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    Clinical Trial Results:
    A phase III, open-label study of once daily BI 201335 240 mg for 24 weeks in combination with pegylated interferon-a (PegIFN) and ribavirin (RBV) in patients with genotype 1 chronic hepatitis C infection who failed a prior PegIFN / RBV treatment

    Summary
    EudraCT number
    		 2011-000141-20
    Trial protocol
    		 GB   PT   DE   AT   BE   ES  
    Global end of trial date
    24 Jun 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jun 2016
    First version publication date
    26 Jul 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    1220.48
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01330316
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Boehringer Ingelheim
    Sponsor organisation address
    Binger Strasse 173, Ingelheim am Rhein, Germany, 55216
    Public contact
    QRPE Processes and Systems Coordination Clinical Trial Information Disclosure, Boehringer Ingelheim Pharma GmbH & Co. KG, +1 8002430127, clintriage.rdg@boehringer-ingelheim.com
    Scientific contact
    QRPE Processes and Systems Coordination Clinical Trial Information Disclosure, Boehringer Ingelheim Pharma GmbH & Co. KG, +1 8002430127, clintriage.rdg@boehringer-ingelheim.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Aug 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Jun 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jun 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The objective of this trial is to collect evidence for the safety and efficacy of 24 weeks of treatment with BI 201335 240mg given once daily in combination with 24 or 48 weeks of PegIFN and RBV in HCV GT-1 infected treatment-experienced patients who have been withdrawn from PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and 1220.47 trials of the BI 201335 Phase III program.
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Rescue medication was allowed for all patients as required. An independent data monitoring committee (DMC) was established to ensure the welfare of patients participating in this trial.
    Background therapy
    		 Pegylated interferon α-2a (PegIFN) and Ribavirin (RBV)
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Oct 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 24 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Portugal: 7
    Country: Number of subjects enrolled
    Spain: 6
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    France: 17
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    Canada: 14
    Country: Number of subjects enrolled
    Japan: 14
    Country: Number of subjects enrolled
    Romania: 1
    Country: Number of subjects enrolled
    Russian Federation: 4
    Country: Number of subjects enrolled
    Korea, Republic of: 5
    Country: Number of subjects enrolled
    Switzerland: 1
    Country: Number of subjects enrolled
    United States: 24
    Country: Number of subjects enrolled
    Taiwan: 1
    Worldwide total number of subjects
    121
    EEA total number of subjects
    58
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    110
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This was a multi-national, open-label trial enrolling 2 cohorts of patients with chronic Hepatitis C Virus (HCV) infection of genotype 1 (GT-1) who were randomized to the placebo arm (+ Pegylated interferon α-2a/Ribavirin) and experienced virologic failure in one of the 1220.7(2010-021715-17), 1220.30(2010-021716-42), 1220.47(2010-021716-42) trials

    Pre-assignment
    Screening details
    		 Eligible patients who entered the rollover trial within 14 weeks of their last study visit in one of the predecessor trials were not required to do a screening visit (treatment start: Day 1). Eligible patients who were outside of this 14-week window were required to do a screening visit (Visit 1) and started treatment at Visit 2 (Day 1).

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Relapse
    Arm description
    		 Faldaprevir (FDV) 240 mg once daily combined with Pegylated interferon α-2a (PegIFN)/ Ribavirin (RBV) for 24 weeks was administered for relapser patients. At week 24, patients who did not achieve early treatment success (ETS) continue with an additional 24 weeks of PegIFN/RBV. ETS is defined as Hepatitis C virus (HCV) Ribonucleic Acid (RNA) <25 Internalional Units (IU)/millilitre (ml) (detected or undetected) at week 4 and <25 IU/ml (undetected) at week 8. Patients who had undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels at the end of treatment in one of the previous studies (see recruitment details) but had detectable levels in subsequent assessments are called relapser.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Faldaprevir (FDV)
    Investigational medicinal product code
    BI 201335
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    240 mg Faldaprevir once daily for 24 weeks.

    Investigational medicinal product name
    Pegasys (R)
    Investigational medicinal product code
    Other name
    Pegylated interferon-α 2a
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Up to 180 Microgram (mcg) once weekly for 24 weeks. All relapsed patients who do not achieve ETS at week 8 will extend treatment for additional 24 weeks.

    Investigational medicinal product name
    Copegus (R)
    Investigational medicinal product code
    Other name
    Ribavirin
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The daily dose is 1000 milligram (mg) (<75 kilogram (kg) body weight) or 1200mg (≥ 75 kg body weight), administered twice daily. All relapsed patients who do not achieve ETS at week 8 will extend treatment for additional 24 weeks.

