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    Clinical Trial Results:
    An International, Multicenter, Open-Label Study Evaluating Sustained Virological Response and Safety With Boceprevir in Triple Combination Therapy With Peginterferon Alfa-2a (40KD) and Ribavirin in Treatment-Naive Patients With Genotype 1 Chronic Hepatitis C

    Summary
    EudraCT number
    		 2011-004810-41
    Trial protocol
    		 AT   HU   ES   PL   DE  
    Global end of trial date
    20 Jun 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 May 2016
    First version publication date
    07 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MV28073
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01591460
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    Roche Trial Information Hotline , F. Hoffmann-La Roche AG, 41 61 6878333, global.trial_information@roche.com
    Scientific contact
    Roche Trial Information Hotline , F. Hoffmann-La Roche AG, 41 61 6878333, global.trial_information@roche.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
    26 Aug 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This prospective, international, multicenter, open-label, uncontrolled Phase 3b/4 study in treatment-naive participants with chronic hepatitis C (CHC) genotype 1 was designed to evaluate the efficacy and safety of triple combination therapy with peginterferon alfa-2a (PEG-IFN), ribavirin (RBV), and boceprevir when given as a response-guided treatment regimen for 28 to 48 weeks.
    Protection of trial subjects
    The study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice (GCP) according to the regulations and procedures described in the protocol. Investigators were trained according to applicable Sponsor Standard Operating Procedures (SOPs).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Jun 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Romania: 39
    Country: Number of subjects enrolled
    Poland: 45
    Country: Number of subjects enrolled
    Spain: 21
    Country: Number of subjects enrolled
    Austria: 21
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Hungary: 31
    Worldwide total number of subjects
    165
    EEA total number of subjects
    165
    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)
    153
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study consisted of a Screening phase which began within up to 4 weeks (in exceptional cases up to 8 weeks) prior to the first dose of study medication. Inclusion/exclusion criteria were checked.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Total Population
    Arm description
    		 Treatment-naive participants with CHC received treatment with PEG-IFN 180 micrograms (mcg) subcutaneous (SC) once weekly, weight-based RBV 1000 to 1200 milligrams (mg) orally (PO) daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a less than (<) 1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Peginterferon alfa-2a
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received PEG-IFN 180 mcg SC once weekly for up to 48 weeks.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses for up to 48 weeks.

    Investigational medicinal product name
    Boceprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received boceprevir 800 mg PO every 7 to 9 hours for up to 44 weeks.

    Number of subjects in period 1
    		Total Population
    Started
    165
    Completed
    139
    Not completed
    26
         Consent withdrawn by subject
    1
         Protocol violation
    1
         Rebound or breakthrough
    3
         Futility rule (Week 24)
    3
         Participant refusal
    3
         Lost to follow-up
    1
         Treatment discontinued by error
    1
         Futility rule (Week 12)
    7
         Adverse event or intercurrent illness
    5
         Noncompliance
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Total Population
    Reporting group description
    		 Treatment-naive participants with CHC received treatment with PEG-IFN 180 micrograms (mcg) subcutaneous (SC) once weekly, weight-based RBV 1000 to 1200 milligrams (mg) orally (PO) daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a less than (<) 1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.

    Reporting group values
    		 Total Population Total
    Number of subjects
    		 165 165
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.8 ( 12.53 ) -
    Gender categorical
    Units: Subjects
        Female
    		 83 83
        Male
    		 82 82

    End points

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    End points reporting groups
    Reporting group title
    Total Population
    Reporting group description
    		 Treatment-naive participants with CHC received treatment with PEG-IFN 180 micrograms (mcg) subcutaneous (SC) once weekly, weight-based RBV 1000 to 1200 milligrams (mg) orally (PO) daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a less than (<) 1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.

    Subject analysis set title
    Cirrhotics
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.

    Subject analysis set title
    Poor Responders
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.

    Subject analysis set title
    Late Responders
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.

    Subject analysis set title
    Early Responders
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.

    Subject analysis set title
    Others
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.

    Primary: Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT)

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    End point title
    		 Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT) [1]
    End point description
    SVR at 12 weeks after EOT was defined as an undetectable HCV RNA viral load obtained 12 weeks following completion of treatment. HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower limit of detection (LOD) of 10 to 15 international units per milliliter (IU/mL). The percentage of participants with SVR was calculated as [number of participants with undetectable HCV RNA at 12 weeks after EOT divided by the number of participants analyzed] multiplied by 100. All-Treated Population: All enrolled participants who received at least one dose of study medication. Arms were not mutually exclusive.
    End point type
    Primary
    End point timeframe
    At 12 weeks after EOT (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: The study was of an explorative nature; therefore only descriptive and exploratory statistical methods were applied, and no statistical hypothesis testing was carried out.
    End point values
    		 Total Population Cirrhotics Poor Responders Late Responders Early Responders Others
    Number of subjects analysed
    165
    20
    24
    24
    78
    19
    Units: percentage of participants
        number (confidence interval 95%)
    81 (74 to 86)
    70 (46 to 88)
    75 (53 to 90)
    88 (68 to 97)
    95 (87 to 99)
    32 (13 to 57)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With SVR at 24 Weeks After EOT

