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    Clinical Trial Results:
    A Phase 3 Blinded Randomized Study of Peginterferon Lambda-1a and Ribavirin Compared to Peginterferon Alfa-2a and Ribavirin, Each Administered with Telaprevir in Subjects with Genotype-1 Chronic Hepatitis C who are Treatment-naïve or Relapsed on Treatment with Peginterferon Alfa and Ribavirin

    Summary
    EudraCT number
    		 2011-004695-11
    Trial protocol
    		 AT   BE   CZ   GB   PL   IT   ES  
    Global end of trial date
    04 Feb 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 May 2016
    First version publication date
    21 May 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    AI452-020
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01598090
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Bristol-Myers Squibb International Corporation, Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, clinical.trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, clinical.trials@bms.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 Feb 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Feb 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and TVR.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Jun 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Brazil: 95
    Country: Number of subjects enrolled
    Canada: 41
    Country: Number of subjects enrolled
    Israel: 28
    Country: Number of subjects enrolled
    Russian Federation: 139
    Country: Number of subjects enrolled
    Switzerland: 5
    Country: Number of subjects enrolled
    United States: 264
    Country: Number of subjects enrolled
    Austria: 12
    Country: Number of subjects enrolled
    Poland: 100
    Country: Number of subjects enrolled
    Spain: 76
    Country: Number of subjects enrolled
    United Kingdom: 19
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    Czech Republic: 26
    Country: Number of subjects enrolled
    France: 19
    Country: Number of subjects enrolled
    Germany: 22
    Country: Number of subjects enrolled
    Italy: 31
    Worldwide total number of subjects
    881
    EEA total number of subjects
    309
    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)
    851
    From 65 to 84 years
    30
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 A total of 881 subjects were recruited at 98 sites.

    Pre-assignment
    Screening details
    		 Out of 881 subjects enrolled, 27 subjects were treated in Part A and 617 subjects were treated in Part B of the study.

    Period 1
    Period 1 title
    Treatment period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    Part A of this study was open-label. In Part B of this study, treatment assignment was site and subject blinded for the entire duration of the study. A designated member of the study staff at the investigative site and a necessary personnel at the Sponsor not directly involved in the assessment of safety in the study was unblinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
    Arm description
    		 Subjects with genotype (GT) -1 chronic Hepatitis C virus infection received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Peginterferon lambda- 1a
    Investigational medicinal product code
    BMS-914143
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peginterferon lambda-1a 180 mcg was administered subcutaneously once weekly for 24 or 48 weeks.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Ribasphere
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 1000 mg total daily dose was administered orally in 2 divided doses as 400 mg in Ante Meridian (AM) and 600 mg in Post Meridian (PM) (for subjects <75 kg) or 1200 mg total daily dose was administered orally in 2 divided doses as 600 mg in AM and PM (for subjects >=75 kg) with meal for 24 or 48 weeks.

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    Other name
    Incivek
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Telaprevir 750 mg tablets (375 mg*2) were administered orally three times a day for 12 weeks.

    Arm title
    		 Part B: Peginterferon Lambda-1a + RBV + TVR
    Arm description
    		 Subjects who were either treatment naive or who were relapsers to previous Peginterferon alfa-2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Peginterferon lambda- 1a
    Investigational medicinal product code
    BMS-914143
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peginterferon lambda-1a 180 mcg was administered subcutaneously once weekly for 24 or 48 weeks.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Ribasphere
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 1000 mg total daily dose was administered orally in 2 divided doses as 400 mg in AM and 600 mg in PM (for subjects <75 kg) or 1200 mg total daily dose was administered orally in 2 divided doses as 600 mg in AM and PM (for subjects >=75 kg) with meal for 24 or 48 weeks.

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    Other name
    Incivek
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Telaprevir 750 mg tablets (375 mg*2) were administered orally three times a day for 12 weeks.

    Arm title
    		 Part B: Peginterferon Alfa-2a + RBV + TVR
    Arm description
    		 Subjects who were either treatment naive or who were relapsers to previous Peginterferon alfa-2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Peginterferon alfa- 2a
    Investigational medicinal product code
    Other name
    Pegasys
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peginterferon alfa-2a 180 mcg was administered subcutaneously once weekly for 24 or 48 weeks.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Ribasphere
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 1000 mg total daily dose was administered orally in 2 divided doses as 400 mg in AM and 600 mg in PM (for subjects <75 kg) or 1200 mg total daily dose was administered orally in 2 divided doses as 600 mg in AM and PM (for subjects >=75 kg) with meal for 24 or 48 weeks.

