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    Clinical Trial Results:
    A Phase 2, Open-Label Clinical Trial to Study the Efficacy and Safety of 12 weeks of the Combination Regimen of MK-3682 + Ruzasvir in Subjects with Chronic Hepatitis C Virus (HCV)Genotype 1, 2, 3, 4, 5 or 6 Infection

    Summary
    EudraCT number
    		 2016-003227-37
    Trial protocol
    		 GB   ES   PL  
    Global end of trial date
    05 Mar 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Dec 2018
    First version publication date
    19 Dec 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    3682-041
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02956629
    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
    05 Mar 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Mar 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This is a nonrandomized, multi-site, open-label trial to evaluate a novel two-drug combination regimen (uprifosbuvir [MK-3682] 450 mg + ruzasvir [RZR; MK-8408] 180 mg once daily [q.d.] for 12 weeks) in male and female treatment-naïve (TN) or treatment experienced (TE) participants with chronic hepatitis C virus (HCV) infection genotype (GT) GT1, GT2, GT3, GT4, GT5, or GT6 who have not previously received HCV direct-acting antiviral (DAA) therapy. Cirrhotic (C) and non-cirrhotic (NC) participants with and without human immunodeficiency virus (HIV) co-infection will be enrolled. Any GT that meets virologic futility criteria will be given the option of extending treatment with uprifosbuvir + RZR to 16 weeks with ribavirin (RBV) added.
    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
    16 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: 5
    Country: Number of subjects enrolled
    Canada: 40
    Country: Number of subjects enrolled
    Israel: 24
    Country: Number of subjects enrolled
    New Zealand: 14
    Country: Number of subjects enrolled
    Poland: 34
    Country: Number of subjects enrolled
    Russian Federation: 17
    Country: Number of subjects enrolled
    South Africa: 15
    Country: Number of subjects enrolled
    Spain: 28
    Country: Number of subjects enrolled
    United Kingdom: 19
    Country: Number of subjects enrolled
    United States: 86
    Worldwide total number of subjects
    282
    EEA total number of subjects
    81
    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)
    258
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Males and females of at least 18 years of age, with chronic Hepatitis C Virus (HCV) infection were enrolled in this 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
    		 HCV Genotype (GT) 1
    Arm description
    		 Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + Ruzasvir (RZR) 180 mg for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Uprifosbuvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants take 3 tablets each containing 150 mg uprifosbuvir orally once daily (q.d.) by mouth.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavarin (RBV) 200 mg capsule will be taken orally according to package instructions for a maximum of 16 weeks for any GT that meets virologic futility rules on uprifosbuvir + RZR alone.

    Investigational medicinal product name
    Ruzasvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants take 3 capsules each containing 60 mg RZR q.d. by mouth.

    Arm title
    		 HCV GT2
    Arm description
    		 Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Uprifosbuvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants take 3 tablets each containing 150 mg uprifosbuvir orally (q.d.) by mouth.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavarin (RBV) 200 mg capsule will be taken orally according to package instructions for a maximum of 16 weeks for any GT that meets virologic futility rules on uprifosbuvir + RZR alone.

    Investigational medicinal product name
    Ruzasvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants take 3 capsules each containing 60 mg RZR q.d. by mouth.

    Arm title
    		 HCV GT3
    Arm description
    		 Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Uprifosbuvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants take 3 tablets each containing 150 mg uprifosbuvir orally (q.d.) by mouth.

    Investigational medicinal product name
    Ruzasvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants take 3 capsules each containing 60 mg RZR q.d. by mouth.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavarin (RBV) 200 mg capsule will be taken orally according to package instructions for a maximum of 16 weeks for any GT that meets virologic futility rules on uprifosbuvir + RZR alone.

    Arm title
    		 HCV GT4
    Arm description
    		 Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Uprifosbuvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants take 3 tablets each containing 150 mg uprifosbuvir orally (q.d.) by mouth.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavarin (RBV) 200 mg capsule will be taken orally according to package instructions for a maximum of 16 weeks for any GT that meets virologic futility rules on uprifosbuvir + RZR alone.

    Investigational medicinal product name
    Ruzasvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants take 3 capsules each containing 60 mg RZR q.d. by mouth.

    Arm title
    		 HCV GT5
    Arm description
    		 Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Uprifosbuvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants take 3 tablets each containing 150 mg uprifosbuvir orally (q.d.) by mouth.

