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