ACCELERATE Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC) Infection.

SVR was defined as the percentage of participants with undetectable HCV RNA at 24 weeks after the completion of the study treatment. The negative assessment was required to be the last one collected at or after week 36 (ie, on or after study Day 253) for the 16-week treatment group or at or after week 44 (ie, on or after study Day 309) for the 24-week treatment group.

Time frame: Week 40 (for 16-week treatment group); Week 48 (for 24-week treatment group)

Population: Standard population: The standard population includes all randomized participants who received at least one dose of study medication and who did not have any of the major protocol violations or deviations.

Participants with triglyceride level above normal (i.e. \< 200 mg/dL) were analysed.

Time frame: Up to Week 40 and Week 48

Population: The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment.

Participants with changes in Systolic and diastolic blood pressure, heart rate were analysed abnormal vital signs.

Time frame: Up to Week 40 and Week 48

Population: Safety population: The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment.

Virological response 12 weeks post-treatment was defined as the percentage of participants with undetectable HCV RNA 12 weeks after the completion of the study treatment . The negative assessment was required to be the last one collected in the week 28 time window for the 16- week treatment group or in the week 36 time window for the 24-week treatment group.

Time frame: Week 28 (for 16-week treatment group); Week 36 (for 24-week treatment group)

Population: Standard population: The standard population included all randomized participants who received at least one dose of study medication and who did not have any of the major protocol violations or deviations.

An adverse event was defined as any untoward medical occurrence that occurred during he course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.

Time frame: Up to Week 40 and Week 48

Population: Safety population: The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment.

Participants with changes in Hematocrit: Fraction 0.36 - 0.60 g/dL, Hemoglobin: 11.0 -20.0 g/dL, WBC 3.0 - 18.0 g/dL, Platelets 100 - 700 g/dL, Basophils 0.00 - 0.30 g/dL, Lymphocytes 1.00 - 6.30 g/dL, Monocytes 0.08 - 2.00 g/dL, Neutrophils 1.50 or more g/dL, Eosinophils 0.00 - 1.50 g/dL , PTT 0 - 50 seconds, Alkaline Phosphatase 0 - 190 and ASAT 0 - 50 U/L, ALAT 0 - 60 U/L, Gamma - GT 0 - 120 U/L, Total Protein 55 - 87 g/L ;Albumin 27.0 or more g/L, Total Bilirubin 0 - 34.2 μmol/L, BUN 0 - 14.3 mmol/L, Creatinine 0 - 154 μmol/L, Free T3, T4 5 - 40 pmol/L, TSH 0.0 - 10.0 mU/L, Cholesterol 0.0 - 8.3 mmol/L; Triglycerides 0.00 - 2.83 mmol/L, Chloride 95 - 115 mmol/L; Potassium 3.0 - 6.0 mmol/L; Sodium 130 - 150 mmol/L, miscellaneous: Calcium 2.00 - 2.90 mmol/L; Phosphate 0.75 - 1.60 mmol/L; Blood Glucose (Random) 2.80 - 11.10 mmol/L, Uric Acid 0 - 600 μmol/L, Proteinuria, Glycosuria, Hematuria (Qualitative 0 to 4+) 0 - 1 were analysed for the laboratory abnormality.

Time frame: Up to Week 40 and Week 48

Population: Safety population: The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment.

Virological response was defined as the percentage of participants with undetectable HCV RNA at the completion of the study treatment. The negative assessment was required to be the last one collected in the Week 16 time window for the 16-week treatment group or in the Week 24 time window for the 24-week treatment group.

Time frame: Week 16 (for 16-week treatment group); Week 24 (for 24-week treatment group)

Population: Standard population: The standard population included all randomized participants who received at least one dose of study medication and who did not have any of the major protocol violations or deviations.