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    Clinical Trial Results:
    Multicenter, Open-Label, Early Access Program of Telaprevir in Combination With Peginterferon Alfa and Ribavirin in Genotype 1 Chronic Hepatitis C Subjects With Severe Fibrosis and Compensated Cirrhosis

    Summary
    EudraCT number
    		 2010-023669-23
    Trial protocol
    		 AT   IT   CZ   GR   ES   HU   SK  
    Global end of trial date
    30 May 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    23 Jun 2016
    First version publication date
    02 Aug 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Review of data

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    VX-950HEP3002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01508286
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Antwerpseweg 15-17, Beerse, Belgium, B-2340
    Public contact
    Janssen-Cilag International NV - Clinical Registry Group, Janssen Biologics BV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Janssen-Cilag International NV - Clinical Registry Group, Janssen Biologics BV, ClinicalTrialsEU@its.jnj.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
    30 May 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this early access program was to provide telaprevir for participants with genotype 1 chronic hepatitis C with severe fibrosis or compensated cirrhosis who resided in countries in which telaprevir was not commercially available at the time of protocol writing and who were not eligible for enrollment into an ongoing clinical study of telaprevir, and to collect additional safety and tolerability data on telaprevir treatment in combination with pegylated interferon alpha (Peg-IFN-alfa) and ribavirin (RBV).
    Protection of trial subjects
    Assessment of safety and tolerability was based on reported adverse events (AEs), clinical laboratory tests, vital sign measurements, electrocardiogram (ECG) monitoring, and physical examinations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 May 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 60
    Country: Number of subjects enrolled
    Austria: 23
    Country: Number of subjects enrolled
    Belgium: 53
    Country: Number of subjects enrolled
    Brazil: 97
    Country: Number of subjects enrolled
    Switzerland: 17
    Country: Number of subjects enrolled
    Czech Republic: 45
    Country: Number of subjects enrolled
    Germany: 95
    Country: Number of subjects enrolled
    Greece: 29
    Country: Number of subjects enrolled
    Spain: 160
    Country: Number of subjects enrolled
    Hungary: 134
    Country: Number of subjects enrolled
    Italy: 568
    Country: Number of subjects enrolled
    Luxembourg: 4
    Country: Number of subjects enrolled
    New Zealand: 21
    Country: Number of subjects enrolled
    Romania: 218
    Country: Number of subjects enrolled
    Russian Federation: 185
    Country: Number of subjects enrolled
    Serbia: 63
    Worldwide total number of subjects
    1772
    EEA total number of subjects
    1329
    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)
    1585
    From 65 to 84 years
    187
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 2034 participants were screened for this early access program. Of these, 1772 participants were treated with telaprevir. 1587 participants completed the early access program.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Telaprevir + Pegylated Interferon/Ribavirin
    Arm description
    		 Participants received Telaprevir 750 milligram (mg) (2*375 mg) tablet orally every 8 hours for the first 12 weeks of the early access program in combination with Pegylated Interferon/Ribavirin followed by 12 or 36 weeks of treatment with Pegylated Interferon/Ribavirin alone.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    VX-950
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were received Telaprevir 750 (2*375) milligram (mg) tablet orally every 8 hours for first 12 weeks of the early access program in combination with Pegylated Interferon/Ribavirin.

    Number of subjects in period 1
    		Telaprevir + Pegylated Interferon/Ribavirin
    Started
    1772
    Completed
    1587
    Not completed
    185
         Adverse event, serious fatal
    9
         Consent withdrawn by subject
    75
         Adverse event, non-fatal
    2
         Other
    7
         Participant entered another investigational trial
    2
         Lost to follow-up
    90

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Telaprevir + Pegylated Interferon/Ribavirin
    Reporting group description
    		 Participants received Telaprevir 750 milligram (mg) (2*375 mg) tablet orally every 8 hours for the first 12 weeks of the early access program in combination with Pegylated Interferon/Ribavirin followed by 12 or 36 weeks of treatment with Pegylated Interferon/Ribavirin alone.