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    Other name
    Incivek
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Telaprevir 750 mg tablets (375 mg*2) were administered orally three times a day for 12 weeks.

    Number of subjects in period 1 [1]
    		Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
    Started
    27
    411
    206
    Completed
    16
    339
    171
    Not completed
    11
    72
    35
         Consent withdrawn by subject
    -
    4
    3
         Adverse event, non-fatal
    2
    33
    17
         Other reasons
    -
    4
    1
         Lost to follow-up
    1
    5
    1
         Poor/non-compliance
    -
    2
    -
         Subject no longer meets study criteria
    -
    1
    -
         Subject requested to discontinue study treatment
    3
    9
    7
         Lack of efficacy
    5
    14
    6
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Out of 881 subjects who were enrolled, 648 were randomised and only 644 were treated.
    Period 2
    Period 2 title
    Follow-up period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    Part A of this study was open-label. In Part B of this study, treatment assignment will be site and subject blinded for the entire duration of the study. A designated member of the study staff at the investigative site and a necessary personnel at the Sponsor not directly involved in the assessment of safety in the study was unblinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
    Arm description
    		 Subjects were followed up for 48 weeks who received treatment as: Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Part B: Peginterferon Lambda-1a + RBV + TVR
    Arm description
    		 Subjects were followed up for 48 weeks who received treatment as: Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Part B: Peginterferon alfa-2a + RBV + TVR
    Arm description
    		 Subjects were followed up for 48 weeks who received treatment as: Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon alfa-2a + RBV + TVR
    Started
    16
    339
    171
    Completed
    21
    364
    171
    Not completed
    5
    35
    28
         Consent withdrawn by subject
    -
    3
    2
         Death
    -
    1
    -
         Not reported
    -
    10
    4
         Other reasons
    2
    8
    8
         Follow-up no longer required per protocol
    1
    3
    2
         Lost to follow-up
    2
    10
    12
    Joined
    10
    60
    28
         Re-joined for follow-up
    10
    60
    28

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
    Reporting group description
    		 Subjects with genotype (GT) -1 chronic Hepatitis C virus infection received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks.

    Reporting group title
    Part B: Peginterferon Lambda-1a + RBV + TVR
    Reporting group description
    		 Subjects who were either treatment naive or who were relapsers to previous Peginterferon alfa-2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks.

    Reporting group title
    Part B: Peginterferon Alfa-2a + RBV + TVR
    Reporting group description
    		 Subjects who were either treatment naive or who were relapsers to previous Peginterferon alfa-2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks.

    Reporting group values
    		 Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR Total
    Number of subjects
    		 27 411 206 644
    Age categorical
    Units: Subjects
        <21
    		 0 5 2 7
        21 - <65
    		 27 392 197 616
        >=65
    		 0 14 7 21
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.9 ± 8.62 45.8 ± 12.42 45 ± 12.19 -
    Gender categorical
    Units: Subjects
        Female
    		 9 152 80 241
        Male
    		 18 259 126 403

    End points

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    End points reporting groups
    Reporting group title
    Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
    Reporting group description
    		 Subjects with genotype (GT) -1 chronic Hepatitis C virus infection received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks.

    Reporting group title
    Part B: Peginterferon Lambda-1a + RBV + TVR
    Reporting group description
    		 Subjects who were either treatment naive or who were relapsers to previous Peginterferon alfa-2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks.

    Reporting group title
    Part B: Peginterferon Alfa-2a + RBV + TVR
    Reporting group description
    		 Subjects who were either treatment naive or who were relapsers to previous Peginterferon alfa-2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks.
    Reporting group title
    Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
    Reporting group description
    		 Subjects were followed up for 48 weeks who received treatment as: Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks.

    Reporting group title
    Part B: Peginterferon Lambda-1a + RBV + TVR
    Reporting group description
    		 Subjects were followed up for 48 weeks who received treatment as: Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks.

    Reporting group title
    Part B: Peginterferon alfa-2a + RBV + TVR
    Reporting group description
    		 Subjects were followed up for 48 weeks who received treatment as: Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks.

