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

Phase 3

Completed

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
A 1: DCV/ASV/BMS-791325 in treatment-naive subjects	DCV/ASV/BMS-791325	Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks
A 2: DCV/ASV/BMS-791325 in treatment-experienced subjects	DCV/ASV/BMS-791325	Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks

Primary Outcome Measures

Name	Time	Method
Proportion of treated subjects in the naive cohort with sustained virologic response (SVR) 12	Post-Treatment Week 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

Secondary Outcome Measures

Name	Time	Method
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

Locations (44): Scripps Clinic
🇺🇸
La Jolla, California, United States
Medical Associates Research Group
🇺🇸
San Diego, California, United States
Quest Clinical Research
🇺🇸
San Francisco, California, United States
University Of Colorado Denver & Hospital
🇺🇸
Aurora, Colorado, United States
Borland-Groover Clinic
🇺🇸
Jacksonville, Florida, United States
Orlando Immunology Center
🇺🇸
Orlando, Florida, United States
Miami Research Associates
🇺🇸
South Miami, Florida, United States
Gastrointestinal Specialists Of Georgia
🇺🇸
Marietta, Georgia, United States
University Of Chicago Medical Center
🇺🇸
Chicago, Illinois, United States
Indiana University Med Center
🇺🇸
Indianapolis, Indiana, United States
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Scripps Clinic
🇺🇸La Jolla, California, United States