The current trial is designed to prospectively explore the safety of erythropoietin use for the treatment of anemia during boceprevir plus peginterferon alfa-2b/Ribavirin (PEG2b/RBV) therapy and to assess its relationship to efficacy. All participants in this trial will be treated with the triple combination of boceprevir plus PEG2b/RBV. If a participant becomes anemic during treatment, the participant will be randomized to one of two therapeutic strategies for management of anemia (erythropoietin use versus RBV dose reduction).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
687
800 mg given three times a day (TID), orally (PO)
1.5 µg/kg/week given subcutaneously (SC)
Ribavirin weight-based dosing (WBD), 600 to 1400 mg/day given twice daily (BID), orally (PO)
Initial dose of 40,000 Units given subcutaneously (SC) once weekly (QW), with dose adjustment as necessary to achieve and maintain serum hemoglobin levels of 10-12 g/dL
Percentage of Participants With Sustained Virologic Response (SVR)
SVR was defined as undetectable plasma Hepatitis C Virus ribonucleic acid (HCV-RNA) at Follow-up Week 24
Time frame: At Follow-up Week 24
Percentage of Participants Who Discontinued Treatment
Cumulative discontinuation was defined as the sum of discontinuations due to adverse events, viral breakthrough/resistance, detectable HCV-RNA and futility rules (\<2-log10 decline in HCV-RNA at Treatment Week 12, ≥ Lower Limit of Quantification \[LLQ\] HCV-RNA at Treatment Week 24), and other (noncompliance, withdrawal of consent, lost to follow-up).
Time frame: From Study Day 1 up to Study Treatment Week 48
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