Hepatitis C, Chronic
Conditions
Brief 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.
Interventions
DRUGBI 201335
BI 201335 once a day (QD) for 24 weeks
Pegylated Interferon-alpha for 48 weeks
DRUGRibavirin (RBV)
Ribavirin (RBV) for 24 or 48 weeks
DRUGPlacebo
Placebo to BI201335 for 24 weeks
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Chronic hepatitis C genotype 1 infection, diagnosed at least 6 months prior to screening 2. Confirmed prior virological failure with an approved dose of PegIFN/RBV 3. Age 18 to 70 years, 4. HCV RNA (RiboNucleic Acid) = 1,000 IU/mL at screening,
Exclusion criteria
1. HCV infection of mixed genotype; Hepatitis B Virus (HBV) or Human Immunodeficiency Virus (HIV) co-infection 2. Evidence of acute or chronic liver disease due to causes other than chronic HCV infection, 3. Decompensated liver disease, or history of decompensated liver disease, 4. Body weight \< 40 or \> 125 kg, 5. Clinical evidence of significant or unstable cardiovascular disease, chronic pulmonary disease, history or evidence of retinopathy or clinically significant ophthalmological disorder 6. Pre-existing psychiatric condition that could interfere with the subject's participation in and completion of the study 7. Laboratory parameters disorders (thalassemia major, sickle cell anemia or G6PD deficit) 8. Hemoglobin \< 12 g/dL for women and \< 13 g/dL for men 9. 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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Virological Response 12 Weeks Post Treatment (SVR12) | 12 weeks post treatment, up to 60 weeks | Percentage of participants with sustained virological response (SVR12) 12 weeks post treatment defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level \<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early Treatment Success (ETS) | Week 4 and Week 8 | Percentage of participants with early Treatment Success (ETS) defined as a plasma HCV RNA level \<25 IU/mL (undetected or detected) at Week 4 and \<25 IU/mL (undetected) at Week 8. |
| ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | End of treatment, up to 48 weeks | The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment (EoT) when patients do not have sustained virological response 12 weeks post treatment. BL=baseline |
| ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES | End of treatment, up to 48 weeks | The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline |
| AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO | End of treatment, up to 48 weeks | The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline |
| Virological Response After 24 Weeks of Treatment Discontinuation (SVR24) | 24 weeks post treatment, up to 72 weeks | Percentage of participants with virological response after 24 weeks of treatment discontinuation (SVR24) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level \<25 IU/mL (undetected) 24 weeks after the originally planned treatment duration. |
| ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | 12 weeks post treatment, up to 60 weeks | The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline |
| ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | 12 weeks post treatment, up to 60 weeks | The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline |
| AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | 12 weeks post treatment, up to 60 weeks | The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline |
| AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | 12 weeks post treatment, up to 60 weeks | The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline |
| AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | End of treatment, up to 48 weeks | The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment (EoT) when patients have sustained virological response 12 weeks post treatment. BL=baseline |
Countries
Austria, Belgium, Canada, France, Germany, Japan, Portugal, Puerto Rico, Spain, Switzerland, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Relapser:Placebo Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks. | 49 |
| Relapser:Faldaprevir 12 Weeks Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone. | 99 |
| Relapser:Faldaprevir 24 Weeks Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone. | 103 |
| Partial:Placebo Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks. | 29 |
| Partial:Faldaprevir 12 Weeks Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks. | 57 |
| Partial:Faldaprevir 24 Weeks Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks. | 55 |
| Null:Faldaprevir 12 Weeks Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks. | 145 |
| Null:Faldaprevir 24 Weeks Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks. | 140 |
| Total | 677 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 6 | 9 | 0 | 4 | 8 | 12 | 7 |
| Overall Study | Lack of Efficacy | 26 | 3 | 4 | 19 | 7 | 4 | 49 | 44 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Not treated | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Other reason not defined above | 2 | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 4 | 2 | 0 | 0 | 1 | 1 | 3 |
Baseline characteristics
| Characteristic | Partial:Placebo | Relapser:Placebo | Relapser:Faldaprevir 12 Weeks | Relapser:Faldaprevir 24 Weeks | Partial:Faldaprevir 12 Weeks | Partial:Faldaprevir 24 Weeks | Null:Faldaprevir 12 Weeks | Null:Faldaprevir 24 Weeks | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 55.7 years STANDARD_DEVIATION 7.5 | 53.4 years STANDARD_DEVIATION 8.29 | 53.5 years STANDARD_DEVIATION 8.57 | 53.7 years STANDARD_DEVIATION 8.14 | 52.7 years STANDARD_DEVIATION 7.9 | 52.0 years STANDARD_DEVIATION 10.32 | 53.2 years STANDARD_DEVIATION 8.76 | 53.6 years STANDARD_DEVIATION 8.13 | 53.4 years STANDARD_DEVIATION 8.48 |
| Sex: Female, Male Female | 10 Participants | 20 Participants | 44 Participants | 43 Participants | 20 Participants | 20 Participants | 54 Participants | 63 Participants | 274 Participants |
| Sex: Female, Male Male | 19 Participants | 29 Participants | 55 Participants | 60 Participants | 37 Participants | 35 Participants | 91 Participants | 77 Participants | 403 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 74 / 78 | 148 / 156 | 156 / 158 | 142 / 145 | 139 / 140 |
| serious Total, serious adverse events | 1 / 78 | 14 / 156 | 13 / 158 | 16 / 145 | 11 / 140 |
Outcome results
Primary
Sustained Virological Response 12 Weeks Post Treatment (SVR12)
Percentage of participants with sustained virological response (SVR12) 12 weeks post treatment defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level \<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
Time frame: 12 weeks post treatment, up to 60 weeks
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relapser & Partial: Placebo | Sustained Virological Response 12 Weeks Post Treatment (SVR12) | 10.3 percentage of participants |