    Investigational medicinal product name
    Ruzasvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants take 3 capsules each containing 60 mg RZR q.d. by mouth.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavarin (RBV) 200 mg capsule will be taken orally according to package instructions for a maximum of 16 weeks for any GT that meets virologic futility rules on uprifosbuvir + RZR alone.

    Arm title
    		 HCV GT6
    Arm description
    		 Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Uprifosbuvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants take 3 tablets each containing 150 mg uprifosbuvir orally (q.d.) by mouth.

    Investigational medicinal product name
    Ruzasvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants take 3 capsules each containing 60 mg RZR q.d. by mouth.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavarin (RBV) 200 mg capsule will be taken orally according to package instructions for a maximum of 16 weeks for any GT that meets virologic futility rules on uprifosbuvir + RZR alone.

    Number of subjects in period 1
    		HCV Genotype (GT) 1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6
    Started
    78
    47
    61
    56
    18
    22
    Completed
    73
    41
    57
    55
    18
    21
    Not completed
    5
    6
    4
    1
    0
    1
         Consent withdrawn by subject
    3
    1
    -
    -
    -
    -
         Adverse event, non-fatal
    -
    -
    1
    -
    -
    -
         Lost to follow-up
    2
    5
    3
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HCV Genotype (GT) 1
    Reporting group description
    		 Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + Ruzasvir (RZR) 180 mg for 12 weeks.

    Reporting group title
    HCV GT2
    Reporting group description
    		 Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.

    Reporting group title
    HCV GT3
    Reporting group description
    		 Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.

    Reporting group title
    HCV GT4
    Reporting group description
    		 Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.

    Reporting group title
    HCV GT5
    Reporting group description
    		 Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.

    Reporting group title
    HCV GT6
    Reporting group description
    		 Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.

    Reporting group values
    		 HCV Genotype (GT) 1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6 Total
    Number of subjects
    		 78 47 61 56 18 22 282
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 75 41 59 51 12 20 258
        From 65-84 years
    		 3 6 2 5 6 2 24
        85 years and over
    		 0 0 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47.9 ( 12.6 ) 52.7 ( 11.9 ) 48.4 ( 10.1 ) 46.4 ( 13.0 ) 57.4 ( 12.4 ) 53.3 ( 11.0 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 35 24 27 23 11 6 126
        Male
    		 43 23 34 33 7 16 156

    End points

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    End points reporting groups
    Reporting group title
    HCV Genotype (GT) 1
    Reporting group description
    		 Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + Ruzasvir (RZR) 180 mg for 12 weeks.

    Reporting group title
    HCV GT2
    Reporting group description
    		 Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.

    Reporting group title
    HCV GT3
    Reporting group description
    		 Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.

    Reporting group title
    HCV GT4
    Reporting group description
    		 Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.

    Reporting group title
    HCV GT5
    Reporting group description
    		 Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.

    Reporting group title
    HCV GT6
    Reporting group description
    		 Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.

    Primary: Primary: Percentage of participants with sustained virologic response (SVR) 12 weeks after completing study therapy (SVR12)

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    End point title
    		 Primary: Percentage of participants with sustained virologic response (SVR) 12 weeks after completing study therapy (SVR12) [1]
    End point description
    Plasma levels of hepatitis C virus (HCV) ribonucleic acid (RNA) were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from participants. SVR12 is the absence of detectable RNA of the hepatitis C virus, (<lower limit of quantification [LLOQ] of 15 IU/mL) for at least 12 weeks after completing treatment. The population analyzed was all participants who were assigned to treatment, and received at least one dose of study medication.
    End point type
    Primary
    End point timeframe
    12 weeks after completing study therapy (Week 24)
    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 comparisons between treatment groups were neither planned nor performed for this primary endpoint.
    End point values
    		 HCV Genotype (GT) 1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6
    Number of subjects analysed
    78
    47
    61
    56
    18
    22
    Units: Percentage of participants
        number (confidence interval 95%)
    92.3 (84.0 to 97.1)
    91.5 (79.6 to 97.6)
    73.8 (60.9 to 84.2)
    98.2 (90.4 to 100.0)
    100.0 (81.5 to 100.0)
    90.9 (70.8 to 98.9)
    No statistical analyses for this end point

    Primary: Percentage of participants experiencing an adverse event (AE)

