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    Clinical Trial Results:
    A Randomized, Double-Blind Study to Evaluate the Safety and Antiviral Activity of IDX184 in Combination with Pegylated Interferon and Ribavirin for 12 Weeks in Treatment-Naïve Subjects with Genotype 1 Chronic Hepatitis C Infection

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    		 2011-001878-25
    Trial protocol
    		 BG  
    Global end of trial date
    31 Oct 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Apr 2016
    First version publication date
    23 Apr 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    2355-005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01371604
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Idenix Protocol Number: IDX-08C-005
    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
    31 Oct 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objectives of this study were to evaluate the safety and tolerability of MK-2355 (IDX184) in combination with peg-interferon alfa-2a (Peg-IFN) and ribavirin (RBV), and to evaluate antiviral activity of MK-2355 in combination with Peg-IFN/RBV at Week 12.
    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
    15 Nov 2011
    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
    Bulgaria: 4
    Country: Number of subjects enrolled
    Israel: 8
    Country: Number of subjects enrolled
    United States: 56
    Worldwide total number of subjects
    68
    EEA total number of subjects
    4
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    68
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Adult (18 to 65 years of age) treatment-naive (TN) participants infected with hepatitis C virus (HCV) genotype (GT) 1 and compensated liver disease were enrolled.

    Pre-assignment
    Screening details
    		 The screening period was up to 49 days (from Day -56 to Day -7). Two of the 70 screened participants were considered screen failures; a total of 68 participants were randomized into Period 1.

    Period 1
    Period 1 title
    Period 1: MK-2355 + Peg-IFN/RBV
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MK-2355 50 mg + Peg-IFN/RBV
    Arm description
    		 TN participants with HCV GT1 took 1 MK-2355 50 mg tablet and 1 matching placebo tablet q.d. in combination with Peg-IFN and RBV for 12 weeks. Peg-IFN was administered weekly via subcutaneous injection and RBV was taken b.i.d. by mouth with food at a total daily dose of 1000 mg/day or 1200 mg/day. After completing the 12-week MK-2355 50 mg regimen, participants took Peg-IFN and RBV for an additional 12 or 36 weeks based on treatment response.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-2355
    Investigational medicinal product code
    Other name
    IDX-184
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    MK-2355 was taken as either 1 or 2 50 mg tablet(s) once daily (q.d.) for 12 weeks.

    Investigational medicinal product name
    Peg-IFN
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peg-IFN (180 µg) was administered once weekly via subcutaneous injection.

    Investigational medicinal product name
    RBV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV (200 mg tablets) was taken twice daily (b.i.d.) by mouth with food at a total daily dose dependent on body weight (<75 kilograms [kg] = 1000 mg/day or ≥75 kg = 1200 mg/day).

    Arm title
    		 MK-2355 100 mg + Peg-IFN/RBV
    Arm description
    		 TN participants with HCV GT1 took 2 MK-2355 50 mg tablets q.d. in combination with Peg-IFN and RBV for 12 weeks. Peg-IFN was administered weekly via subcutaneous injection and RBV was taken b.i.d. by mouth with food at a total daily dose of 1000 mg/day or 1200 mg/day. After completing the 12-week MK-2355 100 mg regimen, participants took Peg-IFN and RBV for an additional 12 or 36 weeks based on treatment response.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-2355
    Investigational medicinal product code
    Other name
    IDX-184
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two 50 mg tablets (100 mg) q.d. for 12 weeks

    Investigational medicinal product name
    Peg-IFN
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peg-IFN (180 µg) was administered weekly via subcutaneous injection.

    Investigational medicinal product name
    RBV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV (200 mg tablets) was taken b.i.d. by mouth with food at a total daily dose dependent on body weight (<75 kilograms [kg] = 1000 mg/day or ≥75 kg = 1200 mg/day).