| Relapser & Partial: Faldaprevir 12 Weeks | Sustained Virological Response 12 Weeks Post Treatment (SVR12) | 65.4 percentage of participants |
| Relapser & Partial: Faldaprevir 24 Weeks | Sustained Virological Response 12 Weeks Post Treatment (SVR12) | 61.4 percentage of participants |
| Null:Faldaprevir 12 Weeks | Sustained Virological Response 12 Weeks Post Treatment (SVR12) | 33.8 percentage of participants |
| Null:Faldaprevir 24 Weeks | Sustained Virological Response 12 Weeks Post Treatment (SVR12) | 32.9 percentage of participants |
p-value: <0.000195% CI: [44.4, 65]Cochran-Mantel-Haenszel
p-value: <0.000195% CI: [40.1, 60.8]Cochran-Mantel-Haenszel
95% CI: [-5.8, 14.9]
95% CI: [-10.9, 10.7]
Comparison: Comparison is based on the Null:Faldaprevir 12 weeks vs historical rate of 20%.p-value: <0.0001Normal approximation
Comparison: Comparison is based on the Null:Faldaprevir 24 weeks vs historical rate of 20%.p-value: 0.0001Normal approximation
Secondary
ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES
The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
Time frame: 12 weeks post treatment, up to 60 weeks
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Relapser & Partial: Placebo | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL normal to SVR12 normal | 3 participants |
| Relapser & Partial: Placebo | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL elevated to SVR12 normal | 3 participants |
| Relapser & Partial: Placebo | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | No ALT data available at SVR12 visit | 1 participants |
| Relapser & Partial: Placebo | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | SVR12=YES | 7 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL normal to SVR12 normal | 31 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | SVR12=YES | 69 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL elevated to SVR12 normal | 35 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | No ALT data available at SVR12 visit | 1 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | SVR12=YES | 72 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL normal to SVR12 normal | 31 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | No ALT data available at SVR12 visit | 0 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL elevated to SVR12 normal | 38 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | No ALT data available at SVR12 visit | 0 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | SVR12=YES | 1 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL normal to SVR12 normal | 0 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL elevated to SVR12 normal | 1 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL normal to SVR12 normal | 13 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | SVR12=YES | 33 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | No ALT data available at SVR12 visit | 0 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL elevated to SVR12 normal | 20 participants |
| Partial:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | SVR12=YES | 25 participants |
| Partial:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | No ALT data available at SVR12 visit | 0 participants |
| Partial:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL normal to SVR12 normal | 10 participants |
| Partial:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL elevated to SVR12 normal | 11 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL elevated to SVR12 normal | 32 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | No ALT data available at SVR12 visit | 1 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL normal to SVR12 normal | 13 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | SVR12=YES | 49 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | No ALT data available at SVR12 visit | 0 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | SVR12=YES | 46 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL normal to SVR12 normal | 10 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL elevated to SVR12 normal | 35 participants |
Secondary
ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO
The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
Time frame: 12 weeks post treatment, up to 60 weeks
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Relapser & Partial: Placebo | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | SVR12=NO | 42 participants |
| Relapser & Partial: Placebo | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL normal to SVR12 normal | 0 participants |
| Relapser & Partial: Placebo | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL elevated to SVR12 normal | 1 participants |
| Relapser & Partial: Placebo | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | No ALT data available at SVR12 visit | 33 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | No ALT data available at SVR12 visit | 7 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL normal to SVR12 normal | 9 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | SVR12=NO | 30 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL elevated to SVR12 normal | 6 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | SVR12=NO | 31 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | No ALT data available at SVR12 visit | 3 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL normal to SVR12 normal | 6 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL elevated to SVR12 normal | 6 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | SVR12=NO | 28 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL normal to SVR12 normal | 0 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL elevated to SVR12 normal | 0 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | No ALT data available at SVR12 visit | 23 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | No ALT data available at SVR12 visit | 6 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL elevated to SVR12 normal | 4 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL normal to SVR12 normal | 2 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | SVR12=NO | 24 participants |
| Partial:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | No ALT data available at SVR12 visit | 5 participants |
| Partial:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL elevated to SVR12 normal | 3 participants |
| Partial:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL normal to SVR12 normal | 4 participants |
| Partial:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | SVR12=NO | 30 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | No ALT data available at SVR12 visit | 27 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | SVR12=NO | 96 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL elevated to SVR12 normal | 7 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL normal to SVR12 normal | 11 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL normal to SVR12 normal | 6 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL elevated to SVR12 normal | 9 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | No ALT data available at SVR12 visit | 30 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO | SVR12=NO | 94 participants |
