PegIntron Dose will be administered once weekly subcutaneously on the same day of the week: Screening 2 Weight 40-50 kg Volume to Inject (mL) 0.22; Screening 2 Weight 51-60 kg Volume to Inject (mL) 0.28; Screening 2 Weight 61-75 kg Volume to Inject (mL) 0.33; Screening 2 Weight 76-85 kg Volume to Inject (mL) 0.41; Screening 2 Weight 86-104 kg Volume to Inject (mL) 0.48; Screening 2 Weight 105-125 kg Volume to Inject (mL) 0.58 from two vials REBETOL Dosage (for Use With PegIntron): Screening 2 Weight 40-65 kg Daily Dose 800 mg; Screening 2 Weight >65-85 kg Daily Dose 1000 mg; Screening 2 Weight >85-105 kg Daily Dose 1200 mg; Screening 2 Weight >105-125 kg Daily Dose 1400 mg The PEGASYS dose of 1 mL (180 µg) will be administered once weekly subcutaneously on the same day of the week COPEGUS Dosage (for Use With PEGASYS): Screening 2 Weight <75 kg Daily Dose 1000 mg; Screening 2 Weight > or = 75 kg Daily Dose 1200mg NOTE: Double Blind for PegIntron; Open Label for REBETOL, PEGASYS and COPEGUS NOTE: REBETOL is the Schering-Plough brand name for ribavirin. COPEGUS is the Hoffman-La Roche brand name for ribavirin.
INCLUSION CRITERIA: * Previously untreated adults with chronic hepatitis C (hepatitis C virus ribonucleic acid \[HCV RNA\] quantitative polymerase chain reaction \[qPCR\] plasma positive) * Individuals with HCV genotype 1 (mixed 1a/1b is acceptable) * Compensated liver disease * Pretreatment liver biopsy slides available * Adults aged 18-70 * Individuals weighing 88-275 pounds (40-125 kg) * Free from substance abuse for past 2 years * Those suffering from diabetes and/or hypertension must have normal eye exams and retinal photographs (these will be done as part of the study before hepatitis C treatment is given) * Patients and partners of patients willing to use adequate contraception during the course of the study * Hematology laboratory results of: * Hemoglobin (HGB) ≥ 12 g/dL for females or ≥ 13g/dL for males * White Blood Cell Count (WBC) ≥ 3,000/mm\^3 * Neutrophils ≥ 1,500/mm\^3 * Platelets ≥ 80,000/mm\^3 * Chemistry laboratory results of: * Normal Thyroid Stimulating Hormone (TSH), albumin, creatinine, and direct bilirubin * Antinuclear antibody (ANA) ≤ 1:320 * Fasting Glucose 70-140 mg/dL Note: If glucose levels are between 116-140 mg/dL or an individual has diabetes, glycosylated hemoglobin \[HbA1C\] must be ≤ 8.5% EXCLUSION CRITERIA: * Previous hepatitis C treatment * Pregnant women or partners of pregnant women * Patients or partners of patients who intend to become pregnant any time during the 48 weeks * Women who are breastfeeding * Individuals with liver disease not caused by hepatitis C * Individuals infected with the hepatitis B virus and/or human immunodeficiency virus (HIV) * Patients with a history of liver cancer (hepatocellular carcinoma) * Known blood disorders such as hemoglobinopathy, coagulopathy, or glucose-6-phosphate dehydrogenase \[G6PD\] deficiency * Body organ transplant * Any known or suspected cancer within the past 5 years * Individuals who currently use epoetin \[EPO\], granulocyte colony stimulating factor \[G-CSF\] and/or granulocyte monocyte colony stimulating factor \[GM-CSF\] * Those having a history of or active clinical gout * Individuals who have chronic pulmonary disease * Individuals who have a medical condition that would likely require systemic steroids * Those with a history of central nervous system (CNS trauma) or seizure disorders * Current or previous use of lithium or antipsychotic drugs * Individuals who currently have or show signs of moderate to severe depression or history of significant psychiatric disorders * Patients with clinically significant electrocardiogram (ECG) abnormalities * Individuals with serious heart problems such as those who have had a heart attack, uncontrolled high blood pressure, or other heart problems * Patients that weigh \> 231-275 pounds (105-125 kg) AND have a body mass index (BMI) \> 30 AND have 3 or more of the risk factors below: (a) Strong family history of coronary heart disease (CHD) which includes 2 or more first-degree relatives with CHD or family history of early CHD at age \< 55 for male relatives or \< 65 for female relatives (b) Individuals with abnormal total cholesterol and/or sub fractions (uncontrolled hypercholesterolemia) (c) Diabetes (d) Hypertension (e) Smoking
sont désignés dans cette étude