Peginterferon with or without ribavirin has minimal effect on quality of life, behavioral/emotional, and cognitive outcomes in children

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...

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Published in:Hepatology (Baltimore, Md.) Md.), 2011-05, Vol.53 (5), p.1468-1475
Main Authors: Rodrigue, James R., Balistreri, William, Haber, Barbara, Jonas, Maureen M., Mohan, Parvathi, Molleston, Jean P., Murray, Karen F., Narkewicz, Michael R., Rosenthal, Philip, Smith, Lesley J., Lobritto, Steven J., Schwarz, Kathleen B., Robuck, Patricia R., Barton, Bruce, González‐Peralta, Regino P.
Format: Article
Language:English
Subjects:
Adolescent
Antibiotics. Antiinfectious agents. Antiparasitic agents
Antiviral agents
Antiviral Agents - pharmacology
Antiviral Agents - therapeutic use
Behavior - drug effects
Biological and medical sciences
Child
Child, Preschool
Cognition - drug effects
Drug Therapy, Combination
Emotions - drug effects
Female
Gastroenterology. Liver. Pancreas. Abdomen
Hepatitis
Hepatitis C - drug therapy
Hepatitis C virus
Hepatology
Humans
Interferon-alpha - pharmacology
Interferon-alpha - therapeutic use
Liver. Biliary tract. Portal circulation. Exocrine pancreas
Male
Medical sciences
Pharmacology. Drug treatments
Polyethylene Glycols - pharmacology
Polyethylene Glycols - therapeutic use
Prospective Studies
Quality of Life
Recombinant Proteins
Ribavirin - pharmacology
Ribavirin - therapeutic use
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Summary: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. Conclusion: Overall QOL and psychosocial functioning are not deleteriously impacted by PEG 2a + RV or PL treatment of children with HCV. (HEPATOLOGY 2011;)
ISSN:0270-9139
1527-3350
DOI:10.1002/hep.24248