title: Durability of sustained response shown in paediatric patients with chronic hepatitis C who were treated with interferon alfa-2b plus ribavirin.
abstract: 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.
authors.affiliation: Liver Unit, Birmingham Children's Hospital, Birmingham, UK. Deirdre.Kelly@bch.nhs.uk
authors.forename: D A
authors.initials: DA
authors.lastname: Kelly
authors.forename: B
authors.initials: B
authors.lastname: Haber
authors.forename: R P
authors.initials: RP
authors.lastname: González-Peralta
authors.forename: K F
authors.initials: KF
authors.lastname: Murray
authors.forename: M M
authors.initials: MM
authors.lastname: Jonas
authors.forename: J P
authors.initials: JP
authors.lastname: Molleston
authors.forename: M R
authors.initials: MR
authors.lastname: Narkewicz
authors.forename: F R
authors.initials: FR
authors.lastname: Sinatra
authors.forename: T
authors.initials: T
authors.lastname: Lang
authors.forename: A
authors.initials: A
authors.lastname: Lachaux
authors.forename: S
authors.initials: S
authors.lastname: Wirth
authors.forename: M
authors.initials: M
authors.lastname: Shelton
authors.forename: H S
authors.initials: HS
authors.lastname: Te
authors.forename: H
authors.initials: H
authors.lastname: Pollack
authors.forename: W
authors.initials: W
authors.lastname: Deng
authors.forename: S
authors.initials: S
authors.lastname: Noviello
authors.forename: J K
authors.initials: JK
authors.lastname: Albrecht
mesh_terms: D000293:Adolescent; D000998:Antiviral Agents / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D005260:Female; D005500:Follow-Up Studies; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D011994:Recombinant Proteins / Q000008:administration & dosage; D012254:Ribavirin / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D012254:Ribavirin