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    Clinical Trial Results:
    A Randomized, Open-Labeled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 and ABT-333 Co-administered with Ribavirin Compared to Telaprevir Co-administered with Pegylated Interferon α-2a and Ribavirin in Treatment-Experienced Adults with Chronic Hepatitis C Genotype 1 Virus Infection (MALACHITE II)

    Summary
    EudraCT number
    		 2012-003738-18
    Trial protocol
    		 HU   FI   SK   PL  
    Global end of trial date
    20 Jul 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jul 2016
    First version publication date
    29 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M13-862
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01854528
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6 4XE
    Public contact
    Global Medical Information, AbbVie, 001 800-633-9110,
    Scientific contact
    Yan Luo, MD, PhD, AbbVie, yan.luo@abbvie.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
    20 Jul 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jul 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to assess the efficacy (the percentage of subjects achieving 12-week sustained virologic response, SVR12, [HCV RNA < LLOQ 12 weeks post-treatment]) and safety of ABT-450/r/ABT-267 and ABT-333 co-administered with RBV for 12 weeks compared to 12 weeks of treatment with telaprevir and pegIFN/RBV followed by either 12 weeks or 36 weeks of pegIFN/RBV, per local prescribing information, in treatment-experienced HCV genotype 1-infected adults.
    Protection of trial subjects
    Subject read and understood the information provided about the study and gave written permission.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jun 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 34
    Country: Number of subjects enrolled
    Slovakia: 15
    Country: Number of subjects enrolled
    Finland: 1
    Country: Number of subjects enrolled
    Hungary: 17
    Country: Number of subjects enrolled
    Argentina: 1
    Country: Number of subjects enrolled
    Australia: 20
    Country: Number of subjects enrolled
    Chile: 9
    Country: Number of subjects enrolled
    Romania: 57
    Worldwide total number of subjects
    154
    EEA total number of subjects
    124
    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)
    152
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 154 subjects were randomized: 6 subjects did not receive at least 1 dose of study drug and were excluded from the analyses; 148 subjects received at least 1 dose and were included in the intent-to-treat (ITT) population.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 3-DAA/RBV
    Arm description
    		 3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-450/r/ABT-267
    Investigational medicinal product code
    Other name
    ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, Viekirax
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ABT-450 (150 mg) coformulated with ritonavir (100 mg) and ABT-267 (25 mg) administered once daily

    Investigational medicinal product name
    ABT-333
    Investigational medicinal product code
    Other name
    dasabuvir, Exviera
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ABT-333 250 mg administered twice daily

    Investigational medicinal product name
    Ribivarin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    weight-based ribivarin administered twice daily

    Arm title
    		 TPV/RBV
    Arm description
    		 TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Pegylated Interferon a-2a (PegINF)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PegINF 180 mcg administered weekly

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    telepravir 750 mg administered every 8 hours.

    Investigational medicinal product name
    Ribivarin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    weight-based ribivarin administered twice daily

    Number of subjects in period 1 [1]
    		3-DAA/RBV TPV/RBV
    Started
    101
    47
    Completed
    101
    32
    Not completed
    0
    15
         Virologic failure
    -
    9
         Adverse event
    -
    4
         Withdrawal by subject
    -
    2
    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: A total of 154 subjects were randomized: 6 subjects did not receive at least 1 dose of study drug and were excluded from the analyses; 148 subjects received at least 1 dose and were included in the intent-to-treat (ITT) population.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    3-DAA/RBV
    Reporting group description
    		 3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.

    Reporting group title
    TPV/RBV
    Reporting group description
    		 TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.

    Reporting group values
    		 3-DAA/RBV TPV/RBV Total
    Number of subjects
    		 101 47 148
    Age categorical
    Units: Subjects
    Age continuous
    All randomized subjects who received at least 1 dose of study drug (ITT population) were included in baseline analysis population.
    Units: years
        arithmetic mean (standard deviation)
    		 46.9 ± 12.15 45 ± 10.35 -
    Gender categorical
    All randomized subjects who received at least 1 dose of study drug (ITT population) were included in baseline analysis population.
    Units: Subjects
        Female
    		 46 19 65
        Male
    		 55 28 83

    End points

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    End points reporting groups
    Reporting group title
    3-DAA/RBV
    Reporting group description
    		 3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.

    Reporting group title
    TPV/RBV
    Reporting group description
    		 TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.

