Phase 3
Completed N=310
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)
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01399619 ↗
Enrolled (actual)
310
Serious AEs
8.8%
Results posted
Sep 2015
Primary outcomePrimary: Sustained Virological Response (SVR12) — 70.7; 78.6; 76.7; 72.4 percentage of participants — p=<0.0001
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sustained Virological Response (SVR12) |
70.7; 78.6; 76.7; 72.4; 71.8 | <0.0001 sig |
| SECONDARY Virological Response 24 Weeks Post Treatment (SVR24) |
69.9; 78.6; 74.4; 71.4; 70.8 | — |
| SECONDARY Early Treatment Success (ETS) |
95; 70; 73; 150; 245; 83 | — |
| SECONDARY The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes |
87; 66; 66; 134; 221; 29 | — |
| SECONDARY The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no |
36; 18; 20; 51; 87; 18 | — |
| SECONDARY The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes |
87; 66; 66; 134; 221; 28 | — |
| SECONDARY The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no |
36; 18; 20; 51; 87; 8 | — |
| SECONDARY The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes |
87; 66; 66; 134; 221; 41 | — |
| SECONDARY The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no |
36; 18; 20; 51; 87; 14 | — |
| SECONDARY The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes |
87; 66; 66; 134; 221; 41 | — |
| SECONDARY The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no |
36; 18; 20; 51; 87; 6 | — |
Eligibility Criteria
Inclusion criteria
- Chronic hepatitis C (HCV) genotype 1 infection
- Chronic Human Immunodeficiency Virus (HIV) -1 infection
- HCV treatment naive or HCV treatment experienced but only relapsers
- Age 18 to 70 years
- Antiretroviral treatment naive or on stable Highly Active Antiretroviral Therapy (HAART)
- Karnofsky score >70
- HCV viral load >1.000 IU/mL
Exclusion criteria
- HCV infection of mixed genotype (1/2, 1/3, 1/4)
- Evidence of acute or chronic liver due to chronic HCV infection
- Hepatitis B virus (HBV) infection with presence of HBs-Ag
- Active malignancy or history or malignancy within the last 5 years
- Received concomitant systemic antiviral (other than antiretroviral), hematopoietic growth factor or immunomodulatory treatment in 28 days prior enrolment.
- 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
- Hemoglobin </=11g/dL for women and </= 12 g/dL for men
- Patients with stable cardiac disease and Hemoglobin <12g/dL
- Known hypersensitivity to any ingredient of the study drugs
Data sourced from ClinicalTrials.gov (NCT01399619). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.