    Arm title
    		 Non-relapse
    Arm description
    		 Faldaprevir (FDV) 240mg once daily combined with Pegylated interferon α-2a (PegIFN)/ Ribavirin (RBV) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV for non-relapser patients. Non-relapser are non-responder (null and partial) and breakthrough patients. Null responders are patients who did not achieve > 2 log10decrease in HCV RNA from baseline during the treatment period. Partial non-responders are patients who achieved > 2 log10 decrease in HCV RNA from baseline but who never achieved an undetectable level of HCV RNA. Breakthrough are patients who achieved an undetectable HCV RNA during the treatment period but had detectable HCV RNA at the end of treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Faldaprevir (FDV)
    Investigational medicinal product code
    BI 201335
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    240mg Faldaprevir once daily combined with PegIFN/RBV for 24 weeks.

    Investigational medicinal product name
    Pegasys (R)
    Investigational medicinal product code
    Other name
    Pegylated interferon-α 2a
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Up to 180 Microgram (mcg) once weekly for 24 weeks. All relapsed patients who do not achieve ETS at week 8 will extend treatment for additional 24 weeks.

    Investigational medicinal product name
    Copegus (R)
    Investigational medicinal product code
    Other name
    Ribavirin
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The daily dose is 1000 milligram (mg) (<75 kilogram (kg) body weight) or 1200mg (≥ 75 kg body weight), administered twice daily. All relapsed patients who do not achieve ETS at week 8 will extend treatment for additional 24 weeks.

    Number of subjects in period 1 [1]
    		Relapse Non-relapse
    Started
    43
    75
    Completed
    41
    60
    Not completed
    2
    15
         Adverse event, non-fatal
    2
    2
         Withdrawal by Subject
    -
    1
         Other than specified
    -
    1
         Lost to follow-up
    -
    1
         Lack of efficacy
    -
    10
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline characteristics are based on patients who were randomised after successfully completing the screening period and received at least one of the study medication.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Relapse
    Reporting group description
    		 Faldaprevir (FDV) 240 mg once daily combined with Pegylated interferon α-2a (PegIFN)/ Ribavirin (RBV) for 24 weeks was administered for relapser patients. At week 24, patients who did not achieve early treatment success (ETS) continue with an additional 24 weeks of PegIFN/RBV. ETS is defined as Hepatitis C virus (HCV) Ribonucleic Acid (RNA) <25 Internalional Units (IU)/millilitre (ml) (detected or undetected) at week 4 and <25 IU/ml (undetected) at week 8. Patients who had undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels at the end of treatment in one of the previous studies (see recruitment details) but had detectable levels in subsequent assessments are called relapser.

    Reporting group title
    Non-relapse
    Reporting group description
    		 Faldaprevir (FDV) 240mg once daily combined with Pegylated interferon α-2a (PegIFN)/ Ribavirin (RBV) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV for non-relapser patients. Non-relapser are non-responder (null and partial) and breakthrough patients. Null responders are patients who did not achieve > 2 log10decrease in HCV RNA from baseline during the treatment period. Partial non-responders are patients who achieved > 2 log10 decrease in HCV RNA from baseline but who never achieved an undetectable level of HCV RNA. Breakthrough are patients who achieved an undetectable HCV RNA during the treatment period but had detectable HCV RNA at the end of treatment.

    Reporting group values
    		 Relapse Non-relapse Total
    Number of subjects
    		 43 75 118
    Age categorical
    Units: Subjects
    Age Continuous
    Full analysis set (FAS): This set included all patients who entered the trial, were dispensed study medication, and were documented to have taken at least one dose of study medication.
    Units: years
        arithmetic mean (standard deviation)
    		 55.4 ( 7.38 ) 53.4 ( 9.46 ) -
    Gender, Male/Female
    Full analysis set (FAS): This set included all patients who entered the trial, were dispensed study medication, and were documented to have taken at least one dose of study medication.
    Units: participants
        Female
    		 16 25 41
        Male
    		 27 50 77

    End points

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    End points reporting groups
    Reporting group title
    Relapse
    Reporting group description
    		 Faldaprevir (FDV) 240 mg once daily combined with Pegylated interferon α-2a (PegIFN)/ Ribavirin (RBV) for 24 weeks was administered for relapser patients. At week 24, patients who did not achieve early treatment success (ETS) continue with an additional 24 weeks of PegIFN/RBV. ETS is defined as Hepatitis C virus (HCV) Ribonucleic Acid (RNA) <25 Internalional Units (IU)/millilitre (ml) (detected or undetected) at week 4 and <25 IU/ml (undetected) at week 8. Patients who had undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels at the end of treatment in one of the previous studies (see recruitment details) but had detectable levels in subsequent assessments are called relapser.

