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    Clinical Trial Results:
    A Phase II Multicenter, Parallel-Group, Randomized, Dose-Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following 12 Weeks of Oral Administration of GSK2336805 With Pegylated Interferon and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 or 4 Hepatitis C Infection.

    Summary
    EudraCT number
    2012-000523-40
    Trial protocol
    BE   DE   BG  
    Global end of trial date
    16 Jul 2014

    Results information
    Results version number
    v2(current)
    This version publication date
    25 Mar 2016
    First version publication date
    21 May 2015
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Minor corrections required.

    Trial information

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    Trial identification
    Sponsor protocol code
    HAI115879
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    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
    19 Aug 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study are: • To evaluate the 12-week safety and tolerability of 40 and 60 mg of GSK2336805 when given in combination with pegylated interferon alfa-2a (PEG) and ribavirin (RIBA). • To evaluate 12-week antiviral activity of 40 and 60 mg of GSK2336805 when given in combination with PEG and RIBA as measured by eRVR (defined as undetectable plasma HCV RNA at Weeks 4 and 12)
    Protection of trial subjects
    Not applicable
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    07 Aug 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    Bulgaria: 48
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    United States: 172
    Country: Number of subjects enrolled
    Puerto Rico: 44
    Worldwide total number of subjects
    286
    EEA total number of subjects
    70
    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)
    280
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Participants (par.) with treatment-naïve (TN) chronic Genotype 1 (G1) hepatitis C virus (HCV) infection were randomly allocated on a 2:2:1 basis to 2 dose levels of GSK2336805 or telaprevir. In a nonrandomized single-arm cohort, par. with TN genotype 4 (G4) chronic HCV infection were enrolled in parallel at the dose level of 60 mg of GSK2336805.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    GSK2336805 40 mg, Genotype 1 HCV
    Arm description
    Participants with chronic G1 HCV infection received GSK2336805 40 milligrams (mg) orally (20 mg x 2 tablets) once daily (OD) in the morning with food in combination with antiviral therapy (Pegylated Interferon Alfa-2a [PEG] + Ribavirin [RIBA]) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the extended rapid virologic response (eRVR) achievement. PEG dose was 180 micrograms (µg) once weekly subcutaneous (SC) injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kilogram [kg]) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken in 2 divided doses with food.
    Arm type
    Experimental

    Investigational medicinal product name
    GSK2336805
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg, 2 tablets per day in morning with food

    Investigational medicinal product name
    Peginterferon alfa-2a (PEGASYS)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    180 micrograms per week by subcutaneous injection in the abdomen or thigh

    Investigational medicinal product name
    Ribavirin (Ripasphere)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    1000 mg if < 75 kg, 5 capsules (2 in morning and 3 in evening), 1200 mg if > or equal to 75 kg, 6 capsules (3 in morning and 3 in evening)

    Arm title
    GSK2336805 60 mg, Genotype 1 HCV
    Arm description
    Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2 divided doses with food.
    Arm type
    Experimental

    Investigational medicinal product name
    GSK2336805
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    60 mg, 2 tablets per day in morning with food

    Investigational medicinal product name
    Peginterferon alfa-2a (PEGASYS)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    180 micrograms per week by subcutaneous injection in the abdomen or thigh

    Investigational medicinal product name
    Ribavirin (Ripasphere)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    1000 mg if < 75 kg, 5 capsules (2 in morning and 3 in evening), 1200 mg if > or equal to 75 kg, 6 capsules (3 in morning and 3 in evening)

    Arm title
    Telaprevir, Genotype 1 HCV
    Arm description
    Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2 divided doses with food.
    Arm type
    Experimental

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 x 375 mg tablets taken orally 3 times a day (7-9 hours apart) with food

    Investigational medicinal product name
    Peginterferon alfa-2a (PEGASYS)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    180 micrograms per week by subcutaneous injection in the abdomen or thigh

    Investigational medicinal product name
    Ribavirin (Ripasphere)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    1000 mg if < 75 kg, 5 capsules (2 in morning and 3 in evening), 1200 mg if > or equal to 75 kg, 6 capsules (3 in morning and 3 in evening)

    Arm title
    GSK2336805 60 mg, Genotype 4 HCV
    Arm description
    Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2 divided doses with food.
    Arm type
    Experimental

    Investigational medicinal product name
    GSK2336805
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    60 mg, 2 tablets per day in morning with food

    Investigational medicinal product name
    Peginterferon alfa-2a (PEGASYS)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    180 micrograms per week by subcutaneous injection in the abdomen or thigh

    Investigational medicinal product name
    Ribavirin (Ripasphere)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    1000 mg if < 75 kg, 5 capsules (2 in morning and 3 in evening), 1200 mg if > or equal to 75 kg, 6 capsules (3 in morning and 3 in evening)

    Number of subjects in period 1 [1]
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Started
    41
    40
    17
    13
    Completed
    29
    28
    9
    11
    Not completed
    12
    12
    8
    2
         Physician decision
    1
    -
    -
    -
         Lack of efficacy
    4
    7
    1
    -
         Adverse event, non-fatal
    3
    1
    2
    -
         Consent withdrawn by subject
    2
    3
    3
    2
         Lost to follow-up
    2
    1
    2
    -
    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: A total of 286 participants were screened for enrollment and the eligible subjects were randomly assigned to the treatment groups. Of the 118 randomly assigned participants, the analysis populations included 111 participants in the Safety Population, 111 participants in the ITT Population.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK2336805 40 mg, Genotype 1 HCV
    Reporting group description
    Participants with chronic G1 HCV infection received GSK2336805 40 milligrams (mg) orally (20 mg x 2 tablets) once daily (OD) in the morning with food in combination with antiviral therapy (Pegylated Interferon Alfa-2a [PEG] + Ribavirin [RIBA]) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the extended rapid virologic response (eRVR) achievement. PEG dose was 180 micrograms (µg) once weekly subcutaneous (SC) injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kilogram [kg]) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken in 2 divided doses with food.

    Reporting group title
    GSK2336805 60 mg, Genotype 1 HCV
    Reporting group description
    Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2 divided doses with food.

    Reporting group title
    Telaprevir, Genotype 1 HCV
    Reporting group description
    Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2 divided doses with food.

    Reporting group title
    GSK2336805 60 mg, Genotype 4 HCV
    Reporting group description
    Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2 divided doses with food.

    Reporting group values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV Total
    Number of subjects
    41 40 17 13 111
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    43.7 ± 13.23 40.8 ± 9.87 39.4 ± 12.02 45.3 ± 11.46 -
    Gender categorical
    Units: Subjects
        Female
    13 16 6 3 38
        Male
    28 24 11 10 73
    Race
    Units: Subjects
        African American/African Heritage
    6 6 2 3 17
        Asian - South East Asian Heritage
    0 0 0 1 1
        White - Arabic/North African Heritage
    1 0 0 5 6
        White - White/Caucasian/European Heritage
    33 33 15 4 85
        Mixed Race
    1 1 0 0 2

    End points

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    End points reporting groups
    Reporting group title
    GSK2336805 40 mg, Genotype 1 HCV
    Reporting group description
    Participants with chronic G1 HCV infection received GSK2336805 40 milligrams (mg) orally (20 mg x 2 tablets) once daily (OD) in the morning with food in combination with antiviral therapy (Pegylated Interferon Alfa-2a [PEG] + Ribavirin [RIBA]) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the extended rapid virologic response (eRVR) achievement. PEG dose was 180 micrograms (µg) once weekly subcutaneous (SC) injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kilogram [kg]) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken in 2 divided doses with food.

    Reporting group title
    GSK2336805 60 mg, Genotype 1 HCV
    Reporting group description
    Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2 divided doses with food.

    Reporting group title
    Telaprevir, Genotype 1 HCV
    Reporting group description
    Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2 divided doses with food.

    Reporting group title
    GSK2336805 60 mg, Genotype 4 HCV
    Reporting group description
    Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2 divided doses with food.

    Subject analysis set title
    GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2 divided doses with food.

    Primary: Number of participants achieving extended rapid virologic response (eRVR)

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    End point title
    Number of participants achieving extended rapid virologic response (eRVR) [1]
    End point description
    Extended rapid virologic response (eRVR) is defined as plasma HCV ribonucleic acid (RNA) <lower limit of quantification (LLOQ) and target not detected at Weeks 4 and 12. Participants who discontinued prior to Week 12 assessments or had missing HCV RNA values at Weeks 4 and 12 were treated as non-responders. Intent-To-Treat (ITT) Population: comprised of all participants who met the study criteria and were randomly assigned to treatment in the study with documented evidence of having received at least 1 dose of randomized treatment and at least 1 post Baseline HCV RNA measurement.
    End point type
    Primary
    End point timeframe
    Week 4 and Week 12
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary comparison of eRVR was performed using a Bayesian probability model.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [2]
    40 [3]
    17 [4]
    13 [5]
    Units: Participants
    23
    21
    9
    9
    Notes
    [2] - ITT Population
    [3] - ITT Population
    [4] - ITT Population
    [5] - ITT Population
    No statistical analyses for this end point

    Primary: Number of participants with any adverse events (AEs) and any serious adverse events (SAEs) up to Week 12

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    End point title
    Number of participants with any adverse events (AEs) and any serious adverse events (SAEs) up to Week 12 [6]
    End point description
    An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. Safety Population: comprised of all participants who received at least 1 dose of study medication (GSK2336805 or telaprevir).
    End point type
    Primary
    End point timeframe
    From the start of study treatment up to Week 12
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [7]
    40 [8]
    17 [9]
    13 [10]
    Units: Participants
        Any AE
    39
    37
    17
    13
        Any SAE
    0
    2
    3
    1
    Notes
    [7] - Safety Population
    [8] - Safety Population
    [9] - Safety Population
    [10] - Safety Population
    No statistical analyses for this end point

    Primary: Mean change from Baseline in systolic blood pressure and diastolic blood pressure at the indicated time points up to Week 12

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    End point title
    Mean change from Baseline in systolic blood pressure and diastolic blood pressure at the indicated time points up to Week 12 [11]
    End point description
    Blood pressure measurements were taken to observe vital signs and included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and Post-treatment (PT) Follow Up (FU) Weeks 4, 12 and 24. Change from Baseline in SBP and DBP is summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
    End point type
    Primary
    End point timeframe
    Baseline, Day 2, Weeks 1, 2, 4, 6, 8, and 12
    Notes
    [11] - 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: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [12]
    40 [13]
    17 [14]
    13 [15]
    Units: Millimeters of mercury (mmHg)
    arithmetic mean (standard deviation)
        DBP; Day2; n=41, 40, 17, 13
    -1.2 ± 6.63
    -1 ± 7.03
    -3 ± 9.03
    -1.5 ± 10.45
        DBP; Week1; n=41, 39, 15, 13
    -0.4 ± 7.98
    -2.2 ± 9.13
    1 ± 10.54
    -1 ± 7.99
        DBP; Week2; n=41, 39, 14, 13
    -0.4 ± 10.41
    -1.7 ± 9.52
    -0.3 ± 8.8
    -2.8 ± 11.09
        DBP; Week4; n=41, 39, 14, 13
    -1.2 ± 7.73
    -4.4 ± 9.78
    -3.9 ± 9.74
    0.8 ± 9.92
        DBP; Week6; n=41, 39, 13, 13
    -1.2 ± 7.65
    -4.8 ± 9.86
    -5.9 ± 7.82
    -1.6 ± 10.1
        DBP; Week8; n=41, 39, 13, 13
    -2.1 ± 10
    -2.9 ± 9.11
    -4.4 ± 7.63
    -2.4 ± 9.02
        DBP; Week12; n=38, 35, 12, 13
    0.3 ± 8.48
    -4.4 ± 10.24
    -3.5 ± 9.2
    -1 ± 9.11
        SBP; Day2; n=41, 40, 17, 13
    -1.4 ± 10.1
    -0.8 ± 12.85
    -3.3 ± 10.46
    -1.3 ± 13.95
        SBP; Week1; n=41, 39, 15, 13
    0.9 ± 12.99
    -3 ± 11.24
    -4.5 ± 12.67
    -2.6 ± 11.84
        SBP; Week2; n=41, 39, 14, 13
    -2 ± 10.57
    -0.7 ± 11.67
    -4.1 ± 12.67
    -4.2 ± 17.35
        SBP; Week4; n=41, 39, 14, 13
    -3.6 ± 11.56
    -4.2 ± 16.2
    -3.8 ± 9.73
    -5.2 ± 15.3
        SBP; Week6; n=41, 39, 13, 13
    -0.4 ± 14.47
    -3.8 ± 13.28
    -5.9 ± 11.39
    0.2 ± 14.47
        SBP; Week8; n=41, 39, 13, 13
    -3.7 ± 12.15
    -1.5 ± 12.64
    -2.9 ± 10.36
    -4.2 ± 12.95
        SBP; Week12; n=38, 35, 12, 13
    -1.9 ± 13.65
    -1.4 ± 11.72
    -5.2 ± 5.81
    -2.6 ± 19.16
    Notes
    [12] - Safety Population
    [13] - Safety Population
    [14] - Safety Population
    [15] - Safety Population
    No statistical analyses for this end point

