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    Clinical Trial Results:
    A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared with Telaprevir in Combination with Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Patients with Chronic Hepatitis-C

    Summary
    EudraCT number
    		 2011-004237-14
    Trial protocol
    		 DE   AT   ES   GB   IT   DK  
    Global end of trial date
    20 Mar 2014

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    AI444-052
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01492426
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussee 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
    20 Mar 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Mar 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to compare rates of sustained virologic response, defined as Hepatitis C virus RNA < LOQ (target detected [TD] or target not detected [TND]) at follow-up Week 12, for genotype-1b subjects treated with either BMS-790052 (daclatasvir) or telaprevir in combination with peginterferon (PegINF)-alfa 2a/ribavirin.
    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
    22 Feb 2012
    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
    Poland: 94
    Country: Number of subjects enrolled
    Spain: 32
    Country: Number of subjects enrolled
    United Kingdom: 16
    Country: Number of subjects enrolled
    Austria: 41
    Country: Number of subjects enrolled
    Denmark: 6
    Country: Number of subjects enrolled
    France: 82
    Country: Number of subjects enrolled
    Germany: 84
    Country: Number of subjects enrolled
    Italy: 54
    Country: Number of subjects enrolled
    Argentina: 28
    Country: Number of subjects enrolled
    Australia: 29
    Country: Number of subjects enrolled
    Canada: 52
    Country: Number of subjects enrolled
    Israel: 55
    Country: Number of subjects enrolled
    Russian Federation: 30
    Country: Number of subjects enrolled
    Switzerland: 7
    Country: Number of subjects enrolled
    United States: 183
    Worldwide total number of subjects
    793
    EEA total number of subjects
    409
    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)
    751
    From 65 to 84 years
    42
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 90 sites in 15 countries.

    Pre-assignment
    Screening details
    		 A total of 793 subjects were enrolled, of which 605 subjects were randomised into the study. A total of 602 subjects were treated.

    Period 1
    Period 1 title
    Treatment Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    As this was an open-label study, blinding was not applicable.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Daclatasvir + PegIFNalfa-2a+ Ribavirin
    Arm description
    		 Subjects received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegIFNalfa-2a 180 µg administered subcutaneously once a week and ribavirin administered in a body weight stratified dose range of 1000 – 1200 mg per day (for subjects weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day) for 24 or 48 weeks depending on response.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daclatasvir
    Investigational medicinal product code
    BMS-790052
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daclatasvir 60-mg tablet was administered orally once daily for 24 weeks.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Copegus
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin body-weight stratified dose ranging between 1000-1200 mg per day was administered with food for 24 or 48 weeks depending on response.

    Investigational medicinal product name
    Peginterferon alfa-2a
    Investigational medicinal product code
    Other name
    Pegasys
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PegIFNalfa-2a 180-µg was administered subcutaneously once a week for 24 or 48 weeks depending on response.

    Arm title
    		 Telaprevir + PegIFNalfa-2a + Ribavirin
    Arm description
    		 Subjects received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PegIFNalfa-2a 180 µg was co-administered subcutaneously once a week and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food for 24 or 48 weeks depending on response.
    Arm type
    		 Active comparator

    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 was administered orally (2*375-mg tablet 3 times daily approximately 7-9 hours apart) for 12 weeks.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Copegus
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin body-weight stratified dose ranging between 1000-1200-mg per day was administered with food for 24 or 48 weeks depending on response.

    Investigational medicinal product name
    Peginterferon alfa-2a
    Investigational medicinal product code
    Other name
    Pegasys
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PegIFNalfa-2a 180-µg was administered subcutaneously once a week for 24 or 48 weeks depending on response.