    Reporting group values
    		 Telaprevir + Pegylated Interferon/Ribavirin Total
    Number of subjects
    		 1772 1772
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 1585 1585
        From 65 to 84 years
    		 187 187
        85 years and over
    		 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 53 ± 9.49 -
    Title for Gender
    Units: subjects
        Female
    		 651 651
        Male
    		 1121 1121

    End points

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    End points reporting groups
    Reporting group title
    Telaprevir + Pegylated Interferon/Ribavirin
    Reporting group description
    		 Participants received Telaprevir 750 milligram (mg) (2*375 mg) tablet orally every 8 hours for the first 12 weeks of the early access program in combination with Pegylated Interferon/Ribavirin followed by 12 or 36 weeks of treatment with Pegylated Interferon/Ribavirin alone.

    Subject analysis set title
    Treatment naive
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants who had never received hepatitis C virus (HCV) drugs.

    Subject analysis set title
    Prior relapser
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with confirmed detectable hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period after previous HCV RNA ‘less than (<) lower limit of quantification (LLOQ), target not detected’ at the end of treatment.

    Subject analysis set title
    Prior null responder
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants who had a < 2-log10 decrease in HCV RNA level at Week 12 compared to baseline HCV RNA level during prior treatment.

    Subject analysis set title
    Prior partial responder
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants who had a greater than or equal to (>=) 2-log10 decrease in HCV RNA level at Week 12 compared to baseline HCV RNA level, but never had HCV RNA ‘<LLOQ, target not detected’ during prior treatment.

    Subject analysis set title
    Prior non-responder
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants who never had HCV RNA ‘<LLOQ, target not detected’ during prior treatment. This includes prior null responder and prior partial responder.

    Subject analysis set title
    Viral breakthroughs
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    A confirmed increase greater than (>) 1 log10 in HCV RNA level from the lowest level reached during the considered treatment phase up to the considered time point, if the lowest level reached was >LLOQ, or a confirmed value of HCV RNA >100 International units per milliliter (IU/mL) in participants whose HCV RNA had previously become <LLOQ (‘target detected’ or ‘target not detected’) during the considered treatment phase.

    Primary: Percentage of Participants Achieving Sustained Virologic Response (SVR) 24actual (Snapshot, less than [<] lower limit of quantification [LLOQ]) 24 Weeks After the Last Actual Dose of Hepatitis C Virus (HCV) Drug

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    End point title
    		 Percentage of Participants Achieving Sustained Virologic Response (SVR) 24actual (Snapshot, less than [<] lower limit of quantification [LLOQ]) 24 Weeks After the Last Actual Dose of Hepatitis C Virus (HCV) Drug [1]
    End point description
    The SVR24actual (Snapshot, <LLOQ), defined as achieving HCV RNA <LLOQ at the last nonmissing measurement in the Week 24 Follow-up visit window (that is, date from last intake of HCV drug [telaprevir, Peg-IFN-alfa, or RBV] +71 days until date of last contact).
    End point type
    Primary
    End point timeframe
    Week 72
    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: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    		 Treatment naive Prior relapser Prior null responder Prior partial responder Prior non-responder
    Number of subjects analysed
    355
    586
    495
    234
    830
    Units: Percentage
        number (not applicable)
    73.8
    78.2
    44
    60.3
    50.5
    No statistical analyses for this end point

    Primary: Percentage of Participants Achieving Sustained Virologic Response (SVR) 24actual (Snapshot, 'less than [<] lower limit of quantification [LLOQ], target not detected’) 24 Weeks After the Last Actual Dose of Hepatitis C Virus (HCV) Drug

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    End point title
    		 Percentage of Participants Achieving Sustained Virologic Response (SVR) 24actual (Snapshot, 'less than [<] lower limit of quantification [LLOQ], target not detected’) 24 Weeks After the Last Actual Dose of Hepatitis C Virus (HCV) Drug [2]
    End point description
    The SVR24actual (Snapshot, ‘<LLOQ, target not detected’), defined as achieving HCV RNA ‘<LLOQ, target not detected’ at the last nonmissing measurement in the Week 24 Follow-up visit window.
    End point type
    Primary
    End point timeframe
    Week 72
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    		 Treatment naive Prior relapser Prior null responder Prior partial responder Prior non-responder
    Number of subjects analysed
    355
    586
    495
    234
    830
    Units: Percentage
        number (not applicable)
    73.5
    77.6
    43.8
    60.3
    50.2
    No statistical analyses for this end point

