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    Clinical Trial Results:
    A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults with Chronic Hepatitis C Virus Genotype 1 Infection (ENDURANCE-1)

    Summary
    EudraCT number
    		 2015-002087-17
    Trial protocol
    		 HU   PT   BE   AT   SE   DE   LT   ES   PL   GB   IT  
    Global end of trial date
    06 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Dec 2017
    First version publication date
    07 Dec 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M13-590
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02604017
    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
    Federico Mensa, Abbvie, federico.mensa@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
    06 Jan 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study seeks to evaluate the efficacy and safety of ABT-493/ABT-530 in subjects with Genotype 1 hepatitis C virus infection without cirrhosis
    Protection of trial subjects
    Subjects read and understood the information provided about the study and gave written permission.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Oct 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 39
    Country: Number of subjects enrolled
    Portugal: 21
    Country: Number of subjects enrolled
    Romania: 41
    Country: Number of subjects enrolled
    Spain: 34
    Country: Number of subjects enrolled
    Sweden: 6
    Country: Number of subjects enrolled
    United Kingdom: 28
    Country: Number of subjects enrolled
    Austria: 24
    Country: Number of subjects enrolled
    Belgium: 38
    Country: Number of subjects enrolled
    France: 25
    Country: Number of subjects enrolled
    Germany: 24
    Country: Number of subjects enrolled
    Hungary: 36
    Country: Number of subjects enrolled
    Lithuania: 6
    Country: Number of subjects enrolled
    Australia: 37
    Country: Number of subjects enrolled
    Canada: 46
    Country: Number of subjects enrolled
    Chile: 30
    Country: Number of subjects enrolled
    Israel: 34
    Country: Number of subjects enrolled
    Korea, Republic of: 35
    Country: Number of subjects enrolled
    Mexico: 5
    Country: Number of subjects enrolled
    New Zealand: 6
    Country: Number of subjects enrolled
    Puerto Rico: 24
    Country: Number of subjects enrolled
    Switzerland: 27
    Country: Number of subjects enrolled
    Taiwan: 35
    Country: Number of subjects enrolled
    United States: 72
    Country: Number of subjects enrolled
    Italy: 31
    Worldwide total number of subjects
    704
    EEA total number of subjects
    353
    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)
    627
    From 65 to 84 years
    77
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 This study included a 35-day screening period.

    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-493/ABT-530 for 12 weeks
    Arm description
    		 ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-493/ABT-530
    Investigational medicinal product code
    Other name
    ABT-493 also known as glecaprevir, ABT-530 also known as pibrentasvir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet; ABT-493 coformulated with ABT-530

    Arm title
    		 ABT-493/ABT-530 for 8 weeks
    Arm description
    		 ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-493/ABT-530
    Investigational medicinal product code
    Other name
    ABT-493 also known as glecaprevir, ABT-530 also known as pibrentasvir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet; ABT-493 coformulated with ABT-530

    Number of subjects in period 1 [1]
    		ABT-493/ABT-530 for 12 weeks ABT-493/ABT-530 for 8 weeks
    Started
    352
    351
    Completed
    346
    343
    Not completed
    6
    8
         Not specified
    1
    -
         Lost to follow-up
    5
    6
         Withdrew consent
    -
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 704 subjects were randomized; 1 subject did not receive at least 1 dose of study drug and was excluded from the analyses.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ABT-493/ABT-530 for 12 weeks
    Reporting group description
    		 ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.

    Reporting group title
    ABT-493/ABT-530 for 8 weeks
    Reporting group description
    		 ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.

    Reporting group values
    		 ABT-493/ABT-530 for 12 weeks ABT-493/ABT-530 for 8 weeks Total
    Number of subjects
    		 352 351 703
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50.27 ± 11.62 51.58 ± 11.9 -
    Gender categorical
    Units: Subjects
        Female
    		 176 184 360
        Male
    		 176 167 343

    End points

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    End points reporting groups
    Reporting group title
    ABT-493/ABT-530 for 12 weeks
    Reporting group description
    		 ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.

