Hepatitis C
Conditions
Brief summary
The aim of this trial is to evaluate the safety and efficacy of BI 201335 given for 12 or 24 weeks in combination with PegIFN alfa-2b/RBV given for 24 or 48 weeks in chronic genotype 1 hepatitis C virus infected treatment-naïve and treatment-experienced Japanese patients
Interventions
BI 201335 high dose with PegIFN/RBV
BI 201335 low dose with PegIFN/RBV
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening in addition to: * positive anti-HCV antibodies or detected HCV RNA at least 6 months before screening; or, * liver biopsy consistent with chronic HCV infection. 2. HCV genotype 1 infection confirmed by genotypic testing at screening 3. (For Cohort 1 only) Therapy-naïve to interferon, pegylated interferon, and ribavirin (For Cohort 2 only) Confirmed prior virological failure (null response, partial response, breakthrough or relapse) with an approved dose of PegIFN alfa/RBV or IFN beta/RBV for at least 12 weeks and with an 8-week washout period before screening 4. HCV RNA = 100,000 IU/mL at screening 5. Documentation of a liver biopsy within 3 years or fibroscan within 6 months before randomization (Visit 2) 6. Age 20 to 70 years 7. Female patients who are infertile or who are of childbearing potential with a negative pregnancy test and agreeing to use one accepted method of birth control in addition to the use of a condom by their male partners. or Male patients who are infertile, who are without pregnant female partners or who consistently and correctly use condoms. 8. Signed informed consent form before trial participation
Exclusion criteria
1. HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening, 2. Evidence of acute or chronic liver disease due to causes other than chronic HCV infection. Steatosis diagnosed incidentally (e.g. by biopsy) without clinical relevance is not an exclusion criterion. 3. HIV co-infection, 4. Hepatitis B virus (HBV) infection based on presence of hepatitis B surface antigen (HBsAg), 5. Active malignancy, or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix), 6. Active or, history of alcohol or illicit drug abuse within the past 12 months, 7. A condition that is defined as one which in the opinion of investigator may put the patient at risk because of participation in this study, may influence the results of this study, or limit the patient's ability to participate in this study, 8. Usage of any investigational drugs within 30 days prior to screening, or planned usage of an investigational drug during the course of this study, 9. Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to screening. Patients being treated with oral antivirals such as acyclovir, famciclovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection, may be screened, 10. Received silymarin (milk thistle), glycyrrhizin (Stronger Neo-Minophagen C; SNMC), or Sho-saiko-to (SST) within 28 days prior to randomization (Visit 2) and throughout the treatment phase of this trial, 11. (For Cohort 2 only) Patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than (pegylated) interferon alfa, interferon beta or ribavirin for acute or chronic HCV infection including and not restricted to protease or polymerase inhibitors, 12. Known hypersensitivity to any ingredient of the study drugs, 13. Alpha fetoprotein value \>100 ng/mL at screening; if \>20 ng/mL and =100 ng/mL, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, CT scan, or MRI) within last 6 months prior to randomization (Visit 2), Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Investigator Defined Drug-related Adverse Events | Up to 52 weeks | Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT) | EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72) | Plasma HCV RNA level \<25 IU/mL (undetected) 24 weeks after the originally planned treatment duration |
| Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8 | up to 8 weeks | Plasma HCV RNA level \<25 IU/mL (detected or undetected) at Week 4 and HCV RNA \<25 IU/mL (undetected) at Week 8 |
| Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | EOT (up to Week 24 or 48) | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline |
| Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | EOT (up to Week 24 or 48) | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline |
| Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | 12 weeks after the EOT (up to Week 36 or 60) | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline |
| Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT) | EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60) | Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level \<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration |
| Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | EOT (up to Week 24 or 48) | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline |
| Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | EOT (up to Week 24 or 48) | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline |
| Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | 12 weeks after the EOT (up to Week 36 or 60) | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline |
| Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | 12 weeks after the EOT (up to Week 36 or 60) | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline |
| Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | 12 weeks after the EOT (up to Week 36 or 60) | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Faldaprevir 120 mg q.d - Cohort I Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | 44 |
| Faldaprevir 240 mg q.d - Cohort I Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | 43 |
| Relapser Patients - Cohort II Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients. | 29 |
| Partial Responder Patients - Cohort II Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. | 3 |