    Primary: Percentage of Subjects With Sustained Virologic Response 12 Weeks After Treatment

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    End point title
    		 Percentage of Subjects With Sustained Virologic Response 12 Weeks After Treatment
    End point description
    The percentage of subjects with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.
    End point type
    Primary
    End point timeframe
    12 weeks after the last dose of study drug
    End point values
    		 3-DAA/RBV TPV/RBV
    Number of subjects analysed
    101 [1]
    47 [2]
    Units: percentage of subjects
        number (not applicable)
    100
    66
    Notes
    [1] - ITT population: All randomized subjects who received at least 1 dose of study drug.
    [2] - ITT population: All randomized subjects who received at least 1 dose of study drug.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    P-value for the difference in sustained virologic response rates 12 weeks after the last dose between treatment groups with HCV subgenotype (1a, non-1a) from stratum adjusted Mantel-Haenszel with previous type of response to pegIFN/RBV treatment (relapser, partial or null responder) as strata.
    Comparison groups
    3-DAA/RBV v TPV/RBV
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Stratum adjusted Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    34.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21.09
         upper limit
    		 47.42

    Secondary: Mean Change From Baseline to Final Treatment Visit in the Mental Component Summary (MCS) Score of the Short-Form 36 Health Survey - Version 2 (SF-36v2)

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    End point title
    		 Mean Change From Baseline to Final Treatment Visit in the Mental Component Summary (MCS) Score of the Short-Form 36 Health Survey - Version 2 (SF-36v2)
    End point description
    The SF-36v2 is a general health-related quality of life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises a total of 36 items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Domain scores were aggregated into an MCS score (from 0 to 100; a higher score indicates better mental function and well-being).
    End point type
    Secondary
    End point timeframe
    Baseline and Final Treatment Visit (up to Week 12 for 3-DAA/RBV and up to Week 24 or 48 for TPV/RBV)
    End point values
    		 3-DAA/RBV TPV/RBV
    Number of subjects analysed
    101 [3]
    45 [4]
    Units: units on a scale
        arithmetic mean (standard deviation)
    -1.3 ± 8.32
    -9.8 ± 11.05
    Notes
    [3] - All subjects in the ITT population with evaluable data
    [4] - All subjects in the ITT population with evaluable data
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    P-value from ANCOVA model including baseline score and region as covariates and treatment arm as a factor.
    Comparison groups
    3-DAA/RBV v TPV/RBV
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    8.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.43
         upper limit
    		 11.85

    Secondary: Mean Change From Baseline to Final Treatment Visit in the Physical Component Summary (PCS) Score of the Short-Form 36 Health Survey - Version 2 (SF-36v2)

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    End point title
    		 Mean Change From Baseline to Final Treatment Visit in the Physical Component Summary (PCS) Score of the Short-Form 36 Health Survey - Version 2 (SF-36v2)
    End point description
    The SF-36v2 is a general health-related quality of life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises a total of 36 items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Domain scores were aggregated into a PCS score (range = 0 to 100; a higher score indicates better mental function and well-being).
    End point type
    Secondary
    End point timeframe
    Baseline and Final Treatment Visit (up to Week 12 for 3-DAA/RBV and up to Week 24 or 48 for TPV/RBV)
    End point values
    		 3-DAA/RBV TPV/RBV
    Number of subjects analysed
    101 [5]
    45 [6]
    Units: units of a scale
        arithmetic mean (standard deviation)
    0.4 ± 7.16
    -7.7 ± 7.72
    Notes
    [5] - All subjects in the ITT population with evaluable data
    [6] - All subjects in the ITT population with evaluable data
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    P-value from ANCOVA model including baseline score and region as covariates and treatment arm as a factor.
    Comparison groups
    3-DAA/RBV v TPV/RBV
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    7.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.11
         upper limit
    		 9.98

    Secondary: Percentage of Subjects With Sustained Virologic Response 24 Weeks After Treatment

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    End point title
    		 Percentage of Subjects With Sustained Virologic Response 24 Weeks After Treatment
    End point description
    The percentage of subjects with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 24 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.
    End point type
    Secondary
    End point timeframe
    24 weeks after the last dose of study drug
    End point values
    		 3-DAA/RBV TPV/RBV
    Number of subjects analysed
    101 [7]
    47 [8]
    Units: percentage of subjects
        number (not applicable)
    99
    66
    Notes
    [7] - All subjects in the ITT population with evaluable data
    [8] - All subjects in the ITT population with evaluable data
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    P-value from logistic regression model including treatment arm, baseline log10 HCV RNA level, HCV subgenotype, and previous response to pegIFN/RBV treatment as predictors.
    Comparison groups
    3-DAA/RBV v TPV/RBV
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    54.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.9
         upper limit
    		 435.1

