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    Clinical Trial Results:
    Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) with or Without Ribavirin for Participants with Hepatitis C Genotype 1, 4, or 6 Infections Who Have Failed Prior Treatment with Pegylated Interferon + Ribavirin

    Summary
    EudraCT number
    		 2014-000824-12
    Trial protocol
    		 DK   ES   FI   PL   NL  
    Global end of trial date
    19 Jun 2015

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    5172-068
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02105701
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Jun 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is an efficacy and safety study of grazoprevir (MK-5172) in combination with elbasvir (MK-8742) with or without ribavirin (RBV) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infections who have failed prior therapy with pegylated interferon and RBV. The primary study hypothesis is that in at least one of the study arms, the percentage of participants achieving sustained viral response 12 weeks after the end of all study treatment (SVR12) will be superior to 58%.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Jun 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
    Australia: 15
    Country: Number of subjects enrolled
    Canada: 33
    Country: Number of subjects enrolled
    Denmark: 14
    Country: Number of subjects enrolled
    Finland: 2
    Country: Number of subjects enrolled
    France: 26
    Country: Number of subjects enrolled
    Israel: 24
    Country: Number of subjects enrolled
    Korea, Republic of: 15
    Country: Number of subjects enrolled
    Malaysia: 10
    Country: Number of subjects enrolled
    Netherlands: 16
    Country: Number of subjects enrolled
    New Zealand: 11
    Country: Number of subjects enrolled
    Poland: 17
    Country: Number of subjects enrolled
    Spain: 22
    Country: Number of subjects enrolled
    Taiwan: 20
    Country: Number of subjects enrolled
    United States: 195
    Worldwide total number of subjects
    420
    EEA total number of subjects
    97
    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)
    363
    From 65 to 84 years
    57
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Female and male adult participants with HCV genotype (GT) 1, 4, or 6 were recruited.

    Pre-assignment
    Screening details
    		 The screening period lasted for up to 45 days.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Grazoprevir + Elbasvir 12 weeks
    Arm description
    		 Participants received grazoprevir 100 mg/elbasvir 50 mg fixed dose combination (FDC) tablets once daily (q.d.) by mouth for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Grazoprevir + Elbasvir FDC
    Investigational medicinal product code
    Other name
    Zepatier®; MK-5172A
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants took a FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg q.d. by mouth for 12 or 16 weeks depending on allocation.

    Arm title
    		 Grazoprevir + Elbasvir + RBV 12 weeks
    Arm description
    		 Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules twice daily (b.i.d.) by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Rebetol®
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants took 200 mg ribavirin capsules b.i.d. at a total daily dose of 800 mg to 1600 mg based on body weight for 12 or 16 weeks depending on allocation.

    Investigational medicinal product name
    Grazoprevir + Elbasvir FDC
    Investigational medicinal product code
    Other name
    Zepatier®; MK-5172A
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants took a FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg q.d. by mouth for 12 or 16 weeks depending on allocation.

    Arm title
    		 Grazoprevir + Elbasvir 16 weeks
    Arm description
    		 Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Grazoprevir + Elbasvir FDC
    Investigational medicinal product code
    Other name
    Zepatier®; MK-5172A
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants took a FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg q.d. by mouth for 12 or 16 weeks depending on allocation.

    Arm title
    		 Grazoprevir + Elbasvir + RBV 16 weeks
    Arm description
    		 Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Rebetol®
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants took 200 mg ribavirin capsules b.i.d. at a total daily dose of 800 mg to 1600 mg based on body weight for 12 or 16 weeks depending on allocation.

    Investigational medicinal product name
    Grazoprevir + Elbasvir FDC
    Investigational medicinal product code
    Other name
    Zepatier®; MK-5172A
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants took a FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg q.d. by mouth for 12 or 16 weeks depending on allocation.

