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    Clinical Trial Results:
    Safety and Efficacy of 120 mg and 240 mg BI 201335 once daily in combination with pegylated interferon alpha 2a and ribavirin for treatment of chronic Hepatitis C (HCV) genotype 1 infection in HIV/HCV-co-infected patients. A multinational, randomised, parallel group, open-label trial

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2010-021734-59
    Trial protocol
    		 GB   ES   DE   IT  
    Global end of trial date
    19 Jun 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    23 Jul 2016
    First version publication date
    26 Jul 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Data correction due to a system error in EudraCT - Results

    Trial information

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    Trial identification
    Sponsor protocol code
    1220.19
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01399619
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Boehringer Ingelheim
    Sponsor organisation address
    Binger Strasse 173, 55216 Ingelheim am Rhein, Germany,
    Public contact
    QRPE Processes and Systems Coordination Clinical Trial Information Disclosure , Boehringer Ingelheim, +1 800 243 0127 , clintriage.rdg@boehringer-ingelheim.com
    Scientific contact
    QRPE Processes and Systems Coordination Clinical Trial Information Disclosure , Boehringer Ingelheim, +1 800 243 0127 , 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
    31 Jul 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Sep 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this trial is to evaluate the safety and efficacy of an open-label treatment with BI 201335 240 mg once daily given for 12 or 24 weeks (wk) or BI 201335 120 mg once daily for 24 wk, each in combination with pegylated interferon-alpha2a and ribavirin given for 24 or 48 wk in hepatitis C virus (HCV)/human immunodeficiency virus (HIV) coinfected patients, who are HCV-treatment naive or HCV-treatment relapsers and HIV treatment-naive- or, who are being treated with Highly active antiretroviral therapy (HAART) containing an acceptable combination of the following antiretrovirals: raltegravir, darunavir/ritonavir, efavirenz, atazanavir/ ritonavir (limited to 20 patients), maraviroc, tenofovir, abacavir, emtricitabine, and lamivudine. Results of this trial will be compared with historical efficacy and safety data of randomized trials of 48 wk of treatment with pegylated interferon-alpha2a and ribavirin for HCV genotype 1 (GT-1) infection in HIV/HCV co-infected patients.
    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.
    Background therapy
    		 All treatment groups included a background therapy of pegylated interferon alpha 2a and ribavirin (pegIFN and RBV)
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Oct 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research
    Long term follow-up duration
    		 30 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 119
    Country: Number of subjects enrolled
    United Kingdom: 72
    Country: Number of subjects enrolled
    France: 21
    Country: Number of subjects enrolled
    Germany: 51
    Country: Number of subjects enrolled
    Italy: 26
    Country: Number of subjects enrolled
    Brazil: 28
    Country: Number of subjects enrolled
    United States: 119
    Country: Number of subjects enrolled
    Switzerland: 17
    Worldwide total number of subjects
    453
    EEA total number of subjects
    289
    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)
    441
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that they (the subject) met all strictly implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Faldaprevir 120 mg-24 Wk
    Arm description
    		 Faldaprevir (BI 201335) 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Faldaprevir
    Investigational medicinal product code
    BI 201335
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    one soft gelatine capsule of BI 201335 (Faldaprevir) once a day 120 mg

    Investigational medicinal product name
    pegIFN
    Investigational medicinal product code
    Other name
    Pegasys®
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dose: 180 μg once weekly, Mode of Admin.: Subcutaneous (SC) injection.

    Investigational medicinal product name
    RBV
    Investigational medicinal product code
    Other name
    Copegus®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose: 1000 mg (<75 kg body weight) or 1200 mg (≥75 kg body weight) total daily dose, divided in 2 doses for twice daily administration. Mode of Admin.: Oral.

    Arm title
    		 Faldaprevir 240 mg-12Wk
    Arm description
    		 Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Faldaprevir
    Investigational medicinal product code
    BI 201335
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    patient to receive two capsules of BI 201335 once a day (total daily dose 240 mg).

    Investigational medicinal product name
    pegIFN
    Investigational medicinal product code
    Other name
    Pegasys®
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dose: 180 μg once weekly; Mode of Admin.: Subcutaneous (SC) injection.

