Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3

Study Overview
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Brief Summary
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The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin

Official Title
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A Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a, With and Without Daclatasvir, Compared to Peginterferon Alfa-2a, Each in Combination With Ribavirin, in the Treatment of Naïve Genotype 2 and 3 Chronic Hepatitis C Subjects

Conditions
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Hepatitis C Virus (HCV)

Intervention / Treatment
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* Biological: Pegylated interferon lambda (pegIFNλ)
* Biological: Pegylated interferon lambda (pegIFNλ)
* Biological: Pegylated interferon alfa-2a (pegIFNα-2a)
* Drug: Ribavirin
* Drug: Ribavirin
* Drug: Daclatasvir
* Drug: Placebo matching Daclatasvir


Participation Criteria
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Eligibility Criteria
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Chronic hepatitis C, Genotype 2 or 3 Naïve to prior anti-HCV therapy Exclusion Criteria: Infected with HCV other than Genotype 2 or 3 Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening Evidence of liver disease other than HCV Active substance abuse Evidence of decompensated cirrhosis

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: pegIFNλ + Ribavirin + Placebo matching Daclatasvir<br> | Biological: Pegylated interferon lambda (pegIFNλ)<br>* Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks<br>* Other names: BMS-914143;Drug: Ribavirin<br>* Tablets, Oral, 400 mg, Twice daily, 24 weeks<br>* Other names: Ribasphere;Drug: Placebo matching Daclatasvir<br>* Tablets, Oral, 0 mg, Once daily, 12 weeks<br>|
| Experimental: Arm 2: pegIFNλ + Ribavirin + Daclatasvir<br> | Biological: Pegylated interferon lambda (pegIFNλ)<br>* Syringe, Subcutaneous, 180 μg, Once weekly, 12 weeks<br>* Other names: BMS-914143;Drug: Ribavirin<br>* Tablets, Oral, 400 mg, Twice daily, 12 weeks<br>* Other names: Ribasphere;Drug: Daclatasvir<br>* Tablets, Oral, 60 mg, Once daily, 12 weeks<br>* Other names: BMS-790052;|
| Experimental: Arm 3: pegIFNα-2a + Ribavirin + Placebo matching Daclatasvir<br> | Biological: Pegylated interferon alfa-2a (pegIFNα-2a)<br>* Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks<br>* Other names: Pegasys;Drug: Ribavirin<br>* Tablets, Oral, 400 mg, Twice daily, 24 weeks<br>* Other names: Ribasphere;Drug: Placebo matching Daclatasvir<br>* Tablets, Oral, 0 mg, Once daily, 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who achieve Sustained Virologic Response at post-treatment follow-up week 12 (SVR12) |  | Post-treatment follow-up week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with on-treatment constitutional symptoms (fatigue or asthenia) |  | Up to week 12 or week 24 | 
| Proportion of subjects with Rapid virologic response (RVR) [undetectable Hepatitis C virus (HCV) Ribonucleic acid (RNA)] |  | On-treatment Week 4 | 
| Proportion of subjects with treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, neutropenia as defined by ANC < 750 mm3 or thrombocytopenia as defined by platelets < 50,000 mm3) | Hb = Hemoglobin ANC = Absolute neutrophil count | Up to week 12 or week 24 | 
| Proportion of subjects with on-treatment interferon-associated flu-like symptoms (as defined by pyrexia or chills or pain) |  | Up to week 12 or week 24 | 
| Proportion of subjects with on-treatment musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain) |  | Up to week 12 or week 24 | 
| Proportion of subjects with Sustained Virologic Response at post-treatment follow-up week 24 (SVR24) by treatment group |  | Post-treatment week 24 | 
| Proportion of subjects with on-treatment Serious adverse events (SAEs) |  | Up to week 12 or week 24 | 
| Proportion of subjects with dose reductions |  | Up to week 12 or week 24 | 
| Proportion of subjects who discontinue due to Adverse events (AEs) |  | Up to week 12 or week 24 | 
| Proportion of subjects with SVR12 in subjects with genotype-3 (GT-3) chronic HCV infection |  | Post-treatment follow-up week 12 |