Safety and Efficacy Study of Peginterferon Lambda-1a vs. Peginterferon Alfa-2a, Plus Ribavirin in Subjects With Genotype 1 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 Peginterferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Peginterferon alfa-2a plus Ribavirin.

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

Conditions
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Hepatitis C Virus (HCV)

Intervention / Treatment
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* Biological: Peginterferon Lambda-1a
* Drug: Ribavirin
* Biological: Peginterferon alfa-2a


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic hepatitis C, Genotype 1 HCV RNA ≥100,000 IU/mL at screening Liver biopsy documenting no cirrhosis (within prior 3 years). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease Naïve to prior anti-HCV therapy Exclusion Criteria: Infected with HCV other than Genotype 1 Positive Hepatitis B Surface Antigen (HBsAg), or Human Immunodeficiency Virus (HIV)-1/HIV-2 antibody 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 history of 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: Peginterferon Lambda-1a + Ribavirin<br>Peginterferon Lambda-1a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks | Biological: Peginterferon Lambda-1a<br> <br> * Other names: BMS-914143;Drug: Ribavirin<br> <br> * Other names: Ribasphere;|
| Active Comparator: Peginterferon alfa-2a + Ribavirin<br>Peginterferon alfa-2a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks | Drug: Ribavirin<br> <br> * Other names: Ribasphere;Biological: Peginterferon alfa-2a<br> <br> * Other names: Pegasys;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who develop treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, and/or neutropenia as defined by ANC < 750 mm3 and/or thrombocytopenia as defined by platelets < 50,000 mm3) in treatment-naive subjects | ANC = Absolute Neutrophil Count Hb = Hemoglobin | Up to 48 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with Sustained Virologic Response at Post-Treatment Follow-up Week 24 (SVR24), defined as Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < Lower Limit of Quantitation of Assay (LLOQ) |  | At Post-Treatment Follow-up Week 24 | 
| Proportion of subjects with Rapid Virologic Response (RVR) (HCV RNA not detected) |  | On treatment Week 4 (of an up to 48-week treatment period) | 
| Proportion of subjects with on-treatment Serious Adverse Events (SAEs) through end of treatment |  | Up to 48 weeks of treatment | 
| Proportion of subjects with dose reductions through end of treatment |  | Up to 48 weeks of treatment | 
| Proportion of subjects who discontinue due to Adverse Events (AEs) through end of treatment |  | Up to 48 weeks of treatment | 
| Proportion of subjects with on-treatment Interferon (IFN)-associated symptoms as determined by adverse event reporting | On-treatment IFN-associated symptoms are: Flu-like symptoms (as defined by pyrexia or chills or pain) Musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain) Neurological symptoms (headache or dizziness) Constitutional symptoms (fatigue or asthenia) Psychiatric symptoms (depression or irritability or insomnia) | Up to 48 weeks of treatment |