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    Clinical Trial Results:
    Full title of the trial: A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naïve Subjects with Chronic HCV GT1, GT4, and GT6 Infection Who are on Opiate Substitution Therapy

    Summary
    EudraCT number
    		 2014-000343-32
    Trial protocol
    		 DE   ES   NL   GB   RO   FR  
    Global end of trial date
    04 Dec 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Dec 2019
    First version publication date
    03 Dec 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    5172-062
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02105688
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Merck Registration: MK-5172-062
    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
    04 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Jun 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Dec 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This was a 2-part study. The purpose of Part A was to assess the efficacy and safety of grazoprevir (MK-5172) 100 mg in combination with elbasvir (MK-8742) 50 mg for 12 weeks in the treatment of chronic Hepatitis C Virus (HCV) Genotype (GT)1, GT4, or GT6 infection in treatment-naïve participants who are on opiate substitution therapy. The primary hypothesis was that the percentage of participants who received grazoprevir/elbasvir fixed-dose combination (FDC) in the Immediate Treatment Arm (ITA) and achieved a Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) would be superior to 67%. In addition, participants who received at least 1 dose of grazoprevir/elbasvir in Part A were eligible to participate in Part B, which was a 3-year observational follow-up.
    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
    02 Sep 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 51
    Country: Number of subjects enrolled
    Canada: 14
    Country: Number of subjects enrolled
    France: 17
    Country: Number of subjects enrolled
    Germany: 12
    Country: Number of subjects enrolled
    Israel: 6
    Country: Number of subjects enrolled
    Netherlands: 4
    Country: Number of subjects enrolled
    New Zealand: 10
    Country: Number of subjects enrolled
    Norway: 9
    Country: Number of subjects enrolled
    Romania: 15
    Country: Number of subjects enrolled
    Spain: 21
    Country: Number of subjects enrolled
    Taiwan: 15
    Country: Number of subjects enrolled
    United Kingdom: 27
    Country: Number of subjects enrolled
    United States: 100
    Worldwide total number of subjects
    301
    EEA total number of subjects
    105
    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)
    298
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 301 participants were randomized to either the Immediate Treatment Arm or to the Deferred Treatment Arm during Part A. 199 participants who completed Part A were enrolled in Part B; of these, 142 participants completed the study.

    Period 1
    Period 1 title
    Part A: Double-Blind
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Immediate Treatment Arm: Grazoprevir/Elbasvir
    Arm description
    		 In Part A, participants received grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Grazoprevir 100 mg/Elbasvir 50 mg FDC tablet
    Investigational medicinal product code
    Other name
    MK-5172A
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Grazoprevir 100 mg/Elbasvir 50 mg fixed dose combination (FDC) tablet, taken once daily by mouth for 12 weeks.

    Arm title
    		 Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir
    Arm description
    		 In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo to Grazoprevir 100 mg/Elbasvir 50 mg FDC tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to Grazoprevir 100 mg/Elbasvir 50 mg FDC tablet, taken once daily by mouth for 12 weeks.

    Investigational medicinal product name
    Grazoprevir 100 mg/Elbasvir 50 mg FDC tablet
    Investigational medicinal product code
    Other name
    MK-5172A
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Grazoprevir 100 mg/Elbasvir 50 mg fixed dose combination (FDC) tablet, taken once daily by mouth for 12 weeks.

    Number of subjects in period 1
    		Immediate Treatment Arm: Grazoprevir/Elbasvir Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir
    Started
    201
    100
    Completed
    181
    83
    Not completed
    20
    17
         Adverse event, serious fatal
    -
    1
         Consent withdrawn by subject
    4
    2
         Physician decision
    -
    1
         Adverse event, non-fatal
    1
    -
         Status Unknown
    -
    2
         Lost to follow-up
    15
    11
    Period 2
    Period 2 title
    Part B: Observational Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Immediate Treatment Arm: Grazoprevir/Elbasvir
    Arm description
    		 In Part A, participants received grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir
    Arm description
    		 In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2 [1]
    		Immediate Treatment Arm: Grazoprevir/Elbasvir Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir
    Started
    131
    68
    Completed
    94
    48
    Not completed
    37
    20
         Adverse event, serious fatal
    2
    1
         Consent withdrawn by subject
    9
    3
         Physician decision
    3
    1
         Lost to follow-up
    23
    15
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Only participants who completed Part A and met Part B extension criteria were eligible to enter Part B.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Immediate Treatment Arm: Grazoprevir/Elbasvir
    Reporting group description
    		 In Part A, participants received grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).

