The objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1) PegIntron 1.5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2) PegIntron 1µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3) PEGASYS 180 µg/wk plus COPEGUS 1000-1200 mg/day.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4,469
1.5 ug/kg/week subcutaneously (SC) for 48 weeks
1.0 ug/kg/week SC for 48 weeks
weight based dose 800-1400 mg/day orally (PO) for 48 weeks
Sustained Virologic Response (SVR) Rate
SVR rate is the percentage of participants with undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of the 24-week post-treatment follow-up.
Time frame: Assessed at the end of a 24-week post-treatment follow-up
Mean Change From Baseline in the Log Viral Load at Treatment Week 4
The difference between viral load levels in the blood at the start of the study and Treatment Week 4, expressed in terms of a logarithmic scale with base 10, and averaged for all the participants in each treatment group.
Time frame: Assessed at Baseline and Treatment Week 4
Virologic Response Rate at Treatment Week 12
Percentage of participants with undetectable hepatitis C RNA (HCV-RNA) at Treatment Week 12
Time frame: Assessed at Treatment Week 12
Mean Change From Baseline in the Log Viral Load at Treatment Week 2
The difference between viral load levels in the blood at the start of the study and Treatment Week 2, expressed in terms of a logarithmic scale with base 10, and averaged for all the participants in each treatment group.
Time frame: Assessed at Baseline and Treatment Week 2
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180 ug/week SC administered for 48 weeks
1000-1200 mg/day PO for 48 weeks