    Reporting group title
    Non-relapse
    Reporting group description
    		 Faldaprevir (FDV) 240mg once daily combined with Pegylated interferon α-2a (PegIFN)/ Ribavirin (RBV) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV for non-relapser patients. Non-relapser are non-responder (null and partial) and breakthrough patients. Null responders are patients who did not achieve > 2 log10decrease in HCV RNA from baseline during the treatment period. Partial non-responders are patients who achieved > 2 log10 decrease in HCV RNA from baseline but who never achieved an undetectable level of HCV RNA. Breakthrough are patients who achieved an undetectable HCV RNA during the treatment period but had detectable HCV RNA at the end of treatment.

    Primary: Sustained Virological Response (SVR): Plasma HCV RNA level < 25 IU/mL

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    End point title
    		 Sustained Virological Response (SVR): Plasma HCV RNA level < 25 IU/mL [1]
    End point description
    The primary endpoint was SVR12, defined as a plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
    End point type
    Primary
    End point timeframe
    12 weeks post treatment, up to 60 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: All the analyses are descriptive in nature and no hypothesis will be tested.
    End point values
    		 Relapse Non-relapse
    Number of subjects analysed
    43 [2]
    75 [3]
    Units: percentage of participants
        number (confidence interval 95%)
    95.3 (89.1 to 100)
    54.7 (43.4 to 65.9)
    Notes
    [2] - FAS
    [3] - FAS
    No statistical analyses for this end point

    Secondary: Sustained virological response after 24 weeks of treatment discontinuation (SVR24)

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    End point title
    		 Sustained virological response after 24 weeks of treatment discontinuation (SVR24)
    End point description
    Sustained virologic response 24 weeks, defined as a plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.
    End point type
    Secondary
    End point timeframe
    24 weeks post treatment, up to 72 weeks
    End point values
    		 Relapse Non-relapse
    Number of subjects analysed
    43 [4]
    75 [5]
    Units: percentage of participants
        number (confidence interval 95%)
    95.3 (89.1 to 100)
    54.7 (43.4 to 65.9)
    Notes
    [4] - FAS
    [5] - FAS
    No statistical analyses for this end point

    Secondary: Early Treatment Success (ETS)

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    End point title
    		 Early Treatment Success (ETS)
    End point description
    ETS is 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.
    End point type
    Secondary
    End point timeframe
    Week 4 and Week 8
    End point values
    		 Relapse Non-relapse
    Number of subjects analysed
    43 [6]
    75 [7]
    Units: percentage of participants
        number (not applicable)
    97.7
    65.3
    Notes
    [6] - FAS
    [7] - FAS
    No statistical analyses for this end point

    Secondary: Alanine Aminotransferase (ALT) normalisation: ALT in normal range at end of treatment (EoT)

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    End point title
    		 Alanine Aminotransferase (ALT) normalisation: ALT in normal range at end of treatment (EoT)
    End point description
    This will be presented as the number of patients in/not in normal range from baseline EoT. SVR12 is sustained virological response 12 weeks post-treatment.
    End point type
    Secondary
    End point timeframe
    Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers
    End point values
    		 Relapse Non-relapse
    Number of subjects analysed
    43 [8]
    75 [9]
    Units: participants
    number (not applicable)
        SVR12 = Yes
    41
    41
        SVR12 = Yes, Baseline Normal to EOT Normal
    12
    10
        SVR12 = Yes, Baseline Elevated to EOT Normal
    16
    15
        SVR12 = No
    2
    34
        SVR12 = No, Baseline Normal to EOT Normal
    0
    11
        SVR12 = No, Baseline Elevated to EOT Normal
    2
    9
    Notes
    [8] - FAS
    [9] - FAS
    No statistical analyses for this end point

    Secondary: Alanine Aminotransferase (ALT) normalisation: ALT in normal range at 12 weeks post-treatment.

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    End point title
    		 Alanine Aminotransferase (ALT) normalisation: ALT in normal range at 12 weeks post-treatment.
    End point description
    This will be presented as the number of patients in/not in normal range from baseline to 12 weeks post treatment. SVR12 is sustained virological response 12 weeks post-treatment.
    End point type
    Secondary
    End point timeframe
    48 weeks for relapsers with ETS; 60 weeks for non-relapsers and relapsers without ETS
    End point values
    		 Relapse Non-relapse
    Number of subjects analysed
    43 [10]
    75 [11]
    Units: participants
    number (not applicable)
        SVR12 = Yes
    41
    41
        SVR12 = Yes, Baseline Normal to SVR12 Normal
    12
    11
        SVR12 = Yes, Baseline Elevated to SVR12 Normal
    27
    27
        SVR12 = No
    2
    34
        SVR12 = No, Baseline Normal to SVR12 Normal
    0
    8
        SVR12 = No, Baseline Elevated to SVR12 Normal
    1
    2
    Notes
    [10] - FAS
    [11] - FAS
    No statistical analyses for this end point