    Primary: Mean change from Baseline in heart rate at the indicated time points up to Week 12

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    End point title
    Mean change from Baseline in heart rate at the indicated time points up to Week 12 [16]
    End point description
    Vital sign monitoring included heart rate, measured at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4, 12 and 24. Change from Baseline in heart rate is summarized for each post-Baseline assessment upto Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
    End point type
    Primary
    End point timeframe
    Baseline, Day 2, Weeks 1, 2, 4, 6, 8, and 12
    Notes
    [16] - 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: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [17]
    40 [18]
    17 [19]
    13 [20]
    Units: Beats per minute
    arithmetic mean (standard deviation)
        Heart Rate; Day2; n=41, 40, 17, 13
    6.5 ± 8.65
    5.4 ± 9.96
    9.3 ± 11.74
    3.8 ± 5.79
        Heart Rate; Week1; n=41, 39, 15, 13
    1.5 ± 8.33
    3.1 ± 8.75
    8.1 ± 6.32
    7.7 ± 10.11
        Heart Rate; Week2; n=41, 39, 14, 13
    3.8 ± 9.02
    4.2 ± 12.14
    8.7 ± 8.17
    7.8 ± 8.6
        Heart Rate; Week4; n=41, 39, 14, 13
    6.8 ± 9.42
    4.2 ± 11.78
    10.7 ± 11.39
    5.5 ± 8.35
        Heart Rate; Week6; n=41, 39, 13, 13
    8 ± 10.15
    5 ± 10.98
    13.8 ± 9.75
    10.2 ± 8.2
        Heart Rate; Week8; n=41, 39, 13, 13
    4.7 ± 9.91
    6.8 ± 12.42
    14.2 ± 10.36
    12.8 ± 12.27
        Heart Rate; Week12; n=38, 35, 12, 13
    7 ± 9.2
    5.3 ± 12.1
    11 ± 8.02
    8.4 ± 9.47
    Notes
    [17] - Safety Population
    [18] - Safety Population
    [19] - Safety Population
    [20] - Safety Population
    No statistical analyses for this end point

    Primary: Mean change from Baseline in basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the indicated time points up to Week 12

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    End point title
    Mean change from Baseline in basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the indicated time points up to Week 12 [21]
    End point description
    Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the basophils, eosinophils, lymphocytes, total neutrophils platelet count and white blood cell count values are summarized for each post-Baseline assessment until Week 12. . Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 1, 2, 4, 6, 8 and 12
    Notes
    [21] - 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: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [22]
    40 [23]
    17 [24]
    13 [25]
    Units: Giga per liter
    arithmetic mean (standard deviation)
        Basophils; Week1; n=38, 38, 14, 11
    -0.011 ± 0.0191
    -0.011 ± 0.0193
    -0.012 ± 0.0105
    -0.013 ± 0.0119
        Basophils; Week2; n=40, 38, 14, 10
    -0.014 ± 0.0175
    -0.01 ± 0.0192
    -0.009 ± 0.0107
    -0.009 ± 0.0179
        Basophils; Week4; n=41, 38, 14, 13
    -0.017 ± 0.0184
    -0.012 ± 0.0187
    -0.01 ± 0.0118
    -0.015 ± 0.0113
        Basophils; Week6; n=41, 37, 12, 12
    -0.015 ± 0.021
    -0.013 ± 0.0205
    -0.013 ± 0.0114
    -0.013 ± 0.0106
        Basophils; Week8; n=38, 39, 13, 13
    -0.019 ± 0.0155
    -0.016 ± 0.018
    -0.009 ± 0.0132
    -0.012 ± 0.0142
        Basophils; Week12; n=37, 36, 12, 12
    -0.018 ± 0.0184
    -0.013 ± 0.0187
    -0.011 ± 0.0124
    -0.012 ± 0.0153
        Eosinophils; Week1; n=38, 38, 14, 11
    -0.051 ± 0.0874
    -0.075 ± 0.106
    -0.059 ± 0.0578
    -0.085 ± 0.1052
        Eosinophils; Week2; n=40, 38, 14, 10
    -0.08 ± 0.1004
    -0.111 ± 0.0912
    -0.059 ± 0.104
    -0.114 ± 0.1247
        Eosinophils; Week4; n=41, 38, 14, 13
    -0.105 ± 0.0872
    -0.132 ± 0.1057
    -0.079 ± 0.1089
    -0.108 ± 0.0923
        Eosinophils; Week6; n=41, 37, 12, 12
    -0.117 ± 0.0929
    -0.134 ± 0.1182
    -0.113 ± 0.0607
    -0.109 ± 0.1208
        Eosinophils; Week8; n=38, 39, 13, 13
    -0.121 ± 0.0897
    -0.134 ± 0.1061
    -0.13 ± 0.0965
    -0.104 ± 0.0916
        Eosinophils; Week12; n=37, 36, 12, 12
    -0.118 ± 0.0916
    -0.112 ± 0.1594
    -0.106 ± 0.1152
    -0.102 ± 0.1428
        Lymphocytes; Week1; n=38, 38, 14, 11
    -0.319 ± 0.5006
    -0.282 ± 0.5698
    -0.608 ± 0.5466
    -0.371 ± 0.4332
        Lymphocytes; Week2; n=40, 38, 14, 10
    -0.448 ± 0.5385
    -0.603 ± 0.5921
    -0.675 ± 0.5639
    -0.553 ± 0.4346
        Lymphocytes; Week4; n=41, 38, 14, 13
    -0.787 ± 0.5055
    -0.854 ± 0.5114
    -0.989 ± 0.5293
    -0.773 ± 0.4104
        Lymphocytes; Week6; n=41, 37, 12, 12
    -0.963 ± 0.5313
    -1.043 ± 0.5928
    -1.334 ± 0.4906
    -0.93 ± 0.4955
        Lymphocytes; Week8; n=38, 39, 13, 13
    -0.953 ± 0.4624
    -1.061 ± 0.6021
    -1.256 ± 0.3509
    -0.964 ± 0.5098
        Lymphocytes; Week12; n=37, 36, 12, 12
    -1.118 ± 0.5139
    -1.074 ± 0.5883
    -1.438 ± 0.4773
    -1.048 ± 0.6612
        Monocytes; Week1; n=38, 38, 14, 11
    -0.103 ± 0.1418
    -0.056 ± 0.145
    0.034 ± 0.1502
    -0.025 ± 0.0808
        Monocytes; Week2; n=40, 38, 14, 10
    -0.122 ± 0.227
    -0.061 ± 0.1785
    -0.091 ± 0.1562
    -0.034 ± 0.1687
        Monocytes; Week4; n=41, 38, 14, 13
    -0.151 ± 0.1771
    -0.129 ± 0.158
    -0.126 ± 0.1471
    -0.055 ± 0.2103
        Monocytes; Week6; n=41, 37, 12, 12
    -0.182 ± 0.1664
    -0.171 ± 0.1326
    -0.245 ± 0.1786
    -0.135 ± 0.1088
        Monocytes; Week8; n=38, 39, 13, 13
    -0.229 ± 0.167
    -0.165 ± 0.1779
    -0.185 ± 0.1344
    -0.124 ± 0.2164
        Monocytes; Week12; n=37, 36, 12, 12
    -0.185 ± 0.1715
    -0.183 ± 0.1438
    -0.219 ± 0.1493
    -0.133 ± 0.2048
        Total Neutrophils; Week1; n=38, 38, 14, 11
    -2.338 ± 1.4959
    -1.871 ± 1.5089
    -1.158 ± 1.2688
    -1.378 ± 0.598
        Total Neutrophils; Week 2; n=40, 38, 14, 10
    -2.114 ± 1.9189
    -2.121 ± 1.6445
    -1.186 ± 1.3343
    -1.468 ± 0.584
        Total Neutrophils; Week4; n=41, 38, 14, 13
    -2.487 ± 1.9145
    -2.333 ± 1.5497
    -1.412 ± 1.5704
    -1.603 ± 0.5953
        Total Neutrophils; Week6; n=41, 37, 12, 12
    -2.51 ± 1.8144
    -2.247 ± 1.5132
    -1.413 ± 1.4303
    -1.683 ± 0.661
        Total Neutrophils; Week8; n=38, 39, 13, 13
    -2.706 ± 1.7553
    -2.168 ± 1.6902
    -1.222 ± 1.3481
    -1.613 ± 0.6882
        Total Neutrophils; Week12; n=37, 36, 12, 12
    -2.894 ± 1.8124
    -2.188 ± 1.7297
    -1.649 ± 0.8749
    -1.483 ± 0.5873
        Platelet Count; Week1; n=38, 39, 14, 11
    -58.5 ± 36.23
    -51.4 ± 36.42
    -59.5 ± 36.29
    -33.1 ± 33.32
        Platelet Count; Week2; n=41, 38, 14, 11
    -58 ± 43.92
    -57.8 ± 44.02
    -41.4 ± 37.44
    -34.4 ± 41.74
        Platelet Count; Week4; n=41, 38, 14, 13
    -54.4 ± 49.18
    -55.9 ± 47.19
    -56.2 ± 50.99
    -33.8 ± 61.79
        Platelet Count; Week6; n=41, 38, 12, 13
    -66.8 ± 50.43
    -71.9 ± 38.6
    -71.3 ± 47.07
    -46 ± 46.05
        Platelet Count; Week8; n=39, 39, 13, 13
    -74.9 ± 42.31
    -75.7 ± 45.82
    -60.1 ± 43.26
    -52.6 ± 43.54
        Platelet Count; Week12; n=38, 34, 12, 12
    -73.4 ± 45.3
    -85.3 ± 40.42
    -58.8 ± 58.77
    -53 ± 39.49
        White Blood Cell count; Week1; n=38, 38, 14, 11
    -2.83 ± 1.705
    -2.3 ± 1.872
    -1.81 ± 1.516
    -1.87 ± 0.508
        White Blood Cell count; Week2; n=40, 38, 14, 10
    -2.77 ± 2.178
    -2.92 ± 1.81
    -2.01 ± 1.869
    -2.17 ± 0.886
        White Blood Cell count; Week4; n=41, 38, 14, 13
    -3.55 ± 2.183
    -3.47 ± 1.712
    -2.61 ± 2.055
    -2.55 ± 0.919
        White Blood Cell count; Week6; n=41, 37, 12, 12
    -3.78 ± 2.051
    -3.62 ± 1.682
    -3.09 ± 1.69
    -2.85 ± 0.923
        White Blood Cell count; Week8; n=38, 39, 13, 13
    -4.03 ± 2.028
    -3.55 ± 1.896
    -2.8 ± 1.477
    -2.8 ± 1.04
        White Blood Cell count; Week12; n=37, 36, 12, 12
    -4.33 ± 2.149
    -3.58 ± 1.934
    -3.42 ± 1.104
    -2.77 ± 0.963
    Notes
    [22] - Safety Population
    [23] - Safety Population
    [24] - Safety Population
    [25] - Safety Population
    No statistical analyses for this end point

