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    Clinical Trial Results:
    An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Combination With Sofosbuvir and Ribavirin in Chronic Hepatitis C (HCV) Infected Subjects Who Have Experienced Virologic Failure in AbbVie HCV Clinical Studies (MAGELLAN-3)

    Summary
    EudraCT number
    2016-002491-26
    Trial protocol
    GB   SE   ES   DE  
    Global end of trial date
    30 Jul 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    06 Feb 2022
    First version publication date
    06 Feb 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M15-942
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02939989
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AbbVie
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6 4UB
    Public contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@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
    30 Jul 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jul 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study were to assess the efficacy by evaluating the percentage of subjects achieving sustained virologic response 12 weeks postdosing (SVR12) in each treatment arm and safety of glecaprevir/pibrentasvir (GLE/PIB) plus sofosbuvir (SOF) and ribavirin (RBV) in adults or adolescents with chronic HCV genotype 1-6 infection who previously failed HCV treatment in an AbbVie HCV Parent Study.
    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
    21 Nov 2016
    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
    Australia: 2
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    China: 4
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Korea, Republic of: 1
    Country: Number of subjects enrolled
    New Zealand: 6
    Country: Number of subjects enrolled
    Russian Federation: 1
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Sweden: 1
    Country: Number of subjects enrolled
    Switzerland: 2
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    United States: 11
    Worldwide total number of subjects
    33
    EEA total number of subjects
    4
    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)
    26
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants with hepatitis C virus (HCV) genotypes (GT) 1–6 infection who had virologic failure while participating in an AbbVie HCV Parent Study were enrolled at 26 sites in 12 countries.

    Pre-assignment
    Screening details
    Participants were allocated to 1 of 2 treatment arms based on HCV GT, cirrhosis status, and treatment experience with protease inhibitor (PI) and/or nonstructural viral protein 5A protease inhibitor (NS5Ai)-containing regimens prior to enrolling in the AbbVie HCV Parent Study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Glecaprevir/Pibrentasvir + SOF + RBV for 12 weeks
    Arm description
    Participants without cirrhosis who had non-genotype 3 infection and were naïve to PI and NS5Ai prior to participation in AbbVie HCV parent study received daily treatment with glecaprevir/pibrentasvir (GLE/PIB) 300 mg/120 mg plus sofosbuvir (SOF) 400 mg plus twice-daily weight-based ribavirin (RBV) 600 mg - 1200 mg daily total for 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Glecaprevir/Pibrentasvir
    Investigational medicinal product code
    ABT-493/ABT-530
    Other name
    MAVYRET, MAVIRET
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Glecaprevir/pibrentasvir co-formulated film-coated tablets taken orally once a day for a total daily dose of 300 mg/120 mg.

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    SOVALDI
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sofosbuvir 400 mg film-coated tablet taken orally once a day.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin film-coated tablets taken orally twice a day for a total daily dose of 600 mg to 1200 mg based on the participant's age and body weight at Baseline.

    Arm title
    Glecaprevir/Pibrentasvir + SOF + RBV for 16 weeks
    Arm description
    Participants with genotype 3, and/or compensated cirrhosis, and/or experience with PI and/or NS5Ai prior to participation in Abbvie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 16 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Glecaprevir/Pibrentasvir
    Investigational medicinal product code
    ABT-493/ABT-530
    Other name
    MAVYRET, MAVIRET
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Glecaprevir/pibrentasvir co-formulated film-coated tablets taken orally once a day for a total daily dose of 300 mg/120 mg.

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    SOVALDI
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sofosbuvir 400 mg film-coated tablet taken orally once a day.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin film-coated tablets taken orally twice a day for a total daily dose of 600 mg to 1200 mg based on the participant's age and body weight at Baseline.

    Number of subjects in period 1
    Glecaprevir/Pibrentasvir + SOF + RBV for 12 weeks Glecaprevir/Pibrentasvir + SOF + RBV for 16 weeks
    Started
    5
    28
    Completed
    5
    28

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Glecaprevir/Pibrentasvir + SOF + RBV for 12 weeks
    Reporting group description
    Participants without cirrhosis who had non-genotype 3 infection and were naïve to PI and NS5Ai prior to participation in AbbVie HCV parent study received daily treatment with glecaprevir/pibrentasvir (GLE/PIB) 300 mg/120 mg plus sofosbuvir (SOF) 400 mg plus twice-daily weight-based ribavirin (RBV) 600 mg - 1200 mg daily total for 12 weeks.