| Null Responder Patients - Cohort II Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. | 10 |
| Breakthrough Patients - Cohort II Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. | 2 |
| Total | 131 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 13 | 2 | 0 | 0 | 1 |
| Overall Study | Lack of Efficacy | 1 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Faldaprevir 120 mg q.d - Cohort I | Faldaprevir 240 mg q.d - Cohort I | Relapser Patients - Cohort II | Partial Responder Patients - Cohort II | Null Responder Patients - Cohort II | Breakthrough Patients - Cohort II | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 53.5 years STANDARD_DEVIATION 7.61 | 56.6 years STANDARD_DEVIATION 9.3 | 61.3 years STANDARD_DEVIATION 6.79 | 47.0 years STANDARD_DEVIATION 18.08 | 54.9 years STANDARD_DEVIATION 9.55 | 57.5 years STANDARD_DEVIATION 14.85 | 56.3 years STANDARD_DEVIATION 8.97 |
| Sex: Female, Male Female | 22 Participants | 27 Participants | 14 Participants | 2 Participants | 5 Participants | 2 Participants | 72 Participants |
| Sex: Female, Male Male | 22 Participants | 16 Participants | 15 Participants | 1 Participants | 5 Participants | 0 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 44 / 44 | 43 / 43 | 44 / 44 |
| serious Total, serious adverse events | 3 / 44 | 4 / 43 | 1 / 44 |
Outcome results
Primary
Number of Patients With Investigator Defined Drug-related Adverse Events
Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.
Time frame: Up to 52 weeks
Population: Safety analyses were based on the safety analysis set (SAF) that included all patients who took the trial medication and were documented to have taken at least 1 dose of the trial medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Faldaprevir 120 mg q.d - Cohort I | Number of Patients With Investigator Defined Drug-related Adverse Events | 43 participants |
| Faldaprevir 240 mg q.d - Cohort I | Number of Patients With Investigator Defined Drug-related Adverse Events | 43 participants |
| Faldaprevir 240 mg q.d - Cohort II | Number of Patients With Investigator Defined Drug-related Adverse Events | 44 participants |
Secondary
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Time frame: EOT (up to Week 24 or 48)
Population: FAS (All patients who were randomized and received at least 1 dose of the trial medication)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faldaprevir 120 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12=No, no BL or EOT data available | 0 participants |
| Faldaprevir 120 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12=No | 6 participants |
| Faldaprevir 120 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12=No, BL normal to EOT normal | 4 participants |
| Faldaprevir 120 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12=No, BL elevated to EOT normal | 2 participants |
| Faldaprevir 240 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12=No, BL normal to EOT normal | 6 participants |
| Faldaprevir 240 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12=No, no BL or EOT data available | 0 participants |
| Faldaprevir 240 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12=No | 11 participants |
| Faldaprevir 240 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12=No, BL elevated to EOT normal | 2 participants |
| Faldaprevir 240 mg q.d - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12=No, BL elevated to EOT normal | 0 participants |
| Faldaprevir 240 mg q.d - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12=No | 4 participants |
| Faldaprevir 240 mg q.d - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12=No, no BL or EOT data available | 0 participants |
| Faldaprevir 240 mg q.d - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12=No, BL normal to EOT normal | 3 participants |
| Partial Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12=No, BL elevated to EOT normal | 1 participants |
| Partial Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12=No, BL normal to EOT normal | 0 participants |
| Partial Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12=No, no BL or EOT data available | 0 participants |
| Partial Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12=No | 1 participants |
| Null Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12=No | 6 participants |
| Null Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12=No, no BL or EOT data available | 0 participants |
| Null Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12=No, BL elevated to EOT normal | 2 participants |
| Null Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12=No, BL normal to EOT normal | 4 participants |
| Breakthrough Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12=No, BL normal to EOT normal | 0 participants |
| Breakthrough Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12=No | 1 participants |
| Breakthrough Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12=No, no BL or EOT data available | 0 participants |
| Breakthrough Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12=No, BL elevated to EOT normal | 1 participants |
Secondary
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Time frame: EOT (up to Week 24 or 48)
Population: FAS (All patients who were randomized and received at least 1 dose of the trial medication)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faldaprevir 120 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes | 38 participants |
| Faldaprevir 120 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, BL normal to EOT normal | 16 participants |
| Faldaprevir 120 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, BL elevated to EOT normal | 16 participants |
| Faldaprevir 120 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, no BL or EOT data available | 0 participants |
