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    Clinical Trial Results:
    An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects with Chronic Hepatitis C Virus (HCV) Genotype 1, 4, 5, and 6 Infection (SURVEYOR-I)

    Summary
    EudraCT number
    		 2014-002925-36
    Trial protocol
    		 GB  
    Global end of trial date
    19 Feb 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Mar 2017
    First version publication date
    08 Mar 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    M14-867
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02243280
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co.KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6-4UB
    Public contact
    Global Medical Services, AbbVie, 001 800-633-9110,
    Scientific contact
    Armen Asatryan, MD, AbbVie, armen.asatryan@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
    19 Feb 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this Phase 2, open-label, 2-part, multicenter study was to evaluate the efficacy, safety, and pharmacokinetics of co-administration of ABT-493 and ABT-530 with and without ribavirin (RBV) at different doses in chronic Hepatitis C virus (HCV) Genotype 1 (GT1), Genotype 4 (GT4), Genotype 5 (GT5), and Genotype 6 (GT6) infection with compensated cirrhosis (GT1 only) or without cirrhosis (GT1, GT4, GT5, or GT6). Although RBV was initially planned in the protocol, it was not administered in any of the study arms.
    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
    20 Aug 2014
    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
    United States: 129
    Country: Number of subjects enrolled
    Australia: 6
    Country: Number of subjects enrolled
    Canada: 9
    Country: Number of subjects enrolled
    New Zealand: 14
    Country: Number of subjects enrolled
    Puerto Rico: 16
    Worldwide total number of subjects
    174
    EEA total number of subjects
    0
    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)
    151
    From 65 to 84 years
    23
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Inclusion Criteria: Male or female 18 -70 years; Screening laboratory result of HCV GT1, GT4, GT5, or GT6 infection; Chronic HCV infection; Subject either HCV treatment-naïve or combination of pegylated-interferon ribavirin experienced; Subjects must be documented as non-cirrhotic or cirrhotic.

    Pre-assignment
    Screening details
    		 Exclusion criteria: History of severe, life-threatening or other significant sensitivity to any drug; Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab); Co-infection with more than one HCV genotype; Any cause of liver disease other than chronic HCV infection.

    Period 1
    Period 1 title
    Enrolled
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-493
    Investigational medicinal product code
    Other name
    glecaprevir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg once daily (QD)

    Investigational medicinal product name
    ABT-530
    Investigational medicinal product code
    Other name
    pibrentasvir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    120 mg once daily (QD)

    Arm title
    		 Arm B
    Arm description
    		 ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-493
    Investigational medicinal product code
    Other name
    glecaprevir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg once daily (QD)

    Investigational medicinal product name
    ABT-530
    Investigational medicinal product code
    Other name
    pibrentasvir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg once daily (QD)

    Arm title
    		 Arm F
    Arm description
    		 ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-493
    Investigational medicinal product code
    Other name
    glecaprevir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg once daily (QD)

    Investigational medicinal product name
    ABT-530
    Investigational medicinal product code
    Other name
    pibrentasvir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    120 mg once daily (QD)

    Arm title
    		 Arm I
    Arm description
    		 ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-493
    Investigational medicinal product code
    Other name
    glecaprevir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg once daily (QD)

    Investigational medicinal product name
    ABT-530
    Investigational medicinal product code
    Other name
    pibrentasvir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    120 mg once daily (QD)

    Arm title
    		 Arm K
    Arm description
    		 ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-493
    Investigational medicinal product code
    Other name
    glecaprevir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg once daily (QD)

    Investigational medicinal product name
    ABT-530
    Investigational medicinal product code
    Other name
    pibrentasvir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    120 mg once daily (QD)

    Number of subjects in period 1
    		Arm A Arm B Arm F Arm I Arm K
    Started
    40
    39
    27
    34
    34
    Completed
    40
    39
    27
    34
    34
    Period 2
    Period 2 title
    Treated
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis Two subjects in Arm I received the incorrect dose of study drug (ABT-493 200 mg instead of 300 mg) and included in Arm A instead of Arm I in the safety population.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-493
    Investigational medicinal product code
    Other name
    glecaprevir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg once daily (QD)

    Investigational medicinal product name
    ABT-530
    Investigational medicinal product code
    Other name
    pibrentasvir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    120 mg once daily (QD)

