Open Label Trial to Compare BI 207127 to Telaprevir in HCV Patients
Open Label Trial to Compare BI 207127 to Telaprevir in HCV Patients
The aim of this trial is to evaluate efficacy and safety of treatment with 600 mg of BID BI
 207127 in combination with 120 mg QD Faldaprevir and RBV compared to a Telaprevir-based
 regimen along with PegIFN and RBV in chronically infected HCV GT1 treatment naïve patients,
 including patients with compensated cirrhosis.
Inclusion criteria:

 1. Chronic HCV, diagnosed by HCV RNA = 1,000 IU/mL at screening in addition to at least
 one of the following:

 1. positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to
 screening, OR

 2. liver biopsy indicating chronic HCV infection, OR

 3. history of elevated 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:

 1. no prior treatment with any interferon, pegylated interferon, and /or ribavirin
 and

 2. no prior treatment with at least one dose of any other licensed or
 investigational antiviral agent for acute or chronic hepatitis C infection.

 4. Availability of a liver biopsy within three years or fibroscan within 6 months prior
 to randomisation.

 Note: patients who do not have a liver biopsy (nor fibroscan) due to contraindication
 of the procedure should not be excluded for this reason. The decision on the inclusion
 of these patients should be discussed with the CML. 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.

 5. Age 18 - 70 years (inclusive).

 6. Female patients

 1. with documented hysterectomy, or

 2. who have had both ovaries removed, or

 3. with documented tubal ligation, or

 4. who are post-menopausal with last menstrual period at least 12 months prior to
 screening, or

 5. of childbearing potential with a negative serum pregnancy test at screening and
 on Day 1 (Visit 2), who 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

 1. who are documented to be sterile, or

 2. 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

 3. 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).

 7. Signed informed consent form prior to trial participation.

 Exclusion criteria:

 1. HCV infection of mixed genotype (1/2, 1/3, and 1/4), HCV sub-GT1a or GT1 undefined,
 diagnosed at screening by genotypic testing.

 2. Liver disease due to causes other than chronic HCV infection which may include but is
 not limited to hemochromatosis, Wilson's disease, or autoimmune liver disease.

 3. HIV infection.

 4. Hepatitis B virus (HBV) infection based on presence of Hepatitis B surface antigen.

 5. 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 and/or any laboratory results
 (International Normalised Ratio, albumin, bilirubin) indicating a Child-Pugh-Turcotte
 score > 6 points (i.e. CPT-B or -C)

 6. Confirmed or suspected active 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).

 7. Patients with ongoing or historical photosensitivity or recurrent rash.

 8. History of illicit drug use (other than cannabis) or chronic alcohol abuse within 12
 months prior to randomization, in the opinion of the Investigator.

 9. Body mass index <18 or >35 kg/m2.

 10. 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.

 11. Known hypersensitivity to any ingredient of the study drugs.

 12. 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.

 13. 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.

 14. 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. Clinically significant Electrocardiogram (ECG) abnormalities. A history
 of congenital QT prolongation, or a family history of congenital QT prolongation or
 sudden death.

 15. Received silymarin (milk thistle) or glycyrrhizin or Sho-saiko-to (SST) within 28 days
 prior to randomisation 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.

 16. Pre-existing psychiatric conditions that could interfere with the subject's
 participation in and completion of the study including but not limited to severe
 depression or hospitalization for depression, suicidal ideation and attempted suicide,
 schizophrenia, bipolar illness, severe anxiety or personality disorder, history of
 craniocerebral trauma or active seizure disorders requiring medication, a period of
 disability or impairment due to a psychiatric disease current or within the previous 3
 years before randomisation.

 17. Abnormal thyroid function that cannot be controlled effectively by medication.

 18. Active autoimmune-mediated disease (e.g., Crohn's disease, ulcerative colitis,
 idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune
 hemolytic anemia, scleroderma, severe psoriasis).

 19. Requirement for chronic systemic corticosteroids (inhaled or nasally administered or
 pulmonary steroids will be allowed).

 20. History or other evidence of severe retinopathy or clinically significant
 ophthalmological disorder due to diabetes mellitus or hypertension (but not limited to
 these conditions).

 Plus other exclusion criteria relating to Peg interferon, ribavirin and Telaprevir.