| Faldaprevir 240 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes | 32 participants |
| Faldaprevir 240 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, BL elevated to EOT normal | 10 participants |
| Faldaprevir 240 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, BL normal to EOT normal | 18 participants |
| Faldaprevir 240 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, no BL or EOT data available | 0 participants |
| Faldaprevir 240 mg q.d - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, BL normal to EOT normal | 17 participants |
| Faldaprevir 240 mg q.d - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes | 25 participants |
| Faldaprevir 240 mg q.d - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, no BL or EOT data available | 0 participants |
| Faldaprevir 240 mg q.d - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, BL elevated to EOT normal | 7 participants |
| Partial Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, BL normal to EOT normal | 2 participants |
| Partial Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes | 2 participants |
| Partial Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, BL elevated to EOT normal | 0 participants |
| Partial Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, no BL or EOT data available | 0 participants |
| Null Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, no BL or EOT data available | 0 participants |
| Null Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes | 4 participants |
| Null Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, BL normal to EOT normal | 1 participants |
| Null Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, BL elevated to EOT normal | 3 participants |
| Breakthrough Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes | 1 participants |
| Breakthrough Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, BL elevated to EOT normal | 0 participants |
| Breakthrough Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, no BL or EOT data available | 0 participants |
| Breakthrough Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, BL normal to EOT normal | 1 participants |
Secondary
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Time frame: 12 weeks after the EOT (up to Week 36 or 60)
Population: FAS (All patients who were randomized and received at least 1 dose of the trial medication)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faldaprevir 120 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No | 6 participants |
| Faldaprevir 120 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, BL normal to SVR12 normal | 2 participants |
| Faldaprevir 120 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, BL elevated to SVR12 normal | 0 participants |
| Faldaprevir 120 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, no BL or SVR12 data available | 1 participants |
| Faldaprevir 240 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, BL elevated to SVR12 normal | 2 participants |
| Faldaprevir 240 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, BL normal to SVR12 normal | 4 participants |
| Faldaprevir 240 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No | 11 participants |
| Faldaprevir 240 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, no BL or SVR12 data available | 4 participants |
| Faldaprevir 240 mg q.d - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, no BL or SVR12 data available | 1 participants |
| Faldaprevir 240 mg q.d - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, BL elevated to SVR12 normal | 0 participants |
| Faldaprevir 240 mg q.d - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, BL normal to SVR12 normal | 2 participants |
| Faldaprevir 240 mg q.d - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No | 4 participants |
| Partial Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No | 1 participants |
| Partial Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, no BL or SVR12 data available | 0 participants |
| Partial Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, BL normal to SVR12 normal | 0 participants |
| Partial Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, BL elevated to SVR12 normal | 1 participants |
| Null Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, BL elevated to SVR12 normal | 1 participants |
| Null Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, no BL or SVR12 data available | 2 participants |
| Null Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, BL normal to SVR12 normal | 0 participants |
| Null Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No | 6 participants |
| Breakthrough Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, BL normal to SVR12 normal | 0 participants |
| Breakthrough Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, BL elevated to SVR12 normal | 0 participants |
| Breakthrough Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, no BL or SVR12 data available | 1 participants |
| Breakthrough Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No | 1 participants |
Secondary
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Time frame: 12 weeks after the EOT (up to Week 36 or 60)
Population: FAS (All patients who were randomized and received at least 1 dose of the trial medication)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faldaprevir 120 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes | 38 participants |
| Faldaprevir 120 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, BL normal to SVR12 normal | 17 participants |
| Faldaprevir 120 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, BL elevated to SVR12 normal | 19 participants |
| Faldaprevir 120 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, no BL or SVR12 data available | 0 participants |