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    End point title
    		 Percentage of participants experiencing an adverse event (AE) [2]
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example ), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE. The population analyzed was all participants who received at least one dose of study treatment.
    End point type
    Primary
    End point timeframe
    Up to Week 14
    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: Statistical comparisons between treatment groups were neither planned nor performed for this primary endpoint.
    End point values
    		 HCV Genotype (GT) 1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6
    Number of subjects analysed
    78
    47
    61
    56
    18
    22
    Units: Percentage of participants
        number (not applicable)
    60.3
    61.7
    57.4
    55.4
    77.8
    77.3
    No statistical analyses for this end point

    Primary: Percentage of participants experiencing an AE of clinical importance (ECI)

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    End point title
    		 Percentage of participants experiencing an AE of clinical importance (ECI) [3]
    End point description
    Adverse events of clinical importance, excluding overdoses include, but is not limited to, significant changes in alanine aminotransferase, aspartate aminotransferase, blood creatinine, glomerular filtration rate or hepatitis B reactivation. The population analyzed was all participants who received at least one dose of study treatment.
    End point type
    Primary
    End point timeframe
    Up to Week 14
    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: Statistical comparisons between treatment groups were neither planned nor performed for this primary endpoint.
    End point values
    		 HCV Genotype (GT) 1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6
    Number of subjects analysed
    78
    47
    61
    56
    18
    22
    Units: Percentage of participants
        number (not applicable)
    1.3
    2.1
    1.6
    3.6
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of participants experiencing a serious adverse event (SAE)

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    End point title
    		 Percentage of participants experiencing a serious adverse event (SAE) [4]
    End point description
    A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose. The population analyzed was all participants who received at least one dose of study treatment.
    End point type
    Primary
    End point timeframe
    Up to Week 14
    Notes
    [4] - 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 comparisons between treatment groups were neither planned nor performed for this primary endpoint.
    End point values
    		 HCV Genotype (GT) 1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6
    Number of subjects analysed
    78
    47
    61
    56
    18
    22
    Units: Percentage of participants
        number (not applicable)
    3.8
    2.1
    1.6
    3.6
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of participants experiencing a drug-related AE

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    End point title
    		 Percentage of participants experiencing a drug-related AE [5]
    End point description
    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example ), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE. A drug-related AE is determined by the investigator to be related to the use of the drug. The population analyzed was all participants who received at least one dose of study treatment.
    End point type
    Primary
    End point timeframe
    Up to Week 14
    Notes
    [5] - 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 comparisons between treatment groups were neither planned nor performed for this primary endpoint.
    End point values
    		 HCV Genotype (GT) 1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6
    Number of subjects analysed
    78
    47
    61
    56
    18
    22
    Units: Percentage of participants
        number (not applicable)
    37.2
    27.7
    36.1
    28.6
    50.0
    22.7
    No statistical analyses for this end point

    Primary: Percentage of participants experiencing a drug-related SAE

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    End point title
    		 Percentage of participants experiencing a drug-related SAE [6]
    End point description
    SAE is any AE occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose. A drug-related SAE is determined by the investigator to be related to the use of the drug. The population analyzed was all participants who received at least one dose of study treatment.
    End point type
    Primary
    End point timeframe
    Up to Week 14
    Notes
    [6] - 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 comparisons between treatment groups were neither planned nor performed for this primary endpoint.
    End point values
    		 HCV Genotype (GT) 1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6
    Number of subjects analysed
    78
    47
    61
    56
    18
    22
    Units: Percentage of participants
        number (not applicable)
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of participants discontinuing study therapy due to an AE

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    End point title
    		 Percentage of participants discontinuing study therapy due to an AE [7]
    End point description
    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example ), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE. The population analyzed was all participants who received at least one dose of study treatment.
    End point type
    Primary
    End point timeframe
    Up to Week 12
    Notes
    [7] - 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 comparisons between treatment groups were neither planned nor performed for this primary endpoint.
    End point values
    		 HCV Genotype (GT) 1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6
    Number of subjects analysed
    78
    47
    61
    56
    18
    22
    Units: Percentage of participants
        number (not applicable)
    1.3
    2.1
    1.6
    1.8
    0
    4.5
    No statistical analyses for this end point

    Secondary: Percentage of participants with SVR 24 weeks after completing study therapy (SVR24)