    Reporting group title
    Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir
    Reporting group description
    		 In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).

    Reporting group values
    		 Immediate Treatment Arm: Grazoprevir/Elbasvir Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir Total
    Number of subjects
    		 201 100 301
    Age categorical
    Units: Subjects
        Adults (between 18 and 64 years)
    		 198 100 298
        From 65 to 84 years
    		 3 0 3
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47.4 ± 9.9 46.4 ± 9.9 -
    Sex: Female, Male
    Units: Subjects
        Female
    		 48 23 71
        Male
    		 153 77 230

    End points

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    End points reporting groups
    Reporting group title
    Immediate Treatment Arm: Grazoprevir/Elbasvir
    Reporting group description
    		 In Part A, participants received grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).

    Reporting group title
    Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir
    Reporting group description
    		 In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
    Reporting group title
    Immediate Treatment Arm: Grazoprevir/Elbasvir
    Reporting group description
    		 In Part A, participants received grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).

    Reporting group title
    Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir
    Reporting group description
    		 In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).

    Primary: Percentage of participants achieving Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12)

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    End point title
    		 Percentage of participants achieving Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) [1]
    End point description
    Blood was drawn from each participant to assess HCV ribonucleic acid (RNA) plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0 (lower limit of quantification = 15 IU/mL). SVR12 defined as HCV RNA below the lower limit of detection (<LLOQ) at 12 weeks after the end of all study therapy for baseline infection, or HCV RNA≥ LLOQ due to reinfection (after clearance of baseline infection). Clopper-Pearson method used to construct 95% confidence intervals for SVR12 rate. The primary efficacy analysis for Part A was the percentage of participants in the ITA who achieved SVR12. SVR12 was also calculated for the Deferred Treatment Arm (DTA). All randomized participants receiving ≥1 dose of active study treatment and excluding participants for study discontinuation for reasons unrelated to treatment regimen, response to HCV treatment, or baseline GT2, GT3, or GT5 (modified FAS) were analysed. The primary efficacy hypothesis was evaluated within participants of the ITA.
    End point type
    Primary
    End point timeframe
    12 weeks after end of all therapy (Study Week 24 for Immediate Treatment Arm and Study Week 40 for Deferred Treatment Arm)
    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 between-group statistical analyses were performed for this endpoint. A single-sided analysis (exact test) was used to test the null hypothesis, which was that the SVR12 rate for the Immediate Treatment Arm was less than 67% (historical reference rate derived from NCT01667731), and is presented on ClinicalTrials.gov (NCT02105688).
    End point values
    		 Immediate Treatment Arm: Grazoprevir/Elbasvir Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir
    Number of subjects analysed
    198
    88
    Units: Percentage of Participants
        number (confidence interval 95%)
    95.5 (91.5 to 97.9)
    96.6 (90.4 to 99.3)
    No statistical analyses for this end point

    Primary: Percentage of participants experiencing at least one Adverse Event (AE) during the Double-Blind (DB) treatment period and first 14 follow-up days

