Conditions: Hepatitis C, Chronic
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 569
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening). arm 2: Participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.

Interventions: intervention 1: Ribavirin intervention 2: Peginterferon alfa-2a intervention 3: Ribavirin intervention 4: Peginterferon alfa-2a
Intervention descriptions: intervention 1: 1000-1200mg po daily for 48 weeks intervention 2: 180 micrograms sc/week for 48 weeks intervention 3: 1000-1200mg po daily for 48 weeks intervention 4: 180 micrograms sc/week for 48 weeks

Protocol document: