Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Peginterferon Alfa-2a 90 Mcg/Week	Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
Standard of Care Followup	Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment

Participant Flow:   Overall Study

	Peginterferon Alfa-2a 90 Mcg/Week	Standard of Care Followup
STARTED	517	533
COMPLETED	447 [1]	452 [2]
NOT COMPLETED	70	81
Withdrew or lost to follow-up	70	81

Reporting Groups

	Description
Peginterferon Alfa-2a 90 Mcg/Week	Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
Standard of Care Followup	Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment

Baseline Measures

	Peginterferon Alfa-2a 90 Mcg/Week	Standard of Care Followup	Total
Number of Participants   [units: participants]	517	533	1050
Age   [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	489	511	1000
>=65 years	28	22	50
Age   [units: years] Mean ± Standard Deviation	51.1  ± 7.3	50.1  ± 7.0	50.6  ± 7.2
Gender   [units: participants]
Female	155	150	305
Male	362	383	745
Region of Enrollment   [units: participants]
United States	517	533	1050

1.  Primary:

Progression of Liver Disease as Indicated by Death, Hepatic Decompensation, Hepatocellular Carcinoma, or for Patients With Noncirrhotic Fibrosis at Baseline, an Increase in the Ishak Hepatic Fibrosis Score of 2 or More Points   [ Time Frame: 1400 days (3.85 years) post randomization ]

2.  Primary:

Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies   [ Time Frame: 1400 days (3.85 years) post randomization ]

3.  Primary:

Death From Any Cause   [ Time Frame: 1400 days (3.85 years) post randomization ]

4.  Primary:

Development of Hepatocellular Carcinoma (HCC)   [ Time Frame: 1400 days (3.85 years) post randomization ]

5.  Primary:

Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits   [ Time Frame: 1400 days (3.85 years) post randomization ]

6.  Primary:

Variceal Hemorrhage   [ Time Frame: 1400 days (3.85 years) post randomization ]

7.  Primary:

Ascites   [ Time Frame: 1400 days (3.85 years) post randomization ]

8.  Primary:

Spontaneous Bacterial Peritonitis   [ Time Frame: 1400 days (3.85 years) post randomization ]

9.  Primary:

Hepatic Encephalopathy   [ Time Frame: 1400 days (3.85 years) post randomization ]

10.  Secondary:

Serious Adverse Events   [ Time Frame: 1400 days (3.85 years) post randomization ]

11.  Secondary:

Events Requiring Dose Reductions (in Both Treatment Groups).   [ Time Frame: 1400 days (3.85 years) post randomization ]

12.  Secondary:

Changes in Fibrosis From Baseline at Year 2 or Year 4 Biopsy.   [ Time Frame: 1400 days (3.85 years) post randomization ]

13.  Secondary:

Presumed Hepatocellular Carcinoma (HCC)   [ Time Frame: 1400 days (3.85 years) post randomization ]

14.  Secondary:

Quality of Life   [ Time Frame: 1400 days (3.85 years) post randomization ]