    Primary: Mean change from Baseline in red blood cell count at the indicated time points up to Week 12

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    End point title
    Mean change from Baseline in red blood cell count at the indicated time points up to Week 12 [26]
    End point description
    Blood samples were collected for the measurement of red blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the red blood cell count values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 1, 2, 4, 6, 8 and 12
    Notes
    [26] - 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: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [27]
    40 [28]
    17 [29]
    13 [30]
    Units: Trillion per liter
    arithmetic mean (standard deviation)
        Red Blood Cell count; Week1; n=38, 39, 14, 12
    -0.15 ± 0.226
    -0.04 ± 0.279
    -0.18 ± 0.212
    -0.13 ± 0.303
        Red Blood Cell count; Week2; n=41, 38, 14, 12
    -0.48 ± 0.376
    -0.44 ± 0.508
    -0.57 ± 0.312
    -0.28 ± 0.361
        Red Blood Cell count; Week4; n=41, 38, 14, 13
    -0.88 ± 0.507
    -0.64 ± 0.623
    -1.03 ± 0.441
    -0.72 ± 0.559
        Red Blood Cell count; Week6; n=41, 38, 12, 13
    -0.97 ± 0.504
    -0.78 ± 0.563
    -1.28 ± 0.49
    -0.86 ± 0.52
        Red Blood Cell count; Week8; n=39, 39, 13, 13
    -1.01 ± 0.506
    -0.82 ± 0.534
    -1.45 ± 0.357
    -0.85 ± 0.412
        Red Blood Cell count; Week12; n=38, 36, 12, 12
    -1.08 ± 0.48
    -0.79 ± 0.56
    -1.61 ± 0.464
    -0.92 ± 0.459
    Notes
    [27] - Safety Population
    [28] - Safety Population
    [29] - Safety Population
    [30] - Safety Population
    No statistical analyses for this end point

    Primary: Mean change from Baseline in hemoglobin at the indicated time points up to Week 12

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    End point title
    Mean change from Baseline in hemoglobin at the indicated time points up to Week 12 [31]
    End point description
    Blood samples were collected for the measurement of hemoglobin at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hemoglobin values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 1, 2, 4, 6, 8 and 12
    Notes
    [31] - 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: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [32]
    40 [33]
    17 [34]
    13 [35]
    Units: Grams per liter
    arithmetic mean (standard deviation)
        Hemoglobin; Week1; n=38, 39, 14, 12
    -5.2 ± 6.98
    -2.3 ± 9.38
    -6.6 ± 5.83
    -5.3 ± 8.85
        Hemoglobin; Week2; n=41, 38, 14, 12
    -16.7 ± 12.54
    -14.9 ± 16.21
    -20.5 ± 10.66
    -9.9 ± 11.5
        Hemoglobin; Week4; n=41, 38, 14, 13
    -28.6 ± 15.38
    -22.1 ± 18.98
    -34.4 ± 13.55
    -22.5 ± 14.89
        Hemoglobin; Week6; n=41, 38, 12, 13
    -30.1 ± 14.54
    -24.7 ± 16
    -40.8 ± 14.11
    -25.2 ± 12.28
        Hemoglobin; Week8; n=39, 39, 13, 13
    -30.5 ± 13.29
    -25.5 ± 14.22
    -44.9 ± 11.73
    -25.2 ± 8.66
        Hemoglobin; Week12; n=38, 36, 12, 12
    -33 ± 12.88
    -24.1 ± 13.41
    -47.4 ± 14.12
    -27.6 ± 12.05
    Notes
    [32] - Safety Population
    [33] - Safety Population
    [34] - Safety Population
    [35] - Safety Population
    No statistical analyses for this end point

    Primary: Mean change from Baseline in hematocrit at the indicated time points up to Week 12

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    End point title
    Mean change from Baseline in hematocrit at the indicated time points up to Week 12 [36]
    End point description
    Blood samples were collected for the measurement of hematocrit at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hematocrit values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 1, 2, 4, 6, 8 and 12
    Notes
    [36] - 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: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [37]
    40 [38]
    17 [39]
    13 [40]
    Units: Percentage of RBC in blood
    arithmetic mean (standard deviation)
        Hematocrit; Week1; n=38, 39, 14, 12
    -0.0196 ± 0.02345
    -0.0069 ± 0.02751
    -0.0201 ± 0.01921
    -0.0166 ± 0.0298
        Hematocrit; Week2; n=41, 38, 14, 12
    -0.0539 ± 0.03653
    -0.0465 ± 0.04738
    -0.0609 ± 0.03007
    -0.0335 ± 0.03625
        Hematocrit; Week4; n=41, 38, 14, 13
    -0.0848 ± 0.04576
    -0.0621 ± 0.05468
    -0.0999 ± 0.03967
    -0.0668 ± 0.04445
        Hematocrit; Week6; n=41, 38, 12, 13
    -0.0859 ± 0.0411
    -0.0685 ± 0.04487
    -0.1203 ± 0.04463
    -0.074 ± 0.03316
        Hematocrit; Week8; n=39, 39, 13, 13
    -0.0838 ± 0.03955
    -0.0663 ± 0.04144
    -0.1235 ± 0.03288
    -0.07 ± 0.02758
        Hematocrit; Week12; n=38, 36, 12, 12
    -0.0843 ± 0.04038
    -0.0589 ± 0.03648
    -0.1318 ± 0.03847
    -0.0688 ± 0.03298
    Notes
    [37] - Safety Population
    [38] - Safety Population
    [39] - Safety Population
    [40] - Safety Population
    No statistical analyses for this end point

    Primary: Mean change from Baseline in mean corpuscle volume at the indicated time points up to Week 12

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    End point title
    Mean change from Baseline in mean corpuscle volume at the indicated time points up to Week 12 [41]
    End point description
    Blood samples were collected for the measurement of mean corpuscle volume at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the mean corpuscle volume values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 1, 2, 4, 6, 8 and 12
    Notes
    [41] - 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: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [42]
    40 [43]
    17 [44]
    13 [45]
    Units: Femtoliters
    arithmetic mean (standard deviation)
        Mean corpuscle volume; Week1; n=38, 39, 14, 12
    -1.1 ± 1.21
    -0.8 ± 1.37
    -0.4 ± 1.15
    -0.7 ± 1.37
        Mean corpuscle volume; Week2; n=41, 38, 14, 12
    -2 ± 1.84
    -1.4 ± 1.59
    -1.4 ± 1.09
    -1.5 ± 1.45
        Mean corpuscle volume; Week4; n=41, 38, 14, 13
    0.3 ± 3.33
    0.2 ± 3.4
    -0.8 ± 1.58
    -0.2 ± 2.94
        Mean corpuscle volume; Week6; n=41, 38, 12, 13
    2.3 ± 4.76
    1.8 ± 4.67
    -0.2 ± 2.37
    1.4 ± 4.63
        Mean corpuscle volume; Week8; n=39, 39, 13, 13
    3.8 ± 5.39
    3 ± 5.2
    3.1 ± 2.78
    2.2 ± 3.75
        Mean corpuscle volume; Week12; n=38, 34, 12, 12
    5.7 ± 6
    4.2 ± 6.3
    5.3 ± 4.14
    3.8 ± 4.28
    Notes
    [42] - Safety Population
    [43] - Safety Population
    [44] - Safety Population
    [45] - Safety Population
    No statistical analyses for this end point

    Primary: Mean change from Baseline in albumin at the indicated time points up to Week 12

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    End point title
    Mean change from Baseline in albumin at the indicated time points up to Week 12 [46]
    End point description
    Blood samples were collected for the measurement of albumin at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the albumin values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 1, 2, 4, 6, 8 and 12
    Notes
    [46] - 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: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [47]
    40 [48]
    17 [49]
    13 [50]
    Units: Grams per liter
    arithmetic mean (standard deviation)
        Albumin; Week1; n=40, 39, 15, 13
    -0.6 ± 2.67
    -0.3 ± 2.46
    -1.1 ± 1.6
    -1 ± 1.87
        Albumin; Week2; n=41, 38, 14, 13
    -1.3 ± 2.98
    -1.5 ± 2.68
    -2 ± 2.6
    -0.2 ± 2.39
        Albumin; Week4; n=41, 39, 14, 13
    -1.9 ± 2.48
    -1.5 ± 2.52
    -3 ± 3.21
    -1.2 ± 1.46
        Albumin; Week6; n=41, 38, 13, 13
    -2.2 ± 2.65
    -1.5 ± 2.27
    -3.5 ± 3.36
    -2.1 ± 2.22
        Albumin; Week8; n=40, 39, 13, 13
    -2.6 ± 2.99
    -1.7 ± 2
    -3.7 ± 4.71
    -1.5 ± 1.94
        Albumin; Week12; n=37, 35, 12, 13
    -2.1 ± 3.03
    -1.3 ± 2.84
    -3.3 ± 3.02
    -1.6 ± 2.1
    Notes
    [47] - Safety Population
    [48] - Safety Population
    [49] - Safety Population
    [50] - Safety Population
    No statistical analyses for this end point

    Primary: Mean change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase at the indicated time points up to Week 12