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    End point title
    		 Percentage of participants with SVR 24 weeks after completing study therapy (SVR24)
    End point description
    Plasma levels of HCV RNA were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from participants. SVR24 is the absence of detectable RNA of the hepatitis C virus (<LLOQ of 15 IU/mL), for at least 24 weeks after completing treatment. The population analyzed was all participants who were assigned to treatment, and received at least one dose of study medication.
    End point type
    Secondary
    End point timeframe
    24 weeks after completing study therapy (Week 36)
    End point values
    		 HCV Genotype (GT) 1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6
    Number of subjects analysed
    78
    47
    61
    56
    18
    22
    Units: Percentage of participants
        number (confidence interval 95%)
    89.7 (80.8 to 95.5)
    85.1 (71.7 to 93.8)
    72.1 (59.2 to 82.9)
    96.4 (87.7 to 99.6)
    100 (81.5 to 100)
    81.8 (59.7 to 94.8)
    No statistical analyses for this end point

    Secondary: Percentage of participants with virologic failure

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    End point title
    		 Percentage of participants with virologic failure
    End point description
    Virologic failure is the detection of HCV RNA among participants either due to non-response where HCV RNA is detected at end of treatment without HCV RNA <LLOQ having been achieved while on treatment; rebound defined as >1 log10 IU/mL increase in HCV RNA from nadir while on treatment and confirmed from a separate blood draw within 2 weeks; or virologic breakthrough which is confirmed HCV RNA ≥LLOQ, after being <LLOQ previously while on treatment. Confirmation is defined as an HCV RNA ≥LLOQ from a separate blood draw repeated within 2 weeks; or relapse post-treatment. where there is a confirmed HCV RNA ≥LLOQ following end of all study therapy, after becoming undetectable at end of treatment. The population analyzed was participants who followed the protocol sufficiently to allow the analysis of the results.
    End point type
    Secondary
    End point timeframe
    Up to Week 24
    End point values
    		 HCV Genotype (GT) 1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6
    Number of subjects analysed
    78
    47
    61
    56
    18
    22
    Units: Percentage of participants
        number (not applicable)
    3.8
    2.1
    23.0
    0
    0
    13.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 14
    Adverse event reporting additional description
    All participants who received at least one dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    HCV GT1
    Reporting group description
    		 Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.

    Reporting group title
    HCV GT2
    Reporting group description
    		 Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.

    Reporting group title
    HCV GT3
    Reporting group description
    		 Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.

    Reporting group title
    HCV GT4
    Reporting group description
    		 Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.

    Reporting group title
    HCV GT5
    Reporting group description
    		 Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.

    Reporting group title
    HCV GT6
    Reporting group description
    		 Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.