| Faldaprevir 240 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes | 32 participants |
| Faldaprevir 240 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, BL elevated to SVR12 normal | 12 participants |
| Faldaprevir 240 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, BL normal to SVR12 normal | 18 participants |
| Faldaprevir 240 mg q.d - Cohort I | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, no BL or SVR12 data available | 1 participants |
| Faldaprevir 240 mg q.d - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, BL normal to SVR12 normal | 18 participants |
| Faldaprevir 240 mg q.d - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes | 25 participants |
| Faldaprevir 240 mg q.d - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, no BL or SVR12 data available | 0 participants |
| Faldaprevir 240 mg q.d - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, BL elevated to SVR12 normal | 7 participants |
| Partial Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, BL elevated to SVR12 normal | 0 participants |
| Partial Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes | 2 participants |
| Partial Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, BL normal to SVR12 normal | 2 participants |
| Partial Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, no BL or SVR12 data available | 0 participants |
| Null Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, BL normal to SVR12 normal | 1 participants |
| Null Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes | 4 participants |
| Null Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, BL elevated to SVR12 normal | 3 participants |
| Null Responder Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, no BL or SVR12 data available | 0 participants |
| Breakthrough Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, BL normal to SVR12 normal | 1 participants |
| Breakthrough Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes | 1 participants |
| Breakthrough Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, no BL or SVR12 data available | 0 participants |
| Breakthrough Patients - Cohort II | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, BL elevated to SVR12 normal | 0 participants |
Secondary
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Time frame: EOT (up to Week 24 or 48)
Population: FAS (All patients who were randomized and received at least 1 dose of the trial medication)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faldaprevir 120 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12=No, BL normal to EOT normal | 4 participants |
| Faldaprevir 120 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12=No | 6 participants |
| Faldaprevir 120 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12=No, BL elevated to EOT normal | 2 participants |
| Faldaprevir 120 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12=No, no BL or EOT data available | 0 participants |
| Faldaprevir 240 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12=No | 11 participants |
| Faldaprevir 240 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12=No, BL elevated to EOT normal | 3 participants |
| Faldaprevir 240 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12=No, BL normal to EOT normal | 6 participants |
| Faldaprevir 240 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12=No, no BL or EOT data available | 0 participants |
| Faldaprevir 240 mg q.d - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12=No, BL elevated to EOT normal | 0 participants |
| Faldaprevir 240 mg q.d - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12=No, BL normal to EOT normal | 2 participants |
| Faldaprevir 240 mg q.d - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12=No | 4 participants |
| Faldaprevir 240 mg q.d - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12=No, no BL or EOT data available | 0 participants |
| Partial Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12=No | 1 participants |
| Partial Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12=No, BL normal to EOT normal | 1 participants |
| Partial Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12=No, no BL or EOT data available | 0 participants |
| Partial Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12=No, BL elevated to EOT normal | 0 participants |
| Null Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12=No, BL elevated to EOT normal | 2 participants |
| Null Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12=No | 6 participants |
| Null Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12=No, BL normal to EOT normal | 4 participants |
| Null Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12=No, no BL or EOT data available | 0 participants |
| Breakthrough Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12=No, BL normal to EOT normal | 0 participants |
| Breakthrough Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12=No, BL elevated to EOT normal | 1 participants |
| Breakthrough Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12=No, no BL or EOT data available | 0 participants |
| Breakthrough Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12=No | 1 participants |
Secondary
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Time frame: EOT (up to Week 24 or 48)
Population: FAS (All patients who were randomized and received at least 1 dose of the trial medication)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faldaprevir 120 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, no BL or EOT data available | 0 participants |
| Faldaprevir 120 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, BL elevated to EOT normal | 11 participants |
| Faldaprevir 120 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes | 38 participants |