    Number of subjects in period 1 [1]
    		Daclatasvir + PegIFNalfa-2a+ Ribavirin Telaprevir + PegIFNalfa-2a + Ribavirin
    Started
    402
    200
    Completed
    319
    160
    Not completed
    83
    40
         Subject withdrew consent
    1
    2
         Subject request to discontinue study treatment
    7
    3
         Other
    1
    -
         Poor compliance/noncompliance
    1
    -
         Death
    -
    1
         Adverse event
    25
    25
         Lost to follow-up
    9
    4
         Subject no longer meets study criteria
    1
    -
         Lack of efficacy
    38
    5
    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: Of the 793 subjects enrolled, 605 were randomised. A total of 191 enrolled subjects did not enter the treatment period: no longer met study entry criteria during the screening period - 139, Withdrew consent to participate - 28, administrative reason by sponsor - 5, lost to follow up - 3, pre-treatment adverse event - 2, other reasons - 11. 3 subjects who were randomised did not receive study therapy.
    Period 2
    Period 2 title
    Follow-up Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Daclatasvir + PegIFNalfa-2a+ Ribavirin
    Arm description
    		 Subjects were followed up to 48 weeks after treatment with daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegIFNalfa-2a 180 µg administered subcutaneously once a week and ribavirin administered in a body weight stratified dose range of 1000 – 1200 mg per day (for subjects weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day) for 24 or 48 weeks depending on response.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Telaprevir + PegIFNalfa-2a + Ribavirin
    Arm description
    		 Subjects were followed up to 48 weeks after treatment with 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks in combination with PegIFNalfa-2a 180 µg administered subcutaneously once a week and ribavirin administered in a body weight stratified dose range of 1000–1200 mg per day for 24 or 48 weeks depending on response.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Daclatasvir + PegIFNalfa-2a+ Ribavirin Telaprevir + PegIFNalfa-2a + Ribavirin
    Started
    319
    160
    Completed
    359
    181
    Not completed
    25
    10
         Consent withdrawn by subject
    6
    1
         Death
    1
    -
         Other
    4
    2
         Follow-up no longer required per protocol
    2
    1
         Lost to follow-up
    12
    6
    Joined
    65
    31
         Re-joined for follow-up
    65
    31

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Daclatasvir + PegIFNalfa-2a+ Ribavirin
    Reporting group description
    		 Subjects received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegIFNalfa-2a 180 µg administered subcutaneously once a week and ribavirin administered in a body weight stratified dose range of 1000 – 1200 mg per day (for subjects weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day) for 24 or 48 weeks depending on response.

    Reporting group title
    Telaprevir + PegIFNalfa-2a + Ribavirin
    Reporting group description
    		 Subjects received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PegIFNalfa-2a 180 µg was co-administered subcutaneously once a week and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food for 24 or 48 weeks depending on response.

    Reporting group values
    		 Daclatasvir + PegIFNalfa-2a+ Ribavirin Telaprevir + PegIFNalfa-2a + Ribavirin Total
    Number of subjects
    		 402 200 602
    Age categorical
    Units: Subjects
        < 65 years
    		 387 188 575
        >= 65 years
    		 15 12 27
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.5 ( 12.12 ) 47.6 ( 12.29 ) -
    Gender categorical
    Units: Subjects
        Female
    		 145 81 226
        Male
    		 257 119 376

    End points

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    End points reporting groups
    Reporting group title
    Daclatasvir + PegIFNalfa-2a+ Ribavirin
    Reporting group description
    		 Subjects received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegIFNalfa-2a 180 µg administered subcutaneously once a week and ribavirin administered in a body weight stratified dose range of 1000 – 1200 mg per day (for subjects weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day) for 24 or 48 weeks depending on response.

    Reporting group title
    Telaprevir + PegIFNalfa-2a + Ribavirin
    Reporting group description
    		 Subjects received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PegIFNalfa-2a 180 µg was co-administered subcutaneously once a week and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food for 24 or 48 weeks depending on response.
    Reporting group title
    Daclatasvir + PegIFNalfa-2a+ Ribavirin
    Reporting group description
    		 Subjects were followed up to 48 weeks after treatment with daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegIFNalfa-2a 180 µg administered subcutaneously once a week and ribavirin administered in a body weight stratified dose range of 1000 – 1200 mg per day (for subjects weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day) for 24 or 48 weeks depending on response.