    Primary: Percentage of Participants Achieving Sustained Virologic Response (SVR) 24actual (Classic) 24 Weeks After the Last Actual Dose of Hepatitis C Virus (HCV) Drug

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    End point title
    		 Percentage of Participants Achieving Sustained Virologic Response (SVR) 24actual (Classic) 24 Weeks After the Last Actual Dose of Hepatitis C Virus (HCV) Drug [3]
    End point description
    The SVR24actual (Classic), defined as having HCV RNA ‘<LLOQ, target not detected’ at End of Treament, and having at least one nonmissing HCV RNA measurement in the Week 24 Follow-up visit window, and not having relapsed, and having completed treatment (all HCV drugs) or having permanently discontinued at least one of the HCV drugs but for a reason other than virologic failure.
    End point type
    Primary
    End point timeframe
    Week 72
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    		 Treatment naive Prior relapser Prior null responder Prior partial responder Prior non-responder
    Number of subjects analysed
    317
    538
    427
    214
    733
    Units: Percentage
        number (not applicable)
    79.5
    83.8
    50.1
    64.5
    55.8
    No statistical analyses for this end point

    Primary: Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at Each Time Point During Treatment

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    End point title
    		 Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at Each Time Point During Treatment [4]
    End point description
    Change from baseline in log10 of Plasma Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels were measured using HCV test (lower limit of quantification 25 international units/milliliter [IU/mL]). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology. HCV RNA samples were taken pre-dose of Pegylated-interferon (Peg-IFN) administration.
    End point type
    Primary
    End point timeframe
    Baseline and Week 4
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    		 Treatment naive Prior relapser Prior non-responder
    Number of subjects analysed
    355
    586
    830
    Units: International unit per milliliter(IU/ml)
    arithmetic mean (standard deviation)
        Baseline (n= 355, 586, 830)
    6 ± 0.76
    6.1 ± 0.72
    6.2 ± 0.66
        Change at Week 4 (n= 329, 586, 830)
    -5.04 ± 0.892
    -5.1 ± 0.812
    -4.96 ± 1.018
    No statistical analyses for this end point

    Primary: Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4

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    End point title
    		 Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 [5]
    End point description
    Percentage of participants who had a Rapid Virologic Response (RVR) (that is, those with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA] values of less than 25 international units/milliliter [IU/mL], target not detected at Weeks 4 of treatment) were evaluated.
    End point type
    Primary
    End point timeframe
    Week 4
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    		 Treatment naive Prior relapser Prior non-responder
    Number of subjects analysed
    355
    586
    830
    Units: Percentage
        number (not applicable)
    63.9
    69.6
    50.7
    No statistical analyses for this end point

    Primary: Percentage of Participants Achieving Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12

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    End point title
    		 Percentage of Participants Achieving Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12 [6]
    End point description
    Percentage of participants who had a Extended Rapid Virologic Response (eRVR) (that is, those with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA] values of less than 25 international units/milliliter [IU/mL], target not detected at Weeks 4 and 12 of treatment) were evaluated.
    End point type
    Primary
    End point timeframe
    Week 4 and 12
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    		 Treatment naive Prior relapser Prior non-responder
    Number of subjects analysed
    355
    586
    830
    Units: Percentage
        number (not applicable)
    59.2
    65.4
    45.8
    No statistical analyses for this end point

    Primary: Percentage of Participants Having Virologic Response at End of Treatment (Week 24 or 48)

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    End point title
    		 Percentage of Participants Having Virologic Response at End of Treatment (Week 24 or 48) [7]
    End point description
    Virologic response was either defined as having undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) (that is, no HCV RNA was detected in the participants’ plasma samples) or less than 25 international units/milliliter (IU/mL) HCV RNA (that is, the participants’ plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples).
    End point type
    Primary
    End point timeframe
    Week 24 or 48
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    		 Treatment naive Prior relapser Prior null responder Prior partial responder Prior non-responder
    Number of subjects analysed
    355
    586
    495
    234
    830
    Units: Percentage
    number (not applicable)
        Viral Response (‘<LLOQ, target not detected’)
    79.4
    84.8
    54.7
    75.2
    62.3
        Viral Response (<LLOQ)
    81.7
    85.7
    58.2
    78.2
    65.4
    No statistical analyses for this end point