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    End point title
    Mean change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase at the indicated time points up to Week 12 [51]
    End point description
    Blood samples were collected for the measurement of alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), creatine kinase (CK) and gamma glutamyl transferase (GGT) at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4 Change from Baseline in the ALP, ALT, AST, CK and GGT values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 1, 2, 4, 6, 8 and 12
    Notes
    [51] - 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: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [52]
    40 [53]
    17 [54]
    13 [55]
    Units: International units per liter
    arithmetic mean (standard deviation)
        ALP; Week1; n=40, 39, 15, 13
    0 ± 7.73
    1.5 ± 10.21
    3.9 ± 19.36
    -0.2 ± 17.45
        ALP; Week2; n=41, 38, 14, 13
    4.6 ± 9.26
    3.8 ± 16.22
    9.4 ± 21.15
    3.8 ± 12.43
        ALP; Week4; n=41, 39, 14, 13
    8.6 ± 11.12
    7.1 ± 13.76
    11.7 ± 26.61
    7.2 ± 15.3
        ALP; Week6; n=41, 38, 13, 13
    9.1 ± 13.73
    7.2 ± 17.1
    16.6 ± 31.03
    6.6 ± 16.38
        ALP; Week8; n=40, 39, 13, 13
    6.9 ± 15.59
    6.5 ± 15.91
    15.5 ± 25.83
    5.6 ± 14.72
        ALP; Week12; n=37, 35, 12, 13
    6.7 ± 15.56
    6.4 ± 20.78
    11.7 ± 25.09
    7.3 ± 18.33
        ALT; Week1; n=40, 39, 15, 13
    -26.8 ± 31.64
    -24.4 ± 32.39
    -30.7 ± 30.1
    -25.6 ± 20.74
        ALT; Week2; n=41, 38, 14, 13
    -28.2 ± 40.33
    -24.9 ± 47.49
    -35.4 ± 36.38
    -26.8 ± 24.25
        ALT; Week4; n=41, 39, 14, 13
    -32.5 ± 44.5
    -25.3 ± 50.87
    -40.4 ± 38.73
    -33 ± 28.79
        ALT; Week6; n=41, 38, 13, 13
    -36 ± 49.77
    -30.3 ± 50.74
    -40.8 ± 41.51
    -38.4 ± 29.11
        ALT; Week8; n=40, 39, 13, 13
    -36.8 ± 55.75
    -25.4 ± 55.92
    -39.9 ± 40.27
    -39.5 ± 29.92
        ALT; Week12; n=37, 35, 12, 13
    -38.9 ± 59.7
    -23.5 ± 59.69
    -43.7 ± 40.45
    -36.8 ± 24.75
        AST; Week1; n=40, 39, 15, 13
    -12.3 ± 16.28
    -15.2 ± 21.55
    -18.1 ± 21.77
    -13.9 ± 10.52
        AST; Week2; n=41, 38, 14, 13
    -10 ± 20.84
    -11.6 ± 26.3
    -18.4 ± 23.52
    -10.2 ± 12.56
        AST; Week4; n=41, 39, 14, 13
    -12.8 ± 21.45
    -10.6 ± 27.4
    -20.9 ± 25.86
    -15.8 ± 11.92
        AST; Week6; n=41, 38, 13, 13
    -13.8 ± 21.56
    -13.8 ± 25.01
    -21.6 ± 28.43
    -19.5 ± 12.99
        AST; Week8; n=40, 39, 13, 13
    -13.1 ± 26.01
    -7.6 ± 38.38
    -21.8 ± 26.38
    -18.6 ± 12.38
        AST; Week12; n=37, 35, 12, 13
    -14.4 ± 25.58
    -6.5 ± 36.17
    -25.7 ± 27.32
    -17.3 ± 12.68
        CK; Week1; n=40, 39, 15, 13
    18.2 ± 82.13
    -10.9 ± 103.31
    -3.3 ± 32.1
    -43.5 ± 82.73
        CK; Week2; n=41, 38, 14, 13
    -0.7 ± 53.87
    -22.6 ± 77.26
    -9.6 ± 36.26
    -28.5 ± 54.43
        CK; Week4; n=41, 39, 14, 13
    4.5 ± 141.46
    -32.1 ± 59.61
    -14.4 ± 22.06
    -47.7 ± 59.52
        CK; Week6; n=41, 38, 13, 13
    -26 ± 63.11
    56.1 ± 566.79
    -21.5 ± 48.49
    -64.5 ± 110.82
        CK; Week8; n=40, 39, 13, 13
    -21.3 ± 95.03
    -33.2 ± 65.96
    -30.3 ± 51.17
    -66.8 ± 107.3
        CK; Week12; n=37, 35, 12, 13
    -36.3 ± 75.56
    -33.9 ± 47.72
    -20.9 ± 59.82
    -48.5 ± 61.63
        GGT; Week1; n=40, 39, 15, 13
    -3.7 ± 20.79
    -2 ± 16.83
    -10.3 ± 19.38
    -6.4 ± 23.77
        GGT; Week2; n=41, 38, 14, 13
    -11.7 ± 33.78
    -17.1 ± 45.23
    -19.9 ± 29.59
    -7.2 ± 29.11
        GGT; Week4; n=41, 39, 14, 13
    -24.5 ± 52.93
    -25.5 ± 59.64
    -27.7 ± 36.64
    -16.2 ± 36.59
        GGT; Week6; n=41, 38, 13, 13
    -28.1 ± 67.33
    -30.5 ± 72.27
    -30.5 ± 44.3
    -23.8 ± 39.91
        GGT; Week8; n=40, 39, 13, 13
    -32.1 ± 70.41
    -27.2 ± 80.33
    -30.5 ± 45.05
    -28.5 ± 45.5
        GGT; Week12; n=37, 35, 12, 13
    -29.7 ± 80.2
    -20.7 ± 73.43
    -33.6 ± 49.61
    -30 ± 53.44
    Notes
    [52] - Safety Population
    [53] - Safety Population
    [54] - Safety Population
    [55] - Safety Population
    No statistical analyses for this end point

    Primary: Mean change from Baseline in direct bilirubin, total bilirubin and creatinine at the indicated time points up to Week 12

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    End point title
    Mean change from Baseline in direct bilirubin, total bilirubin and creatinine at the indicated time points up to Week 12 [56]
    End point description
    Blood samples were collected for the measurement of direct bilirubin, total bilirubin and creatinine at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the direct bilirubin, total bilirubin and creatinine values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.Note too few par. or no par. were analyzed at the indicated test/time point; therefore, the value of 99999 was entered which represents NA.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 1, 2, 4, 6, 8 and 12
    Notes
    [56] - 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: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [57]
    40 [58]
    17 [59]
    13 [60]
    Units: Micromoles per liter
    arithmetic mean (standard deviation)
        Total Bilirubin; Week1; n=40, 39, 15, 13
    6.9 ± 8.74
    6.7 ± 8.93
    8.1 ± 11.81
    4.2 ± 8.36
        Total Bilirubin; Week2; n=41, 38, 14, 13
    5.8 ± 6.62
    5.5 ± 6.84
    5.6 ± 9.8
    6.5 ± 9.34
        Total Bilirubin; Week4; n=41, 39, 14, 13
    2.2 ± 5.03
    2.9 ± 3.52
    0.7 ± 8.94
    2.5 ± 5.97
        Total Bilirubin; Week6; n=41, 38, 13, 13
    1.5 ± 4.14
    2.7 ± 3.97
    -0.5 ± 9.09
    2.1 ± 6.87
        Total Bilirubin; Week8; n=40, 39, 13, 13
    1.4 ± 4.63
    2.3 ± 4.93
    -0.3 ± 9.83
    1.8 ± 6.39
        Total Bilirubin; Week12; n=37, 35, 12, 13
    0.4 ± 4.46
    1.4 ± 5.61
    -2.8 ± 10.04
    1.2 ± 5.31
        Direct Bilirubin; Week1; n=1, 1, 1, 1
    0 ± 99999
    2 ± 99999
    -8 ± 99999
    -1 ± 0
        Direct Bilirubin; Week2; n=1, 1, 1, 1
    0 ± 99999
    0 ± 99999
    -14 ± 99999
    1 ± 0
        Direct Bilirubin; Week4; n=1, 1, 0, 0
    0 ± 99999
    2 ± 99999
    99999 ± 99999
    99999 ± 99999
        Direct Bilirubin; Week6; n=1, 1, 0, 0
    0 ± 99999
    0 ± 99999
    99999 ± 99999
    99999 ± 99999
        Creatinine; Week1; n=40, 39, 15, 13
    -1.41 ± 5.983
    0.23 ± 5.446
    5.12 ± 7.883
    -3.85 ± 5.868
        Creatinine; Week2; n=41, 38, 14, 13
    -2.47 ± 7.966
    -2.78 ± 5.725
    4.13 ± 6.518
    -1.17 ± 7.692
        Creatinine; Week4; n=41, 39, 14, 13
    -3.4 ± 5.894
    -1.33 ± 6.403
    5.35 ± 10.16
    -3.57 ± 9.599
        Creatinine; Week6; n=41, 38, 13, 13
    -2.15 ± 6.18
    -0.34 ± 7.667
    7.1 ± 7.905
    -2.05 ± 9.365
        Creatinine; Week8; n=40, 39, 13, 13
    -1.88 ± 5.724
    -0.51 ± 5.425
    9.43 ± 10.839
    -0.08 ± 10.23
        Creatinine; Week12; n=38, 35, 12, 13
    -1.49 ± 8.411
    -1.99 ± 8.704
    6.85 ± 10.363
    -2.41 ± 12.239
    Notes
    [57] - Safety Population
    [58] - Safety Population
    [59] - Safety Population
    [60] - Safety Population
    No statistical analyses for this end point

    Primary: Mean change from Baseline in chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/BUN at the indicated time points up to Week 12