    Number of subjects in period 1
    		MK-2355 50 mg + Peg-IFN/RBV MK-2355 100 mg + Peg-IFN/RBV
    Started
    34
    34
    Completed
    19
    23
    Not completed
    15
    11
         Consent withdrawn by subject
    6
    -
         Adverse event, non-fatal
    4
    -
         Lost to follow-up
    -
    3
         Lack of efficacy
    5
    6
         Protocol deviation
    -
    2
    Period 2
    Period 2 title
    Period 2: Peg-IFN/RBV
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Peg-IFN/RBV (eRVR+) 24 Weeks
    Arm description
    		 Participants that completed 12 weeks of treatment with MK-2355 in combination with Peg-IFN/RBV and showed extended Rapid Virologic Response (eRVR; HCV viral ribonucleic acid [RNA] levels <25 IU/mL at Weeks 4 and 12) were pooled and randomized a second time to continue taking Peg-IFN/RBV for an additional 12 weeks (total treatment duration = 24 weeks).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Peg-IFN
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peg-IFN (180 µg) was administered weekly via subcutaneous injection.

    Investigational medicinal product name
    RBV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV (200 mg tablets) was taken by mouth with food twice daily (b.i.d.) at a total daily dose dependent on body weight (<75 kilograms [kg] = 1000 mg/day or ≥75 kg = 1200 mg/day).

    Arm title
    		 Peg-IFN/RBV (eRVR+) 48 Weeks
    Arm description
    		 Participants that completed 12 weeks of treatment with MK-2355 in combination with Peg-IFN/RBV and showed eRVR were pooled and randomized a second time to continue taking Peg-IFN/RBV for an additional 36 weeks (total treatment duration = 48 weeks).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Peg-IFN
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peg-IFN (180 µg) was administered weekly via subcutaneous injection.

    Investigational medicinal product name
    RBV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV (200 mg tablets) was taken by mouth with food twice daily (b.i.d.) at a total daily dose dependent on body weight (<75 kilograms [kg] = 1000 mg/day or ≥75 kg = 1200 mg/day).

    Arm title
    		 Peg-IFN/RBV (eRVR-) 48 Weeks
    Arm description
    		 Participants that completed 12 weeks of treatment with MK-2355 in combination with Peg-IFN/RBV and did not show eRVR continued to take Peg-IFN/RBV for an additional 36 weeks (total treatment duration = 48 weeks).
    Arm type
    		 Experimental

    Investigational medicinal product name
    RBV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV (200 mg tablets) was taken by mouth with food twice daily (b.i.d.) at a total daily dose dependent on body weight (<75 kilograms [kg] = 1000 mg/day or ≥75 kg = 1200 mg/day).

    Investigational medicinal product name
    Peg-IFN
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peg-IFN (180 µg) was administered weekly via subcutaneous injection.

    Number of subjects in period 2 [1]
    		Peg-IFN/RBV (eRVR+) 24 Weeks Peg-IFN/RBV (eRVR+) 48 Weeks Peg-IFN/RBV (eRVR-) 48 Weeks
    Started
    16
    15
    2
    Completed
    16
    15
    2
    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: Of the total 68 participants who were randomized, 42 completed 24 weeks of treatment with MK-2355 and peg-IFN/RBV. Of those 42 participants, a total of 33 continued in study in the eRVR(+/-)-designated groups for up to an additional 24 weeks of peg-IFN/RBV treatment (48 total weeks of study treatment).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MK-2355 50 mg + Peg-IFN/RBV
    Reporting group description
    		 TN participants with HCV GT1 took 1 MK-2355 50 mg tablet and 1 matching placebo tablet q.d. in combination with Peg-IFN and RBV for 12 weeks. Peg-IFN was administered weekly via subcutaneous injection and RBV was taken b.i.d. by mouth with food at a total daily dose of 1000 mg/day or 1200 mg/day. After completing the 12-week MK-2355 50 mg regimen, participants took Peg-IFN and RBV for an additional 12 or 36 weeks based on treatment response.