| Faldaprevir 120 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, BL normal to EOT normal | 21 participants |
| Faldaprevir 240 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, no BL or EOT data available | 0 participants |
| Faldaprevir 240 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes | 32 participants |
| Faldaprevir 240 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, BL elevated to EOT normal | 9 participants |
| Faldaprevir 240 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, BL normal to EOT normal | 18 participants |
| Faldaprevir 240 mg q.d - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, BL elevated to EOT normal | 7 participants |
| Faldaprevir 240 mg q.d - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes | 25 participants |
| Faldaprevir 240 mg q.d - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, no BL or EOT data available | 0 participants |
| Faldaprevir 240 mg q.d - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, BL normal to EOT normal | 16 participants |
| Partial Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, BL normal to EOT normal | 2 participants |
| Partial Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes | 2 participants |
| Partial Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, BL elevated to EOT normal | 0 participants |
| Partial Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, no BL or EOT data available | 0 participants |
| Null Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, no BL or EOT data available | 0 participants |
| Null Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, BL normal to EOT normal | 1 participants |
| Null Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes | 4 participants |
| Null Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, BL elevated to EOT normal | 3 participants |
| Breakthrough Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, BL normal to EOT normal | 1 participants |
| Breakthrough Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, BL elevated to EOT normal | 0 participants |
| Breakthrough Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes, no BL or EOT data available | 0 participants |
| Breakthrough Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12=Yes | 1 participants |
Secondary
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Time frame: 12 weeks after the EOT (up to Week 36 or 60)
Population: FAS (All patients who were randomized and received at least 1 dose of the trial medication)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faldaprevir 120 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, BL elevated to SVR12 normal | 1 participants |
| Faldaprevir 120 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, BL normal to SVR12 normal | 2 participants |
| Faldaprevir 120 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, no BL or SVR12 data available | 1 participants |
| Faldaprevir 120 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No | 6 participants |
| Faldaprevir 240 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, BL normal to SVR12 normal | 3 participants |
| Faldaprevir 240 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No | 11 participants |
| Faldaprevir 240 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, no BL or SVR12 data available | 4 participants |
| Faldaprevir 240 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, BL elevated to SVR12 normal | 1 participants |
| Faldaprevir 240 mg q.d - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, BL elevated to SVR12 normal | 0 participants |
| Faldaprevir 240 mg q.d - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No | 4 participants |
| Faldaprevir 240 mg q.d - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, BL normal to SVR12 normal | 1 participants |
| Faldaprevir 240 mg q.d - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, no BL or SVR12 data available | 1 participants |
| Partial Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No | 1 participants |
| Partial Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, no BL or SVR12 data available | 0 participants |
| Partial Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, BL normal to SVR12 normal | 1 participants |
| Partial Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, BL elevated to SVR12 normal | 0 participants |
| Null Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, no BL or SVR12 data available | 2 participants |
| Null Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, BL normal to SVR12 normal | 1 participants |
| Null Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, BL elevated to SVR12 normal | 0 participants |
| Null Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No | 6 participants |
| Breakthrough Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, BL normal to SVR12 normal | 0 participants |
| Breakthrough Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, no BL or SVR12 data available | 1 participants |
| Breakthrough Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No, BL elevated to SVR12 normal | 0 participants |
| Breakthrough Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | SVR12=No | 1 participants |
Secondary
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Time frame: 12 weeks after the EOT (up to Week 36 or 60)
Population: FAS (All patients who were randomized and received at least 1 dose of the trial medication)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faldaprevir 120 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes | 38 participants |
| Faldaprevir 120 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, no BL or SVR12 data available | 0 participants |
| Faldaprevir 120 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, BL elevated to SVR12 normal | 13 participants |