    Primary: Percentage of Subjects With Extended Rapid Virologic Response (eRVR) - Part A

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    End point title
    		 Percentage of Subjects With Extended Rapid Virologic Response (eRVR) - Part A [1] [2]
    End point description
    eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL). The analysis was performed using Modified Intent-to-Treat method, defined as the proportions of subjects meeting the response criteria in numerator and denominator based on all treated subjects. The analysis was performed in all treated subjects.
    End point type
    Primary
    End point timeframe
    Week 4 and Week 12
    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: Only descriptive summary statistics were planned for this outcome measure.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to evaluate for the specified arm only.
    End point values
    		 Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
    Number of subjects analysed
    27
    Units: Percentage of subjects
        number (confidence interval 95%)
    51.9 (31.9 to 71.3)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B

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    End point title
    		 Percentage of Subjects With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B [3]
    End point description
    SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL). The analysis was performed using Modified Intent-to-Treat method defined as the proportions of subjects meeting the response criteria in numerator and denominator based on all treated subjects. The analysis was performed in all treated subjects.
    End point type
    Primary
    End point timeframe
    Follow-up Week 12
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to evaluate for the specified arm only.
    End point values
    		 Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
    Number of subjects analysed
    411
    206
    Units: Percentage of subjects
        number (confidence interval 95%)
    76.2 (72 to 80.3)
    82 (76.8 to 87.3)
    Statistical analysis title
    		 Comparison of SVR12
    Comparison groups
    Part B: Peginterferon Lambda-1a + RBV + TVR v Part B: Peginterferon Alfa-2a + RBV + TVR
    Number of subjects included in analysis
    617
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    P-value
    		 = 99999 [5]
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Difference in proportions
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.3
         upper limit
    		 0.8
    Notes
    [4] - Non-inferiority of Lambda/RBV/TVR to Alfa/RBV/TVR was not established because the lower limit of the 95% CI was less than the predefined non-inferiority margin of -12%. As a result, key secondary endpoints were not tested hierarchically to compare treatment groups.
    [5] - Non-inferiority testing is based on lower limit of confidence interval.

    Primary: Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation due to AEs, Dose Reductions and Death - Part A

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    End point title
    		 Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation due to AEs, Dose Reductions and Death - Part A [6] [7]
    End point description
    An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject or clinical investigation subject administered an investigational (medicinal) product. An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or caused prolongation of existing hospitalization. Safety analysis included all treated subjects.
    End point type
    Primary
    End point timeframe
    Day 1 of treatment up to Week 48
    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: Only descriptive summary statistics were planned for this outcome measure.
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to evaluate for the specified arm only.
    End point values
    		 Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
    Number of subjects analysed
    27
    Units: Subjects
        AEs
    26
        SAEs
    6
        Drug related AEs
    12
        Discontinuation due to AEs
    2
        Death
    0
        Dose reductions - Lambda
    3
        Dose reductions - RBV
    7
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A

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    End point title
    		 Percentage of Subjects With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A [8]
    End point description
    SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ =25 IU/mL; limit of detection ~ 10 IU/mL). The analysis was performed using Modified Intent-to-Treat method defined as the proportions of subjects meeting the response criteria in numerator and denominator based on all treated subjects. The analysis was performed in all treated subjects.
    End point type
    Secondary
    End point timeframe
    Follow-up Week 12
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to evaluate for the specified arm only.
    End point values
    		 Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
    Number of subjects analysed
    27
    Units: Percentage of subjects
        number (confidence interval 95%)
    48.1 (28.7 to 68.1)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Sustained Virologic Response at Follow-up Week 24 (SVR24) - Part A

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    End point title
    		 Percentage of Subjects With Sustained Virologic Response at Follow-up Week 24 (SVR24) - Part A [9]
    End point description
    SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection ~ 10 IU/mL). The analysis was performed using Modified Intent-to-Treat method defined as the proportions of subjects meeting the response criteria in numerator and denominator based on all treated subjects. The analysis was performed in all treated subjects.
    End point type
    Secondary
    End point timeframe
    Follow-up Week 24
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to evaluate for the specified arm only.
    End point values
    		 Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
    Number of subjects analysed
    27
    Units: Percentage of subjects
        number (confidence interval 95%)
    40.7 (22.4 to 61.2)
    No statistical analyses for this end point

    Secondary: Percentage of Treatment-Naive Subjects With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B