    Reporting group title
    MK-2355 100 mg + Peg-IFN/RBV
    Reporting group description
    		 TN participants with HCV GT1 took 2 MK-2355 50 mg tablets q.d. in combination with Peg-IFN and RBV for 12 weeks. Peg-IFN was administered weekly via subcutaneous injection and RBV was taken b.i.d. by mouth with food at a total daily dose of 1000 mg/day or 1200 mg/day. After completing the 12-week MK-2355 100 mg regimen, participants took Peg-IFN and RBV for an additional 12 or 36 weeks based on treatment response.

    Reporting group values
    		 MK-2355 50 mg + Peg-IFN/RBV MK-2355 100 mg + Peg-IFN/RBV Total
    Number of subjects
    		 34 34 68
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    		 34 34 68
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 48.1 ( 11.3 ) 48.4 ( 9.4 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 12 10 22
        Male
    		 22 24 46

    End points

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    End points reporting groups
    Reporting group title
    MK-2355 50 mg + Peg-IFN/RBV
    Reporting group description
    		 TN participants with HCV GT1 took 1 MK-2355 50 mg tablet and 1 matching placebo tablet q.d. in combination with Peg-IFN and RBV for 12 weeks. Peg-IFN was administered weekly via subcutaneous injection and RBV was taken b.i.d. by mouth with food at a total daily dose of 1000 mg/day or 1200 mg/day. After completing the 12-week MK-2355 50 mg regimen, participants took Peg-IFN and RBV for an additional 12 or 36 weeks based on treatment response.

    Reporting group title
    MK-2355 100 mg + Peg-IFN/RBV
    Reporting group description
    		 TN participants with HCV GT1 took 2 MK-2355 50 mg tablets q.d. in combination with Peg-IFN and RBV for 12 weeks. Peg-IFN was administered weekly via subcutaneous injection and RBV was taken b.i.d. by mouth with food at a total daily dose of 1000 mg/day or 1200 mg/day. After completing the 12-week MK-2355 100 mg regimen, participants took Peg-IFN and RBV for an additional 12 or 36 weeks based on treatment response.
    Reporting group title
    Peg-IFN/RBV (eRVR+) 24 Weeks
    Reporting group description
    		 Participants that completed 12 weeks of treatment with MK-2355 in combination with Peg-IFN/RBV and showed extended Rapid Virologic Response (eRVR; HCV viral ribonucleic acid [RNA] levels <25 IU/mL at Weeks 4 and 12) were pooled and randomized a second time to continue taking Peg-IFN/RBV for an additional 12 weeks (total treatment duration = 24 weeks).

    Reporting group title
    Peg-IFN/RBV (eRVR+) 48 Weeks
    Reporting group description
    		 Participants that completed 12 weeks of treatment with MK-2355 in combination with Peg-IFN/RBV and showed eRVR were pooled and randomized a second time to continue taking Peg-IFN/RBV for an additional 36 weeks (total treatment duration = 48 weeks).

    Reporting group title
    Peg-IFN/RBV (eRVR-) 48 Weeks
    Reporting group description
    		 Participants that completed 12 weeks of treatment with MK-2355 in combination with Peg-IFN/RBV and did not show eRVR continued to take Peg-IFN/RBV for an additional 36 weeks (total treatment duration = 48 weeks).

    Subject analysis set title
    Period 2: Other
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Includes participants who received at least 1 dose of study drug but discontinued prior to Week 20 and were not randomized or assigned to a treatment regimen in Period 2.

    Primary: Percentage of participants experiencing a serious adverse event (SAE) during treatment (Periods 1 and 2)

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    End point title
    		 Percentage of participants experiencing a serious adverse event (SAE) during treatment (Periods 1 and 2) [1]
    End point description
    An SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
    End point type
    Primary
    End point timeframe
    Up to Week 24 or Week 48
    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: Per protocol, only descriptive statistics are presented.
    End point values
    		 MK-2355 50 mg + Peg-IFN/RBV MK-2355 100 mg + Peg-IFN/RBV
    Number of subjects analysed
    34
    34
    Units: Percentage of participants
    3
    6
    No statistical analyses for this end point

    Primary: Percentage of participants experiencing an adverse event (AE) during MK-2355 treatment (Period 1)

