Hepatitis C
Conditions
Brief summary
The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 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: 1. positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening; or, 2. liver biopsy consistent with chronic HCV infection. 2. HCV genotype 1 infection confirmed by genotypic testing at screening. 3. Therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral / immunomodulatory drug for acute or chronic HCV infection. 4. HCV RNA = 1,000 IU/mL at screening 5. Documentation of a liver biopsy within 3 years or fibroscan within 6 months of the screening visit. Note: If cirrhosis has been previously demonstrated on a biopsy, then biopsies obtained more than 3 years before enrolment need not be repeated. Biopsies can be waived for patients who would be placed at risk from the procedure. Inability to do a liver biopsy should not exclude patients from a trial. 6. Age 18 to 70 years 7. Female patients: (c) with documented hysterectomy, (d) who have had both ovaries removed, (e) with documented tubal ligation, (f) who are post-menopausal with last menstrual period at least 12 months prior to screening, or (g) of childbearing potential with a negative serum pregnancy test at screening and Day 1, that, if sexually active, agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin in addition to the consistent and correct use of a condom. Patients must agree not to breast-feed at any time from the date of screening until 7 months after the last dose of ribavirin. Medically accepted methods of contraception for females in this trial are ethinyl estradiol-containing contraceptives, diaphragm with spermicide substance and intra-uterine device. Male patients: 1. who are documented to be sterile, or 2. who are without pregnant female partner(s) and consistently and correctly use a condom while their female partner(s) (if of child-bearing potential) use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin. It is in the responsibility of the male patient to ensure that his partner(s) is not pregnant prior to screening into the study or becomes pregnant during the treatment and the observation phase. 8. Signed informed consent form prior to 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. 3. HIV co-infection. 4. Hepatitis B virus (HBV) infection based on presence of HBs-Ag. 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 other than cannabis 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 28 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 28 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, or Sho-saiko-to (SST) within 28 days prior to screening and throughout the treatment phase. 11. Known hypersensitivity to any ingredient of the study drugs. 12. 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). 13. Decompensated liver disease, or history of decompensated liver disease, as defined by the presence of: hepatic encephalopathy, ascites, or esophageal variceal bleeding and/or laboratory results of any of the following: 1. International normalized ratio (INR) of =1.7 2. Serum Albumin =3.5 g/dL 3. Serum total bilirubin =2.0 mg/dL (except when the increase is predominately due to unconjugated bilirubin and related to Gilberts syndrome). 14. Pre-existing psychiatric condition that could interfere with the subject¿s participation in and completion of the study including but not limited to prior suicidal attempt, schizophrenia, major depression syndrome, severe anxiety, severe personality disorder, a period of disability or impairment due to a psychiatric disease within the past 5 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Virologic Response 12 Weeks Post Treatment (SVR12) | 12 weeks post treatment, up to 60 weeks | Percentage of participants with sustained virologic response 12 weeks post treatment (SVR12) 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 (detected or undetected) at week 4 and HCV RNA \<25 IU/mL (undetected) at week 8. |
| ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | 12 weeks post treatment, up to 60 weeks | The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients have sustained virological response 12 weeks post-treatment. BL = Baseline |
| ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | 12 weeks post treatment, up to 60 weeks | The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline |
| ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES | 12 weeks post treatment, up to 60 weeks | The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline |
| Sustained Virologic Response 24 Weeks Post-treatment (SVR24) | 24 weeks post treatment, up to 72 weeks | Percentage of participants with sustained virologic response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level \< 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration. Hepatitis C virus Ribonucleic acid (HCV RNA) |
| AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | 12 weeks post treatment, up to 60 weeks | The number of participants with aspartate aminotransferase (AST) 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 (EOT) When SVR12=NO | 12 weeks post treatment, up to 60 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 |
| AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES | 12 weeks post treatment, up to 60 weeks | The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks 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 12 weeks 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, When SVR12=NO | 12 weeks post treatment, up to 60 weeks | The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline |
Countries
Canada, Puerto Rico, South Korea, Taiwan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Faldaprevir 120mg and PegIFN/RBV Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone. | 262 |
| Faldaprevir 240mg and PegIFN/RBV Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone. | 263 |
| Placebo and PegIFN/RBV Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone. | 132 |
| Total | 657 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 19 | 32 | 5 |