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    End point title
    Mean change from Baseline in chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/BUN at the indicated time points up to Week 12 [61]
    End point description
    Blood samples were collected for the measurement of Chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/blood urea nitrogen (BUN) at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Bun values are summarized for each post-Baseline assessment until Week 12. . Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 1, 2, 4, 6, 8 and 12
    Notes
    [61] - 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: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [62]
    40 [63]
    17 [64]
    13 [65]
    Units: Millimoles per liter
    arithmetic mean (standard deviation)
        Chloride; Week1; n=40, 39, 15, 13
    0.5 ± 2.1
    -0.4 ± 2.03
    0.6 ± 2.61
    -0.2 ± 1.95
        Chloride; Week2; n=41, 38, 14, 13
    0.7 ± 2.37
    0.1 ± 1.9
    0.5 ± 1.61
    -0.7 ± 2.21
        Chloride; Week4; n=41, 39, 14, 13
    1.7 ± 2.31
    1 ± 2.46
    1.6 ± 2.21
    0.1 ± 2.5
        Chloride; Week6; n=41, 38, 13, 13
    1.6 ± 2.62
    0.8 ± 2.57
    0.8 ± 2.73
    -0.1 ± 1.38
        Chloride; Week8; n=40, 39, 13, 13
    2 ± 3.49
    0.7 ± 2.36
    2.2 ± 3
    -0.8 ± 2.77
        Chloride; Week12; n=37, 35, 12, 13
    1.5 ± 2.36
    0.1 ± 3.35
    1.9 ± 2.61
    1.2 ± 2.95
        Bicarbonate; Week1; n=40, 39, 15, 13
    0 ± 3.05
    -0.9 ± 2.57
    -1.2 ± 2.54
    -0.7 ± 2.56
        Bicarbonate; Week2; n=41, 38, 14, 13
    -0.3 ± 2.2
    -0.8 ± 3.1
    -1.5 ± 2.98
    -0.2 ± 3.65
        Bicarbonate; Week4; n=41, 39, 14, 13
    -0.9 ± 1.91
    -0.8 ± 2.55
    -1.4 ± 1.86
    -0.5 ± 2.67
        Bicarbonate; Week6; n=41, 38, 13, 13
    -0.4 ± 2
    -0.7 ± 2.23
    -1.5 ± 2.18
    0.6 ± 2.6
        Bicarbonate; Week8; n=40, 39, 13, 13
    -0.7 ± 2.41
    -0.8 ± 2.35
    -1.2 ± 2.19
    0 ± 2.2
        Bicarbonate; Week12; n=37, 35, 12, 13
    -0.6 ± 2.42
    -0.9 ± 2.37
    -1.1 ± 2.23
    -0.5 ± 2.76
        Glucose; Week1; n=40, 39, 15, 13
    -0.37 ± 1.485
    -0.34 ± 0.761
    -0.03 ± 0.616
    0.36 ± 1.619
        Glucose; Week2; n=41, 38, 14, 13
    -0.22 ± 1.467
    -0.17 ± 0.791
    0.11 ± 0.52
    0.13 ± 1.765
        Glucose; Week4; n=41, 39, 14, 13
    -0.03 ± 1.162
    0.02 ± 1.054
    -0.11 ± 0.601
    -0.48 ± 0.832
        Glucose; Week6; n=41, 38, 13, 13
    -0.15 ± 1.315
    -0.18 ± 1.154
    0.18 ± 0.772
    -0.55 ± 0.755
        Glucose; Week8; n=40, 39, 13, 13
    -0.05 ± 1.165
    -0.06 ± 0.835
    0.04 ± 0.675
    -0.36 ± 1.191
        Glucose; Week12; n=38, 35, 12, 13
    -0.3 ± 1.877
    -0.39 ± 1.047
    -0.23 ± 0.757
    -0.45 ± 1.063
        Potassium; Week1; n=40, 39, 15, 13
    -0.02 ± 0.392
    -0.06 ± 0.339
    -0.11 ± 0.376
    -0.02 ± 0.313
        Potassium; Week2; n=41, 38, 14, 13
    -0.1 ± 0.428
    -0.12 ± 0.453
    -0.39 ± 0.417
    -0.02 ± 0.316
        Potassium; Week4; n=41, 39, 14, 13
    -0.16 ± 0.411
    -0.11 ± 0.455
    -0.34 ± 0.497
    -0.05 ± 0.499
        Potassium; Week6; n=41, 38, 13, 13
    -0.15 ± 0.483
    -0.16 ± 0.387
    -0.45 ± 0.355
    -0.21 ± 0.38
        Potassium; Week8; n=40, 39, 13, 13
    -0.11 ± 0.49
    -0.19 ± 0.42
    -0.51 ± 0.348
    -0.14 ± 0.348
        Potassium; Week12; n=37, 35, 12, 13
    -0.15 ± 0.394
    -0.21 ± 0.362
    -0.38 ± 0.447
    -0.1 ± 0.428
        Sodium; Week1; n=40, 39, 15, 13
    -0.4 ± 1.85
    -0.8 ± 1.76
    -0.2 ± 2.46
    -0.8 ± 2.08
        Sodium; Week2; n=41, 38, 14, 13
    -0.1 ± 2.15
    -0.6 ± 1.81
    0 ± 1.8
    -1.3 ± 2.25
        Sodium; Week4; n=41, 39, 14, 13
    0.1 ± 2.16
    -0.1 ± 2.2
    0.4 ± 1.78
    -0.8 ± 1.95
        Sodium; Week6; n=41, 38, 13, 13
    0.2 ± 2.39
    -0.3 ± 2.39
    0.2 ± 2.91
    0 ± 2
        Sodium; Week8; n=40, 39, 13, 13
    0.3 ± 3.28
    -0.6 ± 2.24
    1.1 ± 2.18
    -0.6 ± 2.22
        Sodium; Week12; n=37, 35, 12, 13
    0.1 ± 1.91
    -0.3 ± 2.36
    0.8 ± 2.66
    0.5 ± 2.18
        Inorganic Phosphorus; Week1; n=40, 39, 15, 13
    -0.13 ± 0.1599
    -0.086 ± 0.1415
    -0.122 ± 0.1353
    -0.087 ± 0.1489
        Inorganic Phosphorus; Week2; n=41, 38, 14, 13
    -0.141 ± 0.181
    -0.108 ± 0.1754
    -0.081 ± 0.1194
    -0.105 ± 0.1159
        Inorganic Phosphorus; Week4; n=41, 39, 14, 13
    -0.151 ± 0.1666
    -0.125 ± 0.1421
    -0.077 ± 0.1669
    -0.078 ± 0.1871
        Inorganic Phosphorus; Week6; n=41, 38, 13, 13
    -0.171 ± 0.1939
    -0.181 ± 0.1823
    -0.121 ± 0.1549
    -0.159 ± 0.121
        Inorganic Phosphorus; Week8; n=40, 39, 13, 13
    -0.169 ± 0.2025
    -0.23 ± 0.1937
    -0.112 ± 0.1563
    -0.14 ± 0.167
        Inorganic Phosphorus; Week12; n=37, 35, 12, 13
    -0.172 ± 0.1708
    -0.168 ± 0.2047
    -0.117 ± 0.1123
    -0.136 ± 0.1943
        Urea/BUN; Week1; n=40, 39, 15, 13
    0.24 ± 0.996
    0.04 ± 1.002
    0.19 ± 1.287
    -0.01 ± 1.188
        Urea/BUN; Week2; n=41, 38, 14, 13
    0.2 ± 1.012
    -0.13 ± 1.05
    0.08 ± 1.309
    -0.12 ± 1.244
        Urea/BUN; Week4; n=41, 39, 14, 13
    0.03 ± 1.145
    -0.4 ± 1.047
    0.11 ± 1.436
    -0.88 ± 1.137
        Urea/BUN; Week6; n=41, 38, 13, 13
    -0.04 ± 1.09
    -0.29 ± 1.13
    -0.39 ± 0.883
    -1.02 ± 0.667
        Urea/BUN; Week8; n=40, 39, 13, 13
    -0.16 ± 1.088
    -0.46 ± 1.337
    -0.07 ± 1.206
    -0.85 ± 1.067
        Urea/BUN; Week12; n=37, 35, 12, 13
    -0.08 ± 1.164
    -0.31 ± 1.276
    -0.11 ± 1.272
    -0.64 ± 1.81
    Notes
    [62] - Safety Population
    [63] - Safety Population
    [64] - Safety Population
    [65] - Safety Population
    No statistical analyses for this end point

    Primary: Mean change from Baseline in creatinine clearance at the indicated time points up to Week 12

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    End point title
    Mean change from Baseline in creatinine clearance at the indicated time points up to Week 12 [66]
    End point description
    Blood samples were collected for the measurement of Creatinine Clearance at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the Creatinine Clearance values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 1, 2, 4, 6, 8 and 12
    Notes
    [66] - 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: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [67]
    40 [68]
    17 [69]
    13 [70]
    Units: Milliliter per minute (mL/min)
    arithmetic mean (standard deviation)
        Creatinine Clearance; Week1; n=40, 39, 15, 13
    1.5 ± 9.79
    -2.1 ± 19.51
    -9.5 ± 10.09
    5.7 ± 10.18
        Creatinine Clearance; Week2; n=41, 38, 14, 13
    3.3 ± 13.48
    4.7 ± 11.33
    -9 ± 12.55
    -1.8 ± 15.27
        Creatinine Clearance; Week4; n=41, 39, 14, 13
    5 ± 12.45
    1.9 ± 14.72
    -9.1 ± 13.42
    4.5 ± 16.19
        Creatinine Clearance; Week6; n=41, 38, 13, 13
    2.7 ± 11.93
    -0.7 ± 16.25
    -19.1 ± 20.54
    1.5 ± 13.12
        Creatinine Clearance; Week8; n=40, 39, 13, 13
    1.9 ± 10.49
    3.4 ± 19.94
    -17.8 ± 16.1
    -3 ± 14.54
        Creatinine Clearance; Week12; n=38, 35, 12, 13
    -0.2 ± 15.06
    2.2 ± 17.27
    -14.3 ± 16.99
    1.2 ± 20.49
    Notes
    [67] - Safety Population
    [68] - Safety Population
    [69] - Safety Population
    [70] - Safety Population
    No statistical analyses for this end point

    Primary: Number of participants with shift from Baseline in urinalysis data up to Week 12