    Reporting group title
    ABT-493/ABT-530 for 8 weeks
    Reporting group description
    		 ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.

    Primary: Percentage of Subjects With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Mono-infected Hepatitis C Virus Genotype 1 (HCV GT1), Direct-acting Antiviral Agent (DAA) Naïve Subjects in the 12-Week Treatment Arm

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    End point title
    		 Percentage of Subjects With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Mono-infected Hepatitis C Virus Genotype 1 (HCV GT1), Direct-acting Antiviral Agent (DAA) Naïve Subjects in the 12-Week Treatment Arm [1] [2]
    End point description
    SVR12 was defined as 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. The primary efficacy endpoint was noninferiority of the percentage of subjects who achieved SVR12 in the 12-week treatment group compared with the historical control rate for HCV GT1 subjects who are treatment-naïve current standard of care (ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin [3D ± RBV] or previous standard of care (sofosbuvir/ledipasvir [SOF/LDV]). Subjects with missing data after backwards imputation were imputed as nonresponders. Based on a 2-sided significance level of 0.05 and an underlying rate of ≥97% in the 12-week arm, 270 subjects provides >90% power to demonstrate noninferiority with a noninferiority margin of 6% (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 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 lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of subjects with SVR12 must exceed 91% to achieve noninferiority.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint compared the percentage of subjects with SVR12 in the 12-week arm with an historical control per protocol.
    End point values
    		 ABT-493/ABT-530 for 12 weeks
    Number of subjects analysed
    332 [3]
    Units: percentage of subjects
        number (confidence interval 95%)
    99.7 (99.1 to 100)
    Notes
    [3] - All subjects in the ITT population who were mono-infected HCV GT1, DAA-naïve
    No statistical analyses for this end point

    Primary: Percentage of Subjects With SVR12: Noninferiority of 8-Week Arm to 12-Week Arm in Mono-infected HCV GT1, DAA-Naïve Subjects, Excluding Those Who Discontinued/Experienced Virologic Failure by Week 8 or Had No HCV RNA Value at Week 12 or Later

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    End point title
    		 Percentage of Subjects With SVR12: Noninferiority of 8-Week Arm to 12-Week Arm in Mono-infected HCV GT1, DAA-Naïve Subjects, Excluding Those Who Discontinued/Experienced Virologic Failure by Week 8 or Had No HCV RNA Value at Week 12 or Later
    End point description
    SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of mono-infected HCV GT1, DAA-naïve subjects (excluding those who discontinued/experienced virologic failure by Week 8 or had no HCV RNA value at Week 12 or later) who achieved SVR12 in the 8-week treatment arm compared with the 12-week treatment arm. Subjects with missing data after backwards imputation were imputed as nonresponders.
    End point type
    Primary
    End point timeframe
    12 weeks after last actual dose of study drug
    End point values
    		 ABT-493/ABT-530 for 12 weeks ABT-493/ABT-530 for 8 weeks
    Number of subjects analysed
    331 [4]
    332 [5]
    Units: percentage of subjects
        number (confidence interval 95%)
    100 (98.9 to 100)
    100 (98.9 to 100)
    Notes
    [4] - ITT population;HCV GT1;DAA-naïve;exclude discontinued/virologic failure ≤Week 8/no HCV RNA ≥Week 12
    [5] - ITT population;HCV GT1;DAA-naïve;exclude discontinued/virologic failure ≤Week 8/no HCV RNA ≥Week 12
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Based on a 2-sided significance level of 0.05 and an -5% noninferiority margin and an underlying rate of ≥97% in the 8-week arm (270 subjects) and ≥97% in the 12-week arm (270 subjects) provides >90% power to demonstrate noninferiority of the 8-week arm to the 12-week arm.
    Comparison groups
    ABT-493/ABT-530 for 12 weeks v ABT-493/ABT-530 for 8 weeks
    Number of subjects included in analysis
    663
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    Parameter type
    		 Difference in percentage of subjects
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 1.1
    Notes
    [6] - The noninferiority of the rate of SVR12 for the 8-week treatment group as compared with the 12-week treatment group was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the difference in percentage of subjects with SVR12 (8-week group minus 12-week group) must be above -5% to achieve noninferiority.