    Secondary: Aspartate Aminotransferase (AST) normalisation: AST in normal range at end of treatment (EoT)

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    End point title
    		 Aspartate Aminotransferase (AST) normalisation: AST in normal range at end of treatment (EoT)
    End point description
    This will be presented as the number of patients in/not in normal range from baseline to EoT. SVR12 is sustained virological response 12 weeks post-treatment.
    End point type
    Secondary
    End point timeframe
    Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers.
    End point values
    		 Relapse Non-relapse
    Number of subjects analysed
    43 [12]
    75 [13]
    Units: participants
    number (not applicable)
        SVR12 = Yes
    41
    41
        SVR12 = Yes, Baseline Normal to EOT Normal
    15
    13
        SVR12 = Yes, Baseline Elevated to EOT Normal
    14
    11
        SVR12 = No
    2
    34
        SVR12 = No, Baseline Normal to EOT Normal
    1
    12
        SVR12 = No, Baseline Elevated to EOT Normal
    1
    7
    Notes
    [12] - FAS
    [13] - FAS
    No statistical analyses for this end point

    Secondary: Aspartate Aminotransferase (AST) normalisation: AST in normal range at 12 weeks post-treatment.

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    End point title
    		 Aspartate Aminotransferase (AST) normalisation: AST in normal range at 12 weeks post-treatment.
    End point description
    This will be presented as the number of patients in/not in normal range from baseline to 12 weeks post treatment. SVR12 is sustained virological response 12 weeks post-treatment.
    End point type
    Secondary
    End point timeframe
    Week 48 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers
    End point values
    		 Relapse Non-relapse
    Number of subjects analysed
    43 [14]
    75 [15]
    Units: participants
    number (not applicable)
        SVR12 = Yes
    41
    41
        SVR12 = Yes, Baseline Normal to SVR12 Normal
    15
    14
        SVR12 = Yes, Baseline Elevated to SVR12 Normal
    22
    24
        SVR12 = No
    2
    34
        SVR12 = No, Baseline Normal to SVR12 Normal
    1
    10
        SVR12 = No, Baseline Elevated to SVR12 Normal
    0
    3
    Notes
    [14] - FAS
    [15] - FAS
    No statistical analyses for this end point

    Secondary: Occurrence of adverse events (overall and by DAIDS grade)

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    End point title
    		 Occurrence of adverse events (overall and by DAIDS grade)
    End point description
    This outcome measure will be presented as the percentage of subjects with any adverse event (AE). Percentages are calculated using total number of subjects per treatment cohort as the denominator. The intensity of all AEs was evaluated according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) grading scale with AEs of mild, moderate, or severe intensity receiving Grades 1, 2, or 3, respectively. Adverse events judged potentially life threatening received a Grade 4 assessment.
    End point type
    Secondary
    End point timeframe
    from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days
    End point values
    		 Relapse Non-relapse
    Number of subjects analysed
    43 [16]
    75 [17]
    Units: percentage of participants
    number (not applicable)
        Overall
    90.7
    93.3
        Subjects with DAIDS Grade 2, 3 or 4 AEs
    65.1
    56
        Subjects with DAIDS Grade 3 or 4 AEs
    27.9
    17.3
        Subjects with DAIDS Grade 4 AEs
    7
    1.3
    Notes
    [16] - FAS
    [17] - FAS
    No statistical analyses for this end point

    Secondary: Occurrence of adverse events leading to treatment discontinuation

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    End point title
    		 Occurrence of adverse events leading to treatment discontinuation
    End point description
    This outcome measure will be presented as the percentage of subjects with adverse events leading to discontinuation of Faldaprevir and all study medication. Percentages are calculated using total number of subjects per treatment cohort as the denominator.
    End point type
    Secondary
    End point timeframe
    from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days
    End point values
    		 Relapse Non-relapse
    Number of subjects analysed
    43 [18]
    75 [19]
    Units: percentage of participants
    number (not applicable)
        discontinuation of faldaprevir
    4.3
    2.7
        discontinuation of all study medication
    2.3
    0
    Notes
    [18] - FAS
    [19] - FAS
    No statistical analyses for this end point

    Secondary: Occurrence of serious adverse events

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    End point title
    		 Occurrence of serious adverse events
    End point description
    This outcome measure will be presented as the percentage of subjects with any serious adverse event (SAE). Percentages are calculated using total number of subjects per treatment cohort as the denominator.
    End point type
    Secondary
    End point timeframe
    from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days
    End point values
    		 Relapse Non-relapse
    Number of subjects analysed
    43 [20]
    75 [21]
    Units: percentage of participants
        number (not applicable)
    2.3
    8
    Notes
    [20] - FAS
    [21] - FAS
    No statistical analyses for this end point