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    End point title
    		 Percentage of Treatment-Naive Subjects With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B [10]
    End point description
    SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level were measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ =25 IU/mL; limit of detection ~ 10 IU/mL). The analysis was performed using Modified Intent-to-Treat method defined as the proportions of subjects meeting the response criteria in numerator and denominator based on all treated subjects. The analysis was performed in all the treatment-naive treated subjects.
    End point type
    Secondary
    End point timeframe
    Follow-up Week 12
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to evaluate for the specified arm only.
    End point values
    		 Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
    Number of subjects analysed
    311
    155
    Units: Percentage of subjects
        number (confidence interval 95%)
    73.6 (68.7 to 78.5)
    81.9 (75.9 to 88)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Treatment Emergent Cytopenic Abnormalities - Part B

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    End point title
    		 Percentage of Subjects With Treatment Emergent Cytopenic Abnormalities - Part B [11]
    End point description
    Cytopenic abnormalities included anemia defined as hemoglobin <10 grams/decilitre; neutropenia defined as Absolute neutrophil count (ANC) <750 cubic millimetre (mm^3); thrombocytopenia defined as platelets <50,000 mm^3. The analysis was performed using Modified Intent-to-Treat method, defined as the proportions of subjects with abnormalities in numerator and denominator based on all treated subjects. The analysis was performed in all treated subjects.
    End point type
    Secondary
    End point timeframe
    After Day 1 of treatment up to Week 48
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to evaluate for the specified arm only.
    End point values
    		 Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
    Number of subjects analysed
    411
    206
    Units: Percentage of subjects
        number (confidence interval 95%)
    11.7 (8.6 to 14.8)
    55.8 (49 to 62.6)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Extended Rapid Virologic Response (eRVR) - Part B

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    End point title
    		 Percentage of Subjects With Extended Rapid Virologic Response (eRVR) - Part B [12]
    End point description
    eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL). The analysis was performed using Modified Intent-to-Treat method defined as the proportions of subjects meeting the response criteria in numerator and denominator based on all treated subjects. The analysis was performed in all treated subjects.
    End point type
    Secondary
    End point timeframe
    Week 4 and Week 12
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to evaluate for the specified arm only.
    End point values
    		 Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
    Number of subjects analysed
    411
    206
    Units: Percentage of subjects
        number (confidence interval 95%)
    64 (59.3 to 68.6)
    70.9 (64.7 to 77.1)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B

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    End point title
    		 Percentage of Subjects With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B [13]
    End point description
    Flu-like symptoms included pyrexia, chills, and pain. Musculoskeletal symptoms included arthralgia, myalgia, and back pain. The analysis was performed using Modified Intent-to-Treat method, defined as the proportions of subjects with symptoms in numerator and denominator based on all treated subjects. The analysis was performed in all treated subjects.
    End point type
    Secondary
    End point timeframe
    After Day 1 of treatment up to Week 48
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to evaluate for the specified arm only.
    End point values
    		 Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
    Number of subjects analysed
    411
    206
    Units: Percentage of subjects
    number (confidence interval 95%)
        Flu-Like Symptoms
    14.4 (11 to 17.7)
    36.4 (29.8 to 43)
        Musculoskeletal symptoms
    21.4 (17.4 to 25.4)
    30.6 (24.3 to 36.9)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Sustained Virologic Response at Follow-up Week 24 (SVR24) - Part B

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    End point title
    		 Percentage of Subjects With Sustained Virologic Response at Follow-up Week 24 (SVR24) - Part B [14]
    End point description
    SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection ~ 10 IU/mL). The analysis was performed using Observed value method, defined as the proportions of subjects meeting the response criteria in numerator and denominator based on all treated subjects with HCV RNA measured at follow-up Week 24. The analysis was performed in all treated subjects with HCV RNA measured at follow-up Week 24 instead of all treated subjects due to early study termination.
    End point type
    Secondary
    End point timeframe
    Follow-up Week 24
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to evaluate for the specified arm only.
    End point values
    		 Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
    Number of subjects analysed
    223
    108
    Units: Percentage of subjects
        number (confidence interval 95%)
    83 (78 to 87.9)
    87 (80.7 to 93.4)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Rash

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    End point title
    		 Percentage of Subjects With Rash
    End point description
    All skin reactions involving rash or rash-like events that occurred on treatment were reported. The analysis was performed in all treated subjects.
    End point type
    Secondary
    End point timeframe
    Day 1 of treatment up to Week 48
    End point values
    		 Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
    Number of subjects analysed
    27
    411
    206
    Units: Percentage of subjects
        number (not applicable)
    63
    36.3
    38.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 of treatment up to Week 48
    Adverse event reporting additional description
    On-Treatment period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label)
    Reporting group description
    		 Subjects with genotype (GT) -1 chronic Hepatitis C virus infection received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks.