    Primary: Percentage of Subjects With SVR12: Noninferiority of 8-Week Treatment Arm to 12-Week Treatment Arm in Mono-infected HCV GT1, DAA-Naïve Subjects

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    End point title
    		 Percentage of Subjects With SVR12: Noninferiority of 8-Week Treatment Arm to 12-Week Treatment Arm in Mono-infected HCV GT1, DAA-Naïve Subjects
    End point description
    SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of mono-infected HCV GT1, DAA-naïve subjects who achieved SVR12 in the 8-week treatment arm compared with the 12-week treatment arm. Subjects with missing data after backwards imputation were imputed as nonresponders.
    End point type
    Primary
    End point timeframe
    12 weeks after the last actual dose of study drug
    End point values
    		 ABT-493/ABT-530 for 12 weeks ABT-493/ABT-530 for 8 weeks
    Number of subjects analysed
    332 [7]
    335 [8]
    Units: percentage of subjects
        number (confidence interval 95%)
    99.7 (99.1 to 100)
    99.1 (98.1 to 100)
    Notes
    [7] - All subjects in the ITT population who were mono-infected HCV GT1, DAA-naïve
    [8] - All subjects in the ITT population who were mono-infected HCV GT1, DAA-naïve
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Based on a 2-sided significance level of 0.05 and a -5% noninferiority margin, and an underlying rate of ≥97% in the 8-week arm (270 subjects) and ≥97% in the 12-week arm (270 subjects) provides >90% power to demonstrate noninferiority of the 8-week arm to the 12-week arm.
    Comparison groups
    ABT-493/ABT-530 for 12 weeks v ABT-493/ABT-530 for 8 weeks
    Number of subjects included in analysis
    667
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [9]
    Method
    Parameter type
    		 Difference in percentage of subjects
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 0.6
    Notes
    [9] - The noninferiority of the rate of SVR12 for the 8-week treatment group as compared with the 12-week treatment group was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the difference in percentage of subjects with SVR12 must be above -5% to achieve noninferiority.

    Secondary: Percentage of Subjects With SVR12 in Mono-infected HCV GT1 Subjects

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    End point title
    		 Percentage of Subjects With SVR12 in Mono-infected HCV GT1 Subjects
    End point description
    SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. Subjects with missing data after backwards imputation were imputed as nonresponders.
    End point type
    Secondary
    End point timeframe
    12 weeks after last actual dose of study drug
    End point values
    		 ABT-493/ABT-530 for 12 weeks ABT-493/ABT-530 for 8 weeks
    Number of subjects analysed
    334 [10]
    336 [11]
    Units: percentage of subjects
        number (confidence interval 95%)
    99.7 (98.3 to 99.9)
    99.1 (97.4 to 99.7)
    Notes
    [10] - All subjects in the ITT population who were mono-infected HCV GT1
    [11] - All subjects in the ITT population who were mono-infected HCV GT1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With SVR12

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    End point title
    		 Percentage of Subjects With SVR12
    End point description
    SVR12 was defined as plasma HCV RNA level less than the <LLOQ 12 weeks after the last dose of study drug. Subjects with missing data after backwards imputation were imputed as nonresponders.
    End point type
    Secondary
    End point timeframe
    12 weeks after last actual dose of study drug
    End point values
    		 ABT-493/ABT-530 for 12 weeks ABT-493/ABT-530 for 8 weeks
    Number of subjects analysed
    352 [12]
    351 [13]
    Units: percentage of subjects
        number (confidence interval 95%)
    99.7 (98.4 to 99.9)
    99.1 (97.5 to 99.7)
    Notes
    [12] - All subjects in the ITT population
    [13] - All subjects in the ITT population
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With SVR12 in Co-infected HCV GT1/Human Immununovirus Type 1 (HIV-1) Subjects

