Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C

Study Overview
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Brief Summary
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The purpose of this study is to determine if 48 weeks of therapy with Pegylated Interferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Pegylated Interferon Alfa-2a plus Ribavirin.

Official Title
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A Double-Blinded Randomized Control Study Evaluating the Efficacy and Safety of Pegylated Lambda Interferon Compared to Pegylated Alfa-2a Interferon, Each in Combination With Ribavirin, in the Treatment of Naive Genotype 1 or 4 Chronic Hepatitis C Subjects

Conditions
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Hepatitis C Virus (HCV)

Intervention / Treatment
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* Biological: Pegylated Interferon Lambda
* Biological: Pegylated Interferon Alfa-2a
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic hepatitis C, Genotype 1 or 4 HCV Ribonucleic acid (RNA) ≥ 100,000 IU/mL at screening Liver biopsy documenting no cirrhosis (within prior 2 years) or cirrhosis (from any time prior to randomization). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease. Subjects with compensated cirrhosis can enroll and will be capped at 10% Naive to prior anti-HCV therapy Exclusion Criteria: Infected with HCV other than Genotype 1 or 4 Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody or hepatitis D virus (HDV) at screening Evidence of liver disease other than HCV Active substance abuse Use of hematologic growth factors within 90 days prior to study randomization Evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Pegylated Interferon Lambda + Ribavirin<br> | Biological: Pegylated Interferon Lambda<br>* Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks<br>* Other names: BMS-914143;Drug: Ribavirin<br>* Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks<br>* Other names: Ribasphere;|
| Active Comparator: Arm 2: Pegylated Interferon Alfa-2a + Ribavirin<br> | Biological: Pegylated Interferon Alfa-2a<br>* Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks<br>* Other names: Pegasys;Drug: Ribavirin<br>* Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks<br>* Other names: Ribasphere;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Lambda + Ribavirin (RBV) compared to Alfa + RBV in achieving a sustained virological response |  | At follow-up Week 24 (SVR24) following 48 weeks of treatment | 
| The safety of Lambda + RBV compared to Alfa + RBV in reducing cytopenic abnormalities |  | From Day 1 to end of Week 48 on-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of interferon-associated symptoms: a) Flu-like symptoms b) Musculoskeletal symptoms c) Neurologic symptoms d) Psychiatric symptoms e) Constitutional symptoms |  | From Day 1 to end of Week 48 on-treatment |