    Arm title
    		 Arm B
    Arm description
    		 ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-493
    Investigational medicinal product code
    Other name
    glecaprevir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg once daily (QD)

    Investigational medicinal product name
    ABT-530
    Investigational medicinal product code
    Other name
    pibrentasvir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg once daily (QD)

    Arm title
    		 Arm F
    Arm description
    		 ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-493
    Investigational medicinal product code
    Other name
    glecaprevir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg once daily (QD)

    Investigational medicinal product name
    ABT-530
    Investigational medicinal product code
    Other name
    pibrentasvir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    120 mg once daily (QD)

    Arm title
    		 Arm I
    Arm description
    		 ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-493
    Investigational medicinal product code
    Other name
    glecaprevir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg once daily (QD)

    Investigational medicinal product name
    ABT-530
    Investigational medicinal product code
    Other name
    pibrentasvir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    120 mg once daily (QD)

    Arm title
    		 Arm K
    Arm description
    		 ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-493
    Investigational medicinal product code
    Other name
    glecaprevir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg once daily (QD)

    Investigational medicinal product name
    ABT-530
    Investigational medicinal product code
    Other name
    pibrentasvir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    120 mg once daily (QD)

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Two subjects in Arm I received the incorrect dose of study drug (ABT-493 200 mg instead of 300 mg) and are included in Arm A instead of Arm I.
    Number of subjects in period 2
    		Arm A Arm B Arm F Arm I Arm K
    Started
    42
    39
    27
    32
    34
    Completed treatment
    42
    38 [2]
    27
    32
    33
    Completed
    41
    39
    27
    31
    31
    Not completed
    1
    0
    0
    1
    3
         Adverse event, serious fatal
    1
    -
    -
    -
    1
         Lost to follow-up
    -
    -
    -
    1
    2
    Notes
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: One subject discontinued study drug on Day 42 due to noncompliance.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis Two subjects in Arm I received the incorrect dose of study drug (ABT-493 200 mg instead of 300 mg) and included in Arm A instead of Arm I in the safety population.

    Reporting group title
    Arm B
    Reporting group description
    		 ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis

    Reporting group title
    Arm F
    Reporting group description
    		 ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis

    Reporting group title
    Arm I
    Reporting group description
    		 ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis

    Reporting group title
    Arm K
    Reporting group description
    		 ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis

    Reporting group values
    		 Arm A Arm B Arm F Arm I Arm K Total
    Number of subjects
    		 42 39 27 32 34 174
    Age categorical
    Units: Subjects
    Age Continuous
    Safety population: all participants who received at least 1 dose of study drug. Two participants assigned to Arm I received the incorrect dose of study drug throughout their participation in the study (ABT-493 200 mg QD instead of 300 mg) and are therefore included in Arm A instead of Arm I in the safety population.
    Units: years
        arithmetic mean (standard deviation)
    		 52.4 ( 10.01 ) 52.5 ( 10.41 ) 58.9 ( 5.47 ) 55 ( 11.13 ) 53.5 ( 10.34 ) -
    Gender categorical
    Units: Subjects
        Female
    		 17 21 7 16 15 76
        Male
    		 25 18 20 16 19 98

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis

    Reporting group title
    Arm B
    Reporting group description
    		 ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis

    Reporting group title
    Arm F
    Reporting group description
    		 ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis

    Reporting group title
    Arm I
    Reporting group description
    		 ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis

    Reporting group title
    Arm K
    Reporting group description
    		 ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
    Reporting group title
    Arm A
    Reporting group description
    		 ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis Two subjects in Arm I received the incorrect dose of study drug (ABT-493 200 mg instead of 300 mg) and included in Arm A instead of Arm I in the safety population.