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    End point title
    		 Percentage of participants experiencing at least one Adverse Event (AE) during the Double-Blind (DB) treatment period and first 14 follow-up days
    End point description
    An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, 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 of a pre-existing condition that was temporally associated with the use of the Sponsor’s product, was also an AE. For this outcome measure, the primary safety analysis compared the percentage of participants experiencing an AE in the ITA during the DB active treatment period to that of the DTA during the DB placebo treatment period. All randomized participants who received at least one dose of study treatment during the Part A DB period were analysed.
    End point type
    Primary
    End point timeframe
    DB Treatment period plus first 14 follow-up days (up to Study Week 14)
    End point values
    		 Immediate Treatment Arm: Grazoprevir/Elbasvir Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir
    Number of subjects analysed
    201
    100
    Units: Percentage of Participants
        number (not applicable)
    83.1
    83.0
    Statistical analysis title
    		 % Pts With ≥1 AE During DB+14 Days: ITA vs DTA
    Statistical analysis description
    Categorical AE parameters were assessed via point estimates with 95% confidence intervals provided for between-treatment differences in the percentage of participants (pts) with events using the Miettinen and Nurminen method, an unconditional, asymptotic method.
    Comparison groups
    Immediate Treatment Arm: Grazoprevir/Elbasvir v Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.3
         upper limit
    		 10

    Primary: Percentage of participants discontinued from study therapy due to AEs during the DB treatment period

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    End point title
    		 Percentage of participants discontinued from study therapy due to AEs during the DB treatment period
    End point description
    An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, 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 of a pre-existing condition that was temporally associated with the use of the Sponsor’s product, was also an AE. For this outcome measure, the primary safety analysis compared the percentage of participants discontinuing (DC) study therapy due to an AE in the ITA during the DB active treatment period to that of the DTA during the DB placebo treatment period. All randomized participants who received at least one dose of study treatment during the Part A DB period were analysed.
    End point type
    Primary
    End point timeframe
    DB Treatment period (up to Study Week 12)
    End point values
    		 Immediate Treatment Arm: Grazoprevir/Elbasvir Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir
    Number of subjects analysed
    201
    100
    Units: Percentage of Participants
        number (not applicable)
    0.5
    1.0
    Statistical analysis title
    		 % Pts DC Due to AE During DB+14 Days: ITA vs DTA
    Statistical analysis description
    Categorical AE parameters were assessed via point estimates with 95% confidence intervals provided for between-treatment differences in the percentage of participants (pts) with events using the Miettinen and Nurminen method, an unconditional, asymptotic method.
    Comparison groups
    Immediate Treatment Arm: Grazoprevir/Elbasvir v Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in Percentage
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 1.9

    Secondary: Percentage of participants achieving Sustained Virologic Response 24 weeks after the end of all study therapy (SVR24)

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    End point title
    		 Percentage of participants achieving Sustained Virologic Response 24 weeks after the end of all study therapy (SVR24)
    End point description
    Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which has an LLOQ of 15 IU/mL. SVR24 was defined as HCV RNA <LLOQ at 24 weeks after the end of all study therapy. The Clopper-Pearson method was used to construct 95% confidence intervals for the SVR24 rate. The secondary efficacy analysis for Part A evaluated the percentage of participants in the ITA who achieved SVR24. SVR24 was also calculated for the DTA. All randomized participants receiving ≥1 dose of active study treatment and excluding participants for study discontinuation for reasons unrelated to treatment regimen, response to HCV treatment, or baseline genotype (GT)2, GT3, or GT5 (modified FAS) were analysed. The secondary efficacy analysis was evaluated within participants of the ITA.
    End point type
    Secondary
    End point timeframe
    24 weeks after end of all therapy (Study Week 36 for Immediate Treatment Arm and Study Week 52 for Deferred Treatment Arm)
    End point values
    		 Immediate Treatment Arm: Grazoprevir/Elbasvir Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir
    Number of subjects analysed
    186
    85
    Units: Percentage of Participants
        number (confidence interval 95%)
    94.1 (89.7 to 97.0)
    96.5 (90.0 to 99.3)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to approximately 4 years (Study Week 208)
    Adverse event reporting additional description
    AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Immediate Treatment Arm: Grazoprevir/Elbasvir
    Reporting group description
    		 In Part A, participants received grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).

    Reporting group title
    Deferred Treatment Arm: Grazoprevir/Elbasvir
    Reporting group description
    		 In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).