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    End point title
    		 Percentage of Participants With SVR at 24 Weeks After EOT
    End point description
    SVR at 24 weeks after EOT was defined as an undetectable HCV RNA viral load obtained 24 weeks following completion of treatment. HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower LOD of 10 to 15 IU/mL. The percentage of participants with SVR was calculated as [number of participants with undetectable HCV RNA at 24 weeks after EOT divided by the number of participants analyzed] multiplied by 100. All-Treated Population. Arms were not mutually exclusive.
    End point type
    Secondary
    End point timeframe
    At 24 weeks after EOT (up to 72 weeks)
    End point values
    		 Total Population Cirrhotics Poor Responders Late Responders Early Responders Others
    Number of subjects analysed
    165
    20
    24
    24
    78
    19
    Units: percentage of participants
        number (confidence interval 95%)
    80 (73 to 86)
    70 (46 to 88)
    71 (49 to 87)
    88 (68 to 97)
    95 (87 to 99)
    32 (13 to 57)
    No statistical analyses for this end point

    Secondary: HCV RNA Levels

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    End point title
    		 HCV RNA Levels
    End point description
    HCV RNA levels were obtained routinely during and after treatment. Mean HCV RNA levels were calculated by averaging the HCV RNA levels among all participants analyzed at each collection timepoint and expressed in log10 IU/mL. All-Treated Population. Arms were not mutually exclusive.
    End point type
    Secondary
    End point timeframe
    At Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; EOT; and 12 and 24 weeks after EOT (up to 72 weeks)
    End point values
    		 Total Population Cirrhotics Poor Responders Late Responders Early Responders Others
    Number of subjects analysed
    165 [2]
    20 [3]
    24 [4]
    24 [5]
    78 [6]
    19 [7]
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Baseline (n=165,20,24,24,78,19)
    6.29 ( 0.722 )
    6.34 ( 0.71 )
    6.4 ( 0.592 )
    6.46 ( 0.53 )
    6.18 ( 0.796 )
    6.34 ( 0.762 )
        Week 2 (n=159,18,24,23,76,18)
    4.86 ( 1.418 )
    5.06 ( 1.288 )
    6.07 ( 0.61 )
    5.38 ( 0.767 )
    4.27 ( 1.441 )
    4.9 ( 1.597 )
        Week 4 (n=158,20,24,22,75,17)
    4.06 ( 1.525 )
    4.3 ( 1.533 )
    5.78 ( 0.55 )
    4.6 ( 0.874 )
    3.25 ( 1.289 )
    4.24 ( 1.689 )
        Week 6 (n=151,18,24,21,73,15)
    1.75 ( 0.882 )
    2.01 ( 1.002 )
    2.7 ( 0.972 )
    1.91 ( 0.57 )
    1.25 ( 0.154 )
    2.18 ( 1.337 )
        Week 8 (n=160,20,24,24,77,15)
    1.47 ( 0.638 )
    1.69 ( 0.65 )
    1.95 ( 0.874 )
    1.52 ( 0.329 )
    1.18 ( 0 )
    1.84 ( 1.236 )
        Week 12 (n=160,20,24,24,77,15)
    1.35 ( 0.682 )
    1.41 ( 0.393 )
    1.69 ( 1.316 )
    1.25 ( 0.107 )
    1.18 ( 0 )
    1.74 ( 1.292 )
        Week 16 (n=156,19,22,24,78,13)
    1.25 ( 0.405 )
    1.34 ( 0.459 )
    1.46 ( 0.906 )
    1.19 ( 0.045 )
    1.18 ( 0 )
    1.32 ( 0.458 )
        Week 24 (n=152,17,23,24,78,10)
    1.41 ( 1.042 )
    1.8 ( 1.753 )
    1.83 ( 1.696 )
    1.18 ( 0 )
    1.18 ( 0 )
    2.21 ( 1.916 )
        Week 28 (n=143,15,19,23,76,10)
    1.23 ( 0.48 )
    1.18 ( 0 )
    1.45 ( 1.173 )
    1.18 ( 0 )
    1.18 ( 0.025 )
    1.48 ( 0.822 )
        Week 36 (n=71,16,21,24,3,7)
    1.69 ( 1.563 )
    1.54 ( 1.412 )
    2 ( 2.069 )
    1.33 ( 0.745 )
    2.6 ( 2.466 )
    1.91 ( 1.93 )
        EOT (n=162,20,24,23,78,17)
    1.52 ( 1.12 )
    1.58 ( 1.167 )
    1.87 ( 1.563 )
    1.38 ( 0.996 )
    1.18 ( 0.025 )
    2.73 ( 1.943 )
        12 weeks after EOT (n=152,19,24,23,74,12)
    1.92 ( 1.792 )
    2.53 ( 2.34 )
    2.48 ( 2.345 )
    1.48 ( 1.087 )
    1.4 ( 0.946 )
    3.83 ( 2.789 )
        24 weeks after EOT (n=159,20,23,24,78,14)
    2 ( 1.874 )
    2.66 ( 2.351 )
    2.39 ( 2.327 )
    1.77 ( 1.605 )
    1.42 ( 1.053 )
    4.05 ( 2.592 )
    Notes
    [2] - number (n) equals (=) number of participants who provided evaluable data at the respective visit.
    [3] - n = number of participants who provided evaluable data at the respective visit.
    [4] - n = number of participants who provided evaluable data at the respective visit.
    [5] - n = number of participants who provided evaluable data at the respective visit.
    [6] - n = number of participants who provided evaluable data at the respective visit.
    [7] - n = number of participants who provided evaluable data at the respective visit.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Virological Response