    Reporting group title
    Telaprevir + PegIFNalfa-2a + Ribavirin
    Reporting group description
    		 Subjects were followed up to 48 weeks after treatment with 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks in combination with PegIFNalfa-2a 180 µg administered subcutaneously once a week and ribavirin administered in a body weight stratified dose range of 1000–1200 mg per day for 24 or 48 weeks depending on response.

    Primary: Percentage of Genotype 1b Subjects With Sustained Virologic Response at follow-up Week 12 (SVR12)

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    End point title
    		 Percentage of Genotype 1b Subjects With Sustained Virologic Response at follow-up Week 12 (SVR12)
    End point description
    SVR12 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. The analysis was performed in all treated subjects who received at least 1 dose of active study therapy. Here, 'Number of Subjects analysed' signifies Genotype 1b subjects assessed for SVR12 response.
    End point type
    Primary
    End point timeframe
    Week 12 (Follow-up period)
    End point values
    		 Daclatasvir + PegIFNalfa-2a+ Ribavirin Telaprevir + PegIFNalfa-2a + Ribavirin
    Number of subjects analysed
    268
    134
    Units: Percentage of Subjects
        number (confidence interval 95%)
    85.1 (80.2 to 89.1)
    81.3 (73.7 to 87.5)
    Statistical analysis title
    		 Percentage difference of treatments with SVR12
    Statistical analysis description
    Percentage difference between SVR12 rate in the experimental and control arms was computed using a stratum-adjusted Mantel-Haenszel confidence interval (95% level) for the difference in rates. The stratification factors were IL28B rs1297860 single nucleotide polymorphism and baseline cirrhosis status (absent or present), unless otherwise indicated.
    Comparison groups
    Daclatasvir + PegIFNalfa-2a+ Ribavirin v Telaprevir + PegIFNalfa-2a + Ribavirin
    Number of subjects included in analysis
    402
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    		 Stratum-adjusted Mantel-Haenszel
    Parameter type
    		 Percentage difference
    Point estimate
    4.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3
         upper limit
    		 11.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.885
    Notes
    [1] - Test of noninferiority was based on non-inferiority margin of -12% and 2-sided alpha level of 5%. That is, if the lower bound of the 95% CI > -12%, the daclatasvir arm would be considered non-inferior to the telaprevir arm.

    Secondary: Percentage of Genotype 1b Subjects With Rapid Virologic Response (RVR) at Week 4

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    End point title
    		 Percentage of Genotype 1b Subjects With Rapid Virologic Response (RVR) at Week 4
    End point description
    RVR was defined as hepatitis C virus RNA levels lower than lower limit of quantitation, target not detected at Week 4 of treatment. The analysis was performed in all treated subjects who received at least 1 dose of active study therapy. Here, 'Number of Subjects analysed' signifies Genotype 1b subjects assessed for RVR response.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Daclatasvir + PegIFNalfa-2a+ Ribavirin Telaprevir + PegIFNalfa-2a + Ribavirin
    Number of subjects analysed
    268
    134
    Units: Percentage of Subjects
        number (confidence interval 95%)
    77.2 (71.7 to 82.1)
    79.1 (71.2 to 85.6)
    No statistical analyses for this end point

    Secondary: Percentage of Genotype 1b Subjects With Extended Rapid Virologic Response (eRVR) at both Week 4 and Week 12

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    End point title
    		 Percentage of Genotype 1b Subjects With Extended Rapid Virologic Response (eRVR) at both Week 4 and Week 12
    End point description
    eRVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, target not detected at both Weeks 4 and 12 of treatment. The analysis was performed in all treated subjects who received at least 1 dose of active study therapy. Here, 'Number of Subjects analysed' signifies Genotype 1b subjects assessed for eRVR response.
    End point type
    Secondary
    End point timeframe
    Week 4, Week 12
    End point values
    		 Daclatasvir + PegIFNalfa-2a+ Ribavirin Telaprevir + PegIFNalfa-2a + Ribavirin
    Number of subjects analysed
    268
    134
    Units: Percentage of Subjects
        number (confidence interval 95%)
    75 (69.4 to 80.1)
    73.1 (64.8 to 80.4)
    No statistical analyses for this end point

