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)

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,