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    Clinical Trial Results:
    A Randomized, Open-Label Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 and ABT-333 Co-administered with and without Ribavirin Compared to Telaprevir Co-administered with Pegylated Interferon α-2a and Ribavirin in Treatment-Naïve Adults with Chronic Hepatitis C Genotype 1 Virus Infection (MALACHITE I)

    Summary
    EudraCT number
    		 2012-003754-84
    Trial protocol
    		 HU   FI   SK   PL  
    Global end of trial date
    16 Jul 2015

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    M13-774
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01854697
    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 4UB
    Public contact
    Global Medical Services, AbbVie, 001 800-633-9110,
    Scientific contact
    Yan Luo, 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
    16 Jul 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jul 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a study to evaluate the efficacy and safety of three experimental drugs compared with telaprevir (a licensed product) in people with hepatitis C virus infection who have not had treatment before.
    Protection of trial subjects
    Subject and/or legal guardian read and understood the information provided about the study and gave written permission.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Mar 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
    Argentina: 12
    Country: Number of subjects enrolled
    Australia: 36
    Country: Number of subjects enrolled
    Canada: 51
    Country: Number of subjects enrolled
    Chile: 29
    Country: Number of subjects enrolled
    Finland: 4
    Country: Number of subjects enrolled
    Hungary: 32
    Country: Number of subjects enrolled
    Norway: 16
    Country: Number of subjects enrolled
    Poland: 43
    Country: Number of subjects enrolled
    Romania: 83
    Country: Number of subjects enrolled
    Slovakia: 5
    Worldwide total number of subjects
    311
    EEA total number of subjects
    183
    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)
    308
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 This study included a Screening Period of up to 35 days.

    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
    		 Arm A: 3-DAA + RBV in GT1a
    Arm description
    		 ABT-450/ritonavir (r)/ABT-267 150 mg/100 mg/25 mg once daily (QD) and ABT-333 250 mg twice daily (BID) and weight-based ribavirin (RBV) for 12 weeks (3 direct-acting antivirals [DAAs] with RBV in genotype [GT] 1a)
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-450/r/ABT-267
    Investigational medicinal product code
    Other name
    Viekirax, Viekira Pak (with ABT-333), Holkira Pak (with ABT-333), ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ABT-450/r/ABT-267 was to be taken orally as 2 tablets QD, which corresponds to a 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 dose QD.

    Investigational medicinal product name
    ABT-333
    Investigational medicinal product code
    Other name
    dasabuvir, Viekira Pak (with ABT-450/r/ABT-267), Holkira Pak (with ABT-450/r/ABT-267)
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ABT-333 was to be taken orally as 1 tablet BID, which corresponds to a 250 mg dose BID.

    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
    Ribavirin has weight-based dosing 1,000 to 1,200 mg divided BID per prescribing information. Subjects weighing < 75 kg took RBV orally as 2 tablets in the morning and 3 tablets in the evening, which corresponds to a 1,000 mg total daily dose. Subjects weighing ≥ 75 kg took RBV orally as 3 tablets in the morning and 3 tablets in the evening, which corresponds to a 1,200 mg total daily dose.

    Arm title
    		 Arm B: TPV/PR in GT1a
    Arm description
    		 Telaprevir (TPV) 750 mg every 8 hours (q8h) and pegylated interferon (pegIFN) 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV (PR) according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    Other name
    INCIVO®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    TPV 375 mg film-coated tablets, to be taken orally as 2 tablets every 8 hours, which corresponds to 750 mg TPV dose every 8 hours. Alternative dosing schedules for TPV (1,125 mg every 12 hours) were allowed per the prescribing information and only if approved by AbbVie.

    Investigational medicinal product name
    Peginterferon alfa-2a
    Investigational medicinal product code
    Other name
    Pegasys®
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Pegylated interferon α-2a in kits of 1 prefilled syringe with 180 μg/0.5 mL per syringe. PegIFN was administered as an SC injection once per week.

    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
    Ribavirin has weight-based dosing 1,000 to 1,200 mg divided BID per prescribing information. Subjects weighing < 75 kg took RBV orally as 2 tablets in the morning and 3 tablets in the evening, which corresponds to a 1,000 mg total daily dose. Subjects weighing ≥ 75 kg took RBV orally as 3 tablets in the morning and 3 tablets in the evening, which corresponds to a 1,200 mg total daily dose.

