A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1
A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1
To demonstrate the effectiveness of Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed
 dose combination in Genotype 1 Chronic Hepatitis C subjects.
US National Institutes of Health Division of AIDs (DAIDS)
For more information regarding BMS clinical trial participation, please visit
 www.BMSStudyConnect.com

 Inclusion Criteria:

 -  Subject chronically infected with HCV genotype 1 (GT-1)

 -  Subject without cirrhosis or with compensated cirrhosis (Child Pugh Class A)

 -  HCV RNA ≥ 10,000 IU/mL at screening

 -  Treatment-naïve subject with no previous exposure to an interferon formulation (ie,
 IFNα, pegIFNα), Ribavirin (RBV), or HCV DAA (protease, polymerase inhibitor, etc.)

 -  Interferon (IFN) experienced subject who have received previous treatment with IFNα,
 with or without RBV

 Exclusion Criteria:

 -  Liver or any other transplant (including hematopoietic stem cell transplants) other
 than cornea and hair;

 -  Current or known history of cancer (except in situ carcinoma of the cervix or
 adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior
 to screening;

 -  Documented or suspected hepatocellular carcinoma (HCC), as evidenced by previously
 obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy
 if this was performed);

 -  Evidence of decompensated liver disease including, but not limited to, radiologic
 criteria, a history or presence of ascites, bleeding varices, or hepatic
 encephalopathy