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    End point title
    		 Percentage of participants experiencing an adverse event (AE) during MK-2355 treatment (Period 1) [2]
    End point description
    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, and that does not necessarily have a causal relationship with the study drug(s).
    End point type
    Primary
    End point timeframe
    Up to 12 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: Per protocol, only descriptive statistics are presented.
    End point values
    		 MK-2355 50 mg + Peg-IFN/RBV MK-2355 100 mg + Peg-IFN/RBV
    Number of subjects analysed
    34
    34
    Units: Percentage of participants
    91
    88
    No statistical analyses for this end point

    Primary: Number of participants experiencing a Grade 1-4 laboratory abnormality (Periods 1 and 2)

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    End point title
    		 Number of participants experiencing a Grade 1-4 laboratory abnormality (Periods 1 and 2) [3]
    End point description
    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: Per protocol, only descriptive statistics are presented.
    End point values
    		 MK-2355 50 mg + Peg-IFN/RBV MK-2355 100 mg + Peg-IFN/RBV
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: Number of participants
    Notes
    [4] - Laboratory abnormality results were reported as change from baseline per measure (not shown here).
    [5] - Laboratory abnormality results were reported as change from baseline per measure (not shown here).
    No statistical analyses for this end point

    Primary: Percentage of participants with undetectable HCV ribonucleic acid (RNA) viral levels at Week 12 (Period 1)

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    End point title
    		 Percentage of participants with undetectable HCV ribonucleic acid (RNA) viral levels at Week 12 (Period 1) [6]
    End point description
    HCV viral RNA levels were measured after completing 12 weeks of MK-2355 and Peg-IFN/RBV therapy. HCV viral RNA was measured with a commercial laboratory assay which had a LLoQ of 25 IU/mL.
    End point type
    Primary
    End point timeframe
    Week 12
    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: Per protocol, only descriptive statistics are presented.
    End point values
    		 MK-2355 50 mg + Peg-IFN/RBV MK-2355 100 mg + Peg-IFN/RBV
    Number of subjects analysed
    29 [7]
    31 [8]
    Units: Percentage of participants
    77
    79
    Notes
    [7] - Data for 5 participants was unavailable.
    [8] - Data for 3 participants was unavailable.
    No statistical analyses for this end point

    Secondary: Percentage of participants with undetectable HCV RNA viral levels at Week 4 (Period 1)

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    End point title
    		 Percentage of participants with undetectable HCV RNA viral levels at Week 4 (Period 1)
    End point description
    HCV viral RNA levels were measured after completing 4 weeks of MK-2355 and Peg-IFN/RBV therapy. HCV viral RNA was measured with a commercial laboratory assay which had a LLoQ of 25 IU/mL.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 MK-2355 50 mg + Peg-IFN/RBV MK-2355 100 mg + Peg-IFN/RBV
    Number of subjects analysed
    33 [9]
    31 [10]
    Units: Percentage of participants
    53
    56
    Notes
    [9] - Data for 1 participant was unavailable.
    [10] - Data for 5 participants was unavailable.
    No statistical analyses for this end point

    Secondary: Percentage of participants with undetectable HCV RNA viral levels at end of treatment (EOT) (Period 1 or 2)

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    End point title
    		 Percentage of participants with undetectable HCV RNA viral levels at end of treatment (EOT) (Period 1 or 2)
    End point description
    HCV viral RNA levels were determined after completing all study therapy (Week 24 or Week 48). HCV viral RNA was measured with a commercial laboratory assay which had a LLoQ of 25 IU/mL.
    End point type
    Secondary
    End point timeframe
    Week 24 or Week 48
    End point values
    		 Peg-IFN/RBV (eRVR+) 24 Weeks Peg-IFN/RBV (eRVR+) 48 Weeks Peg-IFN/RBV (eRVR-) 48 Weeks Period 2: Other
    Number of subjects analysed
    16
    15
    2
    31 [11]
    Units: Percentage of participants
    100
    100
    100
    17
    Notes
    [11] - Data for 4 participants was unavailable.
    No statistical analyses for this end point

