This study is being done to find out if the addition of boceprevir to standard of care (SOC) treatment with peginterferon alfa-2b (PegIFN-2b) + ribavirin (RBV) is effective for participants with chronic hepatitis C (CHC) genotype 1 and cirrhosis who were not successfully treated by previous SOC. All participants will receive treatment with SOC alone for 4 weeks and then boceprevir will be added to the treatment regimen for 44 additional weeks of combined treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Percentage of Participants Who Achieve Sustained Virological Response at Follow-up Week 24 (SVR24)
Hepatitis C Virus (HCV) ribonucleic acid (RNA) was measured using a polymerase chain reaction assay. SVR24 was defined as HCV RNA less than the Limit of Quantification (\<25 International Units (IU)/mL) 24 weeks after the end of the Treatment Period.
Time frame: Week 72 (24 weeks after end of treatment)
Percentage of Participants With One or More Adverse Events
Adverse events were monitored during the Lead-in and Treatment Periods
Time frame: Up to 48 weeks (Lead-in and Treatment Periods)
Percentage of Participants With an Adverse Event Leading to Discontinuation of Study Medication
Adverse events were monitored during the Lead-in and Treatment Periods
Time frame: Up to 48 weeks (Lead-in and Treatment Periods)
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