    Number of subjects in period 1
    		Grazoprevir + Elbasvir 12 weeks Grazoprevir + Elbasvir + RBV 12 weeks Grazoprevir + Elbasvir 16 weeks Grazoprevir + Elbasvir + RBV 16 weeks
    Started
    105
    104
    105
    106
    Completed
    101
    103
    102
    104
    Not completed
    4
    1
    3
    2
         Adverse event, serious fatal
    1
    -
    -
    -
         Consent withdrawn by subject
    2
    1
    -
    1
         Lost to follow-up
    1
    -
    2
    1
         Protocol deviation
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Grazoprevir + Elbasvir 12 weeks
    Reporting group description
    		 Participants received grazoprevir 100 mg/elbasvir 50 mg fixed dose combination (FDC) tablets once daily (q.d.) by mouth for 12 weeks.

    Reporting group title
    Grazoprevir + Elbasvir + RBV 12 weeks
    Reporting group description
    		 Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules twice daily (b.i.d.) by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.

    Reporting group title
    Grazoprevir + Elbasvir 16 weeks
    Reporting group description
    		 Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.

    Reporting group title
    Grazoprevir + Elbasvir + RBV 16 weeks
    Reporting group description
    		 Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.

    Reporting group values
    		 Grazoprevir + Elbasvir 12 weeks Grazoprevir + Elbasvir + RBV 12 weeks Grazoprevir + Elbasvir 16 weeks Grazoprevir + Elbasvir + RBV 16 weeks Total
    Number of subjects
    		 105 104 105 106 420
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 88 92 89 94 363
        From 65-84 years
    		 17 12 16 12 57
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    		 55.71 ( 9.81 ) 55.46 ( 8.26 ) 54.91 ( 9.79 ) 54.98 ( 9.61 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 39 32 36 42 149
        Male
    		 66 72 69 64 271

    End points

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    End points reporting groups
    Reporting group title
    Grazoprevir + Elbasvir 12 weeks
    Reporting group description
    		 Participants received grazoprevir 100 mg/elbasvir 50 mg fixed dose combination (FDC) tablets once daily (q.d.) by mouth for 12 weeks.

    Reporting group title
    Grazoprevir + Elbasvir + RBV 12 weeks
    Reporting group description
    		 Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules twice daily (b.i.d.) by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.

    Reporting group title
    Grazoprevir + Elbasvir 16 weeks
    Reporting group description
    		 Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.

    Reporting group title
    Grazoprevir + Elbasvir + RBV 16 weeks
    Reporting group description
    		 Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.

    Primary: Percentage of participants achieving undetectable HCV RNA 12 weeks after completing study therapy (SVR12)

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    End point title
    		 Percentage of participants achieving undetectable HCV RNA 12 weeks after completing study therapy (SVR12) [1]
    End point description
    HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
    End point type
    Primary
    End point timeframe
    12 weeks after the end of all study treatment (up to 28 weeks)
    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: Statistical 1-sided comparisons to a historical control SVR rate of 58% were performed but cannot be represented in EudraCT. See complete statistical analyses reported on clinicaltrials.gov (NCT02105701).
    End point values
    		 Grazoprevir + Elbasvir 12 weeks Grazoprevir + Elbasvir + RBV 12 weeks Grazoprevir + Elbasvir 16 weeks Grazoprevir + Elbasvir + RBV 16 weeks
    Number of subjects analysed
    105
    104
    105
    106
    Units: Percentage of participants
        number (confidence interval)
    92.4 (85.5 to 96.7)
    94.2 (87.9 to 97.9)
    92.4 (85.5 to 96.7)
    98.1 (93.4 to 99.8)
    No statistical analyses for this end point

    Primary: Number of participants experiencing adverse events (AE)

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    End point title
    		 Number of participants experiencing adverse events (AE) [2]
    End point description
    An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The number of participants experiencing at least 1 AE during the treatment period was reported.
    End point type
    Primary
    End point timeframe
    Up to 18 weeks
    Notes
    [2] - 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: There was no formal hypothesis testing planned for this endpoint, and there were no between-group statistical comparisons performed.
    End point values
    		 Grazoprevir + Elbasvir 12 weeks Grazoprevir + Elbasvir + RBV 12 weeks Grazoprevir + Elbasvir 16 weeks Grazoprevir + Elbasvir + RBV 16 weeks
    Number of subjects analysed
    105
    104
    105
    106
    Units: Number of participants
    74
    85
    77
    95
    No statistical analyses for this end point

