UNITY 1: A Study of an Investigational Treatment Regimen of Daclatasvir (DCV) + Asunaprevir (ASV) + BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) for 12 Weeks for the Treatment of Chronic Hepatitis C Virus (HCV) Genotype 1 Infection in Non-cirrhotic Subjects

Study Overview
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Brief Summary
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To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and treatment experienced non-cirrhotic subjects

Official Title
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A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Non-cirrhotic Subjects With Genotype 1 Chronic Hepatitis C

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: DCV/ASV/BMS-791325


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: Subjects chronically infected with HCV genotype 1 HCV RNA ≥ 10,000 IU/mL at screening Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), RBV, or HCV DAA (protease, polymerase inhibitor, etc.) Treatment-experienced subjects are eligible Exclusion Criteria: Evidence of cirrhosis Liver or any other organ transplant Current or known history of cancer within 5 years prior to enrollment Documented or suspected HCC Evidence of decompensated liver

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A 1: DCV/ASV/BMS-791325 in treatment-naive subjects<br>Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks | Drug: DCV/ASV/BMS-791325<br> <br> |
| Experimental: A 2: DCV/ASV/BMS-791325 in treatment-experienced subjects<br>Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks | Drug: DCV/ASV/BMS-791325<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of treated subjects in the naive cohort with sustained virologic response (SVR) 12 | SVR12 is defined as HCV ribonucleic acid (RNA) < limit of quantitation (LOQ) target detected or target not detected (LOQ TD/TND) at post treatment Week 12 | Post-Treatment Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects in the experienced cohort with SVR12 |  | Follow up Week 12 | 
| Proportion of subjects in each cohort who achieve HCV RNA <LOQ TD/TND |  | On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24) | 
| Proportion of subjects in each cohort who achieve HCV RNA <LOQ TND |  | On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment weeks 4, 8, 12 and 24 | 
| Safety measured by frequency of serious AEs (SAEs) and discontinuations due to adverse events (AEs) through the end of treatment in each cohort |  | Up to post treatment week 4 (±7 days) | 
| Proportion of anemia defined as Hg <10 g/dL on-treatment and Hg ≥10 g/dL at baseline , in each cohort |  | Up to post treatment week 4 (±7 days) | 
| Rates of selected grade 3-4 lab abnormalities (hematologic and liver function) in each cohort |  | Up to post treatment week 4 (±7 days) | 
| Proportion of subjects in each cohort achieving SVR12 associated with HCV geno subtype 1a vs 1b |  | Post treatment week 12 | 
| Proportion of subjects in each cohort achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism (SNP) status (CC genotype or non-CC genotype) |  | Post treatment week 12 | 
| Proportion of subjects in each cohort achieving SVR12 associated with stage of liver fibrosis |  | Post treatment week 12 |