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    End point title
    		 Percentage of Participants With Virological Response
    End point description
    HCV RNA levels were obtained routinely during and after treatment. The percentage of participants with undetectable HCV RNA viral load (ie, virological response) was calculated as [number of participants with undetectable HCV RNA at each timepoint divided by the number of participants analyzed] multiplied by 100. All-Treated Population. Arms were not mutually exclusive.
    End point type
    Secondary
    End point timeframe
    At Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT (up to 48 weeks)
    End point values
    		 Total Population Cirrhotics Poor Responders Late Responders Early Responders Others
    Number of subjects analysed
    165
    20
    24
    24
    78
    19
    Units: percentage of participants
    number (confidence interval 95%)
        Week 2
    4 (1 to 8)
    0 (0 to 17)
    0 (0 to 14)
    0 (0 to 14)
    6 (2 to 14)
    5 (0 to 26)
        Week 4
    7 (4 to 12)
    0 (0 to 17)
    0 (0 to 14)
    0 (0 to 14)
    14 (7 to 24)
    5 (0 to 26)
        Week 6
    41 (34 to 49)
    35 (15 to 59)
    0 (0 to 14)
    4 (0 to 21)
    71 (59 to 80)
    26 (9 to 51)
        Week 8
    61 (53 to 68)
    45 (23 to 68)
    13 (3 to 32)
    0 (0 to 14)
    100 (95 to 100)
    53 (29 to 76)
        Week 12
    82 (75 to 87)
    65 (41 to 85)
    75 (53 to 90)
    67 (45 to 84)
    100 (95 to 100)
    53 (29 to 76)
        Week 16
    87 (81 to 91)
    70 (46 to 88)
    71 (49 to 87)
    96 (79 to 100)
    100 (95 to 100)
    58 (33 to 80)
        Week 24
    88 (82 to 92)
    80 (56 to 94)
    79 (58 to 93)
    100 (86 to 100)
    100 (95 to 100)
    42 (20 to 67)
        Week 28
    87 (81 to 91)
    80 (56 to 94)
    79 (58 to 93)
    96 (79 to 100)
    99 (93 to 100)
    42 (20 to 67)
        Week 36
    83 (76 to 88)
    75 (51 to 91)
    75 (53 to 90)
    96 (79 to 100)
    95 (87 to 99)
    37 (16 to 62)
        EOT
    87 (81 to 92)
    80 (56 to 94)
    79 (58 to 93)
    96 (79 to 100)
    99 (93 to 100)
    47 (24 to 71)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA

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    End point title
    		 Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA
    End point description
    HCV RNA levels were obtained routinely during and after treatment. Reductions in HCV RNA viral load by 1-log, 2-log, or 3-log increments were determined relative to Baseline HCV RNA. Each increment represents a reduction greater than or equal to (≥) the specified log value, including results for which HCV RNA was below the limit of quantification (25 IU/mL). The percentage of participants with each log reduction in HCV RNA was calculated as [number of participants with log reduction divided by the number of participants analyzed] multiplied by 100. All-Treated Population. Arms were not mutually exclusive.
    End point type
    Secondary
    End point timeframe
    At Weeks 2, 4, 6, 8, 12, 16, 24, and 28
    End point values
    		 Total Population Cirrhotics Poor Responders Late Responders Early Responders Others
    Number of subjects analysed
    165
    20
    24
    24
    78
    19
    Units: percentage of participants
    number (confidence interval 95%)
        3-log, Week 2
    12 (7 to 17)
    5 (0 to 25)
    0 (0 to 14)
    0 (0 to 14)
    19 (11 to 30)
    16 (3 to 40)
        3-log, Week 4
    29 (22 to 37)
    20 (6 to 44)
    0 (0 to 14)
    8 (1 to 27)
    47 (36 to 59)
    26 (9 to 51)
        3-log, Week 6
    88 (82 to 92)
    85 (62 to 97)
    75 (53 to 90)
    92 (73 to 99)
    97 (91 to 100)
    63 (38 to 84)
        3-log, Week 8
    93 (88 to 97)
    95 (75 to 100)
    83 (63 to 95)
    100 (86 to 100)
    100 (95 to 100)
    68 (43 to 87)
        3-log, Week 12
    95 (91 to 98)
    100 (83 to 100)
    88 (68 to 97)
    100 (86 to 100)
    100 (95 to 100)
    74 (49 to 91)
        3-log, Week 16
    94 (89 to 97)
    95 (75 to 100)
    88 (68 to 97)
    100 (86 to 100)
    100 (95 to 100)
    68 (43 to 87)
        3-log, Week 24
    90 (84 to 94)
    80 (56 to 94)
    83 (63 to 95)
    100 (86 to 100)
    100 (95 to 100)
    53 (29 to 76)
        3-log, Week 28
    88 (83 to 93)
    80 (56 to 94)
    79 (58 to 93)
    96 (79 to 100)
    100 (95 to 100)
    53 (29 to 76)
        2-log, Week 2
    27 (20 to 34)
    20 (6 to 44)
    0 (0 to 14)
    8 (1 to 27)
    42 (31 to 54)
    26 (9 to 51)
        2-log, Week 4
    51 (43 to 59)
    50 (27 to 73)
    0 (0 to 14)
    33 (16 to 55)
    76 (65 to 85)
    37 (16 to 62)
        2-log, Week 6
    95 (90 to 97)
    95 (75 to 100)
    96 (79 to 100)
    96 (79 to 100)
    99 (93 to 100)
    74 (49 to 91)
        2-log, Week 8
    97 (93 to 99)
    100 (83 to 100)
    100 (86 to 100)
    100 (86 to 100)
    100 (95 to 100)
    74 (49 to 91)
        2-log, Week 12
    95 (91 to 98)
    100 (83 to 100)
    88 (68 to 97)
    100 (86 to 100)
    100 (95 to 100)
    74 (49 to 91)
        2-log, Week 16
    94 (89 to 97)
    95 (75 to 100)
    88 (68 to 97)
    100 (86 to 100)
    100 (95 to 100)
    68 (43 to 87)
        2-log, Week 24
    90 (84 to 94)
    80 (56 to 94)
    83 (63 to 95)
    100 (86 to 100)
    100 (95 to 100)
    53 (29 to 76)
        2-log, Week 28
    88 (83 to 93)
    80 (56 to 94)
    79 (58 to 93)
    96 (79 to 100)
    100 (95 to 100)
    53 (29 to 76)
        1-log, Week 2
    55 (47 to 62)
    60 (36 to 81)
    0 (0 to 14)
    54 (33 to 74)
    73 (62 to 82)
    42 (20 to 67)
        1-log, Week 4
    81 (74 to 86)
    75 (51 to 91)
    0 (0 to 14)
    100 (86 to 100)
    100 (95 to 100)
    84 (60 to 97)
        1-log, Week 6
    98 (94 to 99)
    95 (75 to 100)
    100 (86 to 100)
    100 (86 to 100)
    100 (95 to 100)
    84 (60 to 97)
        1-log, Week 8
    98 (95 to 100)
    100 (83 to 100)
    100 (86 to 100)
    100 (86 to 100)
    100 (95 to 100)
    84 (60 to 97)
        1-log, Week 12
    96 (92 to 99)
    100 (83 to 100)
    96 (79 to 100)
    100 (86 to 100)
    100 (95 to 100)
    74 (49 to 91)
        1-log, Week 16
    94 (89 to 97)
    95 (75 to 100)
    88 (68 to 97)
    100 (86 to 100)
    100 (95 to 100)
    68 (43 to 87)
        1-log, Week 24
    91 (85 to 95)
    80 (56 to 94)
    88 (68 to 97)
    100 (86 to 100)
    100 (95 to 100)
    58 (33 to 80)
        1-log, Week 28
    88 (83 to 93)
    80 (56 to 94)
    79 (58 to 93)
    96 (79 to 100)
    100 (95 to 100)
    53 (29 to 76)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Virological Relapse Following EOT Response

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    End point title
    		 Percentage of Participants With Virological Relapse Following EOT Response
    End point description
    Virological relapse was defined as a detectable post-treatment HCV RNA viral load following a previously undetectable EOT level (ie, virological response). The percentage of participants with virological relapse was calculated as [number of participants meeting the above criteria divided by the number of participants analyzed] multiplied by 100. All-Treated Population. Arms were not mutually exclusive.
    End point type
    Secondary
    End point timeframe
    Up to 72 weeks (at 12 and 24 weeks after EOT)
    End point values
    		 Total Population Cirrhotics Poor Responders Late Responders Early Responders Others
    Number of subjects analysed
    143 [8]
    16 [9]
    19 [10]
    23 [11]
    77 [12]
    8 [13]
    Units: percentage of participants
        number (confidence interval 95%)
    7 (3 to 12)
    13 (2 to 38)
    5 (0 to 26)
    9 (1 to 28)
    4 (1 to 11)
    25 (3 to 65)
    Notes
    [8] - Only participants with a previous EOT virological response were included in the analysis.
    [9] - Only participants with a previous EOT virological response were included in the analysis.
    [10] - Only participants with a previous EOT virological response were included in the analysis.
    [11] - Only participants with a previous EOT virological response were included in the analysis.
    [12] - Only participants with a previous EOT virological response were included in the analysis.
    [13] - Only participants with a previous EOT virological response were included in the analysis.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Virological Breakthrough Following On-Treatment Response