    Reporting group title
    Part B: Peginterferon Lambda-1a + RBV + TVR
    Reporting group description
    		 Subjects who were either treatment naive or who were relapsers to previous Peginterferon alfa-2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on response (eRVR); Telaprevir 750 mg tablets, orally three times a day for 12 weeks.

    Reporting group title
    Part B: Peginterferon Alfa-2a + RBV + TVR
    Reporting group description
    		 Subjects who were either treatment naive or who were relapsers to previous Peginterferon alfa-2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks.

    Serious adverse events
    		 Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 27 (22.22%)
    43 / 411 (10.46%)
    20 / 206 (9.71%)
         number of deaths (all causes)
    0
    1
    1
         number of deaths resulting from adverse events
    0
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 411 (0.24%)
    0 / 206 (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
    General disorders and administration site conditions
    Strangulated hernia
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 411 (0.24%)
    0 / 206 (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
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 411 (0.00%)
    2 / 206 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 411 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Psychiatric disorders
    Substance-induced psychotic disorder
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 411 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 411 (0.24%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 411 (0.24%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 411 (0.24%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 411 (0.24%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 411 (0.24%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lipase increased
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 411 (0.24%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic enzymes increased
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 411 (0.24%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carotid bruit
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 411 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 411 (0.24%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 411 (0.24%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 411 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 411 (0.24%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Demyelination
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 411 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 411 (0.24%)
    3 / 206 (1.46%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 411 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Ocular icterus
         subjects affected / exposed
    0 / 27 (0.00%)
    3 / 411 (0.73%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 411 (0.00%)
    0 / 206 (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
    Peptic ulcer haemorrhage
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 411 (0.00%)
    0 / 206 (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
    Pancreatitis acute
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 411 (0.49%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 411 (0.24%)
    0 / 206 (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
    Nausea
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 411 (0.24%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 411 (0.24%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 411 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 411 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal vascular malformation
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 411 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    3 / 27 (11.11%)
    11 / 411 (2.68%)
    2 / 206 (0.97%)
         occurrences causally related to treatment / all
    2 / 3
    11 / 11
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    0 / 27 (0.00%)
    4 / 411 (0.97%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatotoxicity
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 411 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 411 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 411 (0.49%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 411 (0.24%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 411 (0.24%)
    5 / 206 (2.43%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug reaction with eosinophilia and systemic symptoms
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 411 (0.00%)
    1 / 206 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 411 (0.24%)
    0 / 206 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 411 (0.24%)