    Primary: Percentage of Participants With Viral Breakthrough

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    End point title
    		 Percentage of Participants With Viral Breakthrough [8]
    End point description
    A confirmed increase >1 log10 in HCV RNA level from the lowest level reached during the considered treatment phase up to the considered time point, if the lowest level reached was >LLOQ, or a confirmed value of HCV RNA >100 IU/mL in participants whose HCV RNA had previously become <LLOQ (detectable or ‘target not detected’) during the considered treatment phase.
    End point type
    Primary
    End point timeframe
    Up to Week 48
    Notes
    [8] - 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: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    		 Treatment naive Prior relapser Prior null responder Prior partial responder Prior non-responder
    Number of subjects analysed
    355
    586
    495
    234
    830
    Units: Percentage
    number (not applicable)
        Week 4
    0
    0.2
    0.2
    0
    0.1
        Week 8
    0
    0
    2.6
    0.4
    1.8
        Week 12
    2
    1.2
    7.5
    2.6
    5.5
        Week 24
    5.9
    4.1
    18.8
    7.7
    14.6
        Week 48
    7.9
    4.8
    24.6
    11.5
    19.3
    No statistical analyses for this end point

    Primary: Percentage of Participants who Relapsed

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    End point title
    		 Percentage of Participants who Relapsed [9]
    End point description
    Relapse (<LLOQ), defined as having HCV RNA <LLOQ at EOT and HCV RNA detectable during the follow-up phase, and not achieving SVR24actual (Snapshot, <LLOQ); or Relapse (‘<LLOQ, target not detected’), defined similarly with the ‘<LLOQ, target not detected’ threshold.
    End point type
    Primary
    End point timeframe
    Week 72
    Notes
    [9] - 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: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    		 Treatment naive Prior relapser Prior null responder Prior partial responder Prior non-responder
    Number of subjects analysed
    355
    586
    495
    234
    830
    Units: Percentage
    number (not applicable)
        25 -< 2000 IU/mL (n = 290, 502, 288, 183, 543)
    0.7
    0.8
    1
    1.1
    1.1
        >= 2000 IU/mL (n = 290, 502, 288, 183, 543)
    8.3
    7.6
    21.5
    20.2
    20.3
        Qualitative Detectable(n =290, 502, 288, 183, 543)
    0.7
    0.4
    1.4
    0.5
    1.1
    No statistical analyses for this end point

    Primary: Percentage of Participants who met a Virologic Stopping Rule

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    End point title
    		 Percentage of Participants who met a Virologic Stopping Rule [10]
    End point description
    Stopping rules based on virologic response at Weeks 4 and 12 were to be applied to ensure that telaprevir or Peg-IFN-alfa/RBV treatments were stopped if a participant had viral breakthrough or failure.
    End point type
    Primary
    End point timeframe
    Week 4 and 12
    Notes
    [10] - 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: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    		 Treatment naive Prior relapser Prior null responder Prior partial responder Prior non-responder
    Number of subjects analysed
    355
    586
    495
    234
    830
    Units: Participants
    number (not applicable)
        Telaprevir stopping rule – Week 4
    2
    0.5
    5.5
    1.3
    4.1
        RBV/Peg-IFN stopping rule – Week 12
    2.3
    0.7
    5.9
    1.3
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 72
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Telaprevir + Pegylated Interferon/Ribavirin
    Reporting group description
    		 Participants received Telaprevir 750 milligram (mg) (2*375 mg) tablet orally every 8 hours for the first 12 weeks of the early access program in combination with Pegylated Interferon/Ribavirin.

