Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)

Inclusion criteria:

1. Chronic hepatitis C genotype 1 infection, diagnosed at least 6 months prior to
screening

2. Confirmed prior virological failure with an approved dose of PegIFN/RBV

3. Age 18 to 70 years,

4. HCV RNA (RiboNucleic Acid) = 1,000 IU/mL at screening,

Exclusion criteria:

1. HCV infection of mixed genotype; Hepatitis B Virus (HBV) or Human Immunodeficiency
Virus (HIV) co-infection

2. Evidence of acute or chronic liver disease due to causes other than chronic HCV
infection,

3. Decompensated liver disease, or history of decompensated liver disease,

4. Body weight < 40 or > 125 kg,

5. Clinical evidence of significant or unstable cardiovascular disease, chronic
pulmonary disease, history or evidence of retinopathy or clinically significant
ophthalmological disorder

6. Pre-existing psychiatric condition that could interfere with the subject's
participation in and completion of the study

7. Laboratory parameters disorders (thalassemia major, sickle cell anemia or G6PD
deficit)

8. Hemoglobin < 12 g/dL for women and < 13 g/dL for men

9. Patients who have been previously treated with at least one dose of any antiviral or
immunomodulatory drug other than interferon alfa or ribavirin for acute or chronic
HCV infection including and not restricted to protease or polymerase inhibitors,