    Investigational medicinal product name
    RBV
    Investigational medicinal product code
    Other name
    Copegus®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose: 1000 mg (<75 kg body weight) or 1200 mg (≥75 kg body weight) total daily dose, divided in 2 doses for twice daily administration. Mode of Admin.: Oral.

    Arm title
    		 Faldaprevir 240 mg-24Wk
    Arm description
    		 Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Faldaprevir
    Investigational medicinal product code
    BI 201335
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    patient to receive two capsules of BI 201335 once a day for 24 weeks (total daily dose 240 mg).

    Investigational medicinal product name
    pegIFN
    Investigational medicinal product code
    Other name
    Pegasys®
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dose: 180 μg once weekly, Mode of Admin.: Subcutaneous (SC) injection.

    Investigational medicinal product name
    RBV
    Investigational medicinal product code
    Other name
    Copegus®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose: 1000 mg (<75 kg body weight) or 1200 mg (≥75 kg body weight) total daily dose, divided in 2 doses for twice daily administration. Mode of Admin.: Oral.

    Arm title
    		 Faldaprevir 240 mg -Prior to Re-randomization at Week 12 (NR)
    Arm description
    		 Patients initially assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at WK 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Faldaprevir
    Investigational medicinal product code
    BI 201335
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    dose: 240 mg. mode of admin.: Oral use.

    Investigational medicinal product name
    RBV
    Investigational medicinal product code
    Other name
    Copegus®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose: 1000 mg (<75 kg body weight) or 1200 mg (≥75 kg body weight) total daily dose, divided in 2 doses for twice daily administration. Mode of Admin.: Oral.

    Investigational medicinal product name
    pegIFN
    Investigational medicinal product code
    Other name
    Pegasys®
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dose: 180 μg once weekly, Mode of Admin.: Subcutaneous (SC) injection.

    Number of subjects in period 1 [1]
    		Faldaprevir 120 mg-24 Wk Faldaprevir 240 mg-12Wk Faldaprevir 240 mg-24Wk Faldaprevir 240 mg -Prior to Re-randomization at Week 12 (NR)
    Started
    123
    84
    86
    17
    Completed
    98
    84
    74
    0
    Not completed
    25
    0
    12
    17
         Consent withdrawn by subject
    6
    -
    3
    4
         not treated
    -
    -
    -
    2
         Adverse event, non-fatal
    10
    -
    4
    10
         Lack of efficacy
    9
    -
    5
    -
         Protocol deviation
    -
    -
    -
    1
    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 trial medication.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Faldaprevir 120 mg-24 Wk
    Reporting group description
    		 Faldaprevir (BI 201335) 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.

    Reporting group title
    Faldaprevir 240 mg-12Wk
    Reporting group description
    		 Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.

    Reporting group title
    Faldaprevir 240 mg-24Wk
    Reporting group description
    		 Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.

    Reporting group title
    Faldaprevir 240 mg -Prior to Re-randomization at Week 12 (NR)
    Reporting group description
    		 Patients initially assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at WK 12.

    Reporting group values
    		 Faldaprevir 120 mg-24 Wk Faldaprevir 240 mg-12Wk Faldaprevir 240 mg-24Wk Faldaprevir 240 mg -Prior to Re-randomization at Week 12 (NR) Total
    Number of subjects
    		 123 84 86 17 310
    Age categorical
    Units: Subjects
    Age continuous
    Full analysis Set (FAS) population: All patients who were randomized and received at least one dose of assigned therapy.
    Units: years
        arithmetic mean (standard deviation)
    		 47.6 ( 7.63 ) 46.1 ( 8.64 ) 46 ( 7.97 ) 51.8 ( 9.09 ) -
    Gender categorical
    based on FAS population.
    Units: Subjects
        Female
    		 20 18 18 4 60
        Male
    		 103 66 68 13 250
    Subject analysis sets

    Subject analysis set title
    Faldaprevir 240 mg - Total (T)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.

    Subject analysis set title
    Faldaprevir - Total
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Total subjects who were treated with faldaprevir.

