Study of Daclatasvir (BMS-790052) and Simeprevir (TMC435) in Patients With Genotype 1 Chronic Hepatitis C Virus

Key Inclusion Criteria: * Hepatitis C virus (HCV) genotype 1a or 1b * Males and females, ≥18 years of age * HCV RNA ≥10,000 IU/mL * Participants with compensated cirrhosis are permitted * Advanced fibrosis (F3/F4) is capped at approximately 35% of the total treated population with a minimum of 20% F4 patients * If no cirrhosis, a liver biopsy within 3 years prior to enrollment * If cirrhosis is present, any prior liver biopsy Key Exclusion Criteria: * Liver or any other transplant (other than cornea and hair) * Evidence of a medical condition contributing to chronic liver disease other than HCV infection * 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 enrollment * Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy * Patients infected with HIV or hepatitis B virus * Gastrointestinal disease impacting absorption of study drug * Uncontrolled diabetes or hypertension * Prior exposure to an HCV direct-acting agent * Any criteria that would exclude the patient from receiving ribavirin * Absolute neutrophil count \<1.5\*1,000,000,000 cells/L (\<1.2\*1,000,000,000 cells/L for Black/African Americans) * Platelets \<90\*1,000,000,000 cells/L * Hemoglobin \<12 g/dL for females, \<13 g/dL for males * Alanine aminotransferase ≥5\*upper limit of normal * In patients without cirrhosis, total bilirubin ≥2 mg/dL unless patient has a documented history of Gilbert's disease * In patients with cirrhosis, total bilirubin o ≥1.5 mg/dL * International normalized ratio ≥1.7 * QTcF or QTcB \>500 mSec * Creatinine clearance ≤50 mL/min * Alpha fetoprotein (AFP) \>100 ng/mL OR * AFP ≥50 ng/mL and ≤100 ng/mL requiring liver ultrasound * Albumin \<3.5 g/dL