Secondary
ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO
The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment (EoT) when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
Time frame: End of treatment, up to 48 weeks
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Relapser & Partial: Placebo | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | BL elevated to EoT normal | 15 participants |
| Relapser & Partial: Placebo | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | No EoT data available for ALT | 1 participants |
| Relapser & Partial: Placebo | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | SVR12=NO | 42 participants |
| Relapser & Partial: Placebo | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | BL normal to EoT normal | 9 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | BL normal to EoT normal | 9 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | No EoT data available for ALT | 0 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | BL elevated to EoT normal | 10 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | SVR12=NO | 30 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | BL elevated to EoT normal | 14 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | BL normal to EoT normal | 6 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | No EoT data available for ALT | 0 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | SVR12=NO | 31 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | BL elevated to EoT normal | 9 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | No EoT data available for ALT | 0 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | SVR12=NO | 28 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | BL normal to EoT normal | 3 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | BL normal to EoT normal | 4 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | SVR12=NO | 24 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | No EoT data available for ALT | 0 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | BL elevated to EoT normal | 14 participants |
| Partial:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | BL normal to EoT normal | 4 participants |
| Partial:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | SVR12=NO | 30 participants |
| Partial:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | No EoT data available for ALT | 1 participants |
| Partial:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | BL elevated to EoT normal | 6 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | BL normal to EoT normal | 15 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | BL elevated to EoT normal | 34 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | SVR12=NO | 96 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | No EoT data available for ALT | 1 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | No EoT data available for ALT | 0 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | SVR12=NO | 94 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | BL normal to EoT normal | 14 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO | BL elevated to EoT normal | 38 participants |
Secondary
ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES
The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
Time frame: End of treatment, up to 48 weeks
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Relapser & Partial: Placebo | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES | SVR12=YES | 7 participants |
| Relapser & Partial: Placebo | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES | BL elevated to EoT normal | 4 participants |
| Relapser & Partial: Placebo | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES | BL normal to EoT normal | 3 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES | BL elevated to EoT normal | 29 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES | BL normal to EoT normal | 30 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES | SVR12=YES | 69 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES | BL elevated to EoT normal | 26 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES | SVR12=YES | 72 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES | BL normal to EoT normal | 30 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES | SVR12=YES | 1 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES | BL normal to EoT normal | 0 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES | BL elevated to EoT normal | 1 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES | BL normal to EoT normal | 10 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES | SVR12=YES | 33 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES | BL elevated to EoT normal | 14 participants |
| Partial:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES | BL normal to EoT normal | 8 participants |
| Partial:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES | SVR12=YES | 25 participants |
| Partial:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES | BL elevated to EoT normal | 8 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES | BL normal to EoT normal | 12 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES | SVR12=YES | 49 participants |
| Null:Faldaprevir 12 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES | BL elevated to EoT normal | 23 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES | SVR12=YES | 46 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES | BL normal to EoT normal | 9 participants |
| Null:Faldaprevir 24 Weeks | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES | BL elevated to EoT normal | 27 participants |
Secondary
AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES
The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
Time frame: 12 weeks post treatment, up to 60 weeks
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Relapser & Partial: Placebo | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | No AST data available at SVR12 visit | 1 participants |
| Relapser & Partial: Placebo | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL normal to SVR12 normal | 2 participants |
| Relapser & Partial: Placebo | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | SVR12=YES | 7 participants |