    Arm title
    		 Arm C: 3-DAA + RBV in GT1b
    Arm description
    		 ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-450/r/ABT-267
    Investigational medicinal product code
    Other name
    Viekirax, Viekira Pak (with ABT-333), Holkira Pak (with ABT-333), ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ABT-450/r/ABT-267 was to be taken orally as 2 tablets QD, which corresponds to a 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 dose QD.

    Investigational medicinal product name
    ABT-333
    Investigational medicinal product code
    Other name
    dasabuvir, Viekira Pak (with ABT-450/r/ABT-267), Holkira Pak (with ABT-450/r/ABT-267)
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ABT-333 was to be taken orally as 1 tablet BID, which corresponds to a 250 mg dose BID.

    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
    Ribavirin has weight-based dosing 1,000 to 1,200 mg divided BID per prescribing information. Subjects weighing < 75 kg took RBV orally as 2 tablets in the morning and 3 tablets in the evening, which corresponds to a 1,000 mg total daily dose. Subjects weighing ≥ 75 kg took RBV orally as 3 tablets in the morning and 3 tablets in the evening, which corresponds to a 1,200 mg total daily dose.

    Arm title
    		 Arm D: 3-DAA in GT1b
    Arm description
    		 ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-450/r/ABT-267
    Investigational medicinal product code
    Other name
    Viekirax, Viekira Pak (with ABT-333), Holkira Pak (with ABT-333), ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ABT-450/r/ABT-267 was to be taken orally as 2 tablets QD, which corresponds to a 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 dose QD.

    Investigational medicinal product name
    ABT-333
    Investigational medicinal product code
    Other name
    dasabuvir, Viekira Pak (with ABT-450/r/ABT-267), Holkira Pak (with ABT-450/r/ABT-267)
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ABT-333 was to be taken orally as 1 tablet BID, which corresponds to a 250 mg dose BID.

    Arm title
    		 Arm E: TPV/PR in GT1b
    Arm description
    		 Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    Other name
    INCIVO®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    TPV 375 mg film-coated tablets, to be taken orally as 2 tablets every 8 hours, which corresponds to 750 mg TPV dose every 8 hours. Alternative dosing schedules for TPV (1,125 mg every 12 hours) were allowed per the prescribing information and only if approved by AbbVie.

    Investigational medicinal product name
    Peginterferon alfa-2a
    Investigational medicinal product code
    Other name
    Pegasys®
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Pegylated interferon α-2a in kits of 1 prefilled syringe with 180 μg/0.5 mL per syringe. PegIFN was administered as an SC injection once per week.

    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
    Ribavirin has weight-based dosing 1,000 to 1,200 mg divided BID per prescribing information. Subjects weighing < 75 kg took RBV orally as 2 tablets in the morning and 3 tablets in the evening, which corresponds to a 1,000 mg total daily dose. Subjects weighing ≥ 75 kg took RBV orally as 3 tablets in the morning and 3 tablets in the evening, which corresponds to a 1,200 mg total daily dose.

    Number of subjects in period 1
    		Arm A: 3-DAA + RBV in GT1a Arm B: TPV/PR in GT1a Arm C: 3-DAA + RBV in GT1b Arm D: 3-DAA in GT1b Arm E: TPV/PR in GT1b
    Started
    69
    34
    84
    83
    41
    Completed
    63
    31
    82
    80
    39
    Not completed
    6
    3
    2
    3
    2
         Withdrew Consent
    -
    1
    -
    1
    -
         To enter another AbbVie study
    1
    -
    -
    -
    1
         Not Specified
    -
    1
    1
    -
    -
         Adverse event
    1
    -
    -
    -
    1
         Lost to follow-up
    4
    1
    1
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A: 3-DAA + RBV in GT1a
    Reporting group description
    		 ABT-450/ritonavir (r)/ABT-267 150 mg/100 mg/25 mg once daily (QD) and ABT-333 250 mg twice daily (BID) and weight-based ribavirin (RBV) for 12 weeks (3 direct-acting antivirals [DAAs] with RBV in genotype [GT] 1a)

