• Proportion of subjects with a sustained virologic response (SVR) at 24 weeks post-treatment. Co-primary treatment comparisons include: Arm 1 (PegIntron 1.5/R) vs Arm 2 (PegIntron 1.0/R), Arm 1 vs Arm 3 (PEGASYS/COPEGUS). [ Time Frame: 48-week treatment; 24-week follow-up ] [ Designated as safety issue: No ]
  

• Comparison of SVR rates of Arm2 vs Arm 3; SVR for African Americans vs non-African Americans; SVR by baseline viral load; virologic response (VR) at end of treatment; VR at Treatment Week 24 (TW24); VR at TW12; relapse rate. [ Time Frame: 48-week treatment; 24-week follow-up ] [ Designated as safety issue: No ]
  

PEG-Intron Dose:

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 PEG-INTRON):

Screening 2 Weight 40-60 kg Daily Dose 800mg; Screening 2 Weight >65-85 kg Daily Dose 1000mg; Screening 2 Weight >85-105 kg Daily Dose 1200mg; Screening 2 Weight >105-125 kg Daily Dose 1400mg

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 <75kg Daily Dose 1000mg; Screening 2 Weight > or = 75kg Daily Dose 1200mg

NOTE: Double Blind for PEG-Intron; Open Label for REBETOL, PEGASYS and COPEGUS

INCLUSION CRITERIA:

• Previously untreated adults with chronic hepatitis C (HCV RNA qPCR plasma positive)
• Individuals with HCV genotype 1 (mixed 1a/1b is acceptable)
• Compensated liver disease
• No significant co-existing psychiatric disease
• Historic 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 mm3
  • Neutrophils > 1,500 mm3
  • Platelets > 80,000 mm3

• 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, 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 breast feeding
• People 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 G6PD deficiency
• Body organ transplant
• Any known or suspected cancer within the past 5 years
• Individuals who currently use EPO, G-CSF and/or GM-CSF
• Those having a history of or active clinical gout
• People 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
• Patients with clinically significant electrocardiogram (ECG) abnormalities
• Individuals with serious heart problems such as those who have had a heart attack, 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) People with abnormal total cholesterol and/or sub fractions (uncontrolled hypercholesterolemia) (c) Diabetes (d) Hypertension (e) Smoking