Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection

Inclusion criteria:

- Chronic hepatitis C virus (HCV) infection of genotype (GT) 1

- Parts 1-3:Treatment naive to Interferon -alfa (IFN), Pegylated interferon -alfa
(PegIFN), ribavirin (RBV), and any direct acting antiviral agent for chronic
hepatitis C

- Part 4: Treatment experienced with confirmed prior virological failure to an approved
dose of PegIFN/RBV (null-response)

- HCV RNA >=10,000 IU/mL at screening

- Liver biopsy within two years or fibroscan within six months prior to baseline

- Liver biopsy within two years or fibroscan within 6 months prior to screening

- Age 18-75 years

Exclusion criteria:

- Hepatitis C virus (HCV) infection of mixed genotype

- Evidence of liver disease due to causes other than chronic HCV infection

- Positive ELISA for human immunodeficiency virus (HIV)

- Hepatitis B virus (HBV) infection

- Decompensated liver disease or history of decompensated liver disease

- Active or suspected malignancy within the last 5 years

- Ongoing or historical photosensitivity or recurrent rash

- History of alcohol or drug abuse (except cannabis) within the past 12 months

- Body mass index (BMI)I <18 or > 35 kg/m2

- Usage of any investigational drugs within 30 days prior to enrolment, or 5
half-lives, whichever is longer; o the planned usage of an investigational drug
during the course of the current study

- Known hypersensitivity to any ingredient of the study drugs

- A condition that is defined as one which in the opinion of the investigator may
interfere with the patient's capability for participation in the trial or may
influence the results of the trial

- Alpha fetoprotein >100ng/mL at screening; if >20ng/mL and <=100ng/mL, patients can be
included if there is no evidence of liver cancer in an appropriate imaging study
within 6 months prior to randomisation

- Total bilirubin > 2 mg/dL with ratio of direct/indirect > 1

- AST or ALT >5xULN

- INR prolonged to >1.7xULN

- Requirement for chronic systemic corticosteroids

- Received concomitant systemic antiviral, hematopoietic growth factor, or
immunomodulatory treatment within 30 days prior to enrolment or 5 half-lives,
whichever is longer

- Received silymarin or glycyrrhizin or Sho-saiko-to within 30 days prior to enrolment

- Contraindications pertaining to PegIFN or RBV