    Secondary: Percentage of Genotype 1b Subjects With Complete Early Virologic Response (cEVR)

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    End point title
    		 Percentage of Genotype 1b Subjects With Complete Early Virologic Response (cEVR)
    End point description
    cEVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, target not detected at Week 12 of treatment. The analysis was performed in all treated subjects who received at least 1 dose of active study therapy. Here, 'Number of Subjects analysed' signifies Genotype 1b subjects assessed for cEVR response.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Daclatasvir + PegIFNalfa-2a+ Ribavirin Telaprevir + PegIFNalfa-2a + Ribavirin
    Number of subjects analysed
    268
    134
    Units: Percentage of Subjects
        number (confidence interval 95%)
    90.7 (86.5 to 93.9)
    90.3 (84 to 94.7)
    No statistical analyses for this end point

    Secondary: Percentage of Genotype 1b Subjects With Sustained Virologic Response at Follow-up Week 24 (SVR24)

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    End point title
    		 Percentage of Genotype 1b Subjects With Sustained Virologic Response at Follow-up Week 24 (SVR24)
    End point description
    SVR24 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, target detected or target not detected at follow-up week 24 of treatment. The analysis was performed in all treated subjects who received at least 1 dose of active study therapy. Here, 'Number of Subjects analysed' signifies Genotype 1b subjects assessed for SVR24 response.
    End point type
    Secondary
    End point timeframe
    Week 24 (Follow-up period)
    End point values
    		 Daclatasvir + PegIFNalfa-2a+ Ribavirin Telaprevir + PegIFNalfa-2a + Ribavirin
    Number of subjects analysed
    268
    134
    Units: Percentage of Subjects
        number (confidence interval 95%)
    84.3 (79.4 to 88.5)
    80.6 (72.9 to 86.9)
    No statistical analyses for this end point

    Secondary: Percentage of Genotype 1a Subjects With Sustained Virologic Response at Follow-up Week 12 (SVR12)

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    End point title
    		 Percentage of Genotype 1a Subjects With Sustained Virologic Response at Follow-up Week 12 (SVR12)
    End point description
    SVR12 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, target detected or target not detected at follow-up week 12 of treatment. The analysis was performed in all treated subjects who received at least 1 dose of active study therapy. Here, 'Number of Subjects analysed' signifies Genotype 1a subjects assessed for SVR12 response.
    End point type
    Secondary
    End point timeframe
    Week 12 (Follow-up period)
    End point values
    		 Daclatasvir + PegIFNalfa-2a+ Ribavirin Telaprevir + PegIFNalfa-2a + Ribavirin
    Number of subjects analysed
    134
    66
    Units: Percentage of Subjects
        number (confidence interval 95%)
    64.9 (56.2 to 73)
    69.7 (57.1 to 80.4)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of study treatment to last dose of study treatment plus 7 days (On-Treatment period)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Telaprevir + PegIFNalfa-2a + Ribavirin
    Reporting group description
    		 Subjects received two telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PegIFNalfa-2a 180 µg was co-administered subcutaneously once a week, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food for 24 or 48 weeks depending on response.

    Reporting group title
    Daclatasvir + PegIFNalfa-2a+ Ribavirin
    Reporting group description
    		 Subjects received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegIFNalfa-2a 180 µg administered subcutaneously once a week and ribavirin administered in a body weight stratified dose range of 1000–1200 mg per day (for Subjects weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day) for 24 or 48 weeks depending on response.