    0 / 206 (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
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 411 (0.24%)
    0 / 206 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) Part B: Peginterferon Lambda-1a + RBV + TVR Part B: Peginterferon Alfa-2a + RBV + TVR
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 27 (96.30%)
    369 / 411 (89.78%)
    197 / 206 (95.63%)
    Investigations
    Amylase increased
         subjects affected / exposed
    0 / 27 (0.00%)
    21 / 411 (5.11%)
    3 / 206 (1.46%)
         occurrences all number
    0
    26
    5
    Blood bilirubin increased
         subjects affected / exposed
    2 / 27 (7.41%)
    19 / 411 (4.62%)
    2 / 206 (0.97%)
         occurrences all number
    3
    25
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 27 (7.41%)
    30 / 411 (7.30%)
    1 / 206 (0.49%)
         occurrences all number
    2
    33
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 27 (3.70%)
    30 / 411 (7.30%)
    1 / 206 (0.49%)
         occurrences all number
    1
    38
    2
    Bilirubin conjugated increased
         subjects affected / exposed
    2 / 27 (7.41%)
    6 / 411 (1.46%)
    1 / 206 (0.49%)
         occurrences all number
    2
    9
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 27 (29.63%)
    66 / 411 (16.06%)
    42 / 206 (20.39%)
         occurrences all number
    9
    76
    54
    Dizziness
         subjects affected / exposed
    2 / 27 (7.41%)
    52 / 411 (12.65%)
    24 / 206 (11.65%)
         occurrences all number
    2
    55
    33
    Dysgeusia
         subjects affected / exposed
    3 / 27 (11.11%)
    11 / 411 (2.68%)
    9 / 206 (4.37%)
         occurrences all number
    3
    11
    11
    Syncope
         subjects affected / exposed
    2 / 27 (7.41%)
    5 / 411 (1.22%)
    1 / 206 (0.49%)
         occurrences all number
    2
    5
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    16 / 27 (59.26%)
    143 / 411 (34.79%)
    75 / 206 (36.41%)
         occurrences all number
    16
    162
    92
    Asthenia
         subjects affected / exposed
    0 / 27 (0.00%)
    81 / 411 (19.71%)
    61 / 206 (29.61%)
         occurrences all number
    0
    95
    69
    Pyrexia
         subjects affected / exposed
    2 / 27 (7.41%)
    31 / 411 (7.54%)
    53 / 206 (25.73%)
         occurrences all number
    2
    37
    61
    Influenza like illness
         subjects affected / exposed
    3 / 27 (11.11%)
    26 / 411 (6.33%)
    36 / 206 (17.48%)
         occurrences all number
    4
    29
    39
    Chills
         subjects affected / exposed
    1 / 27 (3.70%)
    35 / 411 (8.52%)
    35 / 206 (16.99%)
         occurrences all number
    1
    42
    41
    Injection site reaction
         subjects affected / exposed
    4 / 27 (14.81%)
    7 / 411 (1.70%)
    6 / 206 (2.91%)
         occurrences all number
    4
    7
    6
    Pain
         subjects affected / exposed
    2 / 27 (7.41%)
    6 / 411 (1.46%)
    6 / 206 (2.91%)
         occurrences all number
    2
    6
    6
    Oedema peripheral
         subjects affected / exposed
    2 / 27 (7.41%)
    15 / 411 (3.65%)
    3 / 206 (1.46%)
         occurrences all number
    2
    16
    3
    Injection site rash
         subjects affected / exposed
    3 / 27 (11.11%)
    6 / 411 (1.46%)
    0 / 206 (0.00%)
         occurrences all number
    3
    6
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 27 (11.11%)
    53 / 411 (12.90%)
    100 / 206 (48.54%)
         occurrences all number
    3
    55
    111
    Neutropenia
         subjects affected / exposed
    0 / 27 (0.00%)
    10 / 411 (2.43%)
    35 / 206 (16.99%)
         occurrences all number
    0
    17
    45
    Leukopenia
         subjects affected / exposed
    0 / 27 (0.00%)
    9 / 411 (2.19%)
    32 / 206 (15.53%)
         occurrences all number
    0
    13
    41
    Thrombocytopenia
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 411 (0.24%)
    17 / 206 (8.25%)
         occurrences all number
    0
    2
    22
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    11 / 27 (40.74%)
    172 / 411 (41.85%)
    67 / 206 (32.52%)
         occurrences all number
    12
    195
    78
    Diarrhoea
         subjects affected / exposed
    13 / 27 (48.15%)
    61 / 411 (14.84%)
    37 / 206 (17.96%)
         occurrences all number
    13
    70
    43
    Vomiting
         subjects affected / exposed
    5 / 27 (18.52%)
    66 / 411 (16.06%)
    25 / 206 (12.14%)
         occurrences all number
    5
    93
    29
    Anal pruritus
         subjects affected / exposed
    4 / 27 (14.81%)
    59 / 411 (14.36%)
    22 / 206 (10.68%)
         occurrences all number
    4
    64
    22
    Anorectal discomfort
         subjects affected / exposed
    5 / 27 (18.52%)
    28 / 411 (6.81%)
    17 / 206 (8.25%)
         occurrences all number
