PEGYLATED INTERFERON +/- RIBAVIRIN FOR CHILDREN WITH HCV

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a phase III multicenter, randomized placebo-controlled trial of antiviral therapy, in children 5-18 years of age with chronic hepatitis C. The children will be randomized to one of the 2 groups in a 1:1 ratio (PEG-2a (pegylated interferon) + Ribavirn vs. PEG 2a + placebo) according to a computer generated random code. The purpose of this research is to answer, what are the safety and efficacy of peg interferon alfa-2a (PEG-2a) in combination with ribavirn (RV) and PEG-2a alone for the treatment of chronic hepatitis C virus (CHC) in children? Does PEG-2a in combination with RV or PEG-2a alone result in a higher sustained virologic response rate in children with CHC? What are the effects of PEG-2a (with or without concomitant RV) treatment on body mass index, body composition, and linear growth in children with hepatitis C? And how are the short and long term outcomes, including health-related quality of life, cognitive and developmental functioning, and psychosocial functioning and behavior in children treated with PEG-2a (with or without concomitant RV) characterized? Enrolled patients will receive a subcutaneous PEG-2a injection once a week given with placebo or RV tablet/s given orally once or twice daily, depending on the patient's weight. Following the initiation of study drug, patients will return for evaluation at weeks 2, 4, 6 and 8, and then every 4 weeks thereafter, while receiving study drug therapy. Patients will be treated for 24-48 weeks depending on which treatment arm they are randomized to, and their response to the treatment drug. All patients will be followed closely for 24 weeks after discontinuation of study drug and will have 2 annual visits during the long-term follow-up period. Depending on the study visit, the patients will undergo the following procedures: Vital signs amp; physical exam, Blood draw, Pregnancy test, (serum or urine)Urinalysis, Depression screen, Growth/body composition (body composition analysis by DXA scan, (including bone density scans), bioelectrical impedance analysis (BIA), detailed anthropometrics analysis, diet and physical activity history, Quality of Life questionnaire, and Ophthalmology exam.