    Secondary: Occurrence of drug-related AEs as assessed by the investigator

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    End point title
    		 Occurrence of drug-related AEs as assessed by the investigator
    End point description
    This outcome measure will be presented as the percentage of subjects with any drug-related AEs as assessed by the investigator. Percentages are calculated using total number of subjects per treatment cohort as the denominator.
    End point type
    Secondary
    End point timeframe
    from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days
    End point values
    		 Relapse Non-relapse
    Number of subjects analysed
    43 [22]
    75 [23]
    Units: percentage of participants
        number (not applicable)
    88.4
    88
    Notes
    [22] - FAS
    [23] - FAS
    No statistical analyses for this end point

    Secondary: Laboratory test abnormalities by DAIDS grades

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    End point title
    		 Laboratory test abnormalities by DAIDS grades
    End point description
    This Outcome measure will be presented as summary of the percentage of patients with worst on-treatment Division of Acquired Immunodeficiency Syndrome (DAIDS) grade laboratory abnormalities for selected analytes (Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total) with particular relevance to patients with HCV.
    End point type
    Secondary
    End point timeframe
    baseline (day 1, after first dose of randomised treatment) up to 7 days after the last intake of study drug
    End point values
    		 Relapse Non-relapse
    Number of subjects analysed
    43 [24]
    75 [25]
    Units: percentage of participants
    number (not applicable)
        Haemoglobin, Grade 2
    14
    18.9
        Haemoglobin, Grade 3
    11.6
    8.1
        Haemoglobin, Grade 4
    0
    0
        ALT, Grade 2
    7
    6.7
        ALT, Grade 3
    2.3
    4
        ALT, Grade 4
    2.3
    0
        AST, Grade 2
    4.7
    10.7
        AST, Grade 3
    2.3
    2.7
        AST, Grade 4
    2.3
    0
        Bilirubin, total, Grade 2
    32.6
    37.3
        Bilirubin, total, Grade 3
    39.5
    29.3
        Bilirubin, total, Grade 4
    11.6
    13.3
    Notes
    [24] - FAS
    [25] - FAS
    No statistical analyses for this end point

    Secondary: Changes from baseline in laboratory test values over time [Haemoglobin]

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    End point title
    		 Changes from baseline in laboratory test values over time [Haemoglobin]
    End point description
    This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCV have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total. In this outcome measure Haemoglobin is presented.
    End point type
    Secondary
    End point timeframe
    baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)
    End point values
    		 Relapse Non-relapse
    Number of subjects analysed
    43 [26]
    75 [27]
    Units: gram (g)/decilitre (dL)
    arithmetic mean (standard deviation)
        Baseline (N=43, 74)
    14.8 ( 1.3 )
    14.8 ( 1.4 )
        week 4 (N=41, 69)
    12.6 ( 1.6 )
    12.7 ( 1.4 )
        week 12 (N=43, 66)
    11.7 ( 1.6 )
    11.5 ( 1.5 )
        min value on treatment (N=43, 74)
    11.1 ( 1.5 )
    11.3 ( 1.7 )
        max value on treatment (N=43, 74)
    13.7 ( 1.2 )
    14 ( 1.4 )
        last value on treatment (N=43, 74)
    11.4 ( 1.5 )
    11.8 ( 1.6 )
    Notes
    [26] - FAS
    [27] - FAS
    No statistical analyses for this end point

    Secondary: Changes from baseline in laboratory test values over time [ALT]

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    End point title
    		 Changes from baseline in laboratory test values over time [ALT]
    End point description
    This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCV have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total. In this outcome measure ALT is presented.
    End point type
    Secondary
    End point timeframe
    baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)
    End point values
    		 Relapse Non-relapse
    Number of subjects analysed
    43 [28]
    75 [29]
    Units: Units (U)/Litre (L)
    arithmetic mean (standard deviation)
        Baseline (N=43, 75)
    72 ( 79 )
    88 ( 63 )
        week 4 (N=43, 73)
    51 ( 71 )
    57 ( 49 )
        week 12 (N=43, 67)
    43 ( 40 )
    55 ( 62 )
        min value on treatment (N=43, 75)
    30 ( 20 )
    39 ( 38 )
        max value on treatment (N=43, 75)
    68 ( 91 )
    70 ( 62 )
        last value on treatment (N=43, 75)
    40 ( 26 )
    54 ( 52 )
    Notes
    [28] - FAS
    [29] - FAS
    No statistical analyses for this end point