    Serious adverse events
    		 Telaprevir + PegIFNalfa-2a + Ribavirin Daclatasvir + PegIFNalfa-2a+ Ribavirin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    20 / 200 (10.00%)
    26 / 402 (6.47%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 402 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 402 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Haemothorax
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infiltration
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 402 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Bipolar I disorder
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panic attack
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    2 / 200 (1.00%)
    0 / 402 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 402 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panic disorder
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 402 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 402 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 402 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Anaemia postoperative
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 402 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery disease
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 402 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 200 (0.50%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 402 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 402 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Haemolytic anaemia
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    5 / 200 (2.50%)
    0 / 402 (0.00%)
         occurrences causally related to treatment / all
    5 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Duodenitis
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 200 (0.50%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 402 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 402 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 402 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 402 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Drug reaction with eosinophilia and systemic symptoms
         subjects affected / exposed
    1 / 200 (0.50%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dry skin
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash generalised
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug eruption
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 402 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    2 / 200 (1.00%)
    0 / 402 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bursitis
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 200 (0.00%)
    3 / 402 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 200 (0.00%)
    2 / 402 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis infective
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumococcal sepsis
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia mycoplasmal
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 402 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 402 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proctitis infectious
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 402 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 402 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 200 (0.50%)
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Telaprevir + PegIFNalfa-2a + Ribavirin Daclatasvir + PegIFNalfa-2a+ Ribavirin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    194 / 200 (97.00%)
    390 / 402 (97.01%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    57 / 200 (28.50%)
    137 / 402 (34.08%)
         occurrences all number
    73
    175
    Dizziness
         subjects affected / exposed
    18 / 200 (9.00%)
    32 / 402 (7.96%)
         occurrences all number
    18
    35
    Dysgeusia
         subjects affected / exposed
    21 / 200 (10.50%)
    23 / 402 (5.72%)
         occurrences all number
    21
    24
    Disturbance in attention
         subjects affected / exposed
    10 / 200 (5.00%)
    22 / 402 (5.47%)
         occurrences all number
    10
    22
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    98 / 200 (49.00%)
    96 / 402 (23.88%)
         occurrences all number
    105
    116
    Neutropenia
         subjects affected / exposed
    27 / 200 (13.50%)
    87 / 402 (21.64%)
         occurrences all number
    30
    128
    Thrombocytopenia
         subjects affected / exposed
    14 / 200 (7.00%)
    19 / 402 (4.73%)
         occurrences all number
    18
    22
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    81 / 200 (40.50%)
    140 / 402 (34.83%)
         occurrences all number
    83
    148
    Asthenia
         subjects affected / exposed
    53 / 200 (26.50%)
    109 / 402 (27.11%)
         occurrences all number
    59
    116
    Influenza like illness
         subjects affected / exposed
    38 / 200 (19.00%)
    85 / 402 (21.14%)
         occurrences all number
    43
    99
    Pyrexia
         subjects affected / exposed
    42 / 200 (21.00%)
    80 / 402 (19.90%)
         occurrences all number
    56
    102
    Chills
         subjects affected / exposed
    18 / 200 (9.00%)
    31 / 402 (7.71%)
         occurrences all number
    19
    34
    Injection site erythema
         subjects affected / exposed