    Subject analysis sets values
    		 Faldaprevir 240 mg - Total (T) Faldaprevir - Total
    Number of subjects
    185
    308
    Age categorical
    Units: Subjects
    Age continuous
    Full analysis Set (FAS) population: All patients who were randomized and received at least one dose of assigned therapy.
    Units: years
        arithmetic mean (standard deviation)
    46.5 ( 8.36 )
    46.9 ( 8.08 )
    Gender categorical
    based on FAS population.
    Units: Subjects
        Female
    40
    60
        Male
    145
    248

    End points

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    End points reporting groups
    Reporting group title
    Faldaprevir 120 mg-24 Wk
    Reporting group description
    		 Faldaprevir (BI 201335) 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.

    Reporting group title
    Faldaprevir 240 mg-12Wk
    Reporting group description
    		 Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.

    Reporting group title
    Faldaprevir 240 mg-24Wk
    Reporting group description
    		 Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.

    Reporting group title
    Faldaprevir 240 mg -Prior to Re-randomization at Week 12 (NR)
    Reporting group description
    		 Patients initially assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at WK 12.

    Subject analysis set title
    Faldaprevir 240 mg - Total (T)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.

    Subject analysis set title
    Faldaprevir - Total
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Total subjects who were treated with faldaprevir.

    Primary: Sustained Virological Response (SVR12)

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    End point title
    		 Sustained Virological Response (SVR12) [1] [2]
    End point description
    Percentage of participants with sustained Virological Response (SVR12): Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level <25 IU/mL, Undetected 12 Weeks After the Planned End of Treatment. The 95% confidence interval (CI) based on the normal approximation to the binomial distribution was calculated for SVR12 rates
    End point type
    Primary
    End point timeframe
    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: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis were tested.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those arms for which the statistics are presented in the clinical trial report thus, those that would yield meaningful results were reported.
    End point values
    		 Faldaprevir 120 mg-24 Wk Faldaprevir 240 mg-12Wk Faldaprevir 240 mg-24Wk Faldaprevir 240 mg - Total (T) Faldaprevir - Total
    Number of subjects analysed
    123 [3]
    84 [4]
    86 [5]
    185 [6]
    308 [7]
    Units: percentage of participants with SVR12
        number (confidence interval 95%)
    70.7 (62.7 to 78.8)
    78.6 (69.8 to 87.3)
    76.7 (67.8 to 85.7)
    72.4 (66 to 78.9)
    71.8 (66.7 to 76.8)
    Notes
    [3] - FAS
    [4] - FAS
    [5] - FAS
    [6] - FAS
    [7] - FAS
    No statistical analyses for this end point

    Secondary: Virological Response 24 Weeks Post Treatment (SVR24)

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    End point title
    		 Virological Response 24 Weeks Post Treatment (SVR24) [8]
    End point description
    Percentage of participants with virological response 24 weeks post treatment (SVR24): Plasma HCV RNA Level<25IU/mL undetected 24 Weeks After the Planned End of Treatment.
    End point type
    Secondary
    End point timeframe
    72 weeks
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those arms for which the statistics are presented in the clinical trial report thus, those that would yield meaningful results were reported.
    End point values
    		 Faldaprevir 120 mg-24 Wk Faldaprevir 240 mg-12Wk Faldaprevir 240 mg-24Wk Faldaprevir 240 mg - Total (T) Faldaprevir - Total
    Number of subjects analysed
    123 [9]
    84 [10]
    86 [11]
    185 [12]
    308 [13]
    Units: percentage of participants
        number (confidence interval 95%)
    69.9 (61.8 to 78)
    78.6 (69.8 to 87.3)
    74.4 (65.2 to 83.6)
    71.4 (64.8 to 77.9)
    70.8 (65.7 to 75.9)
    Notes
    [9] - FAS
    [10] - FAS
    [11] - FAS
    [12] - FAS
    [13] - FAS
    No statistical analyses for this end point

    Secondary: Early Treatment Success (ETS)