    Secondary: Percentage of participants who achieve sustained viral response (SVR) (Period 2)

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    End point title
    		 Percentage of participants who achieve sustained viral response (SVR) (Period 2)
    End point description
    SVR was defined as undetectable HCV viral RNA 24 weeks after the last dose of study drug. HCV viral RNA was measured with a commercial laboratory assay which had a LLoQ of 25 IU/mL.
    End point type
    Secondary
    End point timeframe
    24 weeks after last dose (Week 48 or Week 72)
    End point values
    		 Peg-IFN/RBV (eRVR+) 24 Weeks Peg-IFN/RBV (eRVR+) 48 Weeks Peg-IFN/RBV (eRVR-) 48 Weeks Period 2: Other
    Number of subjects analysed
    16
    15
    2
    27 [12]
    Units: Percentage of participants
    56
    100
    100
    26
    Notes
    [12] - Data for 8 participants was unavailable.
    No statistical analyses for this end point

    Secondary: Percentage of participants (in Period 2) with HCV RNA levels below the lower limit of quantification (LLoQ) at Week 4

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    End point title
    		 Percentage of participants (in Period 2) with HCV RNA levels below the lower limit of quantification (LLoQ) at Week 4
    End point description
    The percentage of participants with HCV viral RNA <LLoQ at Week 4 is presented according to Period 2 arms. HCV viral RNA was measured with a commercial laboratory assay which had a LLoQ of 25 IU/mL.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Peg-IFN/RBV (eRVR+) 24 Weeks Peg-IFN/RBV (eRVR+) 48 Weeks Peg-IFN/RBV (eRVR-) 48 Weeks Period 2: Other
    Number of subjects analysed
    16
    15
    2
    31 [13]
    Units: Percentage of participants
    100
    100
    0
    40
    Notes
    [13] - Data for 4 participants was unavailable.
    No statistical analyses for this end point

    Secondary: Percentage of participants who achieve HCV RNA <LLoQ at EOT (Period 2)

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    End point title
    		 Percentage of participants who achieve HCV RNA <LLoQ at EOT (Period 2)
    End point description
    The percentage of participants with HCV RNA <LLoQ at EOT is presented according to Period 2 arms. HCV viral RNA was measured with a commercial laboratory assay which had a LLoQ of 25 IU/mL.
    End point type
    Secondary
    End point timeframe
    Week 24 or 48
    End point values
    		 Peg-IFN/RBV (eRVR+) 24 Weeks Peg-IFN/RBV (eRVR+) 48 Weeks Peg-IFN/RBV (eRVR-) 48 Weeks Period 2: Other
    Number of subjects analysed
    16
    15
    2
    26 [14]
    Units: Percentage of participants
    100
    100
    100
    40
    Notes
    [14] - Data for nine participants was unavailable.
    No statistical analyses for this end point

    Secondary: Percentage of participants who achieve HCV RNA <LLoQ at follow-up (Period 2)

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    End point title
    		 Percentage of participants who achieve HCV RNA <LLoQ at follow-up (Period 2)
    End point description
    The percentage of participants with HCV RNA <LLoQ at follow-up (24 weeks after completing study therapy) is presented according to Period 2 arms. HCV viral RNA was measured with a commercial laboratory assay which had a LLoQ of 25 IU/mL.
    End point type
    Secondary
    End point timeframe
    Week 48 or 72
    End point values
    		 Peg-IFN/RBV (eRVR+) 24 Weeks Peg-IFN/RBV (eRVR+) 48 Weeks Peg-IFN/RBV (eRVR-) 48 Weeks Period 2: Other
    Number of subjects analysed
    16
    15
    2
    27 [15]
    Units: Percentage of participants
    56
    100
    100
    51
    Notes
    [15] - Data for 8 participants was unavailable.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 52 weeks for AEs and up to 72 weeks for SAEs
    Adverse event reporting additional description
    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, and that does not necessarily have a causal relationship with the study drug(s).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    MK-2355 100 mg + Peg-IFN/RBV
    Reporting group description
    		 TN participants with HCV GT1 took 2 MK-2355 50 mg tablets q.d. in combination with Peg-IFN and RBV for 12 weeks. Peg-IFN was administered q.w. via subcutaneous injection and RBV was taken b.i.d. by mouth with food at a total daily dose of 1000 mg/day or 1200 mg/day. After completing the 12-week MK-2355 100 mg regimen, participants took Peg-IFN and RBV for an additional 12 or 36 weeks based on treatment response.