| Relapser & Partial: Placebo | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL elevated to SVR12 normal | 4 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | No AST data available at SVR12 visit | 1 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL normal to SVR12 normal | 36 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL elevated to SVR12 normal | 29 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | SVR12=YES | 69 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL normal to SVR12 normal | 41 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | No AST data available at SVR12 visit | 0 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | SVR12=YES | 72 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL elevated to SVR12 normal | 28 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | No AST data available at SVR12 visit | 0 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL normal to SVR12 normal | 0 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | SVR12=YES | 1 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL elevated to SVR12 normal | 1 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | SVR12=YES | 33 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | No AST data available at SVR12 visit | 0 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL normal to SVR12 normal | 16 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL elevated to SVR12 normal | 16 participants |
| Partial:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | No AST data available at SVR12 visit | 0 participants |
| Partial:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL normal to SVR12 normal | 13 participants |
| Partial:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | SVR12=YES | 25 participants |
| Partial:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL elevated to SVR12 normal | 8 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL normal to SVR12 normal | 16 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | SVR12=YES | 49 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL elevated to SVR12 normal | 28 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | No AST data available at SVR12 visit | 1 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL normal to SVR12 normal | 17 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | SVR12=YES | 46 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | No AST data available at SVR12 visit | 0 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES | BL elevated to SVR12 normal | 25 participants |
Secondary
AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO
The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
Time frame: 12 weeks post treatment, up to 60 weeks
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Relapser & Partial: Placebo | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | SVR12=NO | 42 participants |
| Relapser & Partial: Placebo | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL normal to SVR12 normal | 0 participants |
| Relapser & Partial: Placebo | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL elevated to SVR12 normal | 2 participants |
| Relapser & Partial: Placebo | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | No AST data available at SVR12 visit | 33 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | No AST data available at SVR12 visit | 7 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL normal to SVR12 normal | 14 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | SVR12=NO | 30 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL elevated to SVR12 normal | 2 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | SVR12=NO | 31 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | No AST data available at SVR12 visit | 3 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL normal to SVR12 normal | 10 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL elevated to SVR12 normal | 6 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | SVR12=NO | 28 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL normal to SVR12 normal | 0 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL elevated to SVR12 normal | 0 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | No AST data available at SVR12 visit | 23 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | No AST data available at SVR12 visit | 6 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL elevated to SVR12 normal | 6 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL normal to SVR12 normal | 3 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | SVR12=NO | 24 participants |
| Partial:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | No AST data available at SVR12 visit | 6 participants |
| Partial:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL elevated to SVR12 normal | 3 participants |
| Partial:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL normal to SVR12 normal | 3 participants |
| Partial:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | SVR12=NO | 30 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | No AST data available at SVR12 visit | 27 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | SVR12=NO | 96 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL elevated to SVR12 normal | 6 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL normal to SVR12 normal | 13 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL normal to SVR12 normal | 14 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | BL elevated to SVR12 normal | 3 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | No AST data available at SVR12 visit | 30 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO | SVR12=NO | 94 participants |
Secondary
AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO
The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
Time frame: End of treatment, up to 48 weeks
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Relapser & Partial: Placebo | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO | SVR12=NO | 42 participants |
| Relapser & Partial: Placebo | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO | BL elevated to EoT normal | 5 participants |
| Relapser & Partial: Placebo | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO | BL normal to EoT normal | 19 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO | BL elevated to EoT normal | 5 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO | BL normal to EoT normal | 16 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO | SVR12=NO | 30 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO | BL elevated to EoT normal | 9 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO | SVR12=NO | 31 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO | BL normal to EoT normal | 12 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO | SVR12=NO | 28 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO | BL normal to EoT normal | 4 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO | BL elevated to EoT normal | 9 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO | BL normal to EoT normal | 3 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO | SVR12=NO | 24 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO | BL elevated to EoT normal | 14 participants |
