A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection
A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection
The purpose of this study is to determine whether a regimen consisting of daclatasvir and
 asunaprevir is effective in treatment-naive patients with chronic hepatitis genotype 1b
 infection.
For more information regarding BMS clinical trial participation, please visit
 www.BMSStudyConnect.com

 Inclusion Criteria:

 -  Patients chronically infected with HCV Genotype 1b

 -  No previous exposure to any interferon formulation, Ribavirin (RBV), and HCV direct
 acting antiviral agent

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

 -  Seronegative for HIV and HBsAg

 -  BMI of 18-35 kg/m2, inclusive

 -  Patients with compensated cirrhosis are permitted

 Exclusion Criteria:

 -  Infection with HCV other than genotype (GT) -1b

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

 -  Evidence of a medical condition contributing to chronic liver disease other than HCV

 -  Diagnosed or suspected hepatocellular carcinoma or other malignancies

 -  Uncontrolled diabetes or hypertension

 -  History of moderate to severe depression. Well-controlled mild depression is allowed

 -  Confirmed alanine aminotransferase (ALT) ≥ 5x Upper Limit of Normal (ULN)

 -  Confirmed platelet count < 50,000 cells/mm3

 -  Confirmed hemoglobin < 8.5 g/dL