| Overall Study | Lack of Efficacy | 15 | 17 | 15 |
| Overall Study | Lost to Follow-up | 1 | 2 | 1 |
| Overall Study | Not treated | 0 | 1 | 0 |
| Overall Study | Other reason not defined above | 3 | 3 | 1 |
| Overall Study | Protocol Violation | 0 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 15 | 7 |
Baseline characteristics
| Characteristic | Faldaprevir 120mg and PegIFN/RBV | Faldaprevir 240mg and PegIFN/RBV | Placebo and PegIFN/RBV | Total |
|---|---|---|---|---|
| Age, Continuous | 50.2 years STANDARD_DEVIATION 10.05 | 50.4 years STANDARD_DEVIATION 9.4 | 50.2 years STANDARD_DEVIATION 8.78 | 50.3 years STANDARD_DEVIATION 9.53 |
| Sex: Female, Male Female | 105 Participants | 109 Participants | 54 Participants | 268 Participants |
| Sex: Female, Male Male | 157 Participants | 154 Participants | 78 Participants | 389 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 | 255 / 262 | 258 / 263 | 130 / 132 |
| serious Total, serious adverse events | 21 / 262 | 26 / 263 | 8 / 132 |
Outcome results
Primary
Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
Percentage of participants with sustained virologic response 12 weeks post treatment (SVR12) 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: Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Faldaprevir 120mg and PegIFN/RBV | Sustained Virologic Response 12 Weeks Post Treatment (SVR12) | 67.9 percentage of participants |
| Faldaprevir 240mg and PegIFN/RBV | Sustained Virologic Response 12 Weeks Post Treatment (SVR12) | 64.3 percentage of participants |
| Placebo and PegIFN/RBV | Sustained Virologic Response 12 Weeks Post Treatment (SVR12) | 47.0 percentage of participants |
p-value: <0.000195% CI: [10.7, 30.6]Cochran-Mantel-Haenszel
p-value: 0.000795% CI: [7.3, 27.4]Cochran-Mantel-Haenszel
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 12 weeks 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: Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faldaprevir 120mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO | SVR12 = No | 84 participants |
| Faldaprevir 120mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO | SVR12 = No, BL normal to SVR12 normal | 12 participants |
| Faldaprevir 120mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO | SVR12 = No, BL elevated to SVR12 normal | 13 participants |
| Faldaprevir 120mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO | SVR12 = No, No ALT data available at SVR12 visit | 23 participants |
| Faldaprevir 240mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO | SVR12 = No, No ALT data available at SVR12 visit | 34 participants |
| Faldaprevir 240mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO | SVR12 = No | 94 participants |
| Faldaprevir 240mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO | SVR12 = No, BL elevated to SVR12 normal | 16 participants |
| Faldaprevir 240mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO | SVR12 = No, BL normal to SVR12 normal | 11 participants |
| Placebo and PegIFN/RBV | ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO | SVR12 = No, No ALT data available at SVR12 visit | 54 participants |
| Placebo and PegIFN/RBV | ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO | SVR12 = No, BL normal to SVR12 normal | 3 participants |
| Placebo and PegIFN/RBV | ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO | SVR12 = No, BL elevated to SVR12 normal | 2 participants |
| Placebo and PegIFN/RBV | ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO | SVR12 = No | 70 participants |
Secondary
ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES
The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks 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: Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faldaprevir 120mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES | SVR12 = Yes | 178 participants |
| Faldaprevir 120mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES | SVR12 = Yes, BL normal to SVR12 normal | 52 participants |
| Faldaprevir 120mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES | SVR12 = Yes, BL elevated to SVR12 normal | 105 participants |
| Faldaprevir 120mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES | SVR12 = Yes, No ALT data available at SVR12 visit | 9 participants |
| Faldaprevir 240mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES | SVR12 = Yes, No ALT data available at SVR12 visit | 3 participants |
| Faldaprevir 240mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES | SVR12 = Yes | 169 participants |
| Faldaprevir 240mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES | SVR12 = Yes, BL elevated to SVR12 normal | 100 participants |
| Faldaprevir 240mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES | SVR12 = Yes, BL normal to SVR12 normal | 58 participants |
| Placebo and PegIFN/RBV | ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES | SVR12 = Yes, No ALT data available at SVR12 visit | 0 participants |
| Placebo and PegIFN/RBV | ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES | SVR12 = Yes, BL normal to SVR12 normal | 23 participants |
| Placebo and PegIFN/RBV | ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES | SVR12 = Yes, BL elevated to SVR12 normal | 37 participants |
| Placebo and PegIFN/RBV | ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES | SVR12 = Yes | 62 participants |
Secondary
ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO
The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) 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: Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faldaprevir 120mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12 = No | 84 participants |
| Faldaprevir 120mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12 = No, BL normal to EOT normal | 21 participants |
| Faldaprevir 120mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12 = No, BL elevated to EOT normal | 33 participants |