    Primary: Number of participants discontinuing study treatment due to an AE

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    End point title
    		 Number of participants discontinuing study treatment due to an AE [3]
    End point description
    An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
    End point type
    Primary
    End point timeframe
    Up to 16 weeks
    Notes
    [3] - 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: There was no formal hypothesis testing planned for this endpoint, and there were no between-group statistical comparisons performed.
    End point values
    		 Grazoprevir + Elbasvir 12 weeks Grazoprevir + Elbasvir + RBV 12 weeks Grazoprevir + Elbasvir 16 weeks Grazoprevir + Elbasvir + RBV 16 weeks
    Number of subjects analysed
    105
    104
    105
    106
    Units: Number of participants
    1
    1
    0
    5
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving undetectable HCV RNA 24 weeks after the end of all treatment (SVR24)

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    End point title
    		 Percentage of participants achieving undetectable HCV RNA 24 weeks after the end of all treatment (SVR24)
    End point description
    HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
    End point type
    Secondary
    End point timeframe
    24 weeks after the end of all study treatment (up to 40 weeks)
    End point values
    		 Grazoprevir + Elbasvir 12 weeks Grazoprevir + Elbasvir + RBV 12 weeks Grazoprevir + Elbasvir 16 weeks Grazoprevir + Elbasvir + RBV 16 weeks
    Number of subjects analysed
    105
    104
    105
    106
    Units: Percentage of participants
        number (confidence interval)
    91.4 (84.4 to 96)
    94.2 (87.9 to 97.9)
    89.5 (82 to 94.7)
    95.3 (89.3 to 98.5)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 40.
    Adverse event reporting additional description
    AE additional description
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    GZR/EBR 12 Weeks
    Reporting group description
    		 Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.

    Reporting group title
    GZR/EBR + RBV 16 Weeks
    Reporting group description
    		 Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.

    Reporting group title
    GZR/EBR 16 Weeks
    Reporting group description
    		 Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.

    Reporting group title
    GZR/EBR + RBV 12 Weeks
    Reporting group description
    		 Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.