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    End point title
    Number of participants with shift from Baseline in urinalysis data up to Week 12 [71]
    End point description
    Urine samples were collected for urinalysis at Baseline, Weeks 2, 12, 18, 24, 48 and PT FU Weeks 4. Number of participants with shift from Baseline in urinalysis to normal (NL), abnormal (ANL) and missing (MIS) data up to Week 12 are summarized. urine bilirubin (UBIL), urine glucose (UGLU), urine ketones (UKET), urine leukocyte esterase test (ULET) for detecting WBC, urine nitrite (UNIT), urine occult blood (UOB) were performed with dipstick method. Urine microscopy (UM) is performed to detect bacteria (BAC), red blood cells (RBC), white blood cells (WBC). Other urinalysis parameter included urine pH (UpH), urine specific gravity (USG). Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety populat
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 2 and 12
    Notes
    [71] - 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: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [72]
    40 [73]
    17 [74]
    13 [75]
    Units: Participants
        Week 2, UBIL, BL NL to PBL NL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UBIL, BL NL to PBL ANL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UBIL, BL NL to PBL MIS, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UBIL, BL ANL to PBL NL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UBIL, BL ANL to PBL ANL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UBIL, BL ANL to PBL MIS, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UBIL, BL MIS to PBL NL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UBIL, BL MIS to PBL ANL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UBIL, BL MIS to PBL MIS, n=1, 0, 0, 0
    1
    0
    0
    0
        Week 12, UBIL, BL NL to PBL NL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UBIL, BL NL to PBL ANL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UBIL, BL NL to PBL MIS, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UBIL, BL ANL to PBL NL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UBIL, BL ANL to PBL ANL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UBIL, BL ANL to PBL MIS, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UBIL, BL MIS to PBL NL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UBIL, BL MIS to PBL ANL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UBIL, BL MIS to PBL MIS, n=37, 34, 12, 13
    37
    34
    12
    13
        Week 2, UGLU, BL NL to PBL NL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UGLU, BL NL to PBL ANL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UGLU, BL NL to PBL MIS, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UGLU, BL ANL to PBL NL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UGLU, BL ANL to PBL ANL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UGLU, BL ANL to PBL MIS, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UGLU, BL MIS to PBL NL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UGLU, BL MIS to PBL ANL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UGLU, BL MIS to PBL MIS, n=1, 0, 0, 0
    1
    0
    0
    0
        Week 12, UGLU, BL NL to PBL NL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UGLU, BL NL to PBL ANL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UGLU, BL NL to PBL MIS, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UGLU, BL ANL to PBL NL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UGLU, BL ANL to PBL ANL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UGLU, BL ANL to PBL MIS, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UGLU, BL MIS to PBL NL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UGLU, BL MIS to PBL ANL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UGLU, BL MIS to PBL MIS, n=37, 34, 12, 13
    37
    34
    12
    13
        Week 2, UKET, BL NL to PBL NL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UKET, BL NL to PBL ANL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UKET, BL NL to PBL MIS, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UKET, BL ANL to PBL NL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UKET, BL ANL to PBL ANL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UKET, BL ANL to PBL MIS, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UKET, BL MIS to PBL NL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UKET, BL MIS to PBL ANL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UKET, BL MIS to PBL MIS, n=1, 0, 0, 0
    1
    0
    0
    0
        Week 12, UKET, BL NL to PBL NL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UKET, BL NL to PBL ANL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UKET, BL NL to PBL MIS, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UKET, BL ANL to PBL NL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UKET, BL ANL to PBL ANL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UKET, BL ANL to PBL MIS, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UKET, BL MIS to PBL NL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UKET, BL MIS to PBL ANL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UKET, BL MIS to PBL MIS, n=37, 34, 12, 13
    37
    34
    12
    13
        Week 2, ULET, BL NL to PBL NL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, ULET, BL NL to PBL ANL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, ULET, BL NL to PBL MIS, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, ULET, BL ANL to PBL NL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, ULET, BL ANL to PBL ANL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, ULET, BL ANL to PBL MIS, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, ULET, BL MIS to PBL NL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, ULET, BL MIS to PBL ANL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, ULET, BL MIS to PBL MIS, n=1, 0, 0, 0
    1
    0
    0
    0
        Week 12, ULET, BL NL to PBL NL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, ULET, BL NL to PBL ANL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, ULET, BL NL to PBL MIS, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, ULET, BL ANL to PBL NL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, ULET, BL ANL to PBL ANL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, ULET, BL ANL to PBL MIS, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, ULET, BL MIS to PBL NL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, ULET, BL MIS to PBL ANL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, ULET, BL MIS to PBL MIS, n=37, 34, 12, 13
    37
    34
    12
    13
        Week 2, UMBT, BL NL to PBL NL, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 2, UMBT, BL NL to PBL ANL, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 2, UMBT, BL NL to PBL MIS, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 2, UMBT, BL ANL to PBL NL, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 2, UMBT, BL ANL to PBL ANL, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 2, UMBT, BL ANL to PBL MIS, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 2, UMBT, BL MIS to PBL NL, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 2, UMBT, BL MIS to PBL ANL, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 2, UMBT, BL MIS to PBL MIS, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 12, UMBT, BL NL to PBL NL, n=1, 1, 0, 0
    0
    0
    0
    0
        Week 12, UMBT, BL NL to PBL ANL, n=1, 1, 0, 0
    0
    0
    0
    0
        Week 12, UMBT, BL NL to PBL MIS, n=1, 1, 0, 0
    0
    0
    0
    0
        Week 12, UMBT, BL ANL to PBL NL, n=1, 1, 0, 0
    0
    0
    0
    0
        Week 12, UMBT, BL ANL to PBL ANL, n=1, 1, 0, 0
    0
    0
    0
    0
        Week 12, UMBT, BL ANL to PBL MIS, n=1, 1, 0, 0
    0
    0
    0
    0
        Week 12, UMBT, BL MIS to PBL NL, n=1, 1, 0, 0
    0
    0
    0
    0
        Week 12, UMBT, BL MIS to PBL ANL, n=1, 1, 0, 0
    0
    0
    0
    0
        Week 12, UMBT, BL MIS to PBL MIS, n=1, 1, 0, 0
    1
    1
    0
    0
        Week 2, UMRBC, BL NL to PBL NL, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 2, UMRBC, BL NL to PBL ANL, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 2, UMRBC, BL NL to PBL MIS, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 2, UMRBC, BL ANL to PBL NL, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 2, UMRBC, BL ANL to PBL ANL, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 2, UMRBC, BL ANL to PBL MIS, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 2, UMRBC, BL MIS to PBL NL, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 2, UMRBC, BL MIS to PBL ANL, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 2, UMRBC, BL MIS to PBL MIS, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 12, UMRBC, BL NL to PBL NL, n=4, 5, 2, 2
    0
    0
    0
    0
        Week 12, UMRBC, BL NL to PBL ANL, n=4, 5, 2, 2
    0
    0
    0
    0
        Week 12, UMRBC, BL NL to PBL MIS, n=4, 5, 2, 2
    0
    0
    0
    0
        Week 12, UMRBC, BL ANL to PBL NL, n=4, 5, 2, 2
    0
    0
    0
    0
        Week 12, UMRBC, BL ANL to PBL ANL, n=4, 5, 2, 2
    0
    0
    0
    0
        Week 12, UMRBC, BL ANL to PBL MIS, n=4, 5, 2, 2
    0
    0
    0
    0
        Week 12, UMRBC, BL MIS to PBL NL, n=4, 5, 2, 2
    0
    0
    0
    0
        Week 12, UMRBC, BL MIS to PBL ANL, n=4, 5, 2, 2
    0
    0
    0
    0
        Week 12, UMRBC, BL MIS to PBL MIS, n=4, 5, 2, 2
    4
    5
    2
    2
        Week 2, UMWBC, BL NL to PBL NL, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 2, UMWBC, BL NL to PBL ANL, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 2, UMWBC, BL NL to PBL MIS, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 2, UMWBC, BL ANL to PBL NL, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 2, UMWBC, BL ANL to PBL ANL, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 2, UMWBC, BL ANL to PBL MIS, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 2, UMWBC, BL MIS to PBL NL, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 2, UMWBC, BL MIS to PBL ANL, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 2, UMWBC, BL MIS to PBL MIS, n=0, 0, 0, 0
    0
    0
    0
    0
        Week 12, UMWBC, BL NL to PBL NL, n=4, 5, 2, 2
    0
    0
    0
    0
        Week 12, UMWBC, BL NL to PBL ANL, n=4, 5, 2, 2
    0
    0
    0
    0
        Week 12, UMWBC, BL NL to PBL MIS, n=4, 5, 2, 2
    0
    0
    0
    0
        Week 12, UMWBC, BL ANL to PBL NL, n=4, 5, 2, 2
    0
    0
    0
    0
        Week 12, UMWBC, BL ANL to PBL ANL, n=4, 5, 2, 2
    0
    0
    0
    0
        Week 12, UMWBC, BL ANL to PBL MIS, n=4, 5, 2, 2
    0
    0
    0
    0
        Week 12, UMWBC, BL MIS to PBL NL, n=4, 5, 2, 2
    0
    0
    0
    0
        Week 12, UMWBC, BL MIS to PBL ANL, n=4, 5, 2, 2
    0
    0
    0
    0
        Week 12, UMWBC, BL MIS to PBL MIS, n=4, 5, 2, 2
    4
    5
    2
    2
        Week 2, UNIT, BL NL to PBL NL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UNIT, BL NL to PBL ANL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UNIT, BL NL to PBL MIS, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UNIT, BL ANL to PBL NL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UNIT, BL ANL to PBL ANL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UNIT, BL ANL to PBL MIS, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UNIT, BL MIS to PBL NL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UNIT, BL MIS to PBL ANL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UNIT, BL MIS to PBL MIS, n=1, 0, 0, 0
    1
    0
    0
    0
        Week 12, UNIT, BL NL to PBL NL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UNIT, BL NL to PBL ANL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UNIT, BL NL to PBL MIS, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UNIT, BL ANL to PBL NL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UNIT, BL ANL to PBL ANL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UNIT, BL ANL to PBL MIS, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UNIT, BL MIS to PBL NL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UNIT, BL MIS to PBL ANL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UNIT, BL MIS to PBL MIS, n=37, 34, 12, 13
    37
    34
    12
    13
        Week 2, UOB, BL NL to PBL NL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UOB, BL NL to PBL ANL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UOB, BL NL to PBL MIS, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UOB, BL ANL to PBL NL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UOB, BL ANL to PBL ANL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UOB, BL ANL to PBL MIS, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UOB, BL MIS to PBL NL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UOB, BL MIS to PBL ANL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UOB, BL MIS to PBL MIS, n=1, 0, 0, 0
    1
    0
    0
    0
        Week 12, UOB, BL NL to PBL NL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UOB, BL NL to PBL ANL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UOB, BL NL to PBL MIS, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UOB, BL ANL to PBL NL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UOB, BL ANL to PBL ANL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UOB, BL ANL to PBL MIS, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UOB, BL MIS to PBL NL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UOB, BL MIS to PBL ANL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UOB, BL MIS to PBL MIS, n=37, 34, 12, 13
    37
    34
    12
    13
        Week 2, UPH, BL NL to PBL NL, n=1, 0, 0, 0
    1
    0
    0
    0
        Week 2, UPH, BL NL to PBL ANL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UPH, BL NL to PBL MIS, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UPH, BL ANL to PBL NL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UPH, BL ANL to PBL ANL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UPH, BL ANL to PBL MIS, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UPH, BL MIS to PBL NL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UPH, BL MIS to PBL ANL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, UPH, BL MIS to PBL MIS, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 12, UPH, BL NL to PBL NL, n=37, 34, 12, 13
    36
    34
    12
    13
        Week 12, UPH, BL NL to PBL ANL, n=37, 34, 12, 13
    1
    0
    0
    0
        Week 12, UPH, BL NL to PBL MIS, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UPH, BL ANL to PBL NL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UPH, BL ANL to PBL ANL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UPH, BL ANL to PBL MIS, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UPH, BL MIS to PBL NL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UPH, BL MIS to PBL ANL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, UPH, BL MIS to PBL MIS, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 2, USG, BL NL to PBL NL, n=1, 0, 0, 0
    1
    0
    0
    0
        Week 2, USG, BL NL to PBL ANL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, USG, BL NL to PBL MIS, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, USG, BL ANL to PBL NL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, USG, BL ANL to PBL ANL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, USG, BL ANL to PBL MIS, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, USG, BL MIS to PBL NL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, USG, BL MIS to PBL ANL, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 2, USG, BL MIS to PBL MIS, n=1, 0, 0, 0
    0
    0
    0
    0
        Week 12, USG, BL NL to PBL NL, n=37, 34, 12, 13
    37
    34
    12
    12
        Week 12, USG, BL NL to PBL ANL, n=37, 34, 12, 13
    0
    0
    0
    1
        Week 12, USG, BL NL to PBL MIS, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, USG, BL ANL to PBL NL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, USG, BL ANL to PBL ANL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, USG, BL ANL to PBL MIS, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, USG, BL MIS to PBL NL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, USG, BL MIS to PBL ANL, n=37, 34, 12, 13
    0
    0
    0
    0
        Week 12, USG, BL MIS to PBL MIS, n=37, 34, 12, 13
    0
    0
    0
    0
    Notes
    [72] - Safety Population
    [73] - Safety Population
    [74] - Safety Population
    [75] - Safety Population
    No statistical analyses for this end point

    Primary: Mean change from Baseline in ECG heart rate values at the indicated time points up to Week 12

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    End point title
    Mean change from Baseline in ECG heart rate values at the indicated time points up to Week 12 [76]
    End point description
    The electrocardiographic (ECG) parameters heart rate was measured at Baseline, Weeks 1 and 12. Change from Baseline in ECG heart rate is summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 1 and 12
    Notes
    [76] - 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: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [77]
    40 [78]
    17 [79]
    13 [80]
    Units: Beats per minute
    arithmetic mean (standard deviation)
        Week 1, n=41, 40, 15, 12
    3.3 ± 8.28
    0.8 ± 8.49
    4.1 ± 9.52
    4.8 ± 10.62
        Week 12, n=38, 35, 12, 13
    8.3 ± 8.37
    5.1 ± 10.86
    9.3 ± 10.15
    8.5 ± 8
    Notes
    [77] - Safety Population
    [78] - Safety Population
    [79] - Safety Population
    [80] - Safety Population
    No statistical analyses for this end point

    Primary: Mean change from Baseline in PR interval, QRS duration, uncorrected QT interval, QTcB, QTcF values at the indicated time points up to Week 12

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    End point title
    Mean change from Baseline in PR interval, QRS duration, uncorrected QT interval, QTcB, QTcF values at the indicated time points up to Week 12 [81]
    End point description
    The electrocardiographic (ECG) parameters including PR interval, QRS duration, uncorrected QT interval, QT interval corrected Bazett's formula (QTcB), QT interval corrected using Fridericia’s formula (QTcF) were measured at Baseline, Weeks 1 and 12. Change from Baseline in ECG parameters are summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 1 and 12
    Notes
    [81] - 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: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [82]
    40 [83]
    17 [84]
    13 [85]
    Units: Milliseconds
    arithmetic mean (standard deviation)
        PR interval, Week 1, n=41, 40, 15, 12
    0.5 ± 19.43
    1.2 ± 13.57
    2.7 ± 7.27
    -1.6 ± 20.92
        PR interval, Week 12, n=38, 35, 12, 13
    2.9 ± 13.36
    3.2 ± 12.07
    5.5 ± 8.73
    0.2 ± 14.68
        QRS duration, Week 1, n=41, 40, 15, 12
    -6.6 ± 50.28
    0.4 ± 7.69
    2.9 ± 6.61
    0.4 ± 4.03
        QRS duration, Week 12, n=38, 35, 12, 13
    -8.2 ± 51.69
    -1.8 ± 6.44
    0.4 ± 7.54
    -2 ± 4.4
        Uncorrected QT Interval, Week 1, n=41, 40, 15, 12
    -2.3 ± 27.29
    -2.6 ± 22.29
    -2.1 ± 22.39
    5.9 ± 25.68
        Uncorrected QT interval, Week 12, n=38, 35, 12, 13
    -11.8 ± 31.28
    -12 ± 25.22
    -17 ± 18.01
    -4.6 ± 23.36
        Corrected QTcB interval, Week 1, n=41, 40, 15, 12
    7.7087 ± 25.63001
    0.2491 ± 22.90285
    9.8112 ± 20.6771
    19.8879 ± 40.13504
        Corrected QTcB interval, Week 12, n=38, 35, 12, 13
    11.5512 ± 26.5644
    1.7615 ± 20.3859
    11.2801 ± 25.54652
    18.9943 ± 16.76576
        Corrected QTcF interval, Week 1, n=41, 40, 15, 12
    4.1995 ± 23.18239
    -0.7151 ± 19.69091
    5.7676 ± 17.06472
    14.9187 ± 32.2737
        Corrected QTcF interval, Week 12, n=38, 35, 12, 13
    3.3516 ± 26.34546
    -3.1442 ± 17.38368
    1.6147 ± 18.38188
    10.7637 ± 17.07259
    Notes
    [82] - Safety Population
    [83] - Safety Population
    [84] - Safety Population
    [85] - Safety Population
    No statistical analyses for this end point

