A Phase III, Randomised, Partially Double-Blind and Placebo-Controlled Study of BI 207127 in Combination with Faldaprevir and Ribavirin in Treatment-Naïve Patients with Chronic Genotype 1 HCV Infection

1. Chronic hepatitis C infection diagnosed by by positive anti-HCV antibodies and;detected HCV RNA at screening in addition to at least one of the following:;a. positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to;screening, OR;b. liver biopsy indicating chronic HCV infection, OR;c. history of elevated alanine aminotransferase (ALT) levels at least 6 months prior;to screening.;2. HCV infection of sub-GT1b confirmed by genotypic testing at screening.;3. Treatment naïve defined as:;a. no prior treatment with any interferon, pegylated interferon, and /or ribavirin;AND;b. no prior treatment with at least one dose of any other licensed or investigational;antiviral agent of for acute or chronic hepatitis C infection;4. Plasma HCV RNA * 1,000 IU/mL at screening;5. Liver biopsy within three years or fibroscan within 6 months prior to randomisation.;Note: patients with a liver biopsy performed 3 or more years or fibroscan performed 6;months or more prior to randomisation demonstrating cirrhosis do not need to repeat a;liver biopsy or fibroscan. Patients with a liver biopsy performed 3 or more years (or;fibroscan performed 6 months or more) prior to randomisation, negative for the presence;of cirrhosis need to repeat the liver biopsy or fibroscan, with the result available before;randomisation visit.;6. Age 18 * 75 years (inclusive);7. Female patients;a. with documented hysterectomy, OR;b. who have had both ovaries removed, OR;c. with documented tubal ligation, OR;d. who are post-menopausal with last menstrual period at least 12 months prior to;screening, OR;e. of childbearing potential with a negative pregnancy test at screening and on Day 1;(Visit 2), that agree to use two non-hormonal methods of birth control from the date;of screening until 7 months after the last dose of ribavirin. They must not breast-feed;at any time from the date of screening until 7 months after the last dose of ribavirin.;Accepted methods of contraception for females in this trial are diaphragm with;spermicide substances, intrauterine devices, cervical caps and condoms.;Note: Systemic hormonal contraceptives may not be as effective in women taking BI;207127/FDV combination therapy and are not accepted methods of contraception in the;study.;OR;Male patients;a.who are documented to be sterile, OR;b. who consistently and correctly use a condom while their female partners (if of;child-bearing potential) agree to use one of the appropriate medically accepted;methods of birth control from the date of screening until 7 months after the last dose;of ribavirin, AND;c. without pregnant female partners. It is in the responsibility of the male patient to;ensure that his partner (or partners) is not pregnant prior to enrolment into the study;or becomes pregnant during the treatment and follow-up phase. Female partners of;childbearing potential must perform monthly pregnancy tests from the date of;screening until 7 months after the last dose of ribavirin (tests will be provided by the;sponsor).;8. Signed informed consent form prior to trial participation

1. HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing;at screening;2. HCV subtype 1a, GT1 undefined or mixed 1a/1b.;3. Evidence of liver disease mainly due to causes other than chronic HCV infection;such as autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis or;Wilson*s disease.;Note: patients with steatosis as part of the histologic findings on liver biopsy are not;excluded.;4. HIV-1 or HIV-2 infection;5. Hepatitis B virus (HBV) infection based on presence of HBs-Ag;6. Evidence of decompensated liver disease, or history of decompensated liver disease,;defined as history of ascites, hepatic encephalopathy, bleeding esophageal varices or;any other evidence of previous decompensation;7. International Normalized Ratio (INR) of *1.7;8. Serum albumin <3.3 g/dL;9. Serum total bilirubin >2.0 times the upper limit of normal (ULN), unless history of;Gilbert*s disease;10. Active or suspected malignancy or history of malignancy within the last 5 years;(with the exception of appropriately treated basal cell carcinoma of the skin or in situ;carcinoma of the uterine cervix);11. Patients with ongoing or historical photosensitivity or recurrent rash;12. Alcohol or drug abuse (except cannabis) within the past 12 months;13. Body mass index <18 or > 35 kg/m2;14. Usage of any investigational drugs within 28 days prior to randomisation, or the;planned usage of an investigational drug during the course of the current study;15. Known hypersensitivity to any ingredient of the study drugs;16. A condition that is insufficiently diagnosed, treated or clinically unstable which in;the opinion of investigator may put the patient at risk because of participation in this;study, influence the results of this study, or limit the patient*s ability to participate in;this study;17. Alpha fetoprotein value >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;18. A history of severe pre-existing cardiac disease, including unstable or uncontrolled;cardiac disease (e.g. congestive heart failure, myocardial infarction, unstable angina;and arrhythmic disorders) current or within the previous 12 months before;randomisation;19. Received concomitant hematopoietic growth factor, or immunomodulatory treatment;within 28 days prior to randomisation;20. Received silymarin (milk thistle), glycyrrhizin, Sho-saiko-to (SST) or any;medication listed in a restricted medication list provided in ISF within 28 days prior;to randomisation, with the exception of parenteral analgesics used during liver biopsy;procedure.;The following exclusion criteria are potential contraindications for the use of PegIFN;+/- RBV (for rationale please cf. Section 3.2);21. Pre-existing psychiatric conditions including but not limited to severe depression or;hospitalization for depression, suicidal ideation and attempted suicide, schizophrenia,;bipolar illness, severe anxiety or personality disorder, a period of disability or;impairment due to a psychiatric disease current or within the previous 3 years before;randomisation;22. Abnormal thyroid function that cannot be controlled effectively by medication;23. Active autoimmune-mediated disease known to be exacerbated by peginterferon;therapy (e.g., Crohn*s disease, ulcerative colitis, idiopathic thrombocytopenic;purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma,;severe psoriasis);24. Requirement for chronic systemic corticosteroids (nasal or pulmonary steroids will;be allowed);25. History or other evidence of severe retinopathy or clinically significant;ophthalmological disorder due to diabetes mellitus or hypertension (but not limited to;these conditions). For subjects with a history of hypertension or diabetes, written;clearance from an ophthalmologist has to be obtained before the start of treatment;26. Hemoglobin <11.0g/dL for women and <12.0g/dL for men;27. Absolute neutrophil count < 1,500 cells/mm3;28. Platelet count < 90,000 /mm3;29. Creatinine clearance *50 ml/min;30. Diabetes mellitus with HbA1c > 8.5%;31. Clinically evident red blood cell disorders which include but are not limited to;thalassemia major, sickle cell anemia or glucose-6-phosphate dehydrogenase;deficiency or glucose-6-phosphate dehydrogenase deficiency