    Secondary: Changes from baseline in laboratory test values over time [AST]

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    End point title
    		 Changes from baseline in laboratory test values over time [AST]
    End point description
    This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCV have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total. In this outcome measure AST is presented.
    End point type
    Secondary
    End point timeframe
    baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)
    End point values
    		 Relapse Non-relapse
    Number of subjects analysed
    43 [30]
    75 [31]
    Units: U/L
    arithmetic mean (standard deviation)
        Baseline (N=43, 75)
    54 ( 41 )
    68 ( 42 )
        week 4 (N=43, 73)
    48 ( 71 )
    46 ( 33 )
        week 12 (N=43, 67)
    41 ( 37 )
    48 ( 45 )
        min value on treatment (N=43, 75)
    30 ( 16 )
    35 ( 25 )
        max value on treatment (N=43, 75)
    63 ( 89 )
    62 ( 50 )
        last value on treatment (N=43, 75)
    40 ( 23 )
    49 ( 39 )
    Notes
    [30] - FAS
    [31] - FAS
    No statistical analyses for this end point

    Secondary: Changes from baseline in laboratory test values over time [Bilirubin total]

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    End point title
    		 Changes from baseline in laboratory test values over time [Bilirubin total]
    End point description
    This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCV have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total. In this outcome measure Bilirubin total is presented.
    End point type
    Secondary
    End point timeframe
    baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)
    End point values
    		 Relapse Non-relapse
    Number of subjects analysed
    43 [32]
    75 [33]
    Units: milligram (mg)/dL
    arithmetic mean (standard deviation)
        Baseline (N=43, 75)
    0.5 ( 0.2 )
    0.5 ( 0.2 )
        week 4 (N=43, 74)
    2.8 ( 1.6 )
    2.6 ( 1.7 )
        week 12 (N=43, 67)
    2.7 ( 1.8 )
    2.7 ( 1.9 )
        min value on treatment (N=43, 75)
    1.9 ( 1.3 )
    1.9 ( 1.5 )
        max value on treatment (N=43, 75)
    3.6 ( 2.1 )
    3.5 ( 2.2 )
        last value on treatment (N=43, 75)
    2.6 ( 1.8 )
    2.6 ( 1.9 )
    Notes
    [32] - FAS
    [33] - FAS
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Non-Relapse
    Reporting group description
    		 Faldaprevir (FDV) 240mg once daily combined with Pegylated interferon α-2a (PegIFN)/ Ribavirin (RBV) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV for non-relapser patients. Non-relapser are non-responder (null and partial) and breakthrough patients. Null responders are patients who did not achieve > 2 log10decrease in HCV RNA from baseline during the treatment period. Partial non-responders are patients who achieved > 2 log10 decrease in HCV RNA from baseline but who never achieved an undetectable level of HCV RNA. Breakthrough are patients who achieved an undetectable HCV RNA during the treatment period but had detectable HCV RNA at the end of treatment.

    Reporting group title
    Relapse
    Reporting group description
    		 Faldaprevir (FDV) 240 mg once daily combined with Pegylated interferon α-2a (PegIFN)/ Ribavirin (RBV) for 24 weeks was administered for relapser patients. At week 24, patients who did not achieve early treatment success (ETS) continue with an additional 24 weeks of PegIFN/RBV. ETS is defined as Hepatitis C virus (HCV) Ribonucleic Acid (RNA) <25 Internalional Units (IU)/millilitre (ml) (detected or undetected) at week 4 and <25 IU/ml (undetected) at week 8.