    Serious adverse events
    		 HCV GT1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 78 (3.85%)
    1 / 47 (2.13%)
    1 / 61 (1.64%)
    2 / 56 (3.57%)
    0 / 18 (0.00%)
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Investigations
    Ammonia increased
         subjects affected / exposed
    0 / 78 (0.00%)
    0 / 47 (0.00%)
    1 / 61 (1.64%)
    0 / 56 (0.00%)
    0 / 18 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    0 / 78 (0.00%)
    0 / 47 (0.00%)
    1 / 61 (1.64%)
    0 / 56 (0.00%)
    0 / 18 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glomerular filtration rate decreased
         subjects affected / exposed
    0 / 78 (0.00%)
    0 / 47 (0.00%)
    1 / 61 (1.64%)
    0 / 56 (0.00%)
    0 / 18 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 78 (0.00%)
    0 / 47 (0.00%)
    1 / 61 (1.64%)
    0 / 56 (0.00%)
    0 / 18 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 47 (0.00%)
    0 / 61 (0.00%)
    0 / 56 (0.00%)
    0 / 18 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 78 (0.00%)
    0 / 47 (0.00%)
    0 / 61 (0.00%)
    1 / 56 (1.79%)
    0 / 18 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 47 (2.13%)
    0 / 61 (0.00%)
    0 / 56 (0.00%)
    0 / 18 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 78 (0.00%)
    0 / 47 (0.00%)
    1 / 61 (1.64%)
    0 / 56 (0.00%)
    0 / 18 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rhabdomyolysis
         subjects affected / exposed
    0 / 78 (0.00%)
    0 / 47 (0.00%)
    1 / 61 (1.64%)
    0 / 56 (0.00%)
    0 / 18 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    0 / 78 (0.00%)
    0 / 47 (0.00%)
    0 / 61 (0.00%)
    1 / 56 (1.79%)
    0 / 18 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 47 (0.00%)
    0 / 61 (0.00%)
    0 / 56 (0.00%)
    0 / 18 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 47 (0.00%)
    0 / 61 (0.00%)
    0 / 56 (0.00%)
    0 / 18 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 HCV GT1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 78 (35.90%)
    20 / 47 (42.55%)
    30 / 61 (49.18%)
    22 / 56 (39.29%)
    14 / 18 (77.78%)
    10 / 22 (45.45%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 78 (0.00%)
    0 / 47 (0.00%)
    0 / 61 (0.00%)
    1 / 56 (1.79%)
    3 / 18 (16.67%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    3
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 78 (0.00%)
    0 / 47 (0.00%)
    0 / 61 (0.00%)
    0 / 56 (0.00%)
    1 / 18 (5.56%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    2 / 78 (2.56%)
    0 / 47 (0.00%)
    0 / 61 (0.00%)
    2 / 56 (3.57%)
    1 / 18 (5.56%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    0
    2
    1
    0
    Contusion
         subjects affected / exposed
    1 / 78 (1.28%)
    1 / 47 (2.13%)
    0 / 61 (0.00%)
    1 / 56 (1.79%)
    1 / 18 (5.56%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    0
    1
    1
    0
    Joint injury
         subjects affected / exposed
    0 / 78 (0.00%)
    0 / 47 (0.00%)
    0 / 61 (0.00%)
    0 / 56 (0.00%)
    1 / 18 (5.56%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Meniscus injury
         subjects affected / exposed
    0 / 78 (0.00%)
    0 / 47 (0.00%)
    0 / 61 (0.00%)
    0 / 56 (0.00%)
    1 / 18 (5.56%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Traumatic haemorrhage
         subjects affected / exposed
    0 / 78 (0.00%)
    0 / 47 (0.00%)
    0 / 61 (0.00%)
    0 / 56 (0.00%)
    1 / 18 (5.56%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 78 (3.85%)
    0 / 47 (0.00%)
    4 / 61 (6.56%)
    3 / 56 (5.36%)
    0 / 18 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    4
    4
    0
    0
    Headache
         subjects affected / exposed
    7 / 78 (8.97%)
    5 / 47 (10.64%)
    10 / 61 (16.39%)
    8 / 56 (14.29%)
    2 / 18 (11.11%)
    1 / 22 (4.55%)
         occurrences all number
    9
    6
    13
    10
    2
    1
    Somnolence
         subjects affected / exposed
    0 / 78 (0.00%)
    0 / 47 (0.00%)
    0 / 61 (0.00%)
    0 / 56 (0.00%)
    1 / 18 (5.56%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    5 / 78 (6.41%)
    1 / 47 (2.13%)
    6 / 61 (9.84%)
    0 / 56 (0.00%)
    0 / 18 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    5
    1
    6
    0
    0
    0
    Fatigue
         subjects affected / exposed
    14 / 78 (17.95%)
    5 / 47 (10.64%)
    5 / 61 (8.20%)
    4 / 56 (7.14%)
    0 / 18 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    15
    5
    5
    4
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 78 (0.00%)
    0 / 47 (0.00%)
    1 / 61 (1.64%)
    0 / 56 (0.00%)
    1 / 18 (5.56%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 78 (1.28%)
    1 / 47 (2.13%)
    1 / 61 (1.64%)
    2 / 56 (3.57%)
    2 / 18 (11.11%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    1
    2
    2
    1
    Constipation
         subjects affected / exposed
    2 / 78 (2.56%)
    1 / 47 (2.13%)
    1 / 61 (1.64%)
    1 / 56 (1.79%)
    0 / 18 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    2
    1
    1
    1
    0
    2
    Diarrhoea
         subjects affected / exposed
    3 / 78 (3.85%)
    2 / 47 (4.26%)
    2 / 61 (3.28%)
    3 / 56 (5.36%)
    2 / 18 (11.11%)
    1 / 22 (4.55%)