    Reporting group title
    Arm B: TPV/PR in GT1a
    Reporting group description
    		 Telaprevir (TPV) 750 mg every 8 hours (q8h) and pegylated interferon (pegIFN) 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV (PR) according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)

    Reporting group title
    Arm C: 3-DAA + RBV in GT1b
    Reporting group description
    		 ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)

    Reporting group title
    Arm D: 3-DAA in GT1b
    Reporting group description
    		 ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)

    Reporting group title
    Arm E: TPV/PR in GT1b
    Reporting group description
    		 Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)

    Reporting group values
    		 Arm A: 3-DAA + RBV in GT1a Arm B: TPV/PR in GT1a Arm C: 3-DAA + RBV in GT1b Arm D: 3-DAA in GT1b Arm E: TPV/PR in GT1b Total
    Number of subjects
    		 69 34 84 83 41 311
    Age, Customized
    Units: participants
        < 55 years
    		 46 23 59 60 31 219
        >= 55 years
    		 23 11 25 23 10 92
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.1 ( 12.25 ) 44.5 ( 14.1 ) 46.2 ( 11.34 ) 47.1 ( 11.33 ) 45.9 ( 10.78 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 21 17 46 43 24 151
        Male
    		 48 17 38 40 17 160

    End points

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    End points reporting groups
    Reporting group title
    Arm A: 3-DAA + RBV in GT1a
    Reporting group description
    		 ABT-450/ritonavir (r)/ABT-267 150 mg/100 mg/25 mg once daily (QD) and ABT-333 250 mg twice daily (BID) and weight-based ribavirin (RBV) for 12 weeks (3 direct-acting antivirals [DAAs] with RBV in genotype [GT] 1a)

    Reporting group title
    Arm B: TPV/PR in GT1a
    Reporting group description
    		 Telaprevir (TPV) 750 mg every 8 hours (q8h) and pegylated interferon (pegIFN) 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV (PR) according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)

    Reporting group title
    Arm C: 3-DAA + RBV in GT1b
    Reporting group description
    		 ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)

    Reporting group title
    Arm D: 3-DAA in GT1b
    Reporting group description
    		 ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)

    Reporting group title
    Arm E: TPV/PR in GT1b
    Reporting group description
    		 Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)

    Primary: Percentage of Subjects With Sustained Virologic Response 12 Weeks After Treatment (SVR12) - Primary Efficacy Analyses

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    End point title
    		 Percentage of Subjects With Sustained Virologic Response 12 Weeks After Treatment (SVR12) - Primary Efficacy Analyses
    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.
    End point type
    Primary
    End point timeframe
    12 weeks after the last actual dose of active study drug
    End point values
    		 Arm A: 3-DAA + RBV in GT1a Arm B: TPV/PR in GT1a Arm C: 3-DAA + RBV in GT1b Arm D: 3-DAA in GT1b Arm E: TPV/PR in GT1b
    Number of subjects analysed
    69
    34
    84
    83
    41
    Units: percentage of subjects
        number (not applicable)
    97.1
    82.4
    98.8
    97.6
    78
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Arm D: 3-DAA in GT1b v Arm E: TPV/PR in GT1b
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference
    Point estimate
    19.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.4
         upper limit
    		 32.6
    Notes
    [1] - The primary endpoint assessment comparison was made within each of the 2 HCV genotypes (GT1a and GT1b). Within HCV GT1a, the 3-DAA + RBV and TPV/PR arms were compared. Within HCV GT1b, the 3-DAA and TPV/PR arms were compared. The test treatment arm was considered noninferior to the TPV/PR arm in the respective HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of –10.5%.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Arm B: TPV/PR in GT1a v Arm A: 3-DAA + RBV in GT1a
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference
    Point estimate
    14.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.3
         upper limit
    		 28.2
    Notes
    [2] - The primary endpoint assessment comparison was made within each of the 2 HCV genotypes (GT1a and GT1b). Within HCV GT1a, the 3-DAA + RBV and TPV/PR arms were compared. Within HCV GT1b, the 3-DAA and TPV/PR arms were compared. The test treatment arm was considered noninferior to the TPV/PR arm in the respective HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of –10.5%.