    Secondary: Number of participants with any adverse events (AEs) and any serious adverse events (SAEs) after Week 12

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    End point title
    Number of participants with any adverse events (AEs) and any serious adverse events (SAEs) after Week 12
    End point description
    An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.
    End point type
    Secondary
    End point timeframe
    From Week 12 up to Post-Treatment (PT) Week 24 Follow-up (FU)
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [86]
    40 [87]
    17 [88]
    13 [89]
    Units: Participants
        Any AE
    21
    22
    8
    9
        Any SAE
    0
    2
    3
    1
    Notes
    [86] - Safety Population
    [87] - Safety Population
    [88] - Safety Population
    [89] - Safety Population
    No statistical analyses for this end point

    Secondary: Number of participants achieving very rapid virologic response (vRVR), rapid virologic response (RVR), complete early virologic response (cEVR), sustained virologic response 12 and 24 (SVR12 and SVR24) with response guided treatment (RGT)

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    End point title
    Number of participants achieving very rapid virologic response (vRVR), rapid virologic response (RVR), complete early virologic response (cEVR), sustained virologic response 12 and 24 (SVR12 and SVR24) with response guided treatment (RGT)
    End point description
    Blood samples for the determination of HCV RNA levels were collected at Screening and Baseline, every study visit during the Treatment Period, and at PT FU Weeks 4, 12, and 24. Very rapid virologic response (vRVR) is defined as plasma HCV RNA <LLOQ and target not detected 2 weeks after initiation of therapy. Rapid virologic response (RVR) is defined as plasma HCV RNA <LLOQ and target not detected 4 weeks after initiation of therapy. Complete early virologic response (cEVR) is defined as plasma HCV RNA <LLOQ and target not detected 12 weeks after initiation of therapy. Sustained virologic response 12 (SVR12) is defined as plasma HCV RNA <LLOQ and target not detected 12 weeks after completion of all therapy. Sustained virologic response 24 (SVR24) is defined as plasma HCV RNA <LLOQ and target not detected 24 weeks after completion of all therapy. SVR24 with RGT are participants who achieved both SVR24 and eRVR.
    End point type
    Secondary
    End point timeframe
    From the start of the treatment up to PT FU Week 24
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [90]
    40 [91]
    17 [92]
    13 [93]
    Units: Participants
        vRVR
    8
    12
    8
    6
        RVR
    23
    23
    10
    9
        cEVR
    33
    30
    11
    13
        SVR12
    30
    26
    10
    11
        SVR24
    27
    25
    10
    12
        SVR24 with RGT
    17
    17
    9
    9
    Notes
    [90] - ITT Population
    [91] - ITT Population
    [92] - ITT Population
    [93] - ITT Population
    No statistical analyses for this end point

    Secondary: Mean GSK2336805 plasma concentrations on Day 1, Day 2, Week 4, and Week 12

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    End point title
    Mean GSK2336805 plasma concentrations on Day 1, Day 2, Week 4, and Week 12 [94]
    End point description
    Plasma pharmacokinetic (PK) samples were collected for all participants on Day 1 (0 hour [h]-1h, 1h-4h, 4h-8h, 8h-20h), Day 2 (Predose [20-28h]), Week 4 (Predose [20-28h], 0h-1h, 1h-4h, 4h-8h, 8h-20h, 20h-28h) and Week 12 (Predose [20-28h]). PK Population is comprised of all participants who received GSK2336805 and underwent plasma PK sampling (intensive or sparse) during the study. Only participants for whom plasma PK samples were obtained were assessed (represented by n=X, X in category titles).The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of 99999 indicates NA for the mean and the standard deviation).
    End point type
    Secondary
    End point timeframe
    Day 1, Day 2, Week 4, and Week 12
    Notes
    [94] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
    Number of subjects analysed
    41 [95]
    53 [96]
    Units: nanogram per milliliter (ng/mL)
    arithmetic mean (standard deviation)
        Day 1 (0h-1h), n=1, 3
    99999 ± 99999
    604 ± 392.763
        Day 1 (1h-4h), n=35, 42
    290.39 ± 241.05
    445.18 ± 314.624
        Day 1 (4h-8h), n=0, 3
    99999 ± 99999
    221.33 ± 191.996
        Day 1 (8h-20h), n=0, 1
    99999 ± 99999
    99999 ± 99999
        Day 2 Predose (20-28h), n=36, 43
    53.79 ± 52.629
    123.89 ± 257.575
        Week 4 Predose (20-28h), n=33, 42
    81.18 ± 153.462
    146.85 ± 243.331
        Week 4 (0h-1h), n=2, 6
    198.4 ± 242.679
    553 ± 536.451
        Week 4 (1h-4h), n=46, 52
    392.78 ± 275.504
    591.07 ± 402.442
        Week 4 (4h-8h), n=22, 19
    215.55 ± 127.737
    411.68 ± 251.604
        Week 4 (8h-20h), n=1, 2
    99999 ± 99999
    192.5 ± 94.045
        Week 4 (20h-28h), n=11, 10
    51.24 ± 57.261
    66.29 ± 53.604
        Week 12 (Predose [20-28h]), n=26, 35
    45.99 ± 42.034
    142.59 ± 178.252
    Notes
    [95] - PK Population
    [96] - PK Population
    No statistical analyses for this end point

    Secondary: Maximum plasma concentration (Cmax) and concentration at the end of the dosing interval (Ctau) of GSK2336805 at Week 4

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    End point title
    Maximum plasma concentration (Cmax) and concentration at the end of the dosing interval (Ctau) of GSK2336805 at Week 4 [97]
    End point description
    Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7, 24 hours post-dose. : Intensive PK Summary Population is comprised of participants with evaluable GSK2336805 PK parameters at Week 4. Only participants available at the indicated time point were assessed (represented by n=X, X in category titles).
    End point type
    Secondary
    End point timeframe
    Week 4
    Notes
    [97] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
    Number of subjects analysed
    11 [98]
    10 [99]
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Cmax, n=11, 10
    335.35 ± 69.4
    618.75 ± 46.1
        Ctau, n=11, 10
    31.37 ± 135.9
    49.31 ± 97.6
    Notes
    [98] - Intensive PK Summary Population
    [99] - Intensive PK Summary Population
    No statistical analyses for this end point

    Secondary: Time of maximal plasma concentration (tmax) of GSK2336805 at Week 4

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    End point title
    Time of maximal plasma concentration (tmax) of GSK2336805 at Week 4 [100]
    End point description
    Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7, 24 hours postdose.
    End point type
    Secondary
    End point timeframe
    Week 4
    Notes
    [100] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
    Number of subjects analysed
    11 [101]
    10 [102]
    Units: hour
        median (full range (min-max))
    2 (1 to 4)
    2 (1 to 7)
    Notes
    [101] - Intensive PK Summary Population
    [102] - Intensive PK Summary Population
    No statistical analyses for this end point

    Secondary: Area under the concentration-time curve over the dosing interval (AUC[0-tau]) at Week 12

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    End point title
    Area under the concentration-time curve over the dosing interval (AUC[0-tau]) at Week 12 [103]
    End point description
    Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose.
    End point type
    Secondary
    End point timeframe
    Week 12
    Notes
    [103] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
    Number of subjects analysed
    11 [104]
    10 [105]
    Units: hour*nanogram per milliliter(hr*ng/mL)
        geometric mean (geometric coefficient of variation)
    2733.34 ± 82
    4948.23 ± 66.3
    Notes
    [104] - Intensive PK Summary Population
    [105] - Intensive PK Summary Population
    No statistical analyses for this end point

    Secondary: Apparent clearance (CL/F) at Week 12

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    End point title
    Apparent clearance (CL/F) at Week 12 [106]
    End point description
    Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose. Apparent clearance is calculated as dose divided by AUC(0-tau).
    End point type
    Secondary
    End point timeframe
    Week 12
    Notes
    [106] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
    Number of subjects analysed
    11 [107]
    10 [108]
    Units: Liter per hour (L/hr)
        geometric mean (geometric coefficient of variation)
    14.63 ± 82
    12.13 ± 66.3
    Notes
    [107] - Intensive PK Summary Population
    [108] - Intensive PK Summary Population
    No statistical analyses for this end point

    Secondary: Apparent volume of distribution (Vz/F) at Week 12

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    End point title
    Apparent volume of distribution (Vz/F) at Week 12 [109]
    End point description
    Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose. Apparent volume of distribution is calculated as dose divided by (AUC[0-tau] lambda z) where lambda z is the terminal phase rate constant.
    End point type
    Secondary
    End point timeframe
    Week 12
    Notes
    [109] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
    Number of subjects analysed
    11 [110]
    10 [111]
    Units: Liter per hour (L/hr)
        geometric mean (geometric coefficient of variation)
    172.81 ± 76.6
    125.09 ± 67.9
    Notes
    [110] - Intensive PK Summary Population
    [111] - Intensive PK Summary Population
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the indicated time points after Week 12