    5
    30
    18
    Dyspepsia
         subjects affected / exposed
    2 / 27 (7.41%)
    28 / 411 (6.81%)
    13 / 206 (6.31%)
         occurrences all number
    2
    30
    17
    Haemorrhoids
         subjects affected / exposed
    1 / 27 (3.70%)
    17 / 411 (4.14%)
    11 / 206 (5.34%)
         occurrences all number
    1
    17
    11
    Proctalgia
         subjects affected / exposed
    2 / 27 (7.41%)
    8 / 411 (1.95%)
    5 / 206 (2.43%)
         occurrences all number
    2
    9
    6
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 27 (7.41%)
    31 / 411 (7.54%)
    37 / 206 (17.96%)
         occurrences all number
    2
    34
    41
    Cough
         subjects affected / exposed
    3 / 27 (11.11%)
    12 / 411 (2.92%)
    24 / 206 (11.65%)
         occurrences all number
    3
    13
    27
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    3 / 27 (11.11%)
    44 / 411 (10.71%)
    4 / 206 (1.94%)
         occurrences all number
    3
    56
    4
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    13 / 27 (48.15%)
    187 / 411 (45.50%)
    100 / 206 (48.54%)
         occurrences all number
    13
    209
    126
    Rash
         subjects affected / exposed
    12 / 27 (44.44%)
    123 / 411 (29.93%)
    57 / 206 (27.67%)
         occurrences all number
    13
    131
    62
    Dry skin
         subjects affected / exposed
    1 / 27 (3.70%)
    52 / 411 (12.65%)
    27 / 206 (13.11%)
         occurrences all number
    1
    56
    27
    Alopecia
         subjects affected / exposed
    1 / 27 (3.70%)
    9 / 411 (2.19%)
    23 / 206 (11.17%)
         occurrences all number
    1
    9
    24
    Rash generalised
         subjects affected / exposed
    5 / 27 (18.52%)
    4 / 411 (0.97%)
    2 / 206 (0.97%)
         occurrences all number
    5
    4
    2
    Skin exfoliation
         subjects affected / exposed
    2 / 27 (7.41%)
    4 / 411 (0.97%)
    2 / 206 (0.97%)
         occurrences all number
    2
    4
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    8 / 27 (29.63%)
    102 / 411 (24.82%)
    56 / 206 (27.18%)
         occurrences all number
    8
    110
    63
    Anxiety
         subjects affected / exposed
    0 / 27 (0.00%)
    13 / 411 (3.16%)
    11 / 206 (5.34%)
         occurrences all number
    0
    14
    11
    Depression
         subjects affected / exposed
    5 / 27 (18.52%)
    25 / 411 (6.08%)
    11 / 206 (5.34%)
         occurrences all number
    6
    26
    11
    Irritability
         subjects affected / exposed
    3 / 27 (11.11%)
    33 / 411 (8.03%)
    8 / 206 (3.88%)
         occurrences all number
    3
    40
    8
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 27 (3.70%)
    49 / 411 (11.92%)
    43 / 206 (20.87%)
         occurrences all number
    1
    58
    55
    Myalgia
         subjects affected / exposed
    4 / 27 (14.81%)
    49 / 411 (11.92%)
    43 / 206 (20.87%)
         occurrences all number
    4
    61
    56
    Muscle spasms
         subjects affected / exposed
    4 / 27 (14.81%)
    14 / 411 (3.41%)
    2 / 206 (0.97%)
         occurrences all number
    4
    14
    2
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 27 (7.41%)
    3 / 411 (0.73%)
    4 / 206 (1.94%)
         occurrences all number
    2
    4
    4
    Gastroenteritis
         subjects affected / exposed
    2 / 27 (7.41%)
    5 / 411 (1.22%)
    2 / 206 (0.97%)
         occurrences all number
    2
    5
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 27 (3.70%)
    85 / 411 (20.68%)
    42 / 206 (20.39%)
         occurrences all number
    1
    93
    47
    Hyperuricaemia
         subjects affected / exposed
    1 / 27 (3.70%)
    32 / 411 (7.79%)
    11 / 206 (5.34%)
         occurrences all number
    1
    43
    11

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Feb 2013
    The main purpose of this amendment was to clarify primary and secondary objectives, study design, statistical objectives for Part A and Part B of the study, change of medical monitor and study director.
    19 Jun 2013
    The purpose of this amendment was to clarify the duration of treatment for all cirrhotics is 48 weeks, stratification applies for all subjects, inclusion/exclusion criteria, the rash management plan for telaprevir, that Hepatitis C virus RNA results was made available to sites and staff at the end of treatment and during follow-up, and the analysis of the secondary endpoint for Part A was for all subjects in Part A.

    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.
    The study was terminated early as further development of Lambda was terminated, due to the recent approvals of all-oral Hepatitis C virus treatment regimens.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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