    Reporting group title
    Glecaprevir/Pibrentasvir + SOF + RBV for 16 weeks
    Reporting group description
    Participants with genotype 3, and/or compensated cirrhosis, and/or experience with PI and/or NS5Ai prior to participation in Abbvie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 16 weeks.

    Reporting group values
    Glecaprevir/Pibrentasvir + SOF + RBV for 12 weeks Glecaprevir/Pibrentasvir + SOF + RBV for 16 weeks Total
    Number of subjects
    5 28 33
    Age categorical
    Units: Subjects
        < 65 years old
    3 23 26
        ≥ 65 years old
    2 5 7
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    59.6 ± 8.08 54.3 ± 9.35 -
    Gender categorical
    Units: Subjects
        Female
    1 4 5
        Male
    4 24 28
    Race
    Units: Subjects
        White
    3 22 25
        Black or African American
    0 1 1
        Asian
    2 5 7
        American Indian or Alaska Native
    0 0 0
        Native Hawaiian or Other Pacific Islander
    0 0 0
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    0 2 2
        Not Hispanic or Latino
    5 26 31
    HCV Genotype
    Units: Subjects
        Genotype 1
    1 7 8
        Genotype 2
    4 0 4
        Genotype 3
    0 19 19
        Genotype 4
    0 1 1
        Genotype 5
    0 0 0
        Genotype 6
    0 1 1
    Treatment Regimen Received in AbbVie HCV Parent Study
    GLE/PIB = glecaprevir/pibrentasvir; OBV/PTV/RTV + DSV + RBV = ombitasvir/paritaprevir/ritonavir + dasabuvir (VIEKIRAX and EXVIERA) + ribavirin
    Units: Subjects
        GLE/PIB
    4 28 32
        OBV/PTV/RTV + DSV + RBV
    1 0 1
    Treatment Response for AbbVie HCV Parent Study
    Units: Subjects
        On-treatment non-responder
    0 10 10
        Breakthrough
    0 0 0
        Post-treatment relapse
    5 18 23
    HCV Ribonucleic Acid (RNA) Level
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    6.79 ± 0.217 6.23 ± 0.958 -

    End points

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    End points reporting groups
    Reporting group title
    Glecaprevir/Pibrentasvir + SOF + RBV for 12 weeks
    Reporting group description
    Participants without cirrhosis who had non-genotype 3 infection and were naïve to PI and NS5Ai prior to participation in AbbVie HCV parent study received daily treatment with glecaprevir/pibrentasvir (GLE/PIB) 300 mg/120 mg plus sofosbuvir (SOF) 400 mg plus twice-daily weight-based ribavirin (RBV) 600 mg - 1200 mg daily total for 12 weeks.

    Reporting group title
    Glecaprevir/Pibrentasvir + SOF + RBV for 16 weeks
    Reporting group description
    Participants with genotype 3, and/or compensated cirrhosis, and/or experience with PI and/or NS5Ai prior to participation in Abbvie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 16 weeks.

    Subject analysis set title
    Total
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Participants received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 12 or 16 weeks.

    Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

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    End point title
    Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [1]
    End point description
    SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug. Assessed in the intention-to-treat (ITT) population, which included all patients who received at least 1 dose of study drugs. A backward imputation method was used to impute missing responses. Participants with missing data after backward imputation were counted as non-responders.
    End point type
    Primary
    End point timeframe
    12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen.
    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: No formal hypothesis was tested in this study, and comparisons between treatment groups were not planned or conducted.
    End point values
    Glecaprevir/Pibrentasvir + SOF + RBV for 12 weeks Glecaprevir/Pibrentasvir + SOF + RBV for 16 weeks Total
    Number of subjects analysed
    5
    28
    33
    Units: percentage of participants
        number (confidence interval 95%)
    100.0 (56.6 to 100.0)
    96.4 (82.3 to 99.4)
    97.0 (84.7 to 99.5)
    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
    On-treatment virologic failure was defined as meeting one of the following: • confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) at any time point during the treatment period; or • confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA < 15 IU/mL during the treatment period, or • HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    12 or 16 weeks depending on the treatment regimen
    End point values
    Glecaprevir/Pibrentasvir + SOF + RBV for 12 weeks Glecaprevir/Pibrentasvir + SOF + RBV for 16 weeks Total
    Number of subjects analysed
    5
    28
    33
    Units: percentage of participants
        number (confidence interval 95%)
    0 (0.0 to 43.4)
    0 (0.0 to 12.1)
    0 (0.0 to 10.4)
    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 HCV RNA greater than or equal to 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < 15 IU/mL at the end of treatment, and had post-treatment HCV RNA data; participants who had been shown to be re-infected were not considered to have relapsed.
    End point type
    Secondary
    End point timeframe
    From the end of treatment (Week 12 or 16) through 12 weeks after the last dose of study drug (Weeks 24 or 28 depending on the treatment regimen).
    End point values
    Glecaprevir/Pibrentasvir + SOF + RBV for 12 weeks Glecaprevir/Pibrentasvir + SOF + RBV for 16 weeks Total
    Number of subjects analysed
    5
    28
    33
    Units: percentage of participants
        number (confidence interval 95%)
    0.0 (0.0 to 43.4)
    3.6 (0.6 to 17.7)
    3.0 (0.5 to 15.3)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug up to 30 days after last dose; up to 20 weeks.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    GLE/PIB + SOF + RBV for 12 weeks
    Reporting group description
    Participants without cirrhosis who had non-genotype 3 infection and were naïve to PI and NS5Ai prior to participation in AbbVie HCV parent study received daily treatment with glecaprevir/pibrentasvir (GLE/PIB) 300 mg/120 mg plus sofosbuvir (SOF) 400 mg plus twice-daily weight-based ribavirin (RBV) 600 mg - 1200 mg daily total for 12 weeks.