    Reporting group title
    MK-2355 50 mg + Peg-IFN/RBV
    Reporting group description
    		 TN participants with HCV GT1 took 1 MK-2355 50 mg tablet and 1 matching placebo tablet q.d. in combination with Peg-IFN and RBV for 12 weeks. Peg-IFN was administered q.w. via subcutaneous injection and RBV was taken b.i.d. by mouth with food at a total daily dose of 1000 mg/day or 1200 mg/day. After completing the 12-week MK-2355 50 mg regimen, participants took Peg-IFN and RBV for an additional 12 or 36 weeks based on treatment response.

    Serious adverse events
    		 MK-2355 100 mg + Peg-IFN/RBV MK-2355 50 mg + Peg-IFN/RBV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 34 (2.94%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Spinal fracture
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash pruritic
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis viral
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MK-2355 100 mg + Peg-IFN/RBV MK-2355 50 mg + Peg-IFN/RBV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 34 (88.24%)
    32 / 34 (94.12%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 34 (2.94%)
         occurrences all number
    2
    1
    Chills
         subjects affected / exposed
    2 / 34 (5.88%)
    2 / 34 (5.88%)
         occurrences all number
    2
    2
    Fatigue
         subjects affected / exposed
    18 / 34 (52.94%)
    16 / 34 (47.06%)
         occurrences all number
    19
    17
    Influenza like illness
         subjects affected / exposed
    2 / 34 (5.88%)
    5 / 34 (14.71%)
         occurrences all number
    2
    5
    Injection site erythema
         subjects affected / exposed
    1 / 34 (2.94%)
    3 / 34 (8.82%)
         occurrences all number
    1
    4
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    Pain
         subjects affected / exposed
    1 / 34 (2.94%)
    7 / 34 (20.59%)
         occurrences all number
    1
    7
    Pyrexia
         subjects affected / exposed
    7 / 34 (20.59%)
    3 / 34 (8.82%)
         occurrences all number
    7
    6
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 34 (5.88%)
    5 / 34 (14.71%)
         occurrences all number
    2
    5
    Dyspnoea
         subjects affected / exposed
    4 / 34 (11.76%)
    3 / 34 (8.82%)
         occurrences all number
    4
    3
    Epistaxis
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    2
    Rhinorrhoea
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    3
    Sinus congestion
         subjects affected / exposed
    2 / 34 (5.88%)
    2 / 34 (5.88%)
         occurrences all number
    2
    2
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    4 / 34 (11.76%)
    2 / 34 (5.88%)
         occurrences all number
    4
    3
    Depression
         subjects affected / exposed
    6 / 34 (17.65%)
    7 / 34 (20.59%)
         occurrences all number
    7
    7
    Insomnia
         subjects affected / exposed
    6 / 34 (17.65%)
    11 / 34 (32.35%)
         occurrences all number
    6
    12
    Mood altered
         subjects affected / exposed
    4 / 34 (11.76%)
    1 / 34 (2.94%)
         occurrences all number
    4
    2
    Mood swings
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    Investigations
    Weight decreased
         subjects affected / exposed
    3 / 34 (8.82%)
    3 / 34 (8.82%)
         occurrences all number
    4
    3
    White blood cell count decreased
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 34 (2.94%)
         occurrences all number
    2
    1
    Injury, poisoning and procedural complications
    Excoriation
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    Hand fracture
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 34 (5.88%)
    4 / 34 (11.76%)
         occurrences all number
    3
    4
    Dysgeusia
         subjects affected / exposed
    3 / 34 (8.82%)
    1 / 34 (2.94%)
         occurrences all number
    3
    1
    Headache
         subjects affected / exposed
    9 / 34 (26.47%)
    11 / 34 (32.35%)
         occurrences all number
    9
    14
    Memory impairment
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    7 / 34 (20.59%)
    7 / 34 (20.59%)
         occurrences all number
    18
    11
    Leukopenia
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 34 (0.00%)
         occurrences all number
    3
    0
    Neutropenia
         subjects affected / exposed
    5 / 34 (14.71%)
    5 / 34 (14.71%)
         occurrences all number