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    End point title
    		 Percentage of Participants With Virological Breakthrough Following On-Treatment Response
    End point description
    Virological breakthrough was defined as an HCV RNA viral load greater than (>) 1000 IU/mL following a previously undetectable level at any time during treatment (ie, virological response). Participants who ultimately achieved an EOT response were not considered for virological breakthrough. The percentage of participants with virological breakthrough was calculated as [number of participants meeting the above criteria divided by the number of participants analyzed] multiplied by 100. All-Treated Population. Arms were not mutually exclusive.
    End point type
    Secondary
    End point timeframe
    Up to 48 weeks (at Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT)
    End point values
    		 Total Population Cirrhotics Poor Responders Late Responders Early Responders Others
    Number of subjects analysed
    151 [14]
    17 [15]
    19 [16]
    24 [17]
    78 [18]
    13 [19]
    Units: percentage of participants
        number (confidence interval 95%)
    3 (1 to 7)
    0 (0 to 20)
    0 (0 to 18)
    4 (0 to 21)
    0 (0 to 5)
    23 (5 to 54)
    Notes
    [14] - Only participants with a previous on-treatment virological response were included in the analysis.
    [15] - Only participants with a previous on-treatment virological response were included in the analysis.
    [16] - Only participants with a previous on-treatment virological response were included in the analysis.
    [17] - Only participants with a previous on-treatment virological response were included in the analysis.
    [18] - Only participants with a previous on-treatment virological response were included in the analysis.
    [19] - Only participants with a previous on-treatment virological response were included in the analysis.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Virological Rebound Following On-Treatment Decline in HCV RNA

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    End point title
    		 Percentage of Participants With Virological Rebound Following On-Treatment Decline in HCV RNA
    End point description
    Virological rebound was defined as an HCV RNA viral load >1000 IU/mL and a ≥1-log increase from nadir following a decline in HCV RNA from Baseline at any time during treatment (ie, on-treatment decline). Participants who ultimately achieved an EOT response were not considered for virological rebound. The percentage of participants with virological rebound was calculated as [number of participants meeting the above criteria divided by the number of participants analyzed] multiplied by 100.
    End point type
    Secondary
    End point timeframe
    Up to 48 weeks (at Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT)
    End point values
    		 Total Population Cirrhotics Poor Responders Late Responders Early Responders Others
    Number of subjects analysed
    164 [20]
    20 [21]
    24 [22]
    24 [23]
    78 [24]
    18 [25]
    Units: percentage of participants
        number (confidence interval 95%)
    6 (3 to 11)
    5 (0 to 25)
    17 (5 to 37)
    4 (0 to 21)
    0 (0 to 5)
    22 (6 to 48)
    Notes
    [20] - Only participants with a previous on-treatment decline in HCV RNA were included in the analysis.
    [21] - Only participants with a previous on-treatment decline in HCV RNA were included in the analysis.
    [22] - Only participants with a previous on-treatment decline in HCV RNA were included in the analysis.
    [23] - Only participants with a previous on-treatment decline in HCV RNA were included in the analysis.
    [24] - Only participants with a previous on-treatment decline in HCV RNA were included in the analysis.
    [25] - Only participants with a previous on-treatment decline in HCV RNA were included in the analysis.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA

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    End point title
    		 Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA
    End point description
    Treatment was to be discontinued for participants who met prespecified criteria, termed the futility rule, after 12 or 24 weeks of treatment. Participants were discontinued from treatment for one of the following reasons: HCV RNA viral load ≥100 IU/mL (Week 12) or a detectable HCV RNA viral load (Week 24). HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower LOD of 10 to 15 IU/mL. The percentage of participants with treatment discontinued for each reason was calculated as [number of participants meeting one of the above criteria divided by the number of participants analyzed] multiplied by 100. All-Treated Population. Arms were not mutually exclusive.
    End point type
    Secondary
    End point timeframe
    At 12 and 24 weeks
    End point values
    		 Total Population Cirrhotics Poor Responders Late Responders Early Responders Others
    Number of subjects analysed
    165
    20
    24
    24
    78
    19
    Units: percentage of participants
    number (not applicable)
        Week 12
    4
    10
    13
    0
    0
    11
        Week 24
    3
    5
    8
    0
    0
    11
    No statistical analyses for this end point

    Secondary: Duration of Treatment With PEG-IFN, RBV, and Boceprevir

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    End point title
    		 Duration of Treatment With PEG-IFN, RBV, and Boceprevir
    End point description
    The duration of treatment with each study drug was determined as the time from treatment start until the last dose of PEG-IFN, RBV, or boceprevir. Median duration of treatment was determined using the actual duration of treatment among individual participants and expressed in weeks. Safety Population: All participants who received at least one dose of study medication and had at least one post-baseline safety assessment. Arms were not mutually exclusive.
    End point type
    Secondary
    End point timeframe
    Up to 48 weeks (from Baseline until EOT)
    End point values
    		 Total Population Cirrhotics Poor Responders Late Responders Early Responders Others
    Number of subjects analysed
    165 [26]
    20 [27]
    24 [28]
    24 [29]
    78 [30]
    19 [31]
    Units: weeks
    median (full range (min-max))
        PEG-IFN (n=165,20,24,24,78,19)
    28 (1 to 49)
    48 (14 to 48)
    48 (13 to 49)
    48 (32 to 48)
    28 (24 to 32)
    26 (1 to 48)
        RBV (n=165,20,24,24,78,19)
    28 (1 to 49)
    48 (13 to 48)
    48 (14 to 49)
    48 (30 to 49)
    28 (10 to 33)
    27 (1 to 48)
        Boceprevir (n=164,20,24,24,78,18)
    24 (1 to 45)
    44 (8 to 44)
    44 (10 to 45)
    32 (2 to 33)
    24 (6 to 25)
    10 (1 to 44)
    Notes
    [26] - n = number of participants who received the respective study medication.
    [27] - n = number of participants who received the respective study medication.
    [28] - n = number of participants who received the respective study medication.
    [29] - n = number of participants who received the respective study medication.
    [30] - n = number of participants who received the respective study medication.
    [31] - n = number of participants who received the respective study medication.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason

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    End point title
    		 Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason
    End point description
    Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. Adverse event (AE)-related reasons were documented, as well as reasons related to insufficient efficacy ('Poor efficacy') or other safety-related reasons ('Safety/other'). The percentage of participants with a dose modification documented for each reason was calculated as [number of participants with dose modification divided by the number of participants analyzed] multiplied by 100. Safety Population. Arms were not mutually exclusive.
    End point type
    Secondary
    End point timeframe
    Up to 48 weeks (from Baseline until EOT)
    End point values
    		 Total Population Cirrhotics Poor Responders Late Responders Early Responders Others
    Number of subjects analysed
    165 [32]
    20 [33]
    24 [34]
    24 [35]
    78 [36]
    19 [37]
    Units: percentage of participants
    number (not applicable)
        PEG-IFN, Any reason (n=165,20,24,24,78,19)
    52
    60
    54
    46
    42
    84
        PEG-IFN, Anemia (n=165,20,24,24,78,19)
    1
    0
    0
    0
    1
    5
        PEG-IFN, Asthenia (n=165,20,24,24,78,19)
    1
    0
    4
    4
    0
    0
        PEG-IFN, Nausea/vomiting (n=165,20,24,24,78,19)
    0.6
    0
    0
    0
    1
    0
        PEG-IFN, Neutropenia (n=165,20,24,24,78,19)
    36
    30
    38
    33
    36
    47
        PEG-IFN, Rash (n=165,20,24,24,78,19)
    0.6
    5
    0
    0
    0
    0
        PEG-IFN, Thrombocytopenia (n=165,20,24,24,78,19)
    5
    35
    4
    0
    1
    0
        PEG-IFN, Safety/other (n=165,20,24,24,78,19)
    4
    10
    4
    13
    0
    0
        PEG-IFN, Poor efficacy (n=165,20,24,24,78,19)
    8
    15
    21
    4
    0
    21
        PEG-IFN, Not specified (n=165,20,24,24,78,19)
    12
    0
    8
    13
    8
    42
        RBV, Any reason (n=165,20,24,24,78,19)
    64
    65
    67
    46
    62
    89
        RBV, Anemia (n=165,20,24,24,78,19)
    46
    50
    46
    38
    53
    26
        RBV, Asthenia (n=165,20,24,24,78,19)
    0.6
    0
    0
    0
    1
    0
        RBV, Nausea/vomiting (n=165,20,24,24,78,19)
    1
    0
    0
    0
    0
    11
        RBV, Neutropenia (n=165,20,24,24,78,19)
    3
    0
    0
    4
    0
    21
        RBV, Rash (n=165,20,24,24,78,19)
    1
    5
    0
    0
    0
    5
        RBV, Safety/other (n=165,20,24,24,78,19)
    8
    15
    8
    13
    3
    16
        RBV, Poor efficacy (n=165,20,24,24,78,19)
    8
    15
    21
    4
    0
    21
        RBV, Not specified (n=165,20,24,24,78,19)
    11
    0
    8
    8
    8
    42
        Boceprevir, Any reason (n=164,20,24,24,78,18)
    28
    45
    29
    21
    12
    89
        Boceprevir, Anemia (n=164,20,24,24,78,18)
    2
    10
    0
    4
    0
    0
        Boceprevir, Asthenia (n=164,20,24,24,78,18)
    0.6
    0
    0
    0
    1
    0
        Boceprevir, Nausea/vomiting (n=164,20,24,24,78,18)
    1
    0
    0
    0
    0
    11
        Boceprevir, Neutropenia (n=164,20,24,24,78,18)
    4
    0
    0
    4
    0
    28
        Boceprevir, Rash (n=164,20,24,24,78,18)
    1
    5
    0
    0
    0
    6
        Boceprevir, Safety/other (n=164,20,24,24,78,18)
    4
    10
    0
    4
    0
    17
        Boceprevir, Poor efficacy (n=164,20,24,24,78,18)
    7
    15
    21
    0
    0
    17
        Boceprevir, Not specified (n=164,20,24,24,78,18)
    12
    10
    8
    8
    10
    28
    Notes
    [32] - n = number of participants who received the respective study medication.
    [33] - n = number of participants who received the respective study medication.
    [34] - n = number of participants who received the respective study medication.
    [35] - n = number of participants who received the respective study medication.
    [36] - n = number of participants who received the respective study medication.
    [37] - n = number of participants who received the respective study medication.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir

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    End point title
    		 Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir
    End point description
    The frequency of missed treatments was examined using the number of administrations received as a percentage of target administrations for each study drug. The maximum number of possible administrations was considered in terms of once-weekly injections with PEG-IFN and in terms of treatment days with RBV and boceprevir. The percentage of target administrations each participant received was separated into ranges of <60%, 60 to <80%, 80 to <95%, and ≥95% for each study drug. The percentage of participants who received each range of target administrations was calculated as [number of participants in each range divided by the number of participants analyzed] multiplied by 100. Safety Population. Arms were not mutually exclusive.
    End point type
    Secondary
    End point timeframe
    Up to 48 weeks (from Baseline until EOT)
    End point values
    		 Total Population Cirrhotics Poor Responders Late Responders Early Responders
    Number of subjects analysed
    146 [38]
    20 [39]
    24 [40]
    24 [41]
    78 [42]
    Units: percentage of participants
    number (not applicable)
        PEG-IFN, <60%
    8
    25
    25
    0
    0
        PEG-IFN, 60 to <80%
    0.7
    0
    0
    4
    0
        PEG-IFN, 80 to <95%
    5
    5
    0
    17
    4
        PEG-IFN, 95% or more
    86
    70
    75
    79
    96
        RBV, <60%
    9
    25
    25
    4
    1
        RBV, 60 to <80%
    0.7
    0
    0
    4
    0
        RBV, 80 to <95%
    5
    10
    0
    8
    4
        RBV, 95% or more
    86
    65
    75
    83
    95
        Boceprevir, <60%
    10
    30
    25
    8
    1
        Boceprevir, 60 to <80%
    0.7
    5
    0
    0
    0
        Boceprevir, 80 to <95%
    3
    5
    0
    4
    3
        Boceprevir, 95% or more
    86
    60
    75
    88
    96
    Notes
    [38] - Only participants providing evaluable data were included in the analysis.
    [39] - Only participants providing evaluable data were included in the analysis.
    [40] - Only participants providing evaluable data were included in the analysis.
    [41] - Only participants providing evaluable data were included in the analysis.
    [42] - Only participants providing evaluable data were included in the analysis.
    No statistical analyses for this end point

    Secondary: Number of Participants With a Safety-Related Dose Modification

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    End point title
    		 Number of Participants With a Safety-Related Dose Modification
    End point description
    Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. The percentage of participants with a safety-related dose modification (eg, modification due to adverse event or laboratory abnormality) of any study drug was calculated as [number of participants with dose modification divided by the number of participants analyzed] multiplied by 100. Safety Population.
    End point type
    Secondary
    End point timeframe
    Up to 48 weeks (from Baseline until EOT)
    End point values
    		 Total Population
    Number of subjects analysed
    165
    Units: participants
    113
    No statistical analyses for this end point

    Secondary: Time to Safety-Related Dose Modification

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    End point title
    		 Time to Safety-Related Dose Modification
    End point description
    Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. Median time to safety-related dose modification (eg, modification due to adverse event or laboratory abnormality) of any study drug was estimated using Kaplan-Meier and expressed in weeks. Safety Population.
    End point type
    Secondary
    End point timeframe
    Up to 48 weeks (from Baseline until EOT)
    End point values
    		 Total Population
    Number of subjects analysed
    165
    Units: weeks
        median (confidence interval 95%)
    12.1 (10.3 to 16)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Using Concomitant Hematopoietic Stimulants During Treatment and Follow-Up

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    End point title
    		 Percentage of Participants Using Concomitant Hematopoietic Stimulants During Treatment and Follow-Up
    End point description
    Use of concomitant hematopoietic stimulants (such as epoetin) during the 48-week treatment period and/or within 24 weeks of follow-up was documented. The percentage of participants using concomitant hematopoietic stimulants was calculated as [number of participants reporting concomitant use divided by the number of participants analyzed] multiplied by 100. Safety Population.
    End point type
    Secondary
    End point timeframe
    Up to 72 weeks (from Baseline until 24 weeks after EOT)
    End point values
    		 Total Population
    Number of subjects analysed
    165
    Units: percentage of participants
        number (not applicable)
    6
    No statistical analyses for this end point

    Secondary: Percentage of Participants With a Concomitant Disease Prior to or During the Study

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    End point title
    		 Percentage of Participants With a Concomitant Disease Prior to or During the Study
    End point description
    The prevalence of concomitant disease at any time from Screening through the end of follow-up was documented. The percentage of participants with a concomitant disease was calculated as [number of participants reporting or diagnosed with concomitant disease divided by the number of participants analyzed] multiplied by 100. Diseases documented for ≥5% of participants included hypertension, diabetes mellitus, hypothyroidism, and vitamin D deficiency as reported here. Safety Population.
    End point type
    Secondary
    End point timeframe
    Up to 76 weeks (from Screening until 24 weeks after EOT)
    End point values
    		 Total Population
    Number of subjects analysed
    165
    Units: percentage of participants
    number (not applicable)
        Any disease
    53
        Hypertension
    18
        Diabetes mellitus
    8
        Hypothyroidism
    6
        Vitamin D deficiency
    5
    No statistical analyses for this end point

    Secondary: Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up

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    End point title
    		 Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up
    End point description
    Use of concomitant prescription or nonprescription medications during the 48-week treatment period and/or within 24 weeks of follow-up was documented. The percentage of participants using concomitant medications was calculated as [number of participants reporting concomitant use divided by the number of participants analyzed] multiplied by 100. Medication classes reported by >10% of participants included analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), antihistamines, corticosteroids, proton pump inhibitors, vitamins and minerals, and beta-adrenoceptor blocking agents as reported here. Safety Population.
    End point type
    Secondary
    End point timeframe
    Up to 72 weeks (from Baseline until 24 weeks after EOT)
    End point values
    		 Total Population
    Number of subjects analysed
    165
    Units: percentage of participants
    number (not applicable)
        Any medication
    79
        Analgesics
    29
        NSAIDs
    22
        Antihistamines
    19
        Corticosteroids
    19
        Proton pump inhibitors
    17
        Vitamins and minerals
    12
        Beta-adrenoceptor blocking agents
    11
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 72 weeks (from Baseline until 24 weeks after EOT)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Cirrhotics (Safety)
    Reporting group description
    		 Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. Participants with liver cirrhosis were grouped separately in the safety analysis.