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    End point title
    		 Early Treatment Success (ETS) [14]
    End point description
    Early Treatment Success (ETS): 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, Week 8 and Week 60.
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those arms for which the statistics are presented in the clinical trial report thus, those that would yield meaningful results were reported.
    End point values
    		 Faldaprevir 120 mg-24 Wk Faldaprevir 240 mg-12Wk Faldaprevir 240 mg-24Wk Faldaprevir 240 mg - Total (T) Faldaprevir - Total
    Number of subjects analysed
    123 [15]
    84 [16]
    86 [17]
    185 [18]
    308 [19]
    Units: participant(s)
    number (not applicable)
        number of subjects with ETS =yes
    95
    70
    73
    150
    245
        number of subjects with SVR12 among ETS=yes group
    83
    62
    63
    127
    210
    Notes
    [15] - FAS
    [16] - FAS
    [17] - FAS
    [18] - FAS
    [19] - FAS
    No statistical analyses for this end point

    Secondary: The number of participants with Alanine Aminotransferase (ALT) Normalisation at post treatment

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    End point title
    		 The number of participants with Alanine Aminotransferase (ALT) Normalisation at post treatment [20]
    End point description
    The number of participants with Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Post Treatment (SVR12 Visit) based on SVR12=yes or SVR12=no. BL=baseline.
    End point type
    Secondary
    End point timeframe
    60 weeks
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those arms for which the statistics are presented in the clinical trial report thus, those that would yield meaningful results were reported.
    End point values
    		 Faldaprevir 120 mg-24 Wk Faldaprevir 240 mg-12Wk Faldaprevir 240 mg-24Wk Faldaprevir 240 mg - Total (T) Faldaprevir - Total
    Number of subjects analysed
    123 [21]
    84 [22]
    86 [23]
    185 [24]
    308 [25]
    Units: participant(s)
        SVR12=yes
    87
    66
    66
    134
    221
        SVR12=yes, BL normal to SVR12 normal
    28
    17
    26
    45
    73
        SVR12=yes, BL elevated to SVR12 normal
    52
    46
    35
    81
    133
        SVR12=yes, no ALT data available at SVR12 visit
    4
    0
    1
    1
    5
        SVR12=no
    36
    18
    20
    51
    87
        SVR12=no, BL normal to SVR12 normal
    8
    1
    3
    6
    14
        SVR12=no, BL elevated to SVR12 normal
    1
    6
    3
    9
    10
        SVR12=no, no ALT data available at SVR12 visit
    16
    4
    6
    20
    36
    Notes
    [21] - FAS
    [22] - FAS
    [23] - FAS
    [24] - FAS
    [25] - FAS
    No statistical analyses for this end point

    Secondary: The number of participants with Alanine Aminotransferase (ALT) Normalisation at end of treatment

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    End point title
    		 The number of participants with Alanine Aminotransferase (ALT) Normalisation at end of treatment [26]
    End point description
    Alanine Aminotransferase (ALT) normalisation at End of Treatment (EoT) based on SVR12=yes or SVR12=no. BL = baseline.
    End point type
    Secondary
    End point timeframe
    48 weeks
    Notes
    [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those arms for which the statistics are presented in the clinical trial report thus, those that would yield meaningful results were reported.
    End point values
    		 Faldaprevir 120 mg-24 Wk Faldaprevir 240 mg-12Wk Faldaprevir 240 mg-24Wk Faldaprevir 240 mg - Total (T) Faldaprevir - Total
    Number of subjects analysed
    123 [27]
    84 [28]
    86 [29]
    185 [30]
    308 [31]
    Units: participant(s)
        SVR12=yes
    87
    66
    66
    134
    221
        SVR12=yes, BL normal to EoT normal
    29
    16
    26
    43
    72
        SVR12=yes, BL elevated to EoT normal
    45
    34
    32
    66
    111
        SVR12=yes, no BL or EoT data
    0
    0
    0
    1
    1
        SVR12=no
    36
    18
    20
    51
    87
        SVR12=no, BL normal to EoT normal
    18
    5
    5
    18
    36
        SVR12=no, BL elevated to EoT normal
    12
    8
    9
    21
    33
        SVR12=no, no BL or EoT data
    2
    0
    0
    0
    2
    Notes
    [27] - FAS
    [28] - FAS
    [29] - FAS
    [30] - FAS
    [31] - FAS
    No statistical analyses for this end point

    Secondary: The number of participants with Aspartate Aminotransferase (AST) Normalisation at end of treatment