    9
    32
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 34 (2.94%)
         occurrences all number
    2
    1
    Eye disorders
    Vision blurred
         subjects affected / exposed
    1 / 34 (2.94%)
    3 / 34 (8.82%)
         occurrences all number
    1
    3
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    2
    Constipation
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 34 (5.88%)
         occurrences all number
    1
    2
    Diarrhoea
         subjects affected / exposed
    5 / 34 (14.71%)
    1 / 34 (2.94%)
         occurrences all number
    7
    1
    Dyspepsia
         subjects affected / exposed
    4 / 34 (11.76%)
    0 / 34 (0.00%)
         occurrences all number
    4
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 34 (5.88%)
         occurrences all number
    1
    2
    Nausea
         subjects affected / exposed
    8 / 34 (23.53%)
    13 / 34 (38.24%)
         occurrences all number
    10
    15
    Vomiting
         subjects affected / exposed
    4 / 34 (11.76%)
    4 / 34 (11.76%)
         occurrences all number
    4
    4
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    4 / 34 (11.76%)
    3 / 34 (8.82%)
         occurrences all number
    4
    3
    Dry skin
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    Night sweats
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    2
    Pruritus
         subjects affected / exposed
    5 / 34 (14.71%)
    9 / 34 (26.47%)
         occurrences all number
    5
    9
    Rash
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 34 (2.94%)
         occurrences all number
    2
    1
    Rash generalised
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    Rash macular
         subjects affected / exposed
    2 / 34 (5.88%)
    2 / 34 (5.88%)
         occurrences all number
    3
    2
    Rash pruritic
         subjects affected / exposed
    6 / 34 (17.65%)
    5 / 34 (14.71%)
         occurrences all number
    7
    7
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 34 (2.94%)
         occurrences all number
    2
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 34 (17.65%)
    5 / 34 (14.71%)
         occurrences all number
    6
    5
    Back pain
         subjects affected / exposed
    5 / 34 (14.71%)
    1 / 34 (2.94%)
         occurrences all number
    7
    1
    Muscle spasms
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 34 (2.94%)
         occurrences all number
    2
    3
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 34 (2.94%)
    5 / 34 (14.71%)
         occurrences all number
    1
    5
    Musculoskeletal pain
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    Myalgia
         subjects affected / exposed
    6 / 34 (17.65%)
    5 / 34 (14.71%)
         occurrences all number
    7
    5
    Pain in extremity
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 34 (2.94%)
         occurrences all number
    2
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 34 (0.00%)
    3 / 34 (8.82%)
         occurrences all number
    0
    4
    Dermatophytosis
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    2
    Nasopharyngitis
         subjects affected / exposed
    0 / 34 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    2
    Oral herpes
         subjects affected / exposed
    4 / 34 (11.76%)
    1 / 34 (2.94%)
         occurrences all number
    4
    1
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 34 (8.82%)
    1 / 34 (2.94%)
         occurrences all number
    3
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 34 (5.88%)
    2 / 34 (5.88%)
         occurrences all number
    2
    2
    Viral infection
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 34 (5.88%)
         occurrences all number
    1
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 34 (8.82%)
    5 / 34 (14.71%)
         occurrences all number
    4
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Feb 2013
    Amendment 3 included the additional cardiac assessments that were completed as part of the partial clinical hold, as well as the follow-up plan, that was recommended by U.S. FDA.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    15 Aug 2012
    The program was placed on Partial Clinical Hold by the U.S. FDA on 15-Aug-2012; the program was electively discontinued for non-safety reasons on 04-Feb-2013.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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