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; J. P. 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

Disclosures

J Viral Hepat. 2012;19(4):263-270. 

In This Article

Abstract and Introduction

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.

Introduction

The World Health Organization estimates the prevalence of hepatitis C virus (HCV) infection between 1.3% and 1.7% in Europe and the Americas.[1] Seroprevalence of HCV among children is lower than in adults, with estimated rates of 0.1–0.4% in developed countries.[2,3] Although chronic hepatitis C (CHC) is often benign in young children, the occurrence of fibrosis increases with age and duration of the disease.[4] Thus, effective treatment of children with CHC may reduce the progression of liver disease in young adulthood.[5] Studies using interferon (both nonpegylated and pegylated) plus ribavirin for 48 or 52 weeks in children and adolescents with CHC have yielded sustained virologic response (SVR) rates of 46–65%.[6–11] However, the long-term safety of interferon (both nonpegylated and pegylated) plus ribavirin and durability of the virologic response in children are unknown and are essential outcome measures.

In a long-term follow-up study of adults with CHC who attained SVR after treatment with interferon alfa-2b with or without ribavirin, 99% remained virus free during the subsequent 5-year period.[12] Similar findings were seen in adults previously treated with peginterferon alfa-2b plus ribavirin.[13] These findings indicate that sustained loss of serum HCV RNA for 6 months after the end of treatment is an excellent predictor of long-term viral clearance in adult patients with CHC.

The durability of response has not been formally studied in the paediatric population. Although peginterferon plus ribavirin is currently the standard of care for the treatment of paediatric patients with CHC, there are no long-term data on safety or durability of virologic response. Thus, long-term data on children treated with interferon alfa-2b plus ribavirin are uniquely relevant. This study was designed to confirm long-term safety and durability of virologic response in paediatric patients with CHC who were previously treated with interferon alfa-2b plus ribavirin for 48 weeks.[8]

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