    Reporting group title
    Arm B
    Reporting group description
    		 ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis

    Reporting group title
    Arm F
    Reporting group description
    		 ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis

    Reporting group title
    Arm I
    Reporting group description
    		 ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis

    Reporting group title
    Arm K
    Reporting group description
    		 ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis

    Primary: Percentage of participants with sustained virologic response (SVR) 12 weeks post-treatment

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    End point title
    		 Percentage of participants with sustained virologic response (SVR) 12 weeks post-treatment [1]
    End point description
    The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantification [<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 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 primary efficacy endpoint was the percentage of subjects who achieved SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug). For each treatment arm, the number and percentage of subjects achieving SVR12 was summarized along with a 95% confidence interval using Wilson score interval. No further statistical analyses were performed.
    End point values
    		 Arm A Arm B Arm F Arm I Arm K
    Number of subjects analysed
    40 [2]
    39 [3]
    27 [4]
    34 [5]
    34 [6]
    Units: percentage of participants
        number (confidence interval 95%)
    100 (91.2 to 100)
    97.4 (86.8 to 99.5)
    96.3 (81.7 to 99.3)
    100 (89.8 to 100)
    97.1 (85.1 to 99.5)
    Notes
    [2] - Intention-to-treat population: all participants who received at least 1 dose of study drug
    [3] - Intention-to-treat population: all participants who received at least 1 dose of study drug
    [4] - Intention-to-treat population: all participants who received at least 1 dose of study drug
    [5] - Intention-to-treat population: all participants who received at least 1 dose of study drug
    [6] - Intention-to-treat population: all participants who received at least 1 dose of study drug
    No statistical analyses for this end point

    Secondary: Percentage of participants with sustained virologic response (SVR) 4 weeks post-treatment

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    End point title
    		 Percentage of participants with sustained virologic response (SVR) 4 weeks post-treatment
    End point description
    The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] less than the lower limit of quantification [<LLOQ]) 4 weeks after the last dose of study drug.
    End point type
    Secondary
    End point timeframe
    4 weeks after the last actual dose of study drug
    End point values
    		 Arm A Arm B Arm F Arm I Arm K
    Number of subjects analysed
    40 [7]
    39 [8]
    27 [9]
    34 [10]
    34 [11]
    Units: percentage of participants
        number (confidence interval 95%)
    100 (91.2 to 100)
    97.4 (86.8 to 99.5)
    96.3 (81.7 to 99.3)
    100 (89.8 to 100)
    100 (89.8 to 100)
    Notes
    [7] - Intention-to-treat population: all participants who received at least 1 dose of study drug
    [8] - Intention-to-treat population: all participants who received at least 1 dose of study drug
    [9] - Intention-to-treat population: all participants who received at least 1 dose of study drug
    [10] - Intention-to-treat population: all participants who received at least 1 dose of study drug
    [11] - Intention-to-treat population: all participants who received at least 1 dose of study drug
    No statistical analyses for this end point

    Secondary: Percentage of participants with on-treatment virologic failure

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    End point title
    		 Percentage of participants with on-treatment virologic failure
    End point description
    The percentage of participants with on-treatment virologic failure (defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment), confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    Screening, Day 1, Day 3, treatment weeks 1, 2, 4, 6, 8, 10, and 12 or premature discontinuation from treatment
    End point values
    		 Arm A Arm B Arm F Arm I Arm K
    Number of subjects analysed
    40 [12]
    39 [13]
    27 [14]
    34 [15]
    34 [16]
    Units: percentage of participants
        number (confidence interval 95%)
    0 (0 to 8.8)
    0 (0 to 9)
    0 (0 to 12.5)
    0 (0 to 10.2)
    0 (0 to 10.2)
    Notes
    [12] - Intention-to-treat population: all participants who received at least 1 dose of study drug
    [13] - Intention-to-treat population: all participants who received at least 1 dose of study drug
    [14] - Intention-to-treat population: all participants who received at least 1 dose of study drug
    [15] - Intention-to-treat population: all participants who received at least 1 dose of study drug
    [16] - Intention-to-treat population: all participants who received at least 1 dose of study drug
    No statistical analyses for this end point