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    End point title
    		 The number of participants with Aspartate Aminotransferase (AST) Normalisation at end of treatment [32]
    End point description
    Aspartate Aminotransferase (AST) normalisation at End of Treatment (EoT) based on SVR12=yes or SVR12 =no. BL = baseline.
    End point type
    Secondary
    End point timeframe
    48 weeks
    Notes
    [32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those arms for which the statistics are presented in the clinical trial report thus, those that would yield meaningful results were reported.
    End point values
    		 Faldaprevir 120 mg-24 Wk Faldaprevir 240 mg-12Wk Faldaprevir 240 mg-24Wk Faldaprevir 240 mg - Total (T) Faldaprevir - Total
    Number of subjects analysed
    123 [33]
    84 [34]
    86 [35]
    185 [36]
    308 [37]
    Units: participant(s)
        SVR12=yes
    87
    66
    66
    134
    221
        SVR12=yes, BL normal to EoT normal
    41
    25
    28
    54
    95
        SVR12=yes, BL elevated to EoT normal
    32
    25
    27
    52
    84
        SVR12=yes, no BL or EoT data
    0
    0
    0
    1
    1
        SVR12=no
    36
    18
    20
    51
    87
        SVR12=no, BL normal to EoT normal
    14
    6
    7
    19
    33
        SVR12=no, BL elevated to EoT normal
    12
    6
    8
    19
    31
        SVR12=no, no BL or EoT data
    2
    0
    0
    0
    2
    Notes
    [33] - FAS
    [34] - FAS
    [35] - FAS
    [36] - FAS
    [37] - FAS
    No statistical analyses for this end point

    Secondary: The number of participants with Aspartate Aminotransferase (AST) Normalisation at post treatment

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    End point title
    		 The number of participants with Aspartate Aminotransferase (AST) Normalisation at post treatment [38]
    End point description
    AST in normal range at Post Treatment (SVR12 Visit) based on SVR12=yes or SVR12=no. BL = baseline.
    End point type
    Secondary
    End point timeframe
    60 weeks
    Notes
    [38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those arms for which the statistics are presented in the clinical trial report thus, those that would yield meaningful results were reported.
    End point values
    		 Faldaprevir 120 mg-24 Wk Faldaprevir 240 mg-12Wk Faldaprevir 240 mg-24Wk Faldaprevir 240 mg - Total (T) Faldaprevir - Total
    Number of subjects analysed
    123 [39]
    84 [40]
    86 [41]
    185 [42]
    308 [43]
    Units: participant(s)
        SVR12=yes
    87
    66
    66
    134
    221
        SVR12=yes, BL normal to SVR12 normal
    41
    27
    28
    57
    98
        SVR12=yes, BL elevated to SVR12 normal
    36
    36
    33
    69
    105
        SVR12=yes, no AST data available at SVR12 visit
    4
    0
    1
    1
    5
        SVR12=no
    36
    18
    20
    51
    87
        SVR12=no, BL normal to SVR12 normal
    6
    4
    6
    13
    19
        SVR12=no, BL elevated to SVR12 normal
    2
    3
    0
    3
    5
        SVR12=no, no AST data available at SVR12 visit
    16
    4
    6
    20
    36
    Notes
    [39] - FAS
    [40] - FAS
    [41] - FAS
    [42] - FAS
    [43] - FAS
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from the start date of trial medication up to 52 weeks ( AEs occurred from the start date of trial medication up to four weeks after all treatment discontinuation).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Faldaprevir 120 mg -24 Wk
    Reporting group description
    		 Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.

    Reporting group title
    Faldaprevir 240 mg-12Wk
    Reporting group description
    		 Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.

    Reporting group title
    Faldaprevir 240 mg-24Wk
    Reporting group description
    		 Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.

    Reporting group title
    Faldaprevir 240 mg - T
    Reporting group description
    		 Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.

