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