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    End point title
    Mean change from Baseline in basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the indicated time points after Week 12
    End point description
    Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT Week 4. Change from Baseline in the basophils, eosinophils, lymphocytes, total neutrophils platelet count and white blood cell count values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population. System value of 99999 indicates NA (too few participants).
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [112]
    40 [113]
    17 [114]
    13 [115]
    Units: Giga per liter
    arithmetic mean (standard deviation)
        Basophils; Week18; n=37, 33, 13, 12
    -0.019 ± 0.0178
    -0.01 ± 0.0194
    -0.014 ± 0.0112
    -0.012 ± 0.0119
        Basophils; Week24; n=34, 32, 12, 11
    -0.018 ± 0.0177
    -0.01 ± 0.0166
    -0.013 ± 0.0129
    -0.013 ± 0.011
        Basophils; Week30; n=13, 10, 2, 2
    -0.018 ± 0.0142
    -0.012 ± 0.0148
    -0.02 ± 0
    -0.02 ± 0
        Basophils; Week36; n=12, 7, 1, 2
    -0.02 ± 0.0165
    -0.006 ± 0.019
    -0.02 ± 99999
    -0.01 ± 0.0141
        Basophils; Week42; n=10, 6, 2, 2
    -0.015 ± 0.0242
    -0.005 ± 0.0187
    0 ± 0.0424
    -0.015 ± 0.0071
        Basophils; Week48; n=7, 6, 1, 2
    -0.007 ± 0.0214
    -0.007 ± 0.0197
    0.02 ± 99999
    0.005 ± 0.0119
        Basophils; PT Week4; n=32, 34, 11, 11
    -0.007 ± 0.0162
    -0.003 ± 0.0189
    -0.001 ± 0.0181
    -0.003 ± 0.0189
        Eosinophils; Week18; n=37, 33, 13, 12
    -0.119 ± 0.1006
    -0.127 ± 0.1207
    -0.087 ± 0.0507
    -0.068 ± 0.0746
        Eosinophils; Week24; n=34, 32, 12, 11
    -0.128 ± 0.101
    -0.131 ± 0.1103
    -0.118 ± 0.0612
    -0.041 ± 0.1003
        Eosinophils; Week30; n=13, 10, 2, 2
    -0.124 ± 0.0982
    -0.116 ± 0.1117
    -0.13 ± 0.0849
    -0.04 ± 0.0141
        Eosinophils; Week36; n=12, 7, 1, 2
    -0.081 ± 0.1459
    -0.123 ± 0.1003
    -0.06 ± 99999
    -0.05 ± 0.0141
        Eosinophils; Week42; n=10, 6, 2, 2
    -0.105 ± 0.074
    -0.1 ± 0.12
    -0.02 ± 0.0424
    -0.04 ± 0
        Eosinophils; Week48; n=8, 6, 1, 2
    -0.071 ± 0.0889
    -0.11 ± 0.1223
    0.13 ± 99999
    -0.05 ± 0.0141
        Eosinophils; PT Week4; n=32, 34, 11, 11
    -0.069 ± 0.0925
    -0.085 ± 0.1208
    -0.07 ± 0.0694
    -0.018 ± 0.0808
        Lymphocytes; Week18; n=37, 33, 13, 12
    -1.081 ± 0.5533
    -1.157 ± 0.5373
    -0.999 ± 0.4672
    -0.973 ± 0.5328
        Lymphocytes; Week24; n=34, 32, 12, 11
    -1.181 ± 0.4795
    -1.092 ± 0.5598
    -1.405 ± 0.5912
    -1.057 ± 0.4832
        Lymphocytes; Week30; n=13, 10, 2, 2
    -1.225 ± 0.7588
    -1.085 ± 0.798
    -1.905 ± 0.1768
    -1.845 ± 0.2899
        Lymphocytes; Week36; n=12, 7, 1, 2
    -1.267 ± 0.6828
    -1.286 ± 0.8983
    -1.97 ± 99999
    -1.92 ± 0.4808
        Lymphocytes; Week42; n=10, 6, 2, 2
    -1.135 ± 0.8657
    -1.22 ± 0.9909
    -1.125 ± 1.0253
    -1.93 ± 0.1414
        Lymphocytes; Week48; n=7, 6, 1, 2
    -0.779 ± 1.0639
    -1.4 ± 1.0384
    0.09 ± 99999
    -2.2 ± 0.0424
        Lymphocytes; PT Week4; n=32, 34, 11, 11
    -0.681 ± 0.4594
    -0.7 ± 0.6163
    -0.756 ± 0.5874
    -0.737 ± 0.5666
        Monocytes; Week18; n=37, 33, 13, 12
    -0.186 ± 0.1588
    -0.141 ± 0.1339
    -0.088 ± 0.1663
    -0.143 ± 0.1776
        Monocytes; Week24; n=34, 32, 12, 11
    -0.206 ± 0.1692
    -0.156 ± 0.1574
    -0.151 ± 0.1474
    -0.121 ± 0.1902
        Monocytes; Week30; n=13, 10, 2, 2
    -0.151 ± 0.1655
    -0.135 ± 0.091
    -0.4 ± 0.3111
    -0.06 ± 0.0141
        Monocytes; Week36; n=12, 7, 1, 2
    -0.255 ± 0.1474
    -0.18 ± 0.0987
    -0.2 ± 99999
    0.015 ± 0.1061
        Monocytes; Week42; n=10, 6, 2, 2
    -0.184 ± 0.234
    -0.093 ± 0.1743
    -0.025 ± 0.2192
    -0.01 ± 0.099
        Monocytes; Week48; n=7, 6, 1, 2
    -0.066 ± 0.1744
    -0.147 ± 0.088
    0.02 ± 99999
    -0.085 ± 0.1909
        Monocytes; PT Week4; n=32, 34, 11, 11
    -0.047 ± 0.1773
    -0.031 ± 0.165
    0.032 ± 0.1543
    -0.053 ± 0.1536
        Total Neutrophils; Week18; n=37, 33, 13, 12
    -2.702 ± 1.9136
    -2.378 ± 1.6735
    -1.652 ± 0.852
    -1.463 ± 0.7174
        Total Neutrophils; Week24; n=34, 32, 12, 11
    -2.527 ± 1.9492
    -2.187 ± 1.7758
    -1.308 ± 0.7148
    -1.3 ± 0.9956
        Total Neutrophils; Week30; n=13, 10, 2, 2
    -2.402 ± 1.7954
    -2.252 ± 2.3658
    -2.24 ± 1.2869
    -2.085 ± 0.1909
        Total Neutrophils; Week36; n=12, 7, 1, 2
    -2.503 ± 1.6709
    -2.777 ± 2.4215
    -1.61 ± 99999
    -1.63 ± 0.297
        Total Neutrophils; Week42; n=10, 6, 2, 2
    -2.23 ± 2.0311
    -3.085 ± 2.7313
    -0.565 ± 0.7849
    -1.815 ± 0.4455
        Total Neutrophils; Week48; n=7, 6, 1, 2
    -1.129 ± 2.2597
    -2.488 ± 3.397
    0.02 ± 99999
    -1.445 ± 0.4596
        Total Neutrophils; PT Week4; n=32, 34, 11, 11
    -1.158 ± 1.8855
    -0.808 ± 1.6104
    -0.744 ± 1.1276
    -0.671 ± 0.8001
        Platelet Count; Week18; n=38, 34, 13, 12
    -73.7 ± 43.93
    -87.5 ± 38.4
    -55.7 ± 56.96
    -52.1 ± 39.87
        Platelet Count; Week24; n=35, 33, 12, 11
    -67.5 ± 43.22
    -78.8 ± 44.15
    -60.3 ± 56.5
    -51.9 ± 44.19
        Platelet Count; Week30; n=13, 10, 1, 2
    -70 ± 60.5
    -71.9 ± 59.35
    -112 ± 99999
    -36.5 ± 47.38
        Platelet Count; Week36; n=12, 7, 1, 2
    -64.1 ± 41.52
    -75.7 ± 65.89
    -115 ± 99999
    -34 ± 52.33
        Platelet Count; Week42; n=10, 6, 2, 2
    -56.1 ± 53.01
    -67.3 ± 62.09
    -112 ± 0
    -22 ± 52.33
        Platelet Count; Week48; n=9, 6, 1, 2
    -37.7 ± 66.18
    -68.8 ± 65.74
    33 ± 99999
    -14 ± 22.63
        Platelet Count; PT Week4; n=32, 34, 11, 11
    -20.4 ± 44.37
    -28.9 ± 45.92
    -12.4 ± 34.3
    -12.9 ± 42.3
        White Blood Cell count; Week18; n=37, 33, 13, 12
    -4.1 ± 2.258
    -3.81 ± 1.884
    -2.84 ± 0.961
    -2.65 ± 0.923
        White Blood Cell count ; Week24; n=34, 32, 12, 11
    -4.06 ± 2.251
    -3.58 ± 1.977
    -3 ± 1.047
    -2.52 ± 1.272
        White Blood Cell count ; Week30; n=13, 10, 2, 2
    -3.92 ± 2.258
    -3.59 ± 3.051
    -4.7 ± 1.838
    -4.05 ± 0.495
        White Blood Cell count ; Week36; n=12, 7, 1, 2
    -4.13 ± 2.188
    -4.39 ± 3.168
    -3.9 ± 99999
    -3.55 ± 0.919
        White Blood Cell count ; Week42; n=10, 6, 2, 2
    -3.67 ± 2.807
    -4.52 ± 3.68
    -1.75 ± 2.051
    -3.8 ± 0.707
        White Blood Cell count; Week48; n=7, 6, 1, 2
    -2.09 ± 3.304
    -4.17 ± 4.172
    0.2 ± 99999
    -3.8 ± 0.141
        White Blood Cell count; PT Week4; n=32, 34, 11, 11
    -1.97 ± 1.938
    -1.64 ± 1.907
    -1.54 ± 1.638
    -1.45 ± 0.884
    Notes
    [112] - Safety Population
    [113] - Safety Population
    [114] - Safety Population
    [115] - Safety Population
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in red blood cell count at the indicated time points after Week 12

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    End point title
    Mean change from Baseline in red blood cell count at the indicated time points after Week 12
    End point description
    Blood samples were collected for the measurement of red blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the red blood cell count values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of 99999 indicates NA for the mean and the standard deviation).
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [116]
    40 [117]
    17 [118]
    13 [119]
    Units: Trillion per liter
    arithmetic mean (standard deviation)
        Red Blood Cell count; Week 18; n=38, 34, 13, 12
    -1.13 ± 0.494
    -0.88 ± 0.591
    -1.19 ± 0.638
    -0.99 ± 0.498
        Red Blood Cell count; Week 24; n=35, 33, 12, 11
    -1.13 ± 0.482
    -0.94 ± 0.513
    -1.19 ± 0.552
    -1.14 ± 0.528
        Red Blood Cell count; Week 30; n=13, 10, 2, 2
    -1.05 ± 0.511
    -0.75 ± 0.809
    -1.45 ± 0.071
    -1.45 ± 0.354
        Red Blood Cell count; Week 36; n=12, 7, 1, 2
    -0.88 ± 0.67
    -1.06 ± 0.761
    -1 ± 99999
    -1.3 ± 0.283
        Red Blood Cell count; Week 42; n=10, 6, 2, 2
    -0.91 ± 0.674
    -1.17 ± 0.769
    -0.55 ± 0.636
    -1.45 ± 0.354
        Red Blood Cell count; Week 48; n=9, 6, 1, 2
    -0.83 ± 0.791
    -1.03 ± 0.794
    -0.4 ± 99999
    -1.5 ± 0.566
        Red Blood Cell count; PT Week 4; n=32, 34, 11, 11
    -0.57 ± 0.435
    -0.37 ± 0.353
    -0.66 ± 0.437
    -0.65 ± 0.474
    Notes
    [116] - Safety Population
    [117] - Safety Population
    [118] - Safety Population
    [119] - Safety Population
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in hemoglobin at the indicated time points after Week 12

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    End point title
    Mean change from Baseline in hemoglobin at the indicated time points after Week 12
    End point description
    Blood samples were collected for the measurement of hemoglobin at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hemoglobin values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of 99999 indicates NA for the mean and the standard deviation).
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [120]
    40 [121]
    17 [122]
    13 [123]
    Units: Grams per liter
    arithmetic mean (standard deviation)
        Hemoglobin; Week 18; n=38, 34, 13, 12
    -33.6 ± 12.34
    -26.7 ± 14.65
    -35 ± 16.38
    -29 ± 10.61
        Hemoglobin; Week 24; n=35, 33, 12, 11
    -33.4 ± 12.16
    -28 ± 12.44
    -35.6 ± 13.48
    -32.3 ± 14.98
        Hemoglobin; Week 30; n=13, 10, 2, 2
    -30.2 ± 16.13
    -21 ± 20.02
    -40 ± 12.73
    -40 ± 1.41
        Hemoglobin; Week 36; n=12, 7, 1, 2
    -26.7 ± 18.86
    -30 ± 16.37
    -37 ± 99999
    -35 ± 1.41
        Hemoglobin; Week 42; n=10, 6, 2, 2
    -27.1 ± 18.51
    -31.7 ± 19.82
    -25 ± 22.63
    -40 ± 1.41
        Hemoglobin; Week 48; n=9, 6, 1, 2
    -25.9 ± 21.47
    -29.3 ± 20.33
    -18 ± 99999
    -41 ± 8.49
        Hemoglobin; PT Week 4; n=32, 34, 11, 11
    -16.5 ± 11.43
    -11.7 ± 9.57
    -21.4 ± 8.59
    -16.8 ± 11.99
    Notes
    [120] - Safety Population
    [121] - Safety Population
    [122] - Safety Population
    [123] - Safety Population
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in hematocrit at the indicated time points after Week 12

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    End point title
    Mean change from Baseline in hematocrit at the indicated time points after Week 12
    End point description
    Blood samples were collected for the measurement of hematocrit at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hematocrit values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population. The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of 99999 indicates NA).
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [124]
    40 [125]
    17 [126]
    13 [127]
    Units: Percentage of RBC in blood
    arithmetic mean (standard deviation)
        Hematocrit; Week 18; n=38, 34, 13, 12
    -0.083 ± 0.03831
    -0.0622 ± 0.04289
    -0.0776 ± 0.04313
    -0.0699 ± 0.02801
        Hematocrit; Week 24; n=35, 33, 12, 11
    -0.0782 ± 0.04021
    -0.0635 ± 0.03499
    -0.0808 ± 0.03543
    -0.0823 ± 0.03968
        Hematocrit; Week 30; n=13, 10, 2, 2
    -0.0713 ± 0.0486
    -0.0397 ± 0.05793