pretreatment height percentile. Five patients experienced serious adverse events; none related to study drug exposure. SVR after IFN/R predicts long-term clearance of HCV in paediatric patients; growth normalized in the majority of children during the long-term follow-up. Similar long-term results could be expected after peginterferon alfa-2b plus ribavirin treatment.

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