| Faldaprevir 120mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12 = No, No ALT data available at EoT | 3 participants |
| Faldaprevir 240mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12 = No, No ALT data available at EoT | 5 participants |
| Faldaprevir 240mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12 = No | 94 participants |
| Faldaprevir 240mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12 = No, BL elevated to EOT normal | 44 participants |
| Faldaprevir 240mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12 = No, BL normal to EOT normal | 20 participants |
| Placebo and PegIFN/RBV | ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12 = No, No ALT data available at EoT | 1 participants |
| Placebo and PegIFN/RBV | ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12 = No, BL normal to EOT normal | 15 participants |
| Placebo and PegIFN/RBV | ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12 = No, BL elevated to EOT normal | 30 participants |
| Placebo and PegIFN/RBV | ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | SVR12 = No | 70 participants |
Secondary
ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES
The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients have sustained virological response 12 weeks post-treatment. BL = Baseline
Time frame: 12 weeks post treatment, up to 60 weeks
Population: Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faldaprevir 120mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12 = Yes | 178 participants |
| Faldaprevir 120mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12 = Yes, BL normal to EOT normal | 50 participants |
| Faldaprevir 120mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12 = Yes, BL elevated to EOT normal | 89 participants |
| Faldaprevir 120mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12 = Yes, No ALT data available at EoT | 0 participants |
| Faldaprevir 240mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12 = Yes, No ALT data available at EoT | 0 participants |
| Faldaprevir 240mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12 = Yes | 169 participants |
| Faldaprevir 240mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12 = Yes, BL elevated to EOT normal | 81 participants |
| Faldaprevir 240mg and PegIFN/RBV | ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12 = Yes, BL normal to EOT normal | 52 participants |
| Placebo and PegIFN/RBV | ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12 = Yes, No ALT data available at EoT | 0 participants |
| Placebo and PegIFN/RBV | ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12 = Yes, BL normal to EOT normal | 22 participants |
| Placebo and PegIFN/RBV | ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12 = Yes, BL elevated to EOT normal | 35 participants |
| Placebo and PegIFN/RBV | ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12 = Yes | 62 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 12 weeks 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: Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faldaprevir 120mg and PegIFN/RBV | AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO | SVR12 = No | 84 participants |
| Faldaprevir 120mg and PegIFN/RBV | AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO | SVR12 = No, No AST data available at SVR12 visit | 23 participants |
| Faldaprevir 120mg and PegIFN/RBV | AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO | SVR12 = No, BL elevated to SVR12 normal | 15 participants |
| Faldaprevir 120mg and PegIFN/RBV | AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO | SVR12 = No, BL normal to SVR12 normal | 13 participants |
| Faldaprevir 240mg and PegIFN/RBV | AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO | SVR12 = No, BL elevated to SVR12 normal | 12 participants |
| Faldaprevir 240mg and PegIFN/RBV | AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO | SVR12 = No, BL normal to SVR12 normal | 11 participants |
| Faldaprevir 240mg and PegIFN/RBV | AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO | SVR12 = No, No AST data available at SVR12 visit | 34 participants |
| Faldaprevir 240mg and PegIFN/RBV | AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO | SVR12 = No | 94 participants |
| Placebo and PegIFN/RBV | AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO | SVR12 = No, No AST data available at SVR12 visit | 54 participants |
| Placebo and PegIFN/RBV | AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO | SVR12 = No | 70 participants |
| Placebo and PegIFN/RBV | AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO | SVR12 = No, BL normal to SVR12 normal | 3 participants |
| Placebo and PegIFN/RBV | AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO | SVR12 = No, BL elevated to SVR12 normal | 1 participants |
Secondary
AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES
The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks 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: Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faldaprevir 120mg and PegIFN/RBV | AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES | SVR12 = Yes, BL elevated to SVR12 normal | 86 participants |
| Faldaprevir 120mg and PegIFN/RBV | AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES | SVR12 = Yes, BL normal to SVR12 normal | 71 participants |
| Faldaprevir 120mg and PegIFN/RBV | AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES | SVR12 = Yes | 178 participants |
| Faldaprevir 120mg and PegIFN/RBV | AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES | SVR12 = Yes, No AST data available at SVR12 visit | 9 participants |
| Faldaprevir 240mg and PegIFN/RBV | AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES | SVR12 = Yes, BL normal to SVR12 normal | 84 participants |
| Faldaprevir 240mg and PegIFN/RBV | AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES | SVR12 = Yes | 169 participants |
| Faldaprevir 240mg and PegIFN/RBV | AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES | SVR12 = Yes, BL elevated to SVR12 normal | 71 participants |