    Serious adverse events
    		 Faldaprevir 120 mg -24 Wk Faldaprevir 240 mg-12Wk Faldaprevir 240 mg-24Wk Faldaprevir 240 mg - T
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 123 (13.82%)
    5 / 84 (5.95%)
    5 / 86 (5.81%)
    15 / 185 (8.11%)
         number of deaths (all causes)
    0
    1
    1
    3
         number of deaths resulting from adverse events
    0
    0
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lymphoma
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    3 / 123 (2.44%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Sarcoidosis
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Substance use
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 84 (0.00%)
    1 / 86 (1.16%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 84 (1.19%)
    0 / 86 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 84 (0.00%)
    1 / 86 (1.16%)
    2 / 185 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 84 (0.00%)
    1 / 86 (1.16%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 123 (0.81%)
    1 / 84 (1.19%)
    1 / 86 (1.16%)
    2 / 185 (1.08%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterovesical fistula
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 84 (1.19%)
    0 / 86 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 84 (1.19%)
    0 / 86 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Drug reaction with eosinophilia and systemic symptoms
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    Rash
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash erythematous
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash maculo-papular
         subjects affected / exposed
    2 / 123 (1.63%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxic skin eruption
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 84 (1.19%)
    0 / 86 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 84 (1.19%)
    0 / 86 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 84 (1.19%)
    0 / 86 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected cyst
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leishmaniasis
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 84 (0.00%)
    1 / 86 (1.16%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neurosyphilis
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 84 (0.00%)
    0 / 86 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 84 (0.00%)
    1 / 86 (1.16%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Faldaprevir 120 mg -24 Wk Faldaprevir 240 mg-12Wk Faldaprevir 240 mg-24Wk Faldaprevir 240 mg - T
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    116 / 123 (94.31%)
    80 / 84 (95.24%)
    84 / 86 (97.67%)
    178 / 185 (96.22%)
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    31 / 123 (25.20%)
    21 / 84 (25.00%)
    17 / 86 (19.77%)
    39 / 185 (21.08%)
         occurrences all number
    34
    23
    17
    41
    Chills
         subjects affected / exposed
    5 / 123 (4.07%)
    2 / 84 (2.38%)
    7 / 86 (8.14%)
    11 / 185 (5.95%)
         occurrences all number
    6
    2
    8
    12
    Fatigue
         subjects affected / exposed
    39 / 123 (31.71%)
    29 / 84 (34.52%)
    30 / 86 (34.88%)
    65 / 185 (35.14%)
         occurrences all number
    40
    31
    32
    69
    Influenza like illness
         subjects affected / exposed
    14 / 123 (11.38%)
    17 / 84 (20.24%)
    12 / 86 (13.95%)
    31 / 185 (16.76%)
         occurrences all number
    14
    18
    14
    34
    Injection site reaction
         subjects affected / exposed
    3 / 123 (2.44%)
    2 / 84 (2.38%)
    6 / 86 (6.98%)
    8 / 185 (4.32%)
         occurrences all number
    3
    2
    6
    8
    Pyrexia
         subjects affected / exposed
    29 / 123 (23.58%)
    11 / 84 (13.10%)
    10 / 86 (11.63%)
    24 / 185 (12.97%)
         occurrences all number
    37
    12
    12
    27
    Irritability
         subjects affected / exposed
    19 / 123 (15.45%)
    8 / 84 (9.52%)
    5 / 86 (5.81%)
    13 / 185 (7.03%)
         occurrences all number
    19
    8
    5
    13
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    13 / 123 (10.57%)
    8 / 84 (9.52%)
    10 / 86 (11.63%)
    18 / 185 (9.73%)
         occurrences all number
    13
    8
    11
    19
    Dyspnoea
         subjects affected / exposed
    12 / 123 (9.76%)
    8 / 84 (9.52%)
    3 / 86 (3.49%)
    12 / 185 (6.49%)
         occurrences all number
    12
    8
    3
    12
    Oropharyngeal pain
         subjects affected / exposed
    3 / 123 (2.44%)
    6 / 84 (7.14%)
    2 / 86 (2.33%)
    9 / 185 (4.86%)
         occurrences all number
    3
    7
    2
    10
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    9 / 123 (7.32%)
    5 / 84 (5.95%)
    2 / 86 (2.33%)
    8 / 185 (4.32%)
         occurrences all number
    9
    5
    2
    8
    Depressed mood
         subjects affected / exposed
    6 / 123 (4.88%)
    4 / 84 (4.76%)
    7 / 86 (8.14%)
    12 / 185 (6.49%)
         occurrences all number
    6
    4
    7
    12
    Depression
         subjects affected / exposed
    11 / 123 (8.94%)
    9 / 84 (10.71%)
    13 / 86 (15.12%)
    24 / 185 (12.97%)
         occurrences all number
    11
    10
    13
    25
    Insomnia
         subjects affected / exposed
    29 / 123 (23.58%)
    11 / 84 (13.10%)
    14 / 86 (16.28%)
    28 / 185 (15.14%)
         occurrences all number
    29
    11
    14