    Secondary: Percentage of participants with post-treatment relapse

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    End point title
    		 Percentage of participants with post-treatment relapse
    End point description
    Post-treatment relapse was defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
    End point type
    Secondary
    End point timeframe
    From the end of treatment through 12 weeks after the last dose of study drug
    End point values
    		 Arm A Arm B Arm F Arm I Arm K
    Number of subjects analysed
    40 [17]
    38 [18]
    27 [19]
    34 [20]
    33 [21]
    Units: percentage of participants
        number (confidence interval 95%)
    0 (0 to 8.8)
    2.6 (0.5 to 13.5)
    3.7 (0.7 to 18.3)
    0 (0 to 10.2)
    0 (0 to 10.4)
    Notes
    [17] - Participants who rcvd ≥ 1 dose of study drug, completed trt, and had HCV RNA <LLOQ at last trt visit
    [18] - Participants who rcvd ≥ 1 dose of study drug, completed trt, and had HCV RNA <LLOQ at last trt visit
    [19] - Participants who rcvd ≥ 1 dose of study drug, completed trt, and had HCV RNA <LLOQ at last trt visit
    [20] - Participants who rcvd ≥ 1 dose of study drug, completed trt, and had HCV RNA <LLOQ at last trt visit
    [21] - Participants who rcvd ≥ 1 dose of study drug, completed trt, and had HCV RNA <LLOQ at last trt visit
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks.
    Adverse event reporting additional description
    Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis. Two subjects in Arm I received the incorrect dose of study drug (ABT-493 200 mg instead of 300 mg) and included in Arm A instead of Arm I in the safety population.

    Reporting group title
    Arm B
    Reporting group description
    		 ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis

    Reporting group title
    Arm F
    Reporting group description
    		 ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis

    Reporting group title
    Arm I
    Reporting group description
    		 ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6- infected participants without cirrhosis

    Reporting group title
    Arm K
    Reporting group description
    		 ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis

    Serious adverse events
    		 Arm A Arm B Arm F Arm I Arm K
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 39 (0.00%)
    1 / 27 (3.70%)
    0 / 32 (0.00%)
    1 / 34 (2.94%)
         number of deaths (all causes)
    1
    0
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 27 (0.00%)
    0 / 32 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Prostate cancer metastatic
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 39 (0.00%)
    0 / 27 (0.00%)
    0 / 32 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    1 / 27 (3.70%)
    0 / 32 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm A Arm B Arm F Arm I Arm K
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 42 (52.38%)
    22 / 39 (56.41%)
    9 / 27 (33.33%)
    20 / 32 (62.50%)
    19 / 34 (55.88%)
    Injury, poisoning and procedural complications
    Muscle strain
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    2 / 27 (7.41%)
    1 / 32 (3.13%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    2
    1
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 42 (4.76%)
    2 / 39 (5.13%)
    0 / 27 (0.00%)
    2 / 32 (6.25%)
    1 / 34 (2.94%)
         occurrences all number
    2
    2
    0
    2
    1
    Headache
         subjects affected / exposed
    5 / 42 (11.90%)
    8 / 39 (20.51%)
    3 / 27 (11.11%)
    8 / 32 (25.00%)
    1 / 34 (2.94%)
         occurrences all number
    6
    10
    3
    8
    1
    Memory impairment
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 39 (5.13%)
    0 / 27 (0.00%)
    0 / 32 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Paraesthesia
         subjects affected / exposed
    1 / 42 (2.38%)
    2 / 39 (5.13%)
    0 / 27 (0.00%)
    0 / 32 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    10 / 42 (23.81%)
    5 / 39 (12.82%)
    3 / 27 (11.11%)
    3 / 32 (9.38%)
    6 / 34 (17.65%)
         occurrences all number
    10
    6
    3
    3
    6
    Pain
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 39 (2.56%)
    0 / 27 (0.00%)
    1 / 32 (3.13%)
    2 / 34 (5.88%)
         occurrences all number
    1
    1
    0
    1
    2
    Pyrexia
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 39 (2.56%)
    0 / 27 (0.00%)
    0 / 32 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    3
    1
    0
    0
    0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 39 (2.56%)
    0 / 27 (0.00%)
    2 / 32 (6.25%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 27 (0.00%)
    1 / 32 (3.13%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    0
    1
    2
    Diarrhoea
         subjects affected / exposed
    3 / 42 (7.14%)
    3 / 39 (7.69%)
    1 / 27 (3.70%)
    5 / 32 (15.63%)
    3 / 34 (8.82%)
         occurrences all number
    3
    3
    1
    5
    3
    Dry mouth
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 27 (0.00%)
    2 / 32 (6.25%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Flatulence
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 39 (0.00%)
    0 / 27 (0.00%)
    2 / 32 (6.25%)
    0 / 34 (0.00%)
         occurrences all number
    3
    0
    0
    2
    0
    Nausea
         subjects affected / exposed
    5 / 42 (11.90%)
    8 / 39 (20.51%)
    0 / 27 (0.00%)
    3 / 32 (9.38%)
    3 / 34 (8.82%)
         occurrences all number
    5
    8
    0
    3
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 39 (0.00%)
    0 / 27 (0.00%)
    1 / 32 (3.13%)
    3 / 34 (8.82%)
         occurrences all number
    2
    0
    0
    1
    3
    Paranasal sinus discomfort
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 27 (0.00%)
    0 / 32 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    0
    0
    2
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 39 (0.00%)
    0 / 27 (0.00%)
    0 / 32 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    1
    0
    0
    0
    3
    Pruritus
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 39 (2.56%)
    2 / 27 (7.41%)
    1 / 32 (3.13%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    2
    1
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 42 (4.76%)
    3 / 39 (7.69%)
    0 / 27 (0.00%)
    0 / 32 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    2
    3
    0
    0
    1
    Depression
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 39 (0.00%)
    1 / 27 (3.70%)
    2 / 32 (6.25%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    1
    2
    0
    Insomnia
         subjects affected / exposed
    1 / 42 (2.38%)
    3 / 39 (7.69%)
    0 / 27 (0.00%)
    1 / 32 (3.13%)
    2 / 34 (5.88%)
         occurrences all number
    1
    3
    0
    1
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 39 (2.56%)
    0 / 27 (0.00%)
    3 / 32 (9.38%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    0
    3
    1
    Back pain
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 39 (2.56%)
    1 / 27 (3.70%)
    0 / 32 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    1
    1
    1
    0
    2
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 39 (2.56%)
    2 / 27 (7.41%)
    1 / 32 (3.13%)
    1 / 34 (2.94%)
         occurrences all number
    2
    1
    2
    1
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 39 (2.56%)
    0 / 27 (0.00%)
    0 / 32 (0.00%)
    3 / 34 (8.82%)
         occurrences all number
    1
    1
    0
    0
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    1 / 27 (3.70%)
    1 / 32 (3.13%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    1
    1
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Aug 2014
    Amendment 1 (multinational)  Added treatment Arm B to include alternate dose of ABT-530.  Extended Screening Period duration from 35 to 42 days.  Revised the time period for contraception use in inclusion criteria.
    02 Dec 2014
    Amendment 1.01 (multinational)  Added Part 2 including chronic HCV GT1-infected subjects without cirrhosis (8-week treatment duration), HCV GT1-infected subjects with compensated cirrhosis (12-week treatment duration), and HCV GT4-, GT5-, and GT6-infected subjects without cirrhosis (12-week treatment duration), based on the safety and efficacy results from the initial two arms (Part 1, Arms A and B) of the study.  Updated Inclusion Criteria 10 and 11 to enhance the criteria for defining absence of cirrhosis based on FibroTest and aminotransferase/platelet ratio index (APRI) scores.  Updated Resistance Analyses to include phylogenetic analysis of viral subtypes to determine/confirm subtypes of HCV GT4, 5, or 6, so that treatment efficacy could be compared across different subtypes.
    23 Feb 2015
    Amendment 1.02 (US/Puerto Rico)  Added Arm K.  Added a potential method (deep sequencing) to sequence HCV samples.
    12 Mar 2015
    Amendment 1.03 (UK)  Clarified the definition of total abstinence.  Specified all contraceptive methods.  Clarified period of AE collection after completion of study treatment.
    06 Apr 2015
    Amendment 1.01.01 (multinational)  Replaced dose of ABT-493 200 mg with 300 mg in Arm I.  Updated the randomization methods of the population of subjects with compensated cirrhosis in the event that less than 4 arms were opened for enrollment.  Included subjects who were on stable chronic opioid maintenance therapy.  Updated the Toxicity Management section.  Updated results for Part 1 of the study with preliminary safety and efficacy data that would be utilized for the enablement criteria for Part 2.  Clarified that any past historical liver biopsy demonstrating cirrhosis was acceptable, and no further testing was necessary at a later time.
    06 Apr 2015
    Amendment 1.02.01 (US/Puerto Rico)  Implemented the same changes from multinational Amendment 1.01.01 into the US/Puerto Rico-only protocol (Amendment 1.02)
    06 Apr 2015
    Amendment 1.03.01 (UK)  Implemented the same changes from multinational Amendment 1.01.01 into the UK-only protocol (Amendment 1.03).

    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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