| Faldaprevir 120 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, BL normal to SVR12 normal | 23 participants |
| Faldaprevir 240 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, no BL or SVR12 data available | 1 participants |
| Faldaprevir 240 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, BL normal to SVR12 normal | 18 participants |
| Faldaprevir 240 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes | 32 participants |
| Faldaprevir 240 mg q.d - Cohort I | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, BL elevated to SVR12 normal | 12 participants |
| Faldaprevir 240 mg q.d - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes | 25 participants |
| Faldaprevir 240 mg q.d - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, BL elevated to SVR12 normal | 7 participants |
| Faldaprevir 240 mg q.d - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, BL normal to SVR12 normal | 18 participants |
| Faldaprevir 240 mg q.d - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, no BL or SVR12 data available | 0 participants |
| Partial Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, no BL or SVR12 data available | 0 participants |
| Partial Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, BL normal to SVR12 normal | 2 participants |
| Partial Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, BL elevated to SVR12 normal | 0 participants |
| Partial Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes | 2 participants |
| Null Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, BL normal to SVR12 normal | 1 participants |
| Null Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes | 4 participants |
| Null Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, BL elevated to SVR12 normal | 3 participants |
| Null Responder Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, no BL or SVR12 data available | 0 participants |
| Breakthrough Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, no BL or SVR12 data available | 0 participants |
| Breakthrough Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes | 1 participants |
| Breakthrough Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, BL normal to SVR12 normal | 1 participants |
| Breakthrough Patients - Cohort II | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | SVR12=Yes, BL elevated to SVR12 normal | 0 participants |
Secondary
Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8
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: up to 8 weeks
Population: FAS (All patients who were randomized and received at least 1 dose of the trial medication)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Faldaprevir 120 mg q.d - Cohort I | Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8 | 97.7 percentage of participants |
| Faldaprevir 240 mg q.d - Cohort I | Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8 | 93.0 percentage of participants |
| Faldaprevir 240 mg q.d - Cohort II | Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8 | 96.6 percentage of participants |
| Partial Responder Patients - Cohort II | Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8 | 100.0 percentage of participants |
| Null Responder Patients - Cohort II | Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8 | 70.0 percentage of participants |
| Breakthrough Patients - Cohort II | Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8 | 50.0 percentage of participants |
Secondary
Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT)
Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level \<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration
Time frame: EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)
Population: FAS (All patients who were randomized and received at least 1 dose of the trial medication)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Faldaprevir 120 mg q.d - Cohort I | Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT) | 86.4 percentage of participants |
| Faldaprevir 240 mg q.d - Cohort I | Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT) | 74.4 percentage of participants |
| Faldaprevir 240 mg q.d - Cohort II | Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT) | 86.2 percentage of participants |
| Partial Responder Patients - Cohort II | Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT) | 66.7 percentage of participants |
| Null Responder Patients - Cohort II | Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT) | 40.0 percentage of participants |
| Breakthrough Patients - Cohort II | Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT) | 50.0 percentage of participants |
Secondary
Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT)
Plasma HCV RNA level \<25 IU/mL (undetected) 24 weeks after the originally planned treatment duration
Time frame: EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72)
Population: FAS (All patients who were randomized and received at least 1 dose of the trial medication)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Faldaprevir 120 mg q.d - Cohort I | Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT) | 86.4 percentage of participants |
| Faldaprevir 240 mg q.d - Cohort I | Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT) | 72.1 percentage of participants |
| Faldaprevir 240 mg q.d - Cohort II | Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT) | 86.2 percentage of participants |
| Partial Responder Patients - Cohort II | Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT) | 66.7 percentage of participants |
| Null Responder Patients - Cohort II | Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT) | 40.0 percentage of participants |
| Breakthrough Patients - Cohort II | Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT) | 50.0 percentage of participants |