| Partial:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO | BL normal to EoT normal | 5 participants |
| Partial:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO | SVR12=NO | 30 participants |
| Partial:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO | BL elevated to EoT normal | 6 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO | BL normal to EoT normal | 18 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO | SVR12=NO | 96 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO | BL elevated to EoT normal | 24 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO | SVR12=NO | 94 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO | BL normal to EoT normal | 21 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO | BL elevated to EoT normal | 28 participants |
Secondary
AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES
The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment (EoT) when patients have sustained virological response 12 weeks post treatment. BL=baseline
Time frame: End of treatment, up to 48 weeks
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Relapser & Partial: Placebo | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | BL normal to EoT normal | 2 participants |
| Relapser & Partial: Placebo | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | No EoT data available for AST | 1 participants |
| Relapser & Partial: Placebo | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | SVR12=YES | 7 participants |
| Relapser & Partial: Placebo | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | BL elevated to EoT normal | 4 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | No EoT data available for AST | 0 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | SVR12=YES | 69 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | BL normal to EoT normal | 35 participants |
| Relapser & Partial: Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | BL elevated to EoT normal | 24 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | BL normal to EoT normal | 39 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | SVR12=YES | 72 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | BL elevated to EoT normal | 22 participants |
| Relapser & Partial: Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | No EoT data available for AST | 0 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | BL elevated to EoT normal | 1 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | BL normal to EoT normal | 0 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | No EoT data available for AST | 0 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | SVR12=YES | 1 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | BL normal to EoT normal | 13 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | BL elevated to EoT normal | 10 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | SVR12=YES | 33 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | No EoT data available for AST | 0 participants |
| Partial:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | SVR12=YES | 25 participants |
| Partial:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | BL normal to EoT normal | 10 participants |
| Partial:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | BL elevated to EoT normal | 9 participants |
| Partial:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | No EoT data available for AST | 1 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | SVR12=YES | 49 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | BL elevated to EoT normal | 21 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | BL normal to EoT normal | 15 participants |
| Null:Faldaprevir 12 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | No EoT data available for AST | 1 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | BL normal to EoT normal | 16 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | SVR12=YES | 46 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | No EoT data available for AST | 0 participants |
| Null:Faldaprevir 24 Weeks | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES | BL elevated to EoT normal | 20 participants |
Secondary
Early Treatment Success (ETS)
Percentage of participants with early Treatment Success (ETS) defined as a plasma HCV RNA level \<25 IU/mL (undetected or detected) at Week 4 and \<25 IU/mL (undetected) at Week 8.
Time frame: Week 4 and Week 8
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relapser & Partial: Placebo | Early Treatment Success (ETS) | 4.1 percentage of participants |
| Relapser & Partial: Faldaprevir 12 Weeks | Early Treatment Success (ETS) | 85.9 percentage of participants |
| Relapser & Partial: Faldaprevir 24 Weeks | Early Treatment Success (ETS) | 87.4 percentage of participants |
| Null:Faldaprevir 12 Weeks | Early Treatment Success (ETS) | 3.4 percentage of participants |
| Null:Faldaprevir 24 Weeks | Early Treatment Success (ETS) | 66.7 percentage of participants |
| Partial:Faldaprevir 24 Weeks | Early Treatment Success (ETS) | 76.4 percentage of participants |
| Null:Faldaprevir 12 Weeks | Early Treatment Success (ETS) | 58.6 percentage of participants |
| Null:Faldaprevir 24 Weeks | Early Treatment Success (ETS) | 51.4 percentage of participants |
Secondary
Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)
Percentage of participants with virological response after 24 weeks of treatment discontinuation (SVR24) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level \<25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.
Time frame: 24 weeks post treatment, up to 72 weeks
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relapser & Partial: Placebo | Virological Response After 24 Weeks of Treatment Discontinuation (SVR24) | 10.3 percentage of participants |
| Relapser & Partial: Faldaprevir 12 Weeks | Virological Response After 24 Weeks of Treatment Discontinuation (SVR24) | 63.5 percentage of participants |
| Relapser & Partial: Faldaprevir 24 Weeks | Virological Response After 24 Weeks of Treatment Discontinuation (SVR24) | 59.5 percentage of participants |
| Null:Faldaprevir 12 Weeks | Virological Response After 24 Weeks of Treatment Discontinuation (SVR24) | 33.8 percentage of participants |
| Null:Faldaprevir 24 Weeks | Virological Response After 24 Weeks of Treatment Discontinuation (SVR24) | 32.9 percentage of participants |
p-value: <0.000195% CI: [42.4, 63.2]Cochran-Mantel-Haenszel
p-value: <0.000195% CI: [38.2, 58.9]Cochran-Mantel-Haenszel
95% CI: [-6, 14.9]
95% CI: [-10.9, 10.7]
Comparison: Comparison is based on the Null:Faldaprevir 12 weeks vs historical rate of 20%.p-value: <0.0001Normal approximation
Comparison: Comparison is based on the Null:Faldaprevir 24 weeks vs historical rate of 20%.p-value: 0.0001Normal approximation