    28
    Sleep disorder
         subjects affected / exposed
    4 / 123 (3.25%)
    3 / 84 (3.57%)
    5 / 86 (5.81%)
    8 / 185 (4.32%)
         occurrences all number
    4
    3
    5
    8
    Investigations
    Weight decreased
         subjects affected / exposed
    16 / 123 (13.01%)
    10 / 84 (11.90%)
    13 / 86 (15.12%)
    25 / 185 (13.51%)
         occurrences all number
    16
    10
    13
    25
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    9 / 123 (7.32%)
    10 / 84 (11.90%)
    6 / 86 (6.98%)
    20 / 185 (10.81%)
         occurrences all number
    9
    10
    6
    21
    Headache
         subjects affected / exposed
    29 / 123 (23.58%)
    21 / 84 (25.00%)
    22 / 86 (25.58%)
    47 / 185 (25.41%)
         occurrences all number
    31
    22
    24
    50
    Lethargy
         subjects affected / exposed
    1 / 123 (0.81%)
    3 / 84 (3.57%)
    5 / 86 (5.81%)
    8 / 185 (4.32%)
         occurrences all number
    1
    3
    5
    8
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    27 / 123 (21.95%)
    13 / 84 (15.48%)
    15 / 86 (17.44%)
    30 / 185 (16.22%)
         occurrences all number
    27
    14
    15
    31
    Neutropenia
         subjects affected / exposed
    27 / 123 (21.95%)
    6 / 84 (7.14%)
    15 / 86 (17.44%)
    22 / 185 (11.89%)
         occurrences all number
    32
    6
    16
    23
    Eye disorders
    Dry eye
         subjects affected / exposed
    3 / 123 (2.44%)
    5 / 84 (5.95%)
    0 / 86 (0.00%)
    6 / 185 (3.24%)
         occurrences all number
    3
    5
    0
    6
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    7 / 123 (5.69%)
    11 / 84 (13.10%)
    4 / 86 (4.65%)
    17 / 185 (9.19%)
         occurrences all number
    7
    11
    4
    17
    Abdominal pain upper
         subjects affected / exposed
    7 / 123 (5.69%)
    7 / 84 (8.33%)
    3 / 86 (3.49%)
    10 / 185 (5.41%)
         occurrences all number
    7
    8
    3
    11
    Cheilitis
         subjects affected / exposed
    8 / 123 (6.50%)
    4 / 84 (4.76%)
    3 / 86 (3.49%)
    7 / 185 (3.78%)
         occurrences all number
    8
    4
    4
    8
    Diarrhoea
         subjects affected / exposed
    32 / 123 (26.02%)
    24 / 84 (28.57%)
    23 / 86 (26.74%)
    51 / 185 (27.57%)
         occurrences all number
    34
    31
    27
    62
    Dry mouth
         subjects affected / exposed
    6 / 123 (4.88%)
    5 / 84 (5.95%)
    2 / 86 (2.33%)
    7 / 185 (3.78%)
         occurrences all number
    6
    5
    2
    7
    Dyspepsia
         subjects affected / exposed
    6 / 123 (4.88%)
    4 / 84 (4.76%)
    7 / 86 (8.14%)
    11 / 185 (5.95%)
         occurrences all number
    7
    4
    8
    12
    Nausea
         subjects affected / exposed
    34 / 123 (27.64%)
    38 / 84 (45.24%)
    36 / 86 (41.86%)
    81 / 185 (43.78%)
         occurrences all number
    36
    44
    39
    91
    Vomiting
         subjects affected / exposed
    12 / 123 (9.76%)
    14 / 84 (16.67%)
    23 / 86 (26.74%)
    43 / 185 (23.24%)
         occurrences all number
    16
    19
    28
    54
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    7 / 123 (5.69%)
    8 / 84 (9.52%)
    10 / 86 (11.63%)
    19 / 185 (10.27%)
         occurrences all number
    8
    8
    10
    19
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    7 / 123 (5.69%)
    4 / 84 (4.76%)
    6 / 86 (6.98%)
    10 / 185 (5.41%)
         occurrences all number
    7
    4
    6
    10
    Dry skin
         subjects affected / exposed
    17 / 123 (13.82%)
    9 / 84 (10.71%)
    18 / 86 (20.93%)
    27 / 185 (14.59%)
         occurrences all number
    17
    9
    19
    28
    Erythema
         subjects affected / exposed
    8 / 123 (6.50%)
    5 / 84 (5.95%)
    5 / 86 (5.81%)
    10 / 185 (5.41%)
         occurrences all number
    9
    5
    6
    11
    Night sweats
         subjects affected / exposed
    7 / 123 (5.69%)
    6 / 84 (7.14%)
    3 / 86 (3.49%)
    9 / 185 (4.86%)
         occurrences all number
    7
    6
    3
    9
    Pruritus
         subjects affected / exposed
    19 / 123 (15.45%)
    16 / 84 (19.05%)
    17 / 86 (19.77%)
    34 / 185 (18.38%)
         occurrences all number
    21
    16
    17
    34
    Rash
         subjects affected / exposed
    22 / 123 (17.89%)
    16 / 84 (19.05%)
    13 / 86 (15.12%)
    31 / 185 (16.76%)
         occurrences all number
    24
    17
    14
    33
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    11 / 123 (8.94%)
    6 / 84 (7.14%)
    6 / 86 (6.98%)
    13 / 185 (7.03%)
         occurrences all number
    13
    6
    6
    13
    Muscle spasms
         subjects affected / exposed
    3 / 123 (2.44%)
    3 / 84 (3.57%)
    6 / 86 (6.98%)
    9 / 185 (4.86%)
         occurrences all number
    3
    3
    6
    9
    Myalgia
         subjects affected / exposed
    17 / 123 (13.82%)
    9 / 84 (10.71%)
    15 / 86 (17.44%)
    27 / 185 (14.59%)
         occurrences all number
    20
    12
    16
    31
    Infections and infestations
    Oral herpes
         subjects affected / exposed
    8 / 123 (6.50%)
    0 / 84 (0.00%)
    2 / 86 (2.33%)
    2 / 185 (1.08%)
         occurrences all number
    9
    0
    2
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    29 / 123 (23.58%)
    14 / 84 (16.67%)
    18 / 86 (20.93%)
    36 / 185 (19.46%)
         occurrences all number
    29
    14
    19
    37

