A Study to Evaluate the Efficacy and Safety of Boceprevir Added to Standard of Care Therapy in Previously Treated Participants With Chronic Hepatitis C Genotype 1 and Cirrhosis (MK-3034-105)

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-centre Single-arm Study to Evaluate the Efficacy and Safety of BOCEPREVIR 44 Weeks in Addition to Standard of Care (SOC) in Previously Treatment Failure (Relapser, Non-responders, Both Partial and Null) Patients With Chronic Hepatitis C Genotype 1 (G1) and Cirrhosis (F4 Metavir). (MK-3034-105)

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: boceprevir
* Biological: PegIFN-2b
* Drug: RBV


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Weight between 40 kg and 125 kg Documented CHC genotype 1 infection Previous course of treatment with SOC (PegIFN-2a or PegIFN-2b + RBV) with a documented non-response Documented diagnosis of cirrhosis No evidence of hepatocellular carcinoma (HCC) by ultrasound Participant and partner of participant must agree to use 2 effective contraceptives as specified for at least 2 weeks prior to Day 1 of treatment and continue until at least 6 months after last dose of study drug (7 months for male participants) Exclusion criteria: Co-infection with human immunodeficiency virus (HIV) or hepatitis B virus Use of any investigational drugs within 30 days prior to study enrollment Participation in any other clinical trial within 30 days of study enrollment or intention to participate in another clinical trial during this study Evidence of present or previous decompensated liver disease including, but not limited to, a history or presence of clinical ascites or hepatic encephalopathy. Only participants with large (F3) esophageal varices, as determined in an esophagogastroduodenoscopy (EGD) performed within the past 12 months according to international guidelines will be excluded. Clinically significant ocular examination findings Pre-existing significant psychiatric condition(s) Clinical diagnosis of active or recent substance abuse Evidence of active or suspected malignancy, or a history of malignancy, within the last 3 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PegIFN-2b + RBV+ boceprevir<br>Participants will receive PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks and then will receive 44 additional weeks of treatment with PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). | Drug: boceprevir<br> <br> * Other names: SCH 503034;Biological: PegIFN-2b<br> <br> * Other names: SCH 054031;Drug: RBV<br> <br> * Other names: Rebetol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | Up to 48 weeks (Lead-in and Treatment Periods) |