    Serious adverse events
    		 Non-Relapse Relapse
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 75 (8.00%)
    1 / 43 (2.33%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Presyncope
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic failure
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral fungal infection
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Non-Relapse Relapse
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    68 / 75 (90.67%)
    38 / 43 (88.37%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 75 (1.33%)
    3 / 43 (6.98%)
         occurrences all number
    1
    3
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    12 / 75 (16.00%)
    7 / 43 (16.28%)
         occurrences all number
    12
    7
    Chills
         subjects affected / exposed
    2 / 75 (2.67%)
    3 / 43 (6.98%)
         occurrences all number
    2
    3
    Fatigue
         subjects affected / exposed
    9 / 75 (12.00%)
    14 / 43 (32.56%)
         occurrences all number
    9
    14
    Influenza like illness
         subjects affected / exposed
    4 / 75 (5.33%)
    5 / 43 (11.63%)
         occurrences all number
    4
    7
    Malaise
         subjects affected / exposed
    6 / 75 (8.00%)
    1 / 43 (2.33%)
         occurrences all number
    6
    1
    Pyrexia
         subjects affected / exposed
    8 / 75 (10.67%)
    4 / 43 (9.30%)
         occurrences all number
    8
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    11 / 75 (14.67%)
    5 / 43 (11.63%)
         occurrences all number
    11
    5
    Dyspnoea
         subjects affected / exposed
    3 / 75 (4.00%)
    4 / 43 (9.30%)
         occurrences all number
    3
    4
    Psychiatric disorders
    Depression
         subjects affected / exposed
    4 / 75 (5.33%)
    3 / 43 (6.98%)
         occurrences all number
    4
    3
    Insomnia
         subjects affected / exposed
    14 / 75 (18.67%)
    5 / 43 (11.63%)
         occurrences all number
    14
    5
    Irritability
         subjects affected / exposed
    6 / 75 (8.00%)
    2 / 43 (4.65%)
         occurrences all number
    6
    2
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    1 / 75 (1.33%)
    3 / 43 (6.98%)
         occurrences all number
    1
    3
    Weight decreased
         subjects affected / exposed
    3 / 75 (4.00%)
    3 / 43 (6.98%)
         occurrences all number
    3
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    5 / 75 (6.67%)
    3 / 43 (6.98%)
         occurrences all number
    5
    3
    Dysgeusia
         subjects affected / exposed
    4 / 75 (5.33%)
    2 / 43 (4.65%)
         occurrences all number
    4
    2
    Headache
         subjects affected / exposed
    15 / 75 (20.00%)
    10 / 43 (23.26%)
         occurrences all number
    16
    12
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    20 / 75 (26.67%)
    9 / 43 (20.93%)
         occurrences all number
    24
    9
    Neutropenia
         subjects affected / exposed
    7 / 75 (9.33%)
    2 / 43 (4.65%)
         occurrences all number
    7
    2
    Thrombocytopenia
         subjects affected / exposed
    5 / 75 (6.67%)
    1 / 43 (2.33%)
         occurrences all number
    5
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    4 / 75 (5.33%)
    0 / 43 (0.00%)
         occurrences all number
    4
    0
    Abdominal pain
         subjects affected / exposed
    3 / 75 (4.00%)
    6 / 43 (13.95%)
         occurrences all number
    4
    6
    Abdominal pain upper
         subjects affected / exposed
    8 / 75 (10.67%)
    2 / 43 (4.65%)
         occurrences all number
    8
    2
    Diarrhoea
         subjects affected / exposed
    21 / 75 (28.00%)
    14 / 43 (32.56%)
         occurrences all number
    24
    19
    Dry mouth
         subjects affected / exposed
    4 / 75 (5.33%)
    0 / 43 (0.00%)
         occurrences all number
    4
    0
    Dyspepsia
         subjects affected / exposed
    5 / 75 (6.67%)
    2 / 43 (4.65%)
         occurrences all number
    5
    3
    Nausea
         subjects affected / exposed
    34 / 75 (45.33%)
    22 / 43 (51.16%)
         occurrences all number
    36
    25
    Stomatitis
         subjects affected / exposed
    2 / 75 (2.67%)
    3 / 43 (6.98%)
         occurrences all number
    2
    3
    Vomiting
         subjects affected / exposed
    15 / 75 (20.00%)
    11 / 43 (25.58%)
         occurrences all number
    22
    15
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    6 / 75 (8.00%)
    12 / 43 (27.91%)
         occurrences all number
    7
    12
    Jaundice
         subjects affected / exposed
    10 / 75 (13.33%)
    5 / 43 (11.63%)
         occurrences all number
    10
    5
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    6 / 75 (8.00%)
    4 / 43 (9.30%)
         occurrences all number
    6
    4
    Dry skin
         subjects affected / exposed
    8 / 75 (10.67%)
    4 / 43 (9.30%)
         occurrences all number
    9
    4
    Eczema
         subjects affected / exposed
    5 / 75 (6.67%)
    1 / 43 (2.33%)
         occurrences all number
    6
    1
    Photosensitivity reaction
         subjects affected / exposed
    1 / 75 (1.33%)
    3 / 43 (6.98%)
         occurrences all number
    1
    3
    Pruritus
         subjects affected / exposed
    23 / 75 (30.67%)
    13 / 43 (30.23%)
         occurrences all number
    23
    16
    Rash
         subjects affected / exposed
    21 / 75 (28.00%)
    12 / 43 (27.91%)
         occurrences all number
    26
    12
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 75 (5.33%)
    2 / 43 (4.65%)
         occurrences all number
    4
    2
    Back pain
         subjects affected / exposed
    4 / 75 (5.33%)
    0 / 43 (0.00%)
         occurrences all number
    5
    0
