Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)

Inclusion criteria:

1. Chronic hepatitis C (HCV) genotype 1 infection

2. Chronic Human Immunodeficiency Virus (HIV) -1 infection

3. HCV treatment naive or HCV treatment experienced but only relapsers

4. Age 18 to 70 years

5. Antiretroviral treatment naive or on stable Highly Active Antiretroviral Therapy (HAART)

6. Karnofsky score >70

7. HCV viral load >1.000 IU/mL

Exclusion criteria:

1. HCV infection of mixed genotype (1/2, 1/3, 1/4)

2. Evidence of acute or chronic liver due to chronic HCV infection

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

4. Active malignancy or history or malignancy within the last 5 years

5. Received concomitant systemic antiviral (other than antiretroviral), hematopoieticgrowth factor or immunomodulatory treatment in 28 days prior enrolment.

6. Decompensated liver disease,as evidenced by ascites, hepatic encephalopathy,esophageal variceal bleeding, and/or laboratory values that add up to >/= 7 pointsaccording tho the Child-Turcotte-Pugh classification

7. Hemoglobin </=11g/dL for women and </= 12 g/dL for men

8. Patients with stable cardiac disease and Hemoglobin <12g/dL

9. Known hypersensitivity to any ingredient of the study drugs