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    Clinical Trial Results:
    A Randomized, Open-Label, Multicenter Study to Evaluate the Safety and Antiviral Activity of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With and Without Ribavirin in Treatment-Experienced Subjects with Genotype 1b Chronic Hepatitis C Virus (HCV) Infection (PEARL–II)

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    		 2011-005740-95
    Trial protocol
    		 SE   AT   BE   NL   IT   PT  
    Global end of trial date
    13 Oct 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 May 2016
    First version publication date
    18 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M13-389
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01674725
    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
    Jeffrey Enejosa, MD, AbbVie, jeffrey.enejosa@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
    13 Oct 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT- 267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without cirrhosis.
    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
    14 Aug 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Switzerland: 13
    Country: Number of subjects enrolled
    Turkey: 30
    Country: Number of subjects enrolled
    United States: 33
    Country: Number of subjects enrolled
    Netherlands: 5
    Country: Number of subjects enrolled
    Portugal: 4
    Country: Number of subjects enrolled
    Sweden: 11
    Country: Number of subjects enrolled
    Austria: 22
    Country: Number of subjects enrolled
    Belgium: 24
    Country: Number of subjects enrolled
    Italy: 45
    Worldwide total number of subjects
    187
    EEA total number of subjects
    111
    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)
    156
    From 65 to 84 years
    31
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 187 subjects were randomized; 1 subject did not receive study drug and was excluded from the analyses.

    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
    		 ABT-450/r/ABT-267 and ABT-333, Plus RBV
    Arm description
    		 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)

    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
    250 mg twice daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Weight-based (dosed 1,000 or 1,200 mg daily divided twice a day)

    Arm title
    		 ABT-450/r/ABT-267 and ABT-333
    Arm description
    		 ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) 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)

    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
    250 mg twice daily

    Number of subjects in period 1 [1]
    		ABT-450/r/ABT-267 and ABT-333, Plus RBV ABT-450/r/ABT-267 and ABT-333
    Started
    91
    95
    Completed
    89
    94
    Not completed
    2
    1
         Adverse event
    1
    -
         Lost to follow-up
    -
    1
         Withdrawal by subject
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 187 subjects were randomized; 1 subject did not receive study drug and was excluded from the intent-to-treat (ITT) and safety populations.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ABT-450/r/ABT-267 and ABT-333, Plus RBV
    Reporting group description
    		 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
    ABT-450/r/ABT-267 and ABT-333
    Reporting group description
    		 ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks

    Reporting group values
    		 ABT-450/r/ABT-267 and ABT-333, Plus RBV ABT-450/r/ABT-267 and ABT-333 Total
    Number of subjects
    		 91 95 186
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.2 ( 10.9 ) 54.2 ( 10.51 ) -
    Gender categorical
    Units: Subjects
        Female
    		 46 38 84
        Male
    		 45 57 102

    End points

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    End points reporting groups
    Reporting group title
    ABT-450/r/ABT-267 and ABT-333, Plus RBV
    Reporting group description
    		 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
    ABT-450/r/ABT-267 and ABT-333
    Reporting group description
    		 ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks

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

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    End point title
    		 Percentage of Subjects With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses [1]
    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. Subjects with missing data were counted as non-responders. The primary endpoints were noninferiority of the percentage of subjects who achieved sustained virologic response 12 weeks after treatment in each treatment arm compared with the historical control rate for noncirrhotic, treatment-experienced subjects with HCV GT1b infection treated with telaprevir and peginterferon (pegIFN)/RBV. Based on a 2-sided significance level of 0.05 and underlying rates of ≥90% (n=90 in each arm), a total of 180 subjects provides >90% power to demonstrate noninferiority of each regimen to the historical rate (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).
    End point type
    Primary
    End point timeframe
    12 weeks after last dose of study drug
    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 lower confidence bound of the 2-sided 95% confidence interval for the percentage of subjects with sustained virologic response at 12 weeks after treatment must exceed 64% to achieve noninferiority. 95% CI was calculated using the normal approximation to the binomial distribution (ABT-450/r/ABT-267 and ABT-333) or the Wilson score method for the single proportion because the point estimate was 100% (ABT-450/r/ABT-267 and ABT-333, plus RBV).
    End point values
    		 ABT-450/r/ABT-267 and ABT-333, Plus RBV ABT-450/r/ABT-267 and ABT-333
    Number of subjects analysed
    88 [2]
    91 [3]
    Units: percentage of subjects
        number (confidence interval 95%)
    97.7 (94.6 to 100)
    100 (95.9 to 100)
    Notes
    [2] - ITT GT1b population: All subjects with HCV GT1b infection who received at least 1 dose of study drug
    [3] - ITT GT1b population: All subjects with HCV GT1b infection who received at least 1 dose of study drug
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment

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    End point title
    		 Percentage of Subjects With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment
    End point description
    The percentage of subjects with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 12 (End of Treatment)
    End point values
    		 ABT-450/r/ABT-267 and ABT-333, Plus RBV ABT-450/r/ABT-267 and ABT-333
    Number of subjects analysed
    88 [4]
    91 [5]
    Units: percentage of subjects
        number (not applicable)
    42
    5.5
    Notes
    [4] - Subjects in the ITT HCV GT1b population with hemoglobin ≥ LLN reference range at baseline
    [5] - Subjects in the ITT HCV GT1b population with hemoglobin ≥ LLN reference range at baseline
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    ABT-450/r/ABT-267 and ABT-333, Plus RBV v ABT-450/r/ABT-267 and ABT-333
    Number of subjects included in analysis
    179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Percentage of Subjects With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses

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    End point title
    		 Percentage of Subjects With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses
    End point description
    The percentage of subjects with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. Subjects with missing data were counted as non-responders. The secondary endpoints were superiority of the percentage of subjects who achieved sustained virologic response 12 weeks after treatment in each treatment arm compared with the historical control rate for noncirrhotic, treatment-experienced subjects with HCV GT1b infection treated with telaprevir and pegIFN/RBV (75%) (the lower confidence bound must exceed 75% to achieve superiority); and noninferiority of the percentage of subjects who achieved sustained virologic response 12 weeks after treatment with ABT-450/r/ABT-267 and ABT-333, plus RBV compared with ABT-450/r/ABT-267 and ABT-333 (see statistical analysis 1).
    End point type
    Secondary
    End point timeframe
    12 weeks after last dose of study drug
    End point values
    		 ABT-450/r/ABT-267 and ABT-333, Plus RBV ABT-450/r/ABT-267 and ABT-333
    Number of subjects analysed
    88 [6]
    91 [7]
    Units: percentage of subjects
        number (confidence interval 95%)
    97.7 (94.6 to 100)
    100 (95.9 to 100)
    Notes
    [6] - ITT GT1b population
    [7] - ITT GT1b population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    95% CI was calculated using the normal approximation to the binomial distribution.
    Comparison groups
    ABT-450/r/ABT-267 and ABT-333, Plus RBV v ABT-450/r/ABT-267 and ABT-333
    Number of subjects included in analysis
    179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    Method
    Parameter type
    		 Percentage of subjects
    Point estimate
    2.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 5.4
    Notes
    [8] - The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333 treatment group as compared with the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group was analyzed using a noninferiority margin of -10.5%; the lower confidence bound of the 2-sided 95% confidence interval for the difference in percentage of subjects with sustained virologic response at 12 weeks after treatment must exceed -10.5% to achieve noninferiority.