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Oct 2011
    main amendments: 1. Description and rationale of the new trial design (inclusion of the FDV 120 mg group). 2. Explanation of loading dose. 3. Added information about the results of drug interaction trials with ARVs.
    11 Oct 2011
    Main amendments: 1. Clarification of ATZ/RTV intensive PK sampling: medication administration; parameters to be determined; sampling timepoints; assay for ARV concentration determination; and sample handling.
    01 May 2012
    Main amendments: 1. Clarification and guidance on when and how to conduct the progression of liver disease assessment. 2. Change of the primary efficacy endpoint from SVR24 to SVR12 based on regulatory presentations and retrospective analysis of phase II data indicating a 98% positive predictive value (PPV) of SVR12 predicting SVR24. 3. Clarification of inclusion criteria: definition of stable HAART. 4. Clarification of exclusion criteria: allowed enrolment of patients with Child-Turcotte-Pugh classification (CTP) score above threshold due to comedication effect, but not liver decompensation, consistent with update of RBV label; which patients with chronic obstructive pulmonary disease (COPD) should be excluded; limited exception for the white blood cell (WBC) and absolute neutrophil count (ANC) thresholds. 5. Clarification of the stopping rule implementation. 6. Clarification of the criteria for virologic failure. 7. Clarification in wording for AEs and SAEs to comply with BI SOP. 8. Clarification of use of the eCRF skin form page to capture rashes and photosensitivity reactions (protocol-defined AEs of special interest). 9. Clarification of procedures to be done when a patient prematurely discontinued. 10. Clarification of analyses for the SVR12 timepoint; primary and secondary analyses; and safety analyses for HIV disease characteristics.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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