Latino Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) in Treatment-Naive Patients With Chronic Hepatitis C-Genotype 1.

• Percentage of patients with early virologic response [ Time Frame: Weeks 4 and 12 ] [ Designated as safety issue: No ]
• Percentage of patients with virologic response [ Time Frame: Weeks 4, 12, 24, 48 and 12 and 24 weeks post-treatment ] [ Designated as safety issue: No ]
• AEs, laboratory parameters, premature withdrawals [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

• Efficacy: Proportion of patients with early virologic response at Weeks 4 and 12, proportion with virologic response at weeks 4, 12, 24, 48, and 12 and 24 weeks post-treatment
• Safety: adverse events, laboratory values and premature withdrawals

This single arm study will evaluate the efficacy and safety of PEGASYS (180 micrograms sc weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive Latino patients versus non-Latino Caucasian patients with chronic hepatitis C- genotype 1. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ patients.

• Drug: peginterferon alfa-2a [Pegasys]
  180 micrograms sc/week for 48 weeks
• Drug: Copegus
  1000-1200mg po daily for 48 weeks

Inclusion Criteria:

• adult patients 18-65 years of age
• CHC, genotype 1
• serologic evidence of CHC infection by an antibody test
• chronic liver disease, consistent with CHC infection on a liver biopsy obtained within the past 18 months
• compensated liver disease
• use of 2 forms of contraception during the study in both men and women

Exclusion Criteria:

• previous interferon or ribavirin therapy
• systemic antiviral therapy less than 24 weeks before first dose of study drug or expected need for this treatment any time during the study
• medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure)
• decompensated liver disease
• women who are pregnant or breastfeeding