    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 rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12
    End point values
    		 ABT-450/r/ABT-267 and ABT-333, Plus RBV ABT-450/r/ABT-267 and ABT-333
    Number of subjects analysed
    88 [9]
    91 [10]
    Units: percentage of subjects
    number (not applicable)
        Rebound
    0
    0
        Failure to Suppress
    0
    0
    Notes
    [9] - ITT GT1b population
    [10] - ITT GT1b 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 post-treatment period. 95% CI was calculated using the Wilson score method for the single proportion because the point estimate was 0%.
    End point type
    Secondary
    End point timeframe
    Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-Treatment)
    End point values
    		 ABT-450/r/ABT-267 and ABT-333, Plus RBV ABT-450/r/ABT-267 and ABT-333
    Number of subjects analysed
    86 [11]
    91 [12]
    Units: percentage of subjects
        number (confidence interval 95%)
    0 (0 to 4.3)
    0 (0 to 4.1)
    Notes
    [11] - ITT GT1b population with HCV RNA < LLOQ at the final treatment visit and completed treatment
    [12] - ITT GT1b population with HCV RNA < LLOQ at the final treatment visit and completed treatment
    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 (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    ABT-450/r/ABT-267 and ABT-333, Plus RBV
    Reporting group description
    		 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
    ABT-450/r/ABT-267 and ABT-333
    Reporting group description
    		 ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks

    Serious adverse events
    		 ABT-450/r/ABT-267 and ABT-333, Plus RBV ABT-450/r/ABT-267 and ABT-333
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 91 (2.20%)
    2 / 95 (2.11%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Gastrointestinal disorders
    Pancreatitis
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 95 (1.05%)
         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
    		 ABT-450/r/ABT-267 and ABT-333, Plus RBV ABT-450/r/ABT-267 and ABT-333
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    71 / 91 (78.02%)
    62 / 95 (65.26%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 91 (5.49%)
    4 / 95 (4.21%)
         occurrences all number
    5
    4
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    11 / 91 (12.09%)
    7 / 95 (7.37%)
         occurrences all number
    13
    8
    Fatigue
         subjects affected / exposed
    29 / 91 (31.87%)
    16 / 95 (16.84%)
         occurrences all number
    37
    19
    Irritability
         subjects affected / exposed
    5 / 91 (5.49%)
    1 / 95 (1.05%)
         occurrences all number
    5
    1
    Pyrexia
         subjects affected / exposed
    6 / 91 (6.59%)
    8 / 95 (8.42%)
         occurrences all number
    7
    8
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 91 (3.30%)
    7 / 95 (7.37%)
         occurrences all number
    3
    8
    Dyspnoea
         subjects affected / exposed
    8 / 91 (8.79%)
    2 / 95 (2.11%)
         occurrences all number
    8
    2
    Dyspnoea exertional
         subjects affected / exposed
    5 / 91 (5.49%)
    1 / 95 (1.05%)
         occurrences all number
    5
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    13 / 91 (14.29%)
    3 / 95 (3.16%)
         occurrences all number
    14
    3
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    8 / 91 (8.79%)
    0 / 95 (0.00%)
         occurrences all number
    9
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    5 / 91 (5.49%)
    2 / 95 (2.11%)
         occurrences all number
    5
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    8 / 91 (8.79%)
    3 / 95 (3.16%)
         occurrences all number
    9
    3
    Headache
         subjects affected / exposed
    22 / 91 (24.18%)
    22 / 95 (23.16%)
         occurrences all number
    30
    25
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    10 / 91 (10.99%)
    0 / 95 (0.00%)
         occurrences all number
    11
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    5 / 91 (5.49%)
    1 / 95 (1.05%)
         occurrences all number
    7
    1
    Diarrhoea
         subjects affected / exposed
    12 / 91 (13.19%)
    12 / 95 (12.63%)
         occurrences all number
    14
    15
    Nausea
         subjects affected / exposed
    19 / 91 (20.88%)
    6 / 95 (6.32%)
         occurrences all number
    21
    6
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    5 / 91 (5.49%)
    2 / 95 (2.11%)
         occurrences all number
    5
    2
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    13 / 91 (14.29%)
    8 / 95 (8.42%)
         occurrences all number
    19
    10
    Rash
         subjects affected / exposed
    8 / 91 (8.79%)
    1 / 95 (1.05%)
         occurrences all number
    8
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 91 (6.59%)
    6 / 95 (6.32%)
         occurrences all number
    8
    8
    Myalgia
         subjects affected / exposed
    6 / 91 (6.59%)
    4 / 95 (4.21%)
         occurrences all number
    6
    5
    Infections and infestations
    Influenza
         subjects affected / exposed
    2 / 91 (2.20%)
    6 / 95 (6.32%)
         occurrences all number
    2
    7
    Nasopharyngitis
         subjects affected / exposed
    6 / 91 (6.59%)
    6 / 95 (6.32%)
         occurrences all number
    7
    6
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    9 / 91 (9.89%)
    2 / 95 (2.11%)
         occurrences all number
    9
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Feb 2012
    The purpose of this amendment was to clarify when Arms 3 and 4 were opened for enrollment; remove RBV from list of previous anti-HCV agents prohibited in exclusion criteria; correct time frame for qualifying biopsy from 3 years to 24 months; remove requirement for consenting pregnant partners.
    17 Feb 2012
    The purpose of this amendment was to clarify that subjects may not have used other anti-HCV agents with exception of pegIFN/RBV combination therapy.
    25 May 2012
    The purpose of this amendment was to remove the 8-week arms (Arms 3 and 4); replace extended virologic response (eRVR) with end of treatment response (EOTR) as a secondary endpoint; revise treatment futility criteria; update options for treatment for subjects currently undergoing treatment in a study arm or subgenotype that was terminated due to futility criteria being met and allow for use of pegIFN and RBV as an add-on therapy; modify definitions for null responders and nonresponder/partial responders; clarify conditions under which a subject may have been allowed to re-screen; clarify contraception requirements; clarify screening requirements (FibroTest or FibroScan, liver diagnostic testing, HCV genotype 1 result, platelet results, discontinuation of pegIFN/RBV within 2 months of the screening visit); and clarify recording of medications.
    24 Sep 2012
    The purpose of this amendment was to stop further enrollment of HCV GT1a-infected subjects and only allow HCV GT1b-infected subjects to be enrolled, and provide options for the HCV GT1a-infected subjects who were currently enrolled; removing HCV subgenotype from primary and secondary analyses and update screening and inclusion/exclusion criteria.
    28 Nov 2012
    The purpose of this amendment was to modify the protocol to a Phase 3 study; increase sample size of the study and change randomization for 1:1 for all pegIFN/RBV treatment experienced populations (null responders, nonresponders/partial responders, and relapsers); change the investigational product supply to use the combination ABT-450/r/ABT-267 tablet and to adjust the dose and strength of the ABT-333 tablet; and change the primary and secondary endpoints to compare SVR12 rate of each arm with the historical SVR rate of telaprevir plus pegIFN/RBV.
    29 Jan 2013
    The purpose of this amendment was to update the definition of relapsers to expand the timeframe for testing from 24 weeks to 52 weeks to allow subjects that may have detectable viral load documentation more than 24 weeks after treatment; update to allow testing of the genotype/subgenotype if not known prior to completing all the screening procedures; update inclusion criteria (include that depo-progesterone may not be an effective form of contraception for a female subject, depo-progesterone may be an effective form of contraception for female partners of male subjects in the trial); update exclusion criteria (provide guidance for female subjects with borderline human chorionic gonadotropin (hCG) test results; add a contraindicated medication; provide guidance to address subjects with steatosis and steatohepatitis; update absolute neutrophil count (ANC) and international normalized ratio (INR); update conditions for discontinuation and follow-up of subects who become pregnant; add a data monitoring committee DMC).
    08 Apr 2013
    The purpose of this amendment was to prohibit the use of hormonal contraceptives during study drug administration.

    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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