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    End point title
    		 Percentage of Subjects With SVR12 in Co-infected HCV GT1/Human Immununovirus Type 1 (HIV-1) Subjects
    End point description
    SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. Subjects with missing data after backwards imputation were imputed as nonresponders.
    End point type
    Secondary
    End point timeframe
    12 weeks after last actual dose of study drug
    End point values
    		 ABT-493/ABT-530 for 12 weeks ABT-493/ABT-530 for 8 weeks
    Number of subjects analysed
    18 [14]
    15 [15]
    Units: percentage of subjects
        number (confidence interval 95%)
    100 (82.4 to 100)
    100 (79.6 to 100)
    Notes
    [14] - All subjects in the ITT population who were co-infected HCV GT1/HIV-1
    [15] - All subjects in the ITT population who were co-infected HCV GT1/HIV-1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With SVR12 in HCV GT1-infected, Prior Sofosbuvir (SOF) Treatment-Experienced Subjects

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    End point title
    		 Percentage of Subjects With SVR12 in HCV GT1-infected, Prior Sofosbuvir (SOF) Treatment-Experienced Subjects
    End point description
    SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. Subjects with missing data after backwards imputation were imputed as nonresponders.
    End point type
    Secondary
    End point timeframe
    12 weeks after last actual dose of study drug
    End point values
    		 ABT-493/ABT-530 for 12 weeks ABT-493/ABT-530 for 8 weeks
    Number of subjects analysed
    2 [16]
    1 [17]
    Units: percentage of subjects
        number (confidence interval 95%)
    100 (34.2 to 100)
    100 (20.7 to 100)
    Notes
    [16] - All subjects in the ITT population who were HCV GT1-infected, prior SOF-treatment experienced
    [17] - All subjects in the ITT population who were HCV GT1-infected, prior SOF-treatment experienced
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With On-treatment Virologic Failure

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    End point title
    		 Percentage of Subjects With On-treatment Virologic Failure
    End point description
    On-treatment virologic failure was defined as confirmed increase of >1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥100 IU/mL after HCV RNA <LLOQ during treatment, or HCV RNA ≥LLOQ at end of treatment with at least 6 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment
    End point values
    		 ABT-493/ABT-530 for 12 weeks ABT-493/ABT-530 for 8 weeks
    Number of subjects analysed
    352 [18]
    351 [19]
    Units: percentage of subjects
        number (confidence interval 95%)
    0 (0 to 1.1)
    0.3 (0.1 to 1.6)
    Notes
    [18] - All subjects in the ITT population
    [19] - All subjects in the ITT population
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With On-treatment Virologic Failure in Mono-infected HCV GT1, DAA-Naïve Subjects

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    End point title
    		 Percentage of Subjects With On-treatment Virologic Failure in Mono-infected HCV GT1, DAA-Naïve Subjects
    End point description
    On-treatment virologic failure was defined as confirmed increase of >1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥100 IU/mL after HCV RNA <LLOQ during treatment, or HCV RNA ≥LLOQ at end of treatment with at least 6 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment
    End point values
    		 ABT-493/ABT-530 for 12 weeks ABT-493/ABT-530 for 8 weeks
    Number of subjects analysed
    332 [20]
    335 [21]
    Units: percentage of subjects
        number (confidence interval 95%)
    0 (0 to 1.1)
    0.3 (0.1 to 1.7)
    Notes
    [20] - All subjects in the ITT population who were mono-infected HCV GT1, DAA-naïve
    [21] - All subjects in the ITT population who were mono-infected HCV GT1, DAA-naïve
    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
    Post-treatment relapse was defined as confirmed HCV RNA ≥LLOQ between the end of treatment and 12 weeks after the last dose of study drug among subjects 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
    		 ABT-493/ABT-530 for 12 weeks ABT-493/ABT-530 for 8 weeks
    Number of subjects analysed
    352 [22]
    349 [23]
    Units: percentage of subjects
        number (confidence interval 95%)
    0 (0 to 1.1)
    0 (0 to 1.1)
    Notes
    [22] - All subjects who received ≥1 dose study drug; completed treatment; HCV RNA <LLOQ at end of treatment
    [23] - All subjects who received ≥1 dose study drug; completed treatment; HCV RNA <LLOQ at end of treatment
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Post-treatment Relapse in Mono-infected HCV GT1, DAA-Naïve Subjects