| Faldaprevir 240mg and PegIFN/RBV | AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES | SVR12 = Yes, No AST data available at SVR12 visit | 3 participants |
| Placebo and PegIFN/RBV | AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES | SVR12 = Yes, BL elevated to SVR12 normal | 30 participants |
| Placebo and PegIFN/RBV | AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES | SVR12 = Yes, BL normal to SVR12 normal | 29 participants |
| Placebo and PegIFN/RBV | AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES | SVR12 = Yes | 62 participants |
| Placebo and PegIFN/RBV | AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES | SVR12 = Yes, No AST data available at SVR12 visit | 0 participants |
Secondary
AST Normalisation: AST in Normal Range at End of Treatment (EOT) 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: 12 weeks post treatment, up to 60 weeks
Population: Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faldaprevir 120mg and PegIFN/RBV | AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12 = No | 84 participants |
| Faldaprevir 120mg and PegIFN/RBV | AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12 = No, BL normal to EOT normal | 27 participants |
| Faldaprevir 120mg and PegIFN/RBV | AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12 = No, BL elevated to EOT normal | 27 participants |
| Faldaprevir 120mg and PegIFN/RBV | AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12 = No, No AST data available at EoT | 3 participants |
| Faldaprevir 240mg and PegIFN/RBV | AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12 = No, No AST data available at EoT | 5 participants |
| Faldaprevir 240mg and PegIFN/RBV | AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12 = No | 94 participants |
| Faldaprevir 240mg and PegIFN/RBV | AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12 = No, BL elevated to EOT normal | 33 participants |
| Faldaprevir 240mg and PegIFN/RBV | AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12 = No, BL normal to EOT normal | 24 participants |
| Placebo and PegIFN/RBV | AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12 = No, No AST data available at EoT | 1 participants |
| Placebo and PegIFN/RBV | AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12 = No, BL normal to EOT normal | 17 participants |
| Placebo and PegIFN/RBV | AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12 = No, BL elevated to EOT normal | 26 participants |
| Placebo and PegIFN/RBV | AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | SVR12 = No | 70 participants |
Secondary
AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES
The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline
Time frame: 12 weeks post treatment, up to 60 weeks
Population: Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faldaprevir 120mg and PegIFN/RBV | AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12 = Yes | 178 participants |
| Faldaprevir 120mg and PegIFN/RBV | AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12 = Yes, BL normal to EOT normal | 70 participants |
| Faldaprevir 120mg and PegIFN/RBV | AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12 = Yes, BL elevated to EOT normal | 65 participants |
| Faldaprevir 120mg and PegIFN/RBV | AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12 = Yes, No AST data available at EoT | 0 participants |
| Faldaprevir 240mg and PegIFN/RBV | AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12 = Yes, No AST data available at EoT | 0 participants |
| Faldaprevir 240mg and PegIFN/RBV | AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12 = Yes | 169 participants |
| Faldaprevir 240mg and PegIFN/RBV | AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12 = Yes, BL elevated to EOT normal | 51 participants |
| Faldaprevir 240mg and PegIFN/RBV | AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12 = Yes, BL normal to EOT normal | 78 participants |
| Placebo and PegIFN/RBV | AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12 = Yes, No AST data available at EoT | 0 participants |
| Placebo and PegIFN/RBV | AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12 = Yes, BL normal to EOT normal | 26 participants |
| Placebo and PegIFN/RBV | AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12 = Yes, BL elevated to EOT normal | 26 participants |
| Placebo and PegIFN/RBV | AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | SVR12 = Yes | 62 participants |
Secondary
Early Treatment Success (ETS)
Percentage of participants with early treatment success (ETS), defined as a 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: Week 4 and week 8
Population: Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Faldaprevir 120mg and PegIFN/RBV | Early Treatment Success (ETS) | 80.2 percentage of participants |
| Faldaprevir 240mg and PegIFN/RBV | Early Treatment Success (ETS) | 79.1 percentage of participants |
| Placebo and PegIFN/RBV | Early Treatment Success (ETS) | 15.9 percentage of participants |
Secondary
Sustained Virologic Response 24 Weeks Post-treatment (SVR24)
Percentage of participants with sustained virologic response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level \< 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration. Hepatitis C virus Ribonucleic acid (HCV RNA)
Time frame: 24 weeks post treatment, up to 72 weeks
Population: Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication and had SVR data at week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Faldaprevir 120mg and PegIFN/RBV | Sustained Virologic Response 24 Weeks Post-treatment (SVR24) | 67.2 percentage of participants |
| Faldaprevir 240mg and PegIFN/RBV | Sustained Virologic Response 24 Weeks Post-treatment (SVR24) | 62.7 percentage of participants |
| Placebo and PegIFN/RBV | Sustained Virologic Response 24 Weeks Post-treatment (SVR24) | 46.2 percentage of participants |
p-value: <0.000195% CI: [10.7, 30.6]Cochran-Mantel-Haenszel
p-value: 0.001495% CI: [6.5, 26.7]Cochran-Mantel-Haenszel