Phase 3
Completed N=678
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)
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01358864 ↗
Enrolled (actual)
678
Serious AEs
8.1%
Results posted
Oct 2015
Primary outcomePrimary: Sustained Virological Response 12 Weeks Post Treatment (SVR12) — 10.3; 65.4; 61.4; 33.8 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 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sustained Virological Response 12 Weeks Post Treatment (SVR12) |
10.3; 65.4; 61.4; 33.8; 32.9 | <0.0001 sig |
| SECONDARY Virological Response After 24 Weeks of Treatment Discontinuation (SVR24) |
10.3; 63.5; 59.5; 33.8; 32.9 | <0.0001 sig |
| SECONDARY Early Treatment Success (ETS) |
4.1; 85.9; 87.4; 3.4; 66.7; 76.4 | — |
| SECONDARY ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO |
42; 30; 31; 28; 24; 30 | — |
| SECONDARY ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES |
7; 69; 72; 1; 33; 25 | — |
| SECONDARY AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO |
42; 30; 31; 28; 24; 30 | — |
| SECONDARY AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES |
7; 69; 72; 1; 33; 25 | — |
| SECONDARY ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO |
42; 30; 31; 28; 24; 30 | — |
| SECONDARY ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES |
7; 69; 72; 1; 33; 25 | — |
| SECONDARY AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO |
42; 30; 31; 28; 24; 30 | — |
| SECONDARY AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES |
7; 69; 72; 1; 33; 25 | — |
Eligibility Criteria
Inclusion criteria
- Chronic hepatitis C genotype 1 infection, diagnosed at least 6 months prior to screening
- Confirmed prior virological failure with an approved dose of PegIFN/RBV
- Age 18 to 70 years,
- HCV RNA (RiboNucleic Acid) = 1, 000 IU/mL at screening,
Exclusion criteria
- HCV infection of mixed genotype; Hepatitis B Virus (HBV) or Human Immunodeficiency Virus (HIV) co-infection
- Evidence of acute or chronic liver disease due to causes other than chronic HCV infection,
- Decompensated liver disease, or history of decompensated liver disease,
- Body weight 125 kg,
- Clinical evidence of significant or unstable cardiovascular disease, chronic pulmonary disease, history or evidence of retinopathy or clinically significant ophthalmological disorder
- Pre-existing psychiatric condition that could interfere with the subject's participation in and completion of the study
- Laboratory parameters disorders (thalassemia major, sickle cell anemia or G6PD deficit)
- Hemoglobin < 12 g/dL for women and < 13 g/dL for men
- 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,
Data sourced from ClinicalTrials.gov (NCT01358864). 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.