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

James R. Rodrigue, William Balistreri, Barbara Haber, Maureen M. Jonas, Parvathi Mohan, Jean P. Molleston, Karen F. Murray, Michael R. Narkewicz, Philip Rosenthal, Lesley J Smith, Steven J. Lobritto, Kathleen B. Schwarz, Patricia R. Robuck, Bruce Barton, Regino P. González-Peralta

Research output: Contribution to journalArticle

21 Citations (Scopus)

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. Conclusion: Overall QOL and psychosocial functioning are not deleteriously impacted by PEG 2a + RV or PL treatment of children with HCV.

Original languageEnglish
Pages (from-to)1468-1475
Number of pages8
JournalHepatology
Volume53
Issue number5
DOIs
StatePublished - May 1 2011
Externally publishedYes

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Ribavirin
Quality of Life
Placebos
Therapeutics
Hepacivirus
Virus Diseases
peginterferon alfa-2a
Randomized Controlled Trials
Outcome Assessment (Health Care)

ASJC Scopus subject areas

  • Hepatology

Cite this

Rodrigue, J. R., Balistreri, W., Haber, B., Jonas, M. M., Mohan, P., Molleston, J. P., ... 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(5), 1468-1475. https://doi.org/10.1002/hep.24248

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

In: Hepatology, Vol. 53, No. 5, 01.05.2011, p. 1468-1475.

Research output: Contribution to journalArticle

Rodrigue, JR, Balistreri, W, Haber, B, Jonas, MM, Mohan, P, Molleston, JP, Murray, KF, Narkewicz, MR, Rosenthal, P, Smith, LJ, Lobritto, SJ, Schwarz, KB, Robuck, PR, Barton, B & González-Peralta, RP 2011, 'Peginterferon with or without ribavirin has minimal effect on quality of life, behavioral/emotional, and cognitive outcomes in children', Hepatology, vol. 53, no. 5, pp. 1468-1475. https://doi.org/10.1002/hep.24248
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. / Peginterferon with or without ribavirin has minimal effect on quality of life, behavioral/emotional, and cognitive outcomes in children. In: Hepatology. 2011 ; Vol. 53, No. 5. pp. 1468-1475.
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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. Conclusion: Overall QOL and psychosocial functioning are not deleteriously impacted by PEG 2a + RV or PL treatment of children with HCV.",
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AU - Jonas, Maureen M.

AU - Mohan, Parvathi

AU - Molleston, Jean P.

AU - Murray, Karen F.

AU - Narkewicz, Michael R.

AU - Rosenthal, Philip

AU - Smith, Lesley J

AU - Lobritto, Steven J.

AU - Schwarz, Kathleen B.

AU - Robuck, Patricia R.

AU - Barton, Bruce

AU - González-Peralta, Regino P.

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N2 - 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.

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