A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients

Inclusion criteria:

Chronic hepatitis C infection of GT-1 in patients who failed prior treatment with PegIFN
and RBV in the 1220.7, 1220.30 and 1220.47 trials of the BI 201335 Phase III program.

1. Patients from trials 1220.7, 1220.30 and 1220.47 of BI 201335 who have failed
treatment with PegIFN/RBV in the placebo groups due to protocol-defined criteria of
treatment failure (i.e. either non-response on treatment or relapse after end of
treatment [EOT]).

2. Patients must have received at least 4 weeks of assigned trial medication and been
compliant with all study procedures.

3. Female patients:

- with documented hysterectomy,

- who have had both ovaries removed,

- with documented tubal ligation,

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

- of childbearing potential with a negative serum pregnancy test at screening and
Day 1, that, if sexually active, 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 RBV in addition to the consistent and correct use of a
condom. Patients must agree not to breast-feed at any time from the date of
screening until 7 months after the last dose of RBV.

Medically accepted methods of contraception for females in this trial are ethinyl
estradiol-containing contraceptives, diaphragm with spermicide substance,
intra-uterine device and cervical cap.

or

Male patients:

- who are documented to be sterile, or

- who are without pregnant female partner(s) and consistently and correctly use a
condom while their female partner(s) (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. It is in the
responsibility of the male patient to ensure that his partner(s) is not pregnant
prior to screening into the study or becomes pregnant during the treatment and
the observation 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).

4. Signed informed consent form prior to trial participation.

Exclusion criteria:

1. Evidence of acute or chronic liver disease due to causes other than chronic HCV
infection. Incidental steatosis diagnosed by biopsy is not an exclusion criteria.

2. HIV co-infection

3. Hepatitis B virus (HBV) infection based on presence of HBs-Ag

4. Active malignancy, or history of malignancy within the last 5 years prior to
screening (with an exception of appropriately treated basal cell carcinoma of the
skin or in situ carcinoma of the uterine cervix)

5. Active or, history of alcohol or illicit drug abuse other than cannabis within the
past 12 months

6. A condition that is defined as one which in the opinion of investigator may put the
patient at risk because of participation in this study, may influence the results of
this study, or limit the patients ability to participate in this study

7. Usage of any investigational drugs within 30 days prior to screening, or planned
usage of an investigational drug during the course of this study.

8. Received concomitant systemic antiviral, hematopoietic growth factor, or
immunomodulatory treatment within 30 days prior to screening. Patients being treated
with oral antivirals such as acyclovir, famciclovir or valacyclovir for recurrent
herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection,
may be screened.

9. Received silymarin (milk thistle), glycyrrhizin, or Sho-saiko-to (SST) within 28 days
prior to enrolment and throughout the treatment phase of this trial.

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

11. Alpha fetoprotein value > 100 ng/mL at screening; if > 20 ng/mL and = 100 ng/mL,
patients may be included if there is no evidence of liver cancer in an appropriate
imaging study (e.g., ultrasound, CT scan, or MRI) within last 6 months prior to
randomization (Visit 2).

Other exclusion criteria related to pegylated interferon and/or ribavirin restrictions are
not listed here.