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    End point title
    		 Percentage of Subjects With Post-treatment Relapse in Mono-infected HCV GT1, DAA-Naïve Subjects
    End point description
    Post-treatment relapse was defined as confirmed HCV RNA ≥LLOQ between the end of treatment and 12 weeks after the last dose of study drug among mono-infected HCV GT1, DAA-naïve subjects 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
    		 ABT-493/ABT-530 for 12 weeks ABT-493/ABT-530 for 8 weeks
    Number of subjects analysed
    332 [24]
    333 [25]
    Units: percentage of subjects
        number (confidence interval 95%)
    0 (0 to 1.1)
    0 (0 to 1.1)
    Notes
    [24] - All subjects who received ≥1 dose study drug; completed treatment; HCV RNA <LLOQ at end of treatment
    [25] - All subjects who received ≥1 dose study drug; completed treatment; HCV RNA <LLOQ at end of treatment
    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) and serious adverse events (TESAEs) 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
    TEAEs and TESAEs are defined as any adverse event (AE) with an onset or worsening date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the subject.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    ABT-493/ABT-530 for 12 Weeks
    Reporting group description
    		 ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.

    Reporting group title
    ABT-493/ABT-530 for 8 Weeks
    Reporting group description
    		 ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.

    Serious adverse events
    		 ABT-493/ABT-530 for 12 Weeks ABT-493/ABT-530 for 8 Weeks
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 352 (1.14%)
    5 / 351 (1.42%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    0 / 352 (0.00%)
    1 / 351 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    1 / 352 (0.28%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Arterial injury
         subjects affected / exposed
    0 / 352 (0.00%)
    1 / 351 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 352 (0.00%)
    1 / 351 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 352 (0.28%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    0 / 352 (0.00%)
    1 / 351 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 352 (0.28%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    0 / 352 (0.00%)
    1 / 351 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 352 (0.28%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia aspiration
         subjects affected / exposed
    1 / 352 (0.28%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    0 / 352 (0.00%)
    1 / 351 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 352 (0.28%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ABT-493/ABT-530 for 12 Weeks ABT-493/ABT-530 for 8 Weeks
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    130 / 352 (36.93%)
    133 / 351 (37.89%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    62 / 352 (17.61%)
    68 / 351 (19.37%)
         occurrences all number
    72
    73
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    43 / 352 (12.22%)
    31 / 351 (8.83%)
         occurrences all number
    45
    31
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    29 / 352 (8.24%)
    19 / 351 (5.41%)
         occurrences all number
    30
    20
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    17 / 352 (4.83%)
    20 / 351 (5.70%)
         occurrences all number
    17
    20
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    15 / 352 (4.26%)
    21 / 351 (5.98%)
         occurrences all number
    16
    23
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    31 / 352 (8.81%)
    22 / 351 (6.27%)
         occurrences all number
    32
    24

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Dec 2015
    The main purpose of this amendment was to evaluation of hepatitis C virus (HCV) genotype 1 (GT1)-infected non-cirrhotic subjects who are co-infected with human immununovirus type 1 (HIV-1) and/or sofosbuvir (SOF)-experienced plus ribivarin (RBV) with or without pegylated IFN (pegIFN) (SOF plus RBV ± pegIFN), and to clarify the time period for avoiding pregnancy and methods of contraception.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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