    7 / 200 (3.50%)
    21 / 402 (5.22%)
         occurrences all number
    7
    21
    Injection site reaction
         subjects affected / exposed
    5 / 200 (2.50%)
    22 / 402 (5.47%)
         occurrences all number
    6
    22
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    12 / 200 (6.00%)
    18 / 402 (4.48%)
         occurrences all number
    12
    19
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    74 / 200 (37.00%)
    88 / 402 (21.89%)
         occurrences all number
    80
    94
    Diarrhoea
         subjects affected / exposed
    35 / 200 (17.50%)
    63 / 402 (15.67%)
         occurrences all number
    43
    67
    Vomiting
         subjects affected / exposed
    23 / 200 (11.50%)
    26 / 402 (6.47%)
         occurrences all number
    23
    29
    Abdominal pain upper
         subjects affected / exposed
    15 / 200 (7.50%)
    24 / 402 (5.97%)
         occurrences all number
    17
    26
    Dyspepsia
         subjects affected / exposed
    16 / 200 (8.00%)
    17 / 402 (4.23%)
         occurrences all number
    16
    17
    Anal pruritus
         subjects affected / exposed
    25 / 200 (12.50%)
    3 / 402 (0.75%)
         occurrences all number
    27
    3
    Anorectal discomfort
         subjects affected / exposed
    19 / 200 (9.50%)
    3 / 402 (0.75%)
         occurrences all number
    19
    3
    Haemorrhoids
         subjects affected / exposed
    11 / 200 (5.50%)
    7 / 402 (1.74%)
         occurrences all number
    11
    7
    Proctalgia
         subjects affected / exposed
    11 / 200 (5.50%)
    2 / 402 (0.50%)
         occurrences all number
    11
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    31 / 200 (15.50%)
    76 / 402 (18.91%)
         occurrences all number
    32
    82
    Dyspnoea
         subjects affected / exposed
    25 / 200 (12.50%)
    48 / 402 (11.94%)
         occurrences all number
    26
    51
    Oropharyngeal pain
         subjects affected / exposed
    11 / 200 (5.50%)
    22 / 402 (5.47%)
         occurrences all number
    12
    26
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    75 / 200 (37.50%)
    107 / 402 (26.62%)
         occurrences all number
    81
    119
    Rash
         subjects affected / exposed
    69 / 200 (34.50%)
    93 / 402 (23.13%)
         occurrences all number
    78
    105
    Alopecia
         subjects affected / exposed
    32 / 200 (16.00%)
    86 / 402 (21.39%)
         occurrences all number
    33
    86
    Dry skin
         subjects affected / exposed
    34 / 200 (17.00%)
    84 / 402 (20.90%)
         occurrences all number
    34
    90
    Erythema
         subjects affected / exposed
    10 / 200 (5.00%)
    16 / 402 (3.98%)
         occurrences all number
    10
    16
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    35 / 200 (17.50%)
    71 / 402 (17.66%)
         occurrences all number
    36
    76
    Irritability
         subjects affected / exposed
    27 / 200 (13.50%)
    43 / 402 (10.70%)
         occurrences all number
    27
    45
    Depression
         subjects affected / exposed
    12 / 200 (6.00%)
    29 / 402 (7.21%)
         occurrences all number
    12
    30
    Anxiety
         subjects affected / exposed
    16 / 200 (8.00%)
    10 / 402 (2.49%)
         occurrences all number
    16
    10
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    23 / 200 (11.50%)
    61 / 402 (15.17%)
         occurrences all number
    25
    63
    Arthralgia
         subjects affected / exposed
    14 / 200 (7.00%)
    55 / 402 (13.68%)
         occurrences all number
    14
    57
    Back pain
         subjects affected / exposed
    14 / 200 (7.00%)
    27 / 402 (6.72%)
         occurrences all number
    14
    28
    Muscle spasms
         subjects affected / exposed
    11 / 200 (5.50%)
    7 / 402 (1.74%)
         occurrences all number
    11
    8
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    10 / 200 (5.00%)
    7 / 402 (1.74%)
         occurrences all number
    10
    8
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    39 / 200 (19.50%)
    61 / 402 (15.17%)
         occurrences all number
    40
    65

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 May 2011
    • The primary and secondary objectives and endpoints were modified to reflect analysis of GT-1b and GT-1a populations. • The overall risk/benefit section was updated. • Fibroscan as a method of confirming a diagnosis of chronic hepatitis-C was removed. • Subjects with history of coagulopathy were excluded. • Specified washout for investigational drug/placebo and washout period for exclusions prior therapy. • Confirmed length of follow-up period for subjects who discontinued study drug early. • Updated dosing information to allow for missed doses and for country-specific food preference with telaprevir dosing. • Added Grade 4 rash description and management. • Clarified single nucleotide polymorphism sample at screening used for stratification.
    22 Jan 2013
    • Added pertinent telaprevir safety information with regards to fatalities. • Clarified use of prednisone/prednisilone with daclatasvir and clarified that prohibited concomitant medications during daclatasvir dosing refer to systemic dosing.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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