    Reporting group title
    GLE/PIB + SOF + RBV for 16 weeks
    Reporting group description
    Participants with genotype 3, and/or compensated cirrhosis, and/or experience with PI and/or NS5Ai prior to participation in Abbvie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 16 weeks.

    Reporting group title
    Total
    Reporting group description
    Participants received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 12 or 16 weeks.

    Serious adverse events
    GLE/PIB + SOF + RBV for 12 weeks GLE/PIB + SOF + RBV for 16 weeks Total
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 5 (20.00%)
    2 / 28 (7.14%)
    3 / 33 (9.09%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    BRONCHIECTASIS
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 28 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CHRONIC OBSTRUCTIVE PULMONARY DISEASE
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 28 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    ALTERED STATE OF CONSCIOUSNESS
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 28 (3.57%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    LOSS OF CONSCIOUSNESS
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 28 (3.57%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    CHRONIC GASTRITIS
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 28 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    RENAL IMPAIRMENT
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 28 (3.57%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    CHOLELITHIASIS
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 28 (3.57%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HEPATIC FUNCTION ABNORMAL
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 28 (3.57%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    PNEUMONIA BACTERIAL
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 28 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    GLE/PIB + SOF + RBV for 12 weeks GLE/PIB + SOF + RBV for 16 weeks Total
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 5 (100.00%)
    21 / 28 (75.00%)
    26 / 33 (78.79%)
    Investigations
    BLOOD BILIRUBIN INCREASED
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 28 (3.57%)
    2 / 33 (6.06%)
         occurrences all number
    1
    1
    2
    HAEMATOCRIT DECREASED
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 28 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    1
    0
    1
    LYMPHOCYTE COUNT DECREASED
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 28 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    1
    0
    1
    HAEMOGLOBIN DECREASED
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 28 (3.57%)
    2 / 33 (6.06%)
         occurrences all number
    1
    1
    2
    MEAN CELL VOLUME INCREASED
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 28 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    1
    0
    1
    WEIGHT DECREASED
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 28 (3.57%)
    2 / 33 (6.06%)
         occurrences all number
    1
    1
    2
    RED BLOOD CELL COUNT DECREASED
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 28 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    1
    0
    1
    WHITE BLOOD CELL COUNT DECREASED
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 28 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    1
    0
    1
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    0 / 5 (0.00%)
    3 / 28 (10.71%)
    3 / 33 (9.09%)
         occurrences all number
    0
    3
    3
    LARYNGEAL PAIN
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 28 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    1
    0
    1
    Nervous system disorders
    DIZZINESS
         subjects affected / exposed
    1 / 5 (20.00%)
    4 / 28 (14.29%)
    5 / 33 (15.15%)
         occurrences all number
    1
    4
    5
    HEADACHE
         subjects affected / exposed
    1 / 5 (20.00%)
    5 / 28 (17.86%)
    6 / 33 (18.18%)
         occurrences all number
    1
    6
    7
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    0 / 5 (0.00%)
    3 / 28 (10.71%)
    3 / 33 (9.09%)
         occurrences all number
    0
    3
    3
    INFLUENZA LIKE ILLNESS
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 28 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    1
    0
    1
    FATIGUE
         subjects affected / exposed
    1 / 5 (20.00%)
    3 / 28 (10.71%)
    4 / 33 (12.12%)
         occurrences all number
    1
    3
    4
    OEDEMA PERIPHERAL
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 28 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    1
    0
    1
    MALAISE
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 28 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    1
    0
    1
    Psychiatric disorders
    INSOMNIA
         subjects affected / exposed
    1 / 5 (20.00%)
    3 / 28 (10.71%)
    4 / 33 (12.12%)
         occurrences all number