    Serious adverse events
    		 Telaprevir + Pegylated Interferon/Ribavirin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    147 / 1772 (8.30%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Face Oedema
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Asthenia
         subjects affected / exposed
    3 / 1772 (0.17%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Influenza Like Illness
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Fatigue
         subjects affected / exposed
    3 / 1772 (0.17%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Malaise
         subjects affected / exposed
    2 / 1772 (0.11%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Multi-Organ Failure
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Non-Cardiac Chest Pain
         subjects affected / exposed
    2 / 1772 (0.11%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    9 / 1772 (0.51%)
         occurrences causally related to treatment / all
    4 / 9
         deaths causally related to treatment / all
    0 / 0
    Pain
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Testicular Mass
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cough
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Interstitial Lung Disease
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Confusional State
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemoglobin Decreased
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Transaminases Increased
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Weight Decreased
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal Injury
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial Fibrillation
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Coronary Artery Disease
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    2 / 1772 (0.11%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Palpitations
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Coma
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Dizziness
         subjects affected / exposed
    2 / 1772 (0.11%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Hepatic Encephalopathy
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Encephalopathy
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    73 / 1772 (4.12%)
         occurrences causally related to treatment / all
    73 / 73
         deaths causally related to treatment / all
    1 / 1
    Bone Marrow Failure
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Leukopenia
         subjects affected / exposed
    3 / 1772 (0.17%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Lymphopenia
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    5 / 1772 (0.28%)
         occurrences causally related to treatment / all
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    Neutrophilia
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    4 / 1772 (0.23%)
         occurrences causally related to treatment / all
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    Pancytopenia
         subjects affected / exposed
    2 / 1772 (0.11%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Retinal Disorder
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Retinal Haemorrhage
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Anal Fissure
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Erosive Duodenitis
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    2 / 1772 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Haemorrhoidal Haemorrhage
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal Obstruction
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis
         subjects affected / exposed
    3 / 1772 (0.17%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Rectal Haemorrhage
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Hepatic Cirrhosis
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Bile Duct Stone
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatic Failure
         subjects affected / exposed
    2 / 1772 (0.11%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    1 / 1
    Hepatorenal Syndrome
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Drug Rash with Eosinophilia and Systemic Symptoms
         subjects affected / exposed
    3 / 1772 (0.17%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Eczema
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Erythema
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pruritus
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Purpura
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Rash
         subjects affected / exposed
    16 / 1772 (0.90%)
         occurrences causally related to treatment / all
    16 / 16
         deaths causally related to treatment / all
    0 / 0
    Rash Generalised
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Rash Papular
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Toxic Skin Eruption
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal Failure
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Renal Failure Acute
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Back Pain
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Arthritis
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bone Pain
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    2 / 1772 (0.11%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Febrile Infection
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea Infectious
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Intervertebral Discitis
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Oral Candidiasis
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 1772 (0.11%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Psoas Abscess
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis Acute
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 1772 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Tuberculosis
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin Infection
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Dehydration
         subjects affected / exposed
    2 / 1772 (0.11%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    1 / 1
    Hypercatabolism
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Diabetic Ketoacidosis
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    2 / 1772 (0.11%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    1 / 1
    Hyperuricaemia
         subjects affected / exposed
    2 / 1772 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    3 / 1772 (0.17%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Ketoacidosis
         subjects affected / exposed
    1 / 1772 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Telaprevir + Pegylated Interferon/Ribavirin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1293 / 1772 (72.97%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    933 / 1772 (52.65%)
         occurrences all number
    1435
    Thrombocytopenia
         subjects affected / exposed
    126 / 1772 (7.11%)
         occurrences all number
    170
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    151 / 1772 (8.52%)
         occurrences all number
    172
    Gastrointestinal disorders
    Anal Pruritus
         subjects affected / exposed
    100 / 1772 (5.64%)
         occurrences all number
    101
    Nausea
         subjects affected / exposed
    146 / 1772 (8.24%)
         occurrences all number
    154
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    266 / 1772 (15.01%)
         occurrences all number
    282
    Rash
         subjects affected / exposed
    424 / 1772 (23.93%)
         occurrences all number
    500

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 May 2011
    The overall reason for the amendment was to change in collection period for serious adverse events (SAEs) and reporting period for pregnancies and the fact that female participants should discontinue treatment if they become pregnant.
    16 Aug 2011
    The overall reason for the amendment was to add the collection of an optional blood sample for genotype evaluations of specific genetic markers related to treatment response outcomes and specified adverse events including rash.

    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
    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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