title: Peginterferon with or without ribavirin has minimal effect on quality of life, behavioral/emotional, and cognitive outcomes in children.
abstract: The aim of this study was to prospectively assess the quality of life (QOL), behavioral/emotional functioning, and cognitive status of children undergoing treatment for hepatitis C virus (HCV) infection. In all, 114 children (5 to 18 years old) enrolled in a multisite randomized clinical trial (Peds-C) to evaluate peginterferon alpha 2a (PEG 2a) with ribavirin (RV) or with placebo (PL) completed several standardized measures prior to treatment and at 24 weeks, 48 weeks, 6 months following treatment, and at two annual follow-up visits. After 24 weeks of treatment, mean physical QOL scores declined significantly for both groups from baseline to 24 weeks of treatment (F = 5.8, P = 0.004), although scores remained in the average range. There were no significant time or group effects for behavioral/emotional or cognitive functioning. Three children (5%) in the PEG 2a + RV group and no children in the PEG 2a + PL group had a clinically significant increase in depression symptoms. For those children who received 48 weeks of treatment, there were no significant time or group effects on any of the outcome measures (P > 0.05). A majority of children in both the PEG 2a + RV and PEG 2a + PL groups experienced no clinically significant change in physical QOL, behavioral adjustment, depression, or cognitive functioning during or after treatment.
  
  
  CONCLUSIONS
  Overall QOL and psychosocial functioning are not deleteriously impacted by PEG 2a + RV or PL treatment of children with HCV.
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, MA. jrrodrig@bidmc.harvard.edu
authors.forename: James R
authors.initials: JR
authors.lastname: Rodrigue
authors.forename: William
authors.initials: W
authors.lastname: Balistreri
authors.forename: Barbara
authors.initials: B
authors.lastname: Haber
authors.forename: Maureen M
authors.initials: MM
authors.lastname: Jonas
authors.forename: Parvathi
authors.initials: P
authors.lastname: Mohan
authors.forename: Jean P
authors.initials: JP
authors.lastname: Molleston
authors.forename: Karen F
authors.initials: KF
authors.lastname: Murray
authors.forename: Michael R
authors.initials: MR
authors.lastname: Narkewicz
authors.forename: Philip
authors.initials: P
authors.lastname: Rosenthal
authors.forename: Lesley J
authors.initials: LJ
authors.lastname: Smith
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Lobritto
authors.forename: Kathleen B
authors.initials: KB
authors.lastname: Schwarz
authors.forename: Patricia R
authors.initials: PR
authors.lastname: Robuck
authors.forename: Bruce
authors.initials: B
authors.lastname: Barton
authors.forename: Regino P
authors.initials: RP
authors.lastname: González-Peralta
mesh_terms: D000293:Adolescent; D000998:Antiviral Agents / Q000494:pharmacology / Q000627:therapeutic use*; D001519:Behavior / Q000187:drug effects*; D002648:Child; D002675:Child, Preschool; D003071:Cognition / Q000187:drug effects*; D004359:Drug Therapy, Combination; D004644:Emotions / Q000187:drug effects*; D005260:Female; D006526:Hepatitis C / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D011092:Polyethylene Glycols / Q000494:pharmacology / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life; D011994:Recombinant Proteins; D012254:Ribavirin / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a