The Effect of Boceprevir in Russian Participants Diagnosed With Chronic Hepatitis C Genotype 1 (P08160)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Boceprevir (BOC, SCH 503034, MK-3034) in combination with Peginterferon Alfa 2-b (PEG) plus Ribavirin (RBV) [PEG+RBV=PR] is effective in the treatment of chronic hepatitis C (CHC) genotype 1 among the Russian population. The primary hypothesis is that the percentage of participants achieving sustained virologic response in the BOC + PR group is superior to that in the Placebo (PBO) + PR group.

Official Title
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Safety and Efficacy of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for Treatment of Chronic Hepatitis C Genotype 1 in Russia: Previously Untreated Patients and Patients Who Failed Prior Treatment With Pegylated-Interferon Plus Ribavirin

Conditions
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Chronic Hepatitis C Genotype 1

Intervention / Treatment
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* Drug: Boceprevir
* Drug: Placebo
* Biological: peginterferon alfa-2b
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: body weight ≥40 kg and ≤125 kg previously documented CHC genotype 1 infection; must have a liver biopsy with histology consistent with CHC and no other etiology if cirrhosis present, must have an ultrasound within 6 months of the screening visit (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma (HCC) agree to use acceptable methods of contraception with partner previously untreated with pegylated-interferon (either alfa-2a or alfa-2b) plus RBV or failing prior treatment with pegylated-interferon (either alfa-2a or alfa-2b) plus RBV Exclusion criteria: co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus (Hepatitis B surface antigen [HBsAg] positive). required discontinuation of previous interferon or ribavirin regimen for an adverse event (possibly or probably related) treatment with ribavirin within 90 days and any interferon-alpha, based on the amendment, should be within 1 month prior to screening treatment with any investigational drug within 30 days of the screening visit in this trial evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy diabetic and/or hypertensive with clinically significant ocular examination findings clinical diagnosis of substance abuse of specified drugs within specified timeframes any known pre-existing medical condition that could interfere with the participant's participation in and completion of the trial

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RGT BOC + PR<br>Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks. | Drug: Boceprevir<br>* boceprevir 200-mg capsules, 800 mg 3 times a day (TID), orally (PO)<br>* Other names: SCH 503034;Biological: peginterferon alfa-2b<br>* peginterferon alfa-2b 1.5 μg/kg/wk subcutaneously (SC)<br>* Other names: PegIntron;Drug: Ribavirin<br>* ribavirin (weight-based dosing) 800 to 1400 mg/day PO divided twice daily dose (BID).<br>|
| Placebo Comparator: PBO + PR (Control)<br>Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks. | Drug: Placebo<br>* boceprevir-matched placebo four 200-mg capsules PO TID.<br>Biological: peginterferon alfa-2b<br>* peginterferon alfa-2b 1.5 μg/kg/wk subcutaneously (SC)<br>* Other names: PegIntron;Drug: Ribavirin<br>* ribavirin (weight-based dosing) 800 to 1400 mg/day PO divided twice daily dose (BID).<br>|
| Experimental: Crossover Arm<br>Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR. | Drug: Boceprevir<br>* boceprevir 200-mg capsules, 800 mg 3 times a day (TID), orally (PO)<br>* Other names: SCH 503034;Biological: peginterferon alfa-2b<br>* peginterferon alfa-2b 1.5 μg/kg/wk subcutaneously (SC)<br>* Other names: PegIntron;Drug: Ribavirin<br>* ribavirin (weight-based dosing) 800 to 1400 mg/day PO divided twice daily dose (BID).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Sustained Virologic Response At Follow-up Week 24 (SVR24) Among Participants Who Received At Least One Dose of Any Trial Medication (Full Analysis Set Population) | SVR24 was defined as an undetectable plasma Hepatitis C Virus-ribonucleic acid (HCV-RNA) level at Follow-up Week 24 (FW24). If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder. | Follow-up Week 24 (up to 72 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving SVR24 Among Participants Who Received At Least One Dose of Experimental Trial Drug (Modified Intent-To-Treat [mITT] Population) | SVR24 was defined as an undetectable plasma HCV-RNA level at FW24. If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder. | Follow-up Week 24 (up to 72 weeks) | 
| Percentage of Participants Achieving Early Virologic Response (EVR) At Treatment Week (TW) 8 | EVR was defined as an undetectable HCV-RNA level at TW 8. This analysis was conducted when all participants had completed 8 weeks of the study or had discontinued prior to TW 8. | Treatment Week 8 |