A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects

Study Overview
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Brief Summary
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The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subject. The purpose of this study is to compare the anti-viral activity of the co-administration of Asunaprevir (ASV) and Daclatasvir (DCV) to Telaprevir (TVR) included therapy in Japanese Hepatitis C virus (HCV) subjects

Detailed Description
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Intervention Model: Parallel in the Naive cohort and Single group in the Relapser cohort

Official Title
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A Phase 3, Comparative Study of Asunaprevir and Daclatasvir (DUAL) Combination Therapy Versus Telaprevir Therapy in Japanese Genotype 1b Chronic Hepatitis C IFN Eligible-naive Subjects With a Single Arm Assessment of DUAL Therapy in IFN-therapy Relapsers

Conditions
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Hepatitis C Virus Infection

Intervention / Treatment
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* Drug: Daclatasvir
* Drug: Asunaprevir
* Drug: Ribavirin
* Biological: pegIFNα-2b
* Drug: Telaprevir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic HCV-1b infected patient HCV Ribonucleic acid (RNA) > 100,000 IU/mL at screening Ages 20 to 70 years (for the Naive cohort), ages 20 to 75 years (for the Relapser cohort) Treatment naive subjects to Interferon (IFN) based therapy Subjects who had undetectable HCV RNA at end of treatment with prior exposure to an IFN-containing regimen, but HCV RNA detectable within 24 weeks of treatment follow-up Exclusion Criteria: Patients who have; Hepatocellular carcinoma Co-infection with Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV) Severe or uncontrollable complication

Ages Eligible for Study
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Minimum Age: 20 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Daclatasvir + Asunaprevir<br>Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks - Naive cohort | Drug: Daclatasvir<br> <br> Drug: Asunaprevir<br> <br> |
| Active Comparator: Arm 2: Telaprevir + pegIFNα-2b + Ribavirin<br>Telaprevir 750 mg tablets by mouth three times daily, pegIFNα-2b 1.5 μg/kg solution by Subcutaneous weekly & Ribavirin 600- 1000 mg Capsules by mouth twice daily for 24 Weeks - Naive cohort | Drug: Ribavirin<br> <br> Biological: pegIFNα-2b<br> <br> Drug: Telaprevir<br> <br> |
| Experimental: Arm 3: Daclatasvir + Asunaprevir<br>Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks - Relapser cohort | Drug: Daclatasvir<br> <br> Drug: Asunaprevir<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the naive cohort | SVR12 = Sustained virologic response at post-treatment Week 12 LLOQ = Lower Limit of quantitation | After 12 weeks of the last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with hemoglobin < 10g/dL |  | First 12 weeks of treatment | 
| Proportion of subjects with rash-related dermatologic events |  | First 12 weeks of treatment | 
| Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the naive cohort | EOT = End of treatment | At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12; EOT (up to 24 weeks), post-treatment Week 4 and post-treatment Week 24 | 
| Proportion of subjects with HCV RNA target not detected in the naive cohort | eRVR = Extended rapid virologic response | At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 4, post-treatment Week 12 and post-treatment Week 24 | 
| Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the relapser cohort |  | At post-treatment Week 12 | 
| Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the relapser cohort |  | At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12; EOT (up to 24 weeks), post-treatment Week 4 and Week 24 | 
| Proportion of subjects with HCV RNA target not detected in the relapser cohort |  | At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 4, post-treatment Week 12 and post-treatment Week 24 | 
| On treatment safety, as measured by the frequency of Severe adverse events (SAEs), discontinuation and dose modification/interruption due to Adverse events (AEs), Grade 3-4 abnormalities observed from clinical laboratory tests for each treatment group |  | End of treatment (24 weeks) plus 7days |