    Secondary: Percentage of Subjects With Virologic Failure During Treatment

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    End point title
    		 Percentage of Subjects With Virologic Failure During Treatment
    End point description
    Virologic failure during treatment was defined as HCV ribonucleic acid (RNA) confirmed greater than or equal to the lower limit of quantification (≥ LLOQ) after HCV RNA < LLOQ during treatment or confirmed HCV RNA ≥ LLOQ at the end of treatment.
    End point type
    Secondary
    End point timeframe
    Baseline to end of treatment (12 weeks for 3-DAA/RBV and 24 or 48 weeks for TPV/RBV)
    End point values
    		 3-DAA/RBV TPV/RBV
    Number of subjects analysed
    101 [9]
    47 [10]
    Units: percentage of subjects
        number (confidence interval 95%)
    0 (0 to 3.7)
    19.1 (7.9 to 30.4)
    Notes
    [9] - ITT population
    [10] - ITT population
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Virologic Relapse After Treatment

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    End point title
    		 Percentage of Subjects With Virologic Relapse After Treatment
    End point description
    Subjects who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the posttreatment period.
    End point type
    Secondary
    End point timeframe
    Between end of treatment (Week 12 for 3-DAA/RBV and Week 24 or 48 for TPV/RBV) and Post-treatment (up to Week 12 Post-treatment)
    End point values
    		 3-DAA/RBV TPV/RBV
    Number of subjects analysed
    101 [11]
    47 [12]
    Units: percentage of subjects
        number (confidence interval 95%)
    0 (0 to 3.7)
    6.3 (0 to 14.6)
    Notes
    [11] - ITT population
    [12] - ITT population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were collected from the time of study drug administration to 30 days after last dose of study drug (up to 52 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (total up to 101 weeks).
    Adverse event reporting additional description
    AEs were collected from first dose to 30 days after last dose (16 weeks for 12-week treatment, 28 weeks for 24-week treatment, 52 weeks for 48-week treatment); SAEs were collected from the time that informed consent was obtained to end of study (up to 65 weeks for 12-week treatment, 77 weeks for 24-week treatment, 101 weeks for 48-week treatment).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    3-DAA/RBV
    Reporting group description
    		 3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.

    Reporting group title
    TPV/RBV
    Reporting group description
    		 TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.