         occurrences all number
    3
    2
    2
    3
    2
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 47 (0.00%)
    0 / 61 (0.00%)
    0 / 56 (0.00%)
    1 / 18 (5.56%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Nausea
         subjects affected / exposed
    7 / 78 (8.97%)
    1 / 47 (2.13%)
    4 / 61 (6.56%)
    5 / 56 (8.93%)
    1 / 18 (5.56%)
    1 / 22 (4.55%)
         occurrences all number
    9
    1
    5
    6
    1
    1
    Toothache
         subjects affected / exposed
    1 / 78 (1.28%)
    1 / 47 (2.13%)
    0 / 61 (0.00%)
    0 / 56 (0.00%)
    0 / 18 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    5
    1
    0
    0
    0
    2
    Vomiting
         subjects affected / exposed
    4 / 78 (5.13%)
    0 / 47 (0.00%)
    2 / 61 (3.28%)
    1 / 56 (1.79%)
    1 / 18 (5.56%)
    1 / 22 (4.55%)
         occurrences all number
    4
    0
    2
    1
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 78 (2.56%)
    0 / 47 (0.00%)
    1 / 61 (1.64%)
    2 / 56 (3.57%)
    0 / 18 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    2
    0
    1
    2
    0
    2
    Oropharyngeal pain
         subjects affected / exposed
    1 / 78 (1.28%)
    2 / 47 (4.26%)
    1 / 61 (1.64%)
    1 / 56 (1.79%)
    0 / 18 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    3
    1
    1
    0
    3
    Rhinitis allergic
         subjects affected / exposed
    0 / 78 (0.00%)
    0 / 47 (0.00%)
    0 / 61 (0.00%)
    1 / 56 (1.79%)
    1 / 18 (5.56%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 78 (0.00%)
    0 / 47 (0.00%)
    1 / 61 (1.64%)
    2 / 56 (3.57%)
    0 / 18 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    1
    2
    0
    2
    Psoriasis
         subjects affected / exposed
    0 / 78 (0.00%)
    0 / 47 (0.00%)
    0 / 61 (0.00%)
    0 / 56 (0.00%)
    1 / 18 (5.56%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Rash
         subjects affected / exposed
    0 / 78 (0.00%)
    3 / 47 (6.38%)
    3 / 61 (4.92%)
    0 / 56 (0.00%)
    0 / 18 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    4
    3
    0
    0
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 78 (0.00%)
    0 / 47 (0.00%)
    1 / 61 (1.64%)
    0 / 56 (0.00%)
    1 / 18 (5.56%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Insomnia
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 47 (2.13%)
    3 / 61 (4.92%)
    0 / 56 (0.00%)
    1 / 18 (5.56%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    3
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 78 (3.85%)
    0 / 47 (0.00%)
    1 / 61 (1.64%)
    2 / 56 (3.57%)
    2 / 18 (11.11%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    1
    3
    3
    0
    Muscle spasms
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 47 (0.00%)
    1 / 61 (1.64%)
    0 / 56 (0.00%)
    2 / 18 (11.11%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    1
    0
    2
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    0 / 78 (0.00%)
    0 / 47 (0.00%)
    0 / 61 (0.00%)
    0 / 56 (0.00%)
    1 / 18 (5.56%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 47 (0.00%)
    0 / 61 (0.00%)
    3 / 56 (5.36%)
    0 / 18 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    3
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 78 (2.56%)
    3 / 47 (6.38%)
    2 / 61 (3.28%)
    2 / 56 (3.57%)
    3 / 18 (16.67%)
    1 / 22 (4.55%)
         occurrences all number
    3
    3
    2
    2
    3
    2
    Urinary tract infection
         subjects affected / exposed
    3 / 78 (3.85%)
    1 / 47 (2.13%)
    0 / 61 (0.00%)
    0 / 56 (0.00%)
    1 / 18 (5.56%)
    1 / 22 (4.55%)
         occurrences all number
    3
    1
    0
    0
    1
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 78 (3.85%)
    2 / 47 (4.26%)
    3 / 61 (4.92%)
    0 / 56 (0.00%)
    1 / 18 (5.56%)
    0 / 22 (0.00%)
         occurrences all number
    3
    2
    3
    0
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    0 / 78 (0.00%)
    0 / 47 (0.00%)
    0 / 61 (0.00%)
    0 / 56 (0.00%)
    1 / 18 (5.56%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Sep 2016
    Amendment 1: Added stopping criteria and rescue treatment option based on USA Food and Drug Administration (FDA) feedback
    02 Nov 2016
    Amendment 2: The study design was changed to include a rescue regimen in the event that virologic futility criteria are met. Also added anti hepatitis B core antibody (anti-HBc) testing.
    07 Dec 2016
    Amendment 4: Incorporated all changes from Amendment 3 to make this language available to all countries. Further refined the laboratory testing criteria for Hepatitis B virus (HBV). Additionally, added an Event of Clinical Interest related to HBV reactivation, based on the results from this monitoring.
    06 Dec 2017
    Amendment 5: The 3-year long-term follow-up period was removed from the trial. This change was made to due to a strategic decision to discontinue the development of the investigational product.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    05 Mar 2018
    This study was terminated by the Sponsor based on a review of available Phase 2 efficacy data.
    -

    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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