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

• Virological response 24 weeks post treatment (SVR24): Plasma HCV RNA level<25IU/mL (undetected) 24 weeks after the planned end of treatment. [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
• Early Treatment Success (ETS): Plasma HCV RNA level<25 IU/mL (detected or undetected) at Week 4 and HCV RNA< 25 IU/mL, undetected at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) normalisation: ALT and AST in normal range at end of treatment and post-treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

• Virological response after 12 weeks of treattment discontinuation (SVR12): Plasma HCV RNA level<25IU/mL (undetected) 12 weeks after the originally planned treatment duration . [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
• Early Treatment Success (ETS): Plasma HCV RNA level<25 IU/mL (detected or undetected) at Week 4 and HCV RNA< 25 IU/mL, undetected at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Alanine Aminotransferase normalisation: Alanine Aminotransferase in normal range 24 weeks after the end of the originally planned treatment duration [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

the aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV treatment-naive or relapsers patients coinfected with HIV

• Drug: PegIFN/RBV
  PegIFN/RBV for 24 or 48w
• Drug: BI201335
  BI201335 for 12w
• Drug: BI201335 24W
  BI201335 for 24w
• Drug: Bi 201335
  BI 201335 for 24 w

• Experimental: BI201335 12W
  patient to receive two capsules of BI 201335 once a day for 12 weeks and pegIFN/RBV for 24 or 48 weeks
  Interventions:

  • Drug: PegIFN/RBV
  • Drug: BI201335
• Experimental: BI 201335 24W
  patient to receive two capsules of BI 201335 once a day for 24 weeks and PegIFN/RBV for 24 or 48 weeks
  Interventions:

  • Drug: BI201335 24W
  • Drug: PegIFN/RBV
• Experimental: BI 201335 24 W
  patient to receive one capsule of BI 201335 once a day for 24 weeks and pegIFN/RBV for 24 or 48 weeks
  Interventions:

  • Drug: PegIFN/RBV
  • Drug: Bi 201335

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), hematopoietic growth 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 points according 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