    Reporting group title
    Deferred Treatment Arm: Placebo
    Reporting group description
    		 In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up.

    Serious adverse events
    		 Immediate Treatment Arm: Grazoprevir/Elbasvir Deferred Treatment Arm: Grazoprevir/Elbasvir Deferred Treatment Arm: Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 201 (7.96%)
    7 / 95 (7.37%)
    4 / 100 (4.00%)
         number of deaths (all causes)
    3
    1
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer stage II
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 95 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 95 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Squamous cell carcinoma of the oral cavity
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 95 (1.05%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 95 (1.05%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 95 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 201 (0.50%)
    1 / 95 (1.05%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 95 (1.05%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 95 (1.05%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 95 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 95 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Left ventricular failure
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 95 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Ruptured cerebral aneurysm
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 95 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 95 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Emphysema
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 95 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural fibrosis
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 95 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 95 (1.05%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Bipolar disorder
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 95 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 95 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 201 (0.00%)
    1 / 95 (1.05%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug abuse
         subjects affected / exposed
    1 / 201 (0.50%)
    1 / 95 (1.05%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hallucination, auditory
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 95 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Personality disorder
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 95 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 95 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 95 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 201 (0.50%)
    0 / 95 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 95 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 201 (0.50%)
    1 / 95 (1.05%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 95 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 201 (1.00%)
    0 / 95 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 95 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Systemic candida
         subjects affected / exposed
    0 / 201 (0.00%)
    0 / 95 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    		 Immediate Treatment Arm: Grazoprevir/Elbasvir Deferred Treatment Arm: Grazoprevir/Elbasvir Deferred Treatment Arm: Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    108 / 201 (53.73%)
    36 / 95 (37.89%)
    46 / 100 (46.00%)
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    7 / 201 (3.48%)
    5 / 95 (5.26%)
    4 / 100 (4.00%)
         occurrences all number
    7
    5
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    26 / 201 (12.94%)
    12 / 95 (12.63%)
    14 / 100 (14.00%)
         occurrences all number
    31
    15
    20
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    32 / 201 (15.92%)
    13 / 95 (13.68%)
    20 / 100 (20.00%)
         occurrences all number
    32
    14
    22
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    11 / 201 (5.47%)
    3 / 95 (3.16%)
    4 / 100 (4.00%)
         occurrences all number
    12
    3
    4
    Constipation
         subjects affected / exposed
    17 / 201 (8.46%)
    2 / 95 (2.11%)
    4 / 100 (4.00%)
         occurrences all number
    17
    2
    5
    Diarrhoea
         subjects affected / exposed
    20 / 201 (9.95%)
    8 / 95 (8.42%)
    9 / 100 (9.00%)
         occurrences all number
    22
    8
    11
    Nausea
         subjects affected / exposed
    23 / 201 (11.44%)
    8 / 95 (8.42%)
    9 / 100 (9.00%)
         occurrences all number
    23
    8
    9
    Vomiting
         subjects affected / exposed
    8 / 201 (3.98%)
    4 / 95 (4.21%)
    7 / 100 (7.00%)
         occurrences all number
    8
    5
    7
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    13 / 201 (6.47%)
    0 / 95 (0.00%)
    6 / 100 (6.00%)
         occurrences all number
    13
    0
    6
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    8 / 201 (3.98%)
    3 / 95 (3.16%)
    6 / 100 (6.00%)
         occurrences all number
    8
    3
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Jun 2014
    Major changes of protocol amendment (AM) 1 included changes to the trial design with the addition of a deferred treatment arm enrolling 100 additional participants and the conversion from an open–label design to a double-blind design where a placebo control was added.
    31 Oct 2014
    Major changes of protocol AM 2 included changes to eligibility; participants who were infected with HCV GT5 were no longer eligible for enrollment.
    18 May 2015
    Major changes of protocol AM 3 included addition of a 3-year follow-up phase (Part B). Participants would no longer be enrolled in the MK-5172-017 long term follow-up study.

    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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    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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