This open-label, multicenter, phase IV study will evaluate the relationship between the drop in hemoglobin levels and sustained virological response in patients with chronic hepatitis C genotype 1 treated with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a). Patients will receive Copegus 1000 mg or 1200 mg orally daily and Pegasys 180 mcg subcutaneously weekly. Anticipated time on study treatment, depending on virological response, will be 48 or 72 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
180 mcg subcutaneously weekly
1000 mg or 1200 mg orally daily
Unnamed facility
Most, Czechia
Percentage of Participants With Sustained Virological Response (SVR) 24 Weeks After End of Treatment
SVR was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
Time frame: 24 weeks after the end of treatment (72 weeks)
Change From Baseline in Hemoglobin Level at Week 12 of Treatment Among Participants With or Without SVR
Change in hemoglobin level from a baseline level was assessed in the group of participants who achieved SVR and in the group of participants without SVR.
Time frame: Baseline and Week 12
Number of Participants With Decrease in Hemoglobin
The drop in hemoglobin level at Week 12 compared to level at baseline was assessed and categorized in pre-defined categories (up to 20, 20-40, greater than \[\>\] 40 g/L) for the group of participants who achieved SVR and in the group of participants without SVR.
Time frame: Week 12
Lowest Hemoglobin Level During Treatment Among Participants With or Without SVR
The mean minimum hemoglobin value achieved during the treatment was assessed in the group of participants who achieved SVR and in the group of participants without SVR.
Time frame: Week 12
Number of Participants With Reduction in Ribavirin Dose Due to Drop in Hemoglobin Among Participants With or Without SVR
Time frame: Week 12
Number of Participants With Neutropenia Among Participants With or Without SVR
Time frame: Week 12
Number of Participants With Thrombocytopenia Among Participants With or Without SVR
Time frame: Week 12
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