    Secondary: Mean Change From Baseline to the Final Treatment Visit in Short-Form 36 Version 2 Health Status Survey (SF-36V2) Mental Component Summary (MCS)

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    End point title
    		 Mean Change From Baseline to the Final Treatment Visit in Short-Form 36 Version 2 Health Status Survey (SF-36V2) Mental Component Summary (MCS)
    End point description
    SF-36V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQoL) covering 2 summary measures: physical component summary (PCS) and MCS; it consists of 8 subscales. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Subjects self-report on items in a subscale that have choices per item. Scoring is done for both MCS subscale scores and summary scores; for each, the range is 0 (worst HRQoL) to 100 (best HRQoL).
    End point type
    Secondary
    End point timeframe
    From Day 1 of treatment up to 12 weeks for Arms A, C and D and up to 24 or 48 weeks for Arms B and E
    End point values
    		 Arm A: 3-DAA + RBV in GT1a Arm B: TPV/PR in GT1a Arm C: 3-DAA + RBV in GT1b Arm D: 3-DAA in GT1b Arm E: TPV/PR in GT1b
    Number of subjects analysed
    69
    32
    84
    83
    40
    Units: units on a scale
        arithmetic mean (standard deviation)
    -4.2 ( 10.59 )
    -5.8 ( 12.18 )
    -0.3 ( 8.89 )
    -0.1 ( 7.73 )
    -6.4 ( 11.78 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Arm A: 3-DAA + RBV in GT1a v Arm B: TPV/PR in GT1a
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.351
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    2.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.39
         upper limit
    		 6.65
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.28
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Arm C: 3-DAA + RBV in GT1b v Arm E: TPV/PR in GT1b
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Mean of Difference
    Point estimate
    5.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.19
         upper limit
    		 9.47
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.84
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Arm D: 3-DAA in GT1b v Arm E: TPV/PR in GT1b
    Number of subjects included in analysis
    123
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Mean of Difference
    Point estimate
    5.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.01
         upper limit
    		 8.54
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.65

    Secondary: Mean Change From Baseline to the Final Treatment Visit in SF-36V2 Physical Component Summary (PCS)

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    End point title
    		 Mean Change From Baseline to the Final Treatment Visit in SF-36V2 Physical Component Summary (PCS)
    End point description
    SF-36V2 is a generic 36-item questionnaire measuring HRQoL covering 2 summary measures: PCS and MCS; it consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. Subjects self-report on items in a subscale that have choices per item. Scoring is done for both PCS subscale scores and summary scores; for each, the range is 0 (worst HRQoL) to 100 (best HRQoL).
    End point type
    Secondary
    End point timeframe
    From Day 1 of treatment up to 12 weeks for Arms A, C and D and up to 24 or 48 weeks for Arms B and E
    End point values
    		 Arm A: 3-DAA + RBV in GT1a Arm B: TPV/PR in GT1a Arm C: 3-DAA + RBV in GT1b Arm D: 3-DAA in GT1b Arm E: TPV/PR in GT1b
    Number of subjects analysed
    69
    32
    84
    83
    40
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.5 ( 8.63 )
    -5.5 ( 8.26 )
    0.4 ( 5.8 )
    2.2 ( 4.34 )
    -5.5 ( 11.46 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Arm A: 3-DAA + RBV in GT1a v Arm B: TPV/PR in GT1a
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    6.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.72
         upper limit
    		 9.44
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.69
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Arm D: 3-DAA in GT1b v Arm E: TPV/PR in GT1b
    Number of subjects included in analysis
    123
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    6.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.36
         upper limit
    		 9.37
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.27
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Arm C: 3-DAA + RBV in GT1b v Arm E: TPV/PR in GT1b
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    6.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.55
         upper limit
    		 8.85
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.34