    Serious adverse events
    		 GZR/EBR 12 Weeks GZR/EBR + RBV 16 Weeks GZR/EBR 16 Weeks GZR/EBR + RBV 12 Weeks
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 105 (5.71%)
    6 / 106 (5.66%)
    4 / 105 (3.81%)
    8 / 104 (7.69%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatocellular carcinoma
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Splenic marginal zone lymphoma
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Femoral artery occlusion
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Uterine polyp
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Schizophrenia
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Loss of consciousness
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Sudden hearing loss
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal angioedema
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varices oesophageal
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Herpes simplex oesophagitis
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infectious colitis
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parotitis
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GZR/EBR 12 Weeks GZR/EBR + RBV 16 Weeks GZR/EBR 16 Weeks GZR/EBR + RBV 12 Weeks
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    55 / 105 (52.38%)
    84 / 106 (79.25%)
    58 / 105 (55.24%)
    72 / 104 (69.23%)
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    0 / 105 (0.00%)
    7 / 106 (6.60%)
    0 / 105 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    7
    0
    1
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    3 / 105 (2.86%)
    14 / 106 (13.21%)
    1 / 105 (0.95%)
    15 / 104 (14.42%)
         occurrences all number
    3
    23
    1
    22
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    7 / 105 (6.67%)
    6 / 106 (5.66%)
    5 / 105 (4.76%)
    8 / 104 (7.69%)
         occurrences all number
    7
    8
    10
    8
    Headache
         subjects affected / exposed
    21 / 105 (20.00%)
    20 / 106 (18.87%)
    21 / 105 (20.00%)
    21 / 104 (20.19%)
         occurrences all number
    23
    22
    23
    23
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 105 (0.00%)
    17 / 106 (16.04%)
    0 / 105 (0.00%)
    12 / 104 (11.54%)
         occurrences all number
    0
    19
    0
    13
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    8 / 105 (7.62%)
    10 / 106 (9.43%)
    9 / 105 (8.57%)
    11 / 104 (10.58%)
         occurrences all number
    9
    10
    10
    13
    Fatigue
         subjects affected / exposed
    20 / 105 (19.05%)
    32 / 106 (30.19%)
    17 / 105 (16.19%)
    28 / 104 (26.92%)
         occurrences all number
    21
    33
    18
    32
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    6 / 105 (5.71%)
    3 / 106 (2.83%)
    1 / 105 (0.95%)
    3 / 104 (2.88%)
         occurrences all number
    6
    3
    1
    3
    Constipation
         subjects affected / exposed
    1 / 105 (0.95%)
    5 / 106 (4.72%)
    7 / 105 (6.67%)
    3 / 104 (2.88%)
         occurrences all number
    1
    5
    8
    3
    Diarrhoea
         subjects affected / exposed
    5 / 105 (4.76%)
    9 / 106 (8.49%)
    8 / 105 (7.62%)
    4 / 104 (3.85%)
         occurrences all number
    5
    9
    9
    4
    Dyspepsia
         subjects affected / exposed
    3 / 105 (2.86%)
    7 / 106 (6.60%)
    0 / 105 (0.00%)
    4 / 104 (3.85%)
         occurrences all number
    3
    9
    0
    4
    Nausea
         subjects affected / exposed
    9 / 105 (8.57%)
    18 / 106 (16.98%)
    4 / 105 (3.81%)
    15 / 104 (14.42%)
         occurrences all number
    10
    20
    4
    19
    Vomiting
         subjects affected / exposed
    2 / 105 (1.90%)
    9 / 106 (8.49%)
    1 / 105 (0.95%)
    7 / 104 (6.73%)
         occurrences all number
    2
    10
    1
    8
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 105 (5.71%)
    10 / 106 (9.43%)
    4 / 105 (3.81%)
    10 / 104 (9.62%)
         occurrences all number
    6
    10
    4
    10
    Dyspnoea
         subjects affected / exposed
    1 / 105 (0.95%)
    10 / 106 (9.43%)
    1 / 105 (0.95%)
    9 / 104 (8.65%)
         occurrences all number
    1
    10
    1
    11
    Dyspnoea exertional
         subjects affected / exposed
    1 / 105 (0.95%)
    8 / 106 (7.55%)
    0 / 105 (0.00%)
    3 / 104 (2.88%)
         occurrences all number
    1
    8
    0
    4
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 105 (0.95%)
    11 / 106 (10.38%)
    6 / 105 (5.71%)
    11 / 104 (10.58%)
         occurrences all number
    1
    11
    6
    13
    Rash
         subjects affected / exposed
    3 / 105 (2.86%)
    8 / 106 (7.55%)
    1 / 105 (0.95%)
    4 / 104 (3.85%)
         occurrences all number
    3
    10
    1
    4
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    5 / 105 (4.76%)
    10 / 106 (9.43%)
    7 / 105 (6.67%)
    11 / 104 (10.58%)
         occurrences all number
    5
    10
    7
    12
    Irritability
         subjects affected / exposed
    4 / 105 (3.81%)
    8 / 106 (7.55%)
    2 / 105 (1.90%)
    5 / 104 (4.81%)
         occurrences all number
    6
    8
    2
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 105 (3.81%)
    4 / 106 (3.77%)
    7 / 105 (6.67%)
    3 / 104 (2.88%)
         occurrences all number
    4
    5
    8
    4
    Myalgia
         subjects affected / exposed
    2 / 105 (1.90%)
    7 / 106 (6.60%)
    8 / 105 (7.62%)
    6 / 104 (5.77%)
         occurrences all number
    2
    7
    8
    7
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 105 (2.86%)
    5 / 106 (4.72%)
    6 / 105 (5.71%)
    2 / 104 (1.92%)
         occurrences all number
    3
    6
    9
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 105 (1.90%)
    6 / 106 (5.66%)
    1 / 105 (0.95%)
    6 / 104 (5.77%)
         occurrences all number
    2
    6
    1
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Jun 2014
    AM1: The primary purpose of this amendment was to add hormonal contraceptive as a birth control option.
    15 Jul 2014
    AM2: The primary purpose of this amendment was to clarify the urinalysis schedule and, for HIV co-infected participants, to adjust the length of time for dose modifications or changes to antiretroviral therapy (ART) from 8 weeks to 4 weeks.
    29 Sep 2014
    AM3: The primary purpose was to remove GT5 participants from eligibility.

    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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