    1
    3
    4
    IRRITABILITY
         subjects affected / exposed
    0 / 5 (0.00%)
    4 / 28 (14.29%)
    4 / 33 (12.12%)
         occurrences all number
    0
    4
    4
    Gastrointestinal disorders
    ABDOMINAL PAIN
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 28 (7.14%)
    2 / 33 (6.06%)
         occurrences all number
    0
    2
    2
    DRY MOUTH
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 28 (7.14%)
    2 / 33 (6.06%)
         occurrences all number
    0
    2
    2
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 28 (3.57%)
    2 / 33 (6.06%)
         occurrences all number
    1
    1
    2
    GASTRITIS
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 28 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    1
    0
    1
    VOMITING
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 28 (7.14%)
    2 / 33 (6.06%)
         occurrences all number
    0
    2
    2
    NAUSEA
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 28 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    1
    0
    1
    Skin and subcutaneous tissue disorders
    RASH
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 28 (3.57%)
    2 / 33 (6.06%)
         occurrences all number
    1
    2
    3
    PRURITUS
         subjects affected / exposed
    1 / 5 (20.00%)
    6 / 28 (21.43%)
    7 / 33 (21.21%)
         occurrences all number
    2
    6
    8
    Infections and infestations
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 5 (0.00%)
    4 / 28 (14.29%)
    4 / 33 (12.12%)
         occurrences all number
    0
    4
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Aug 2016
    Key changes included: • Added the definition of AbbVie HCV Parent Study. • Updated results from clinical studies. • Added language to enroll certain subjects at AbbVie's discretion. • Added language regarding subject enrollment and the number of subjects to be enrolled in each treatment arm. • Removed text regarding collection of samples for intensive pharmacokinetic (PK) analysis. • Updated the contraception language for male and female subjects • Revised contraception recommendations. • Updated language for pregnancy testing and liver diagnostic testing. • Added language for the HIV-1 antiretroviral (ARV) Regimen Dosing Card and the Study Drug Dosing Card. • Updated Medications and Supplements Prohibited with GLE/PIB Administration Table. • Updated contact information for AE reporting and protocol deviations. • Clarified text for toxicity management of laboratory abnormalities. • Revised sensitivity analysis language to include both Wilson score interval and normal approximation to binomial distribution for the modified intention-to-treat populations. • Revised subgroup analysis. • Updated references. • Updated collection of pregnancy testing and dosing card. • Deleted Post-Treatment Weeks 2 and 8 visits from the Post-Treatment Study Activities Table.
    06 Nov 2017
    • Added a 24-hour emergency number. • Incorporated recent approval of GLE/PIB and updated text to refer to the Investigator's Brochure. • Updated study design to allow patients with virologic failures from AbbVie's Phase 3b/4 GLE/PIB studies. • Included RBV dosing guidelines for adolescents based on baseline age and weight. • Clarified which arm subjects with mixed and unknown HCV genotypes would be enrolled. • Removed collection of dosing information for HIV ARV and collection/analysis of HIV ARV PK samples. • Updated statistical analyses to include subjects infected with more than one HCV genotype. • Clarified that the more restrictive approach to contraception between the local RBV label and the protocol should be used. • Updated list of AIDS-Defining Conditions. • Added exclusion for subjects who had documented HCV reinfection in the parent AbbVie study. • Updated guidance for medications taken during the treatment and post-treatment period. • Provided guidance for prohibited medications or supplements administered with GLE/PIB, added ethinyl estradiol. • Added progestogen to prohibited therapies section. • Updated to ensure all cirrhotic subjects had a protocol required liver ultrasound at the last post-treatment visit. • Clarified that PK samples were not to be collected on Day 1. • Clarified HCV virologic failure criteria. • Clarified when dosing was to be administered at site and use of commercial supplies. • Deleted irrelevant information regarding rationale for dose selection. • Specified minimum requirements for alanine aminotransferase (ALT) elevations and criteria for study drug discontinuation. • Replaced anti-hepatitis A virus immunoglobulin test with anti-hepatitis A virus total test. • Specified that an interim analysis may be conducted. • Specified that for high SVR12 rates less than 100%, the Wilson score test was used for calculating the 95% confidence interval in the primary analysis.

    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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