This multi-center study will evaluate the viral response in patients with chronic hepatitis C, genotype 1, 2, 3 \& 4 on standard anti-viral treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will receive weekly subcutaneous Pegasys plus daily oral Copegus for 24 weeks (genotype 2 \& 3) or 48 weeks (genotype 1 \& 4). Patients identified as slow responders/non-rapid virological responders will be eligible for an additional 24 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,013
standard treatment, subcutaneously weekly
standard treatment, orally daily
Haemek Hospital; Gastroenterology
Afula, Israel
Clalit City Ashdod MC; Liver Clinic
Ashdod, Israel
Barzilai MC; Gastroenterology
Ashkelon, Israel
Batyamon; Liver Unit
Bat Yam, Israel
Soroka Medical Center; Liver Unit
Beersheba, Israel
Soroka Medical Center; Gastroenterology
Beersheba, Israel
Rambam Medical Center; Gastroenterology - Liver Unit
Haifa, Israel
Bnei-Zion Medical Center; Gastroenterology
Haifa, Israel
Carmel Hospital; Liver Unit
Haifa, Israel
Wolfson Hospital; Gastroenterology Unit
Holon, Israel
...and 16 more locations
Percentage of Participants With Partial Early Virological Response (pEVR) to Study Treatment
The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12.
Time frame: Week 12
Percentage of Participants With Complete Early Virologic Response (cEVR) to Study Treatment
The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment
Time frame: Week 12
Percentage of Participants With Undetectable HCV-RNA at End of Treatment Response (ETR) at Week 24
The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment
Time frame: Week 24
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
The rate of participants with RVR was defined as negative HCV-RNA level at Week 4 of study treatment.
Time frame: Week 4
Percentage of Participants Without a RVR (Non-RVR) at Week 4 of Standard Treatment
The rate of participants without a RVR (non-RVR) was defined as detectible HCV-RNA level at Week 4 of standard treatment.
Time frame: Week 4
Percentage of Participants With Non-RVR and Undetectable HCV-RNA at Week 24
The rate of participants with non-RVR and undetectable HCV-RNA at Week 24 was defined as detectable HCV-RNA level at Week 4 of study treatment and undetectable HCV-RNA at Week 24 of study.
Time frame: Week 24
Percentage of Participants With pEVR to Study Treatment at Week 12
The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12.
Time frame: Week 12
Percentge of Participants With a cEVR to Study Treatmen at Week 12 of Study Treatment
The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment.
Time frame: Week 12
Percentage of Participants With Undetectable HCV-RNA at Week 24, But With Detectable HCV-RNA atWeek 12 and Undetectable HCV-RNA at Week 24
The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment.
Time frame: Week 24
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