    Muscle spasms
         subjects affected / exposed
    4 / 75 (5.33%)
    2 / 43 (4.65%)
         occurrences all number
    5
    2
    Myalgia
         subjects affected / exposed
    9 / 75 (12.00%)
    3 / 43 (6.98%)
         occurrences all number
    11
    3
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 75 (1.33%)
    3 / 43 (6.98%)
         occurrences all number
    1
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    16 / 75 (21.33%)
    3 / 43 (6.98%)
         occurrences all number
    17
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jun 2011
    Visit windows changed to offer sites and patients more scheduling flexibility. The definition sustained virological response (SVR) was modified by clarifying that the planned end of treatment for this assessment would be based on cohort and achievement of ETS. Clarification of exclusion criteria: cervical cap deemed inferior barrier and was removed as a sufficient method of contraception per Health Canada. Exclusion criterion describing restriction of patients with decompensated liver disease was modified per Child-Turcotte-Pugh classification, and exclusion criteria for pre-existing psychiatric conditions were modified per an update of the Summary of Product Characteristics (SPC) for RBV. Clarified rules for stopping treatment in case of virological failure. Prohibited increasing the dose of drug up to 240mg after it had been reduced to 120mg during the trial. Removed restrictions on certain contraindicated medications. Added instructions on appropriate management of missed doses of drug. Clarified definition of eRVR and added progression of liver disease progression as other endpoint. Adopted Division of Acquired Immunodeficiency Syndrome (DAIDS) grading system for classifying AE intensity and laboratory tests. Allowed for blood sampling at the first screening visit for patients who were not fasting at the screening visit. Removed requirement for screening visit if the time period between the last study visit of one of the phase III predecessor studies and the first visit for 1220.48 was ≤ 14 weeks. Restricted the discontinuation of pegylated interferon α-2a (PegIFN) for patients who discontinued FDV or ribavirin (RBV) early. Removed list of restricted concomitant medications and added reference to ISF to facilitate updated information as new potential interactions were identified. Definition of virological failure was described in more detail to include a repeat blood draw to determine whether patient could continue study medications.
    05 Mar 2012
    Change: Descriptions of rashes, instructions to discontinue FDV treatment in case of severe photosensitivity reaction with opportunity to continue PegIFN/RBV in conjunction with a dermatology specialist Primary efficacy endpoint from SVR24 to SVR12 Secondary efficacy endpoint to add ALT and AST normalization post treatment Add: Procedure clarification for patients who discontinued early; Criteria/rules for stopping patient treatment due to lack of efficacy Description of AEs defined as always serious per BI SOPs Clarified: Standard of care with PegIFN, RBV Planned treatment interruptions/dose reductions should be considered for treatment compliance calculation AE definitions to include worsening of underlying diseases/pre-existing conditions, changes in vital signs, ECG, physical examination, laboratory values deemed clinically relevant Markers of liver disease progression would be assessed at (early) end of treatment Procedures for patients who prematurely discontinued from treatment or trial Handling of rules for imputing missing SVR12 or SVR24 data Calculation of Child-Turcotte-Pugh score for exclusion of such patients from trial Modified: Analyses for other efficacy endpoint: rapid virological response (VR), complete early VR, week 24 VR, extended rapid VR, ETR Rash management plan to include photosensitivity reaction gradings, no photo documentation for mild rashes, clarified the instructions for potentially life-threatening rashes Jaundice deemed non-specific, removed from list of sensitive markers indicative of liver disease progression Use of oral antivirals, oseltamivir and zanamivir: permitted during trial Planned interim analysis: database lock after last patient’s 12 weeks post-treatment visit. Primary endpoint assessed for all patients. Safety and efficacy data were to be summarized
    09 Jul 2013
    Added that Drug Reaction (or Rash) with Eosinophilia and Systemic Symptoms (DRESS) syndrome had been reported in the FDV program and it was added as a potentially life-threatening example. Patients were to be monitored for the appearance of safety signals related to this syndrome.
    09 Apr 2014
    Removal of extended follow-up visit because sufficient long-term data had been collected as part of the clinical program. Sensitivity analyses were removed. Other secondary analyses were removed (ALT/AST normalization reference; RBV-associated anaemia; reason for further breakout) or added (ETS) to correct errors. Clarified that interim analysis would only performed if requested by regulatory agencies; one database lock would be performed at end of trial only.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    24 Jun 2014
    Boehringer Ingelheim (BI) no longer has any internal HCV direct-acting antiviral agents required to develop an IFN-free clinical development program. As a result, BI withdrew all pending marketing applications for FDV worldwide and is discontinuing further HCV drug development. As a result, this trial was prematurely discontinued.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Due to the premature discontinuation of this trial an abbreviated report format was used.
    For support, Contact us.
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