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Article first published online: 22 APR 2011
Copyright © 2011 American Association for the Study of Liver Diseases
Volume 53, Issue 5, pages 1468–1475, May 2011
How to Cite
Rodrigue, J. R., Balistreri, W., Haber, B., Jonas, M. M., Mohan, P., Molleston, J. P., Murray, K. F., Narkewicz, M. R., Rosenthal, P., Smith, L. J., Lobritto, S. J., Schwarz, K. B., Robuck, P. R., Barton, B. and González-Peralta, R. P. (2011), Peginterferon with or without ribavirin has minimal effect on quality of life, behavioral/emotional, and cognitive outcomes in children. Hepatology, 53: 1468–1475. doi: 10.1002/hep.24248
Potential conflict of interest: Nothing to report.
Supported by the National Institute of Diabetes and Digestive and Kidney Diseases, grant number 1UO1DK067767, with additional support from the Office of Orphan Products Development, Food and Drug Administration. Contents herein are the authors' sole responsibility and do not necessarily represent official NIH views. Additional support is provided by Hoffman-La Roche for the study medications, data coordinating center, and central laboratory costs.
- Issue published online: 22 APR 2011
- Article first published online: 22 APR 2011
- Accepted manuscript online: 23 FEB 2011 09:37AM EST
- Manuscript Accepted: 31 JAN 2011
- Manuscript Received: 26 NOV 2010
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;)