    Reporting group title
    Noncirrhotics (Safety)
    Reporting group description
    		 Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. Participants without liver cirrhosis, including those with transition to cirrhosis, were grouped separately in the safety analysis.

    Serious adverse events
    		 Cirrhotics (Safety) Noncirrhotics (Safety)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 21 (33.33%)
    8 / 144 (5.56%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatic neoplasm
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 144 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 144 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 144 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 144 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 21 (9.52%)
    2 / 144 (1.39%)
         occurrences causally related to treatment / all
    2 / 2
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Granulocytopenia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 144 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 144 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 144 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 144 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 144 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic failure
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 144 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 144 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 144 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Epididymitis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 144 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cirrhotics (Safety) Noncirrhotics (Safety)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 21 (100.00%)
    135 / 144 (93.75%)
    Investigations
    Weight decreased
         subjects affected / exposed
    2 / 21 (9.52%)
    8 / 144 (5.56%)
         occurrences all number
    2
    8
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 21 (9.52%)
    4 / 144 (2.78%)
         occurrences all number
    2
    4
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    6 / 21 (28.57%)
    45 / 144 (31.25%)
         occurrences all number
    6
    46
    Headache
         subjects affected / exposed
    2 / 21 (9.52%)
    32 / 144 (22.22%)
         occurrences all number
    2
    46
    Dizziness
         subjects affected / exposed
    1 / 21 (4.76%)
    13 / 144 (9.03%)
         occurrences all number
    1
    13
    Somnolence
         subjects affected / exposed
    2 / 21 (9.52%)
    4 / 144 (2.78%)
         occurrences all number
    2
    4
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    7 / 21 (33.33%)
    40 / 144 (27.78%)
         occurrences all number
    7
    47
    Influenza like illness
         subjects affected / exposed
    6 / 21 (28.57%)
    34 / 144 (23.61%)
         occurrences all number
    6
    37
    Fatigue
         subjects affected / exposed
    4 / 21 (19.05%)
    31 / 144 (21.53%)
         occurrences all number
    4
    36
    Pyrexia
         subjects affected / exposed
    0 / 21 (0.00%)
    26 / 144 (18.06%)
         occurrences all number
    0
    38
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    5 / 21 (23.81%)
    47 / 144 (32.64%)
         occurrences all number
    5
    65
    Anaemia
         subjects affected / exposed
    7 / 21 (33.33%)
    57 / 144 (39.58%)
         occurrences all number
    7
    59
    Thrombocytopenia
         subjects affected / exposed
    6 / 21 (28.57%)
    13 / 144 (9.03%)
         occurrences all number
    6
    14
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 21 (14.29%)
    23 / 144 (15.97%)
         occurrences all number
    3
    24
    Diarrhoea
         subjects affected / exposed
    4 / 21 (19.05%)
    15 / 144 (10.42%)
         occurrences all number
    4
    16
    Dyspepsia
         subjects affected / exposed
    3 / 21 (14.29%)
    11 / 144 (7.64%)
         occurrences all number
    3
    11
    Vomiting
         subjects affected / exposed
    1 / 21 (4.76%)
    8 / 144 (5.56%)
         occurrences all number
    1
    10
    Abdominal pain
         subjects affected / exposed
    0 / 21 (0.00%)
    9 / 144 (6.25%)
         occurrences all number
    0
    10
    Gastritis
         subjects affected / exposed
    2 / 21 (9.52%)
    2 / 144 (1.39%)
         occurrences all number
    2
    2
    Stomatitis
         subjects affected / exposed
    2 / 21 (9.52%)
    2 / 144 (1.39%)
         occurrences all number
    2
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 21 (14.29%)
    31 / 144 (21.53%)
         occurrences all number
    3
    34
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    4 / 21 (19.05%)
    30 / 144 (20.83%)
         occurrences all number
    4
    31
    Rash
         subjects affected / exposed
    3 / 21 (14.29%)
    19 / 144 (13.19%)
         occurrences all number
    4
    22
    Alopecia
         subjects affected / exposed
    1 / 21 (4.76%)
    19 / 144 (13.19%)
         occurrences all number
    1
    19
    Dry skin
         subjects affected / exposed
    0 / 21 (0.00%)
    8 / 144 (5.56%)
         occurrences all number
    0
    8
    Erythema
         subjects affected / exposed
    2 / 21 (9.52%)
    5 / 144 (3.47%)
         occurrences all number
    2
    5
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    3 / 21 (14.29%)
    17 / 144 (11.81%)
         occurrences all number
    3
    20
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    1 / 21 (4.76%)
    13 / 144 (9.03%)
         occurrences all number
    1
    23
    Arthralgia
         subjects affected / exposed
    1 / 21 (4.76%)
    13 / 144 (9.03%)
         occurrences all number
    1
    14
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 21 (4.76%)
    13 / 144 (9.03%)
         occurrences all number
    1
    14

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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