    Serious adverse events
    		 3-DAA/RBV TPV/RBV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 101 (0.99%)
    5 / 47 (10.64%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 101 (0.00%)
    2 / 47 (4.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Injection site phlebitis
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 47 (2.13%)
         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
    		 3-DAA/RBV TPV/RBV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    54 / 101 (53.47%)
    43 / 47 (91.49%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    5 / 101 (4.95%)
    7 / 47 (14.89%)
         occurrences all number
    5
    8
    Dysgeusia
         subjects affected / exposed
    1 / 101 (0.99%)
    4 / 47 (8.51%)
         occurrences all number
    1
    4
    Headache
         subjects affected / exposed
    29 / 101 (28.71%)
    21 / 47 (44.68%)
         occurrences all number
    34
    23
    Lethargy
         subjects affected / exposed
    5 / 101 (4.95%)
    3 / 47 (6.38%)
         occurrences all number
    5
    3
    Paraesthesia
         subjects affected / exposed
    0 / 101 (0.00%)
    3 / 47 (6.38%)
         occurrences all number
    0
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 101 (2.97%)
    14 / 47 (29.79%)
         occurrences all number
    5
    20
    Leukopenia
         subjects affected / exposed
    0 / 101 (0.00%)
    5 / 47 (10.64%)
         occurrences all number
    0
    12
    Neutropenia
         subjects affected / exposed
    1 / 101 (0.99%)
    12 / 47 (25.53%)
         occurrences all number
    1
    24
    Thrombocytopenia
         subjects affected / exposed
    0 / 101 (0.00%)
    4 / 47 (8.51%)
         occurrences all number
    0
    4
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    8 / 101 (7.92%)
    16 / 47 (34.04%)
         occurrences all number
    8
    16
    Chest pain
         subjects affected / exposed
    0 / 101 (0.00%)
    3 / 47 (6.38%)
         occurrences all number
    0
    3
    Chills
         subjects affected / exposed
    3 / 101 (2.97%)
    5 / 47 (10.64%)
         occurrences all number
    3
    6
    Fatigue
         subjects affected / exposed
    12 / 101 (11.88%)
    12 / 47 (25.53%)
         occurrences all number
    14
    13
    General physical health deterioration
         subjects affected / exposed
    0 / 101 (0.00%)
    3 / 47 (6.38%)
         occurrences all number
    0
    3
    influenza like illness
         subjects affected / exposed
    0 / 101 (0.00%)
    4 / 47 (8.51%)
         occurrences all number
    0
    5
    Injection site erythema
         subjects affected / exposed
    0 / 101 (0.00%)
    3 / 47 (6.38%)
         occurrences all number
    0
    3
    Pyrexia
         subjects affected / exposed
    2 / 101 (1.98%)
    15 / 47 (31.91%)
         occurrences all number
    2
    19
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 101 (2.97%)
    4 / 47 (8.51%)
         occurrences all number
    3
    4
    Abdominal pain upper
         subjects affected / exposed
    3 / 101 (2.97%)
    4 / 47 (8.51%)
         occurrences all number
    3
    4
    Anal pruritus
         subjects affected / exposed
    0 / 101 (0.00%)
    12 / 47 (25.53%)
         occurrences all number
    0
    12
    Aphthous stomatitis
         subjects affected / exposed
    0 / 101 (0.00%)
    3 / 47 (6.38%)
         occurrences all number
    0
    4
    Haemorrhoids
         subjects affected / exposed
    0 / 101 (0.00%)
    3 / 47 (6.38%)
         occurrences all number
    0
    4
    Nausea
         subjects affected / exposed
    10 / 101 (9.90%)
    20 / 47 (42.55%)
         occurrences all number
    11
    22
    Vomiting
         subjects affected / exposed
    3 / 101 (2.97%)
    7 / 47 (14.89%)
         occurrences all number
    3
    8
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 101 (6.93%)
    12 / 47 (25.53%)
         occurrences all number
    8
    16
    Oropharyngeal pain
         subjects affected / exposed
    1 / 101 (0.99%)
    3 / 47 (6.38%)
         occurrences all number
    1
    3
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 101 (0.00%)
    6 / 47 (12.77%)
         occurrences all number
    0
    6
    Dry skin
         subjects affected / exposed
    0 / 101 (0.00%)
    7 / 47 (14.89%)
         occurrences all number
    0
    7
    Eczema
         subjects affected / exposed
    0 / 101 (0.00%)
    3 / 47 (6.38%)
         occurrences all number
    0
    3
    Pruritus
         subjects affected / exposed
    13 / 101 (12.87%)
    19 / 47 (40.43%)
         occurrences all number
    19
    21
    Pruritus generalised
         subjects affected / exposed
    0 / 101 (0.00%)
    3 / 47 (6.38%)
         occurrences all number
    0
    3
    Rash
         subjects affected / exposed
    3 / 101 (2.97%)
    12 / 47 (25.53%)
         occurrences all number
    4
    15
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    0 / 101 (0.00%)
    3 / 47 (6.38%)
         occurrences all number
    0
    3
    Depression
         subjects affected / exposed
    0 / 101 (0.00%)
    3 / 47 (6.38%)
         occurrences all number
    0
    3
    Insomnia
         subjects affected / exposed
    6 / 101 (5.94%)
    10 / 47 (21.28%)
         occurrences all number
    6
    10
    Irritability
         subjects affected / exposed
    2 / 101 (1.98%)
    5 / 47 (10.64%)
         occurrences all number
    2
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 101 (2.97%)
    8 / 47 (17.02%)
         occurrences all number
    3
    10
    Muscle spasms
         subjects affected / exposed
    2 / 101 (1.98%)
    3 / 47 (6.38%)
         occurrences all number
    2
    3
    Myalgia
         subjects affected / exposed
    3 / 101 (2.97%)
    9 / 47 (19.15%)
         occurrences all number
    3
    14
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    2 / 101 (1.98%)
    3 / 47 (6.38%)
         occurrences all number
    2
    3
    Nasopharyngitis
         subjects affected / exposed
    5 / 101 (4.95%)
    5 / 47 (10.64%)
         occurrences all number
    5
    9
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 101 (2.97%)
    8 / 47 (17.02%)
         occurrences all number
    3
    8
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 101 (0.99%)
    3 / 47 (6.38%)
         occurrences all number
    1
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Dec 2012
    The purpose of this amendment was to clarify the definition of relapser and study activities and procedures.
    10 Apr 2013
    The purpose of this amendment was to prohibit the use of hormonal contraceptives during study drug administration.
    18 Jun 2013
    The purpose of this amendment was to adjust the stratification proportion of genotype 1a versus non-1a subjects, clarify re-screening criteria, allow enrollment of subjects with a borderline pregnancy test result under certain circumstances, and allow appropriate use of over-the-counter and prescription medication.
    30 Oct 2013
    The purpose of this amendment was to adjust the stratification proportion of genotype 1a versus non-1a subjects and include the option of conducting certain visits in the home.

    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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