    Secondary: Percentage of Subjects With SVR12 - Secondary Efficacy Analyses

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    End point title
    		 Percentage of Subjects With SVR12 - Secondary Efficacy Analyses
    End point description
    The percentage of subjects with sustained virologic response (plasma HCV RNA level < LLOQ) 12 weeks after the last dose of study drug.
    End point type
    Secondary
    End point timeframe
    12 weeks after the last actual dose of active study drug
    End point values
    		 Arm A: 3-DAA + RBV in GT1a Arm B: TPV/PR in GT1a Arm C: 3-DAA + RBV in GT1b Arm D: 3-DAA in GT1b Arm E: TPV/PR in GT1b
    Number of subjects analysed
    69
    34
    84
    83
    41
    Units: percentage of subjects
        number (not applicable)
    97.1
    82.4
    98.8
    97.6
    78
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Arm A: 3-DAA + RBV in GT1a v Arm B: TPV/PR in GT1a
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.021
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    7.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.4
         upper limit
    		 38
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Arm C: 3-DAA + RBV in GT1b v Arm E: TPV/PR in GT1b
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Difference
    Point estimate
    20.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.9
         upper limit
    		 33.6
    Notes
    [3] - The test treatment arm was considered noninferior to the TPV/PR arm in the GT1b HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Arm C: 3-DAA + RBV in GT1b v Arm E: TPV/PR in GT1b
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    28.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.3
         upper limit
    		 241.1
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Arm D: 3-DAA in GT1b v Arm E: TPV/PR in GT1b
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    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
    Subjects in Arms A, C or D demonstrating any of the following were considered virologic failures and discontinued therapy: • Confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements of >1 log10 IU/mL above nadir) at any time point during treatment • Failure to achieve HCV RNA < LLOQ by Week 6 or • Confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) at any point after HCV RNA < LLOQ during treatment after HCV RNA < LLOQ. Subjects in Arms B and E followed virologic stopping criteria described in the TPV Summary of Product Characteristics; they were considered virologic failures and discontinued therapy as follows: • HCV RNA > 1000 IU/mL at Week 4 to Week 12, discontinue TPV and pegIFN and RBV • HCV RNA > 1000 IU/mL at Week 12, discontinue pegIFN and RBV • Confirmed HCV RNA > lower limit of detection (LLOD) at Week 24, discontinue pegIFN and RBV • Confirmed HCV RNA > LLOD at Week 36, discontinue pegIFN and RBV.
    End point type
    Secondary
    End point timeframe
    12 weeks for Arms A, C and D and 24 weeks or 48 weeks for Arms B and E
    End point values
    		 Arm A: 3-DAA + RBV in GT1a Arm B: TPV/PR in GT1a Arm C: 3-DAA + RBV in GT1b Arm D: 3-DAA in GT1b Arm E: TPV/PR in GT1b
    Number of subjects analysed
    69
    34
    84
    83
    41
    Units: percentage of subjects
        number (not applicable)
    2.9
    5.9
    0
    1.2
    12.2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Post-treatment Relapse

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    End point title
    		 Percentage of Subjects with Post-treatment Relapse
    End point description
    Hepatitis C virus (HCV) ribonucleic acid (RNA) confirmed greater than or equal to the lower limit of quantification (LLOQ) between the end of treatment and 24 weeks post treatment among subjects completing treatment and with HCV RNA less than the LLOQ at the end of treatment.
    End point type
    Secondary
    End point timeframe
    Within 24 weeks post treatment
    End point values
    		 Arm A: 3-DAA + RBV in GT1a Arm B: TPV/PR in GT1a Arm C: 3-DAA + RBV in GT1b Arm D: 3-DAA in GT1b Arm E: TPV/PR in GT1b
    Number of subjects analysed
    66 [4]
    28 [5]
    84 [6]
    81 [7]
    32 [8]
    Units: percentage of subjects
        number (not applicable)
    0
    0
    1.2
    0
    6.3
    Notes
    [4] - subjects with sustained virologic response at Week 24 (SVR24)
    [5] - subjects with sustained virologic response at Week 24 (SVR24)
    [6] - subjects with sustained virologic response at Week 24 (SVR24)
    [7] - subjects with sustained virologic response at Week 24 (SVR24)81
    [8] - subjects with sustained virologic response at Week 24 (SVR24)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Sustained Virologic Response 24 Weeks After Treatment (SVR24)

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    End point title
    		 Percentage of Subjects With Sustained Virologic Response 24 Weeks After Treatment (SVR24)
    End point description
    The percentage of subjects with sustained virologic response (plasma HCV RNA level < LLOQ) 24 weeks after the last dose of study drug.
    End point type
    Secondary
    End point timeframe
    24 weeks after the last actual dose of active study drug
    End point values
    		 Arm A: 3-DAA + RBV in GT1a Arm B: TPV/PR in GT1a Arm C: 3-DAA + RBV in GT1b Arm D: 3-DAA in GT1b Arm E: TPV/PR in GT1b
    Number of subjects analysed
    69
    34
    84
    83
    41
    Units: percentage of subjects
        number (not applicable)
    95.7
    82.4
    97.6
    97.6
    78
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Arm A: 3-DAA + RBV in GT1a v Arm B: TPV/PR in GT1a
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [9]
    Method
    Parameter type
    		 Difference
    Point estimate
    13.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 27
    Notes
    [9] - The test treatment arm was considered noninferior to the TPV/PR arm in the GT1a HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Arm D: 3-DAA in GT1b v Arm E: TPV/PR in GT1b
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [10]
    Method
    Parameter type
    		 Difference
    Point estimate
    19.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.4
         upper limit
    		 32.6
    Notes
    [10] - The test treatment arm was considered noninferior to the TPV/PR arm in the GT1b HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Arm C: 3-DAA + RBV in GT1b v Arm E: TPV/PR in GT1b
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [11]
    Method
    Parameter type
    		 Difference
    Point estimate
    19.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.5
         upper limit
    		 32.7
    Notes
    [11] - The test treatment arm was considered noninferior to the TPV/PR arm in the GT1b HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.
    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
    		 ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks

    Reporting group title
    TPV + PEGIFN + RBV
    Reporting group description
    		 TPV 750 mg q8h and pegIFN 180 μg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir

    Reporting group title
    3 DAA
    Reporting group description
    		 ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks

    Serious adverse events
    		 3 DAA + RBV TPV + PEGIFN + RBV 3 DAA
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 153 (0.65%)
    9 / 75 (12.00%)
    0 / 83 (0.00%)
         number of deaths (all causes)
    2
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    PROSTATE CANCER
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 75 (0.00%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    ACCIDENTAL OVERDOSE
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 75 (1.33%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    0 / 153 (0.00%)
    2 / 75 (2.67%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    CHEST PAIN
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 75 (1.33%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    RETINOPATHY
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 75 (1.33%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    HAEMATOCHEZIA
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 75 (1.33%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 75 (1.33%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    TOXIC SKIN ERUPTION
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 75 (1.33%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    ABSCESS LIMB
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 75 (1.33%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CELLULITIS
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 75 (1.33%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 3 DAA + RBV TPV + PEGIFN + RBV 3 DAA
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    100 / 153 (65.36%)
    74 / 75 (98.67%)
    29 / 83 (34.94%)
    Nervous system disorders
    DYSGEUSIA
         subjects affected / exposed
    2 / 153 (1.31%)
    6 / 75 (8.00%)
    0 / 83 (0.00%)
         occurrences all number
    2
    6
    0
    DIZZINESS
         subjects affected / exposed
    7 / 153 (4.58%)
    13 / 75 (17.33%)
    2 / 83 (2.41%)
         occurrences all number
    7
    14
    2
    HEADACHE
         subjects affected / exposed
    41 / 153 (26.80%)
    23 / 75 (30.67%)
    16 / 83 (19.28%)
         occurrences all number
    48
    30
    17
    LETHARGY
         subjects affected / exposed
    6 / 153 (3.92%)
    4 / 75 (5.33%)
    0 / 83 (0.00%)
         occurrences all number
    6
    4
    0
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    10 / 153 (6.54%)
    32 / 75 (42.67%)
    1 / 83 (1.20%)
         occurrences all number
    12
    47
    1
    LEUKOPENIA
         subjects affected / exposed
    0 / 153 (0.00%)
    4 / 75 (5.33%)
    0 / 83 (0.00%)
         occurrences all number
    0
    4
    0
    NEUTROPENIA
         subjects affected / exposed
    0 / 153 (0.00%)
    14 / 75 (18.67%)
    0 / 83 (0.00%)
         occurrences all number
    0
    17
    0
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    11 / 153 (7.19%)
    15 / 75 (20.00%)
    2 / 83 (2.41%)
         occurrences all number
    16
    18
    2
    CHILLS
         subjects affected / exposed
    3 / 153 (1.96%)
    7 / 75 (9.33%)
    3 / 83 (3.61%)
         occurrences all number
    3
    7
    3
    FATIGUE
         subjects affected / exposed
    21 / 153 (13.73%)
    23 / 75 (30.67%)
    4 / 83 (4.82%)
         occurrences all number
    21
    25
    5
    INFLUENZA LIKE ILLNESS
         subjects affected / exposed
    3 / 153 (1.96%)
    7 / 75 (9.33%)
    1 / 83 (1.20%)
         occurrences all number
    3
    7
    1
    INJECTION SITE ERYTHEMA
         subjects affected / exposed
    0 / 153 (0.00%)
    5 / 75 (6.67%)
    0 / 83 (0.00%)
         occurrences all number
    0
    5
    0
    PYREXIA
         subjects affected / exposed
    4 / 153 (2.61%)
    16 / 75 (21.33%)
    2 / 83 (2.41%)
         occurrences all number
    5
    17
    2
    Eye disorders
    VISION BLURRED
         subjects affected / exposed
    0 / 153 (0.00%)
    5 / 75 (6.67%)
    1 / 83 (1.20%)
         occurrences all number
    0
    5
    1
    Gastrointestinal disorders
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    3 / 153 (1.96%)
    6 / 75 (8.00%)
    1 / 83 (1.20%)
         occurrences all number
    3
    7
    1
    ANAL PRURITUS
         subjects affected / exposed
    1 / 153 (0.65%)
    10 / 75 (13.33%)
    0 / 83 (0.00%)
         occurrences all number
    1
    11
    0
    ANORECTAL DISCOMFORT
         subjects affected / exposed
    1 / 153 (0.65%)
    4 / 75 (5.33%)
    0 / 83 (0.00%)
         occurrences all number
    1
    8
    0
    DIARRHOEA
         subjects affected / exposed
    15 / 153 (9.80%)
    12 / 75 (16.00%)
    7 / 83 (8.43%)
         occurrences all number
    19
    12
    8
    DRY MOUTH
         subjects affected / exposed
    5 / 153 (3.27%)
    4 / 75 (5.33%)
    0 / 83 (0.00%)
         occurrences all number
    5
    4
    0
    HAEMORRHOIDS
         subjects affected / exposed
    0 / 153 (0.00%)
    4 / 75 (5.33%)
    0 / 83 (0.00%)
         occurrences all number
    0
    4
    0
    NAUSEA
         subjects affected / exposed
    32 / 153 (20.92%)
    30 / 75 (40.00%)
    7 / 83 (8.43%)
         occurrences all number
    37
    33
    7
    VOMITING
         subjects affected / exposed
    11 / 153 (7.19%)
    14 / 75 (18.67%)
    1 / 83 (1.20%)
         occurrences all number
    12
    17
    1
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    11 / 153 (7.19%)
    8 / 75 (10.67%)
    1 / 83 (1.20%)
         occurrences all number
    11
    8
    1
    DYSPNOEA
         subjects affected / exposed
    7 / 153 (4.58%)
    5 / 75 (6.67%)
    0 / 83 (0.00%)
         occurrences all number
    7
    5
    0
    Skin and subcutaneous tissue disorders
    ALOPECIA
         subjects affected / exposed
    1 / 153 (0.65%)
    10 / 75 (13.33%)
    1 / 83 (1.20%)
         occurrences all number
    1
    10
    1
    DRY SKIN
         subjects affected / exposed
    3 / 153 (1.96%)
    4 / 75 (5.33%)
    1 / 83 (1.20%)
         occurrences all number
    3
    5
    1
    ECZEMA
         subjects affected / exposed
    1 / 153 (0.65%)
    4 / 75 (5.33%)
    0 / 83 (0.00%)
         occurrences all number
    1
    5
    0
    ERYTHEMA
         subjects affected / exposed
    1 / 153 (0.65%)
    4 / 75 (5.33%)
    0 / 83 (0.00%)
         occurrences all number
    1
    4
    0
    PRURITUS
         subjects affected / exposed
    19 / 153 (12.42%)
    26 / 75 (34.67%)
    5 / 83 (6.02%)
         occurrences all number
    22
    30
    5
    RASH
         subjects affected / exposed
    12 / 153 (7.84%)
    17 / 75 (22.67%)
    0 / 83 (0.00%)
         occurrences all number
    13
    25
    0
    RASH PRURITIC
         subjects affected / exposed
    1 / 153 (0.65%)
    7 / 75 (9.33%)
    0 / 83 (0.00%)
         occurrences all number
    1
    11
    0
    Psychiatric disorders
    DEPRESSION
         subjects affected / exposed
    3 / 153 (1.96%)
    7 / 75 (9.33%)
    0 / 83 (0.00%)
         occurrences all number
    3
    7
    0
    INSOMNIA
         subjects affected / exposed
    14 / 153 (9.15%)
    7 / 75 (9.33%)
    0 / 83 (0.00%)
         occurrences all number
    14
    7
    0
    IRRITABILITY
         subjects affected / exposed
    11 / 153 (7.19%)
    7 / 75 (9.33%)
    0 / 83 (0.00%)
         occurrences all number
    11
    7
    0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    3 / 153 (1.96%)
    6 / 75 (8.00%)
    2 / 83 (2.41%)
         occurrences all number
    3
    6
    2
    BACK PAIN
         subjects affected / exposed
    4 / 153 (2.61%)
    4 / 75 (5.33%)
    1 / 83 (1.20%)
         occurrences all number
    4
    5
    1
    MYALGIA
         subjects affected / exposed
    7 / 153 (4.58%)
    12 / 75 (16.00%)
    2 / 83 (2.41%)
         occurrences all number
    10
    17
    2
    Infections and infestations
    NASOPHARYNGITIS
         subjects affected / exposed
    13 / 153 (8.50%)
    7 / 75 (9.33%)
    4 / 83 (4.82%)
         occurrences all number
    14
    8
    5
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    10 / 153 (6.54%)
    3 / 75 (4.00%)
    1 / 83 (1.20%)
         occurrences all number
    10
    3
    1
    URINARY TRACT INFECTION
         subjects affected / exposed
    2 / 153 (1.31%)
    5 / 75 (6.67%)
    1 / 83 (1.20%)
         occurrences all number
    2
    5
    1
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    6 / 153 (3.92%)
    17 / 75 (22.67%)
    1 / 83 (1.20%)
         occurrences all number
    7
    17
    1
    HYPERTRIGLYCERIDAEMIA
         subjects affected / exposed
    0 / 153 (0.00%)
    4 / 75 (5.33%)
    0 / 83 (0.00%)
         occurrences all number
    0
    5
    0
    HYPOKALAEMIA
         subjects affected / exposed
    1 / 153 (0.65%)
    5 / 75 (6.67%)
    0 / 83 (0.00%)
         occurrences all number
    1
    5
    0
    HYPOPHOSPHATAEMIA
         subjects affected / exposed
    1 / 153 (0.65%)
    4 / 75 (5.33%)
    0 / 83 (0.00%)
         occurrences all number
    1
    5
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 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: ● specify screening criteria that should remain stable did not need to be re-tested if rescreening occurred within the initial 35-day screening window; ● allow for additional rescreening if screening failure related to an eligibility criterion that was subsequently amended; ● update Inclusion Criterion No. 3 to allow enrollment of subjects with a borderline pregnancy test result under certain circumstances; ● amend Exclusion Criterion No. 9 to allow appropriate use of over-the-counter and prescription medication; ● make minor language edits to clarify the eligibility criteria; ● allow informed consent for optional samples to be performed at the Baseline Visit; ● clarify language relating to pill-count requirements; ● clarify that the IRT system should be used for drug accountability; ● update the pregnancy section to be consistent with current AbbVie HCV safety language relating to pregnancy; ● update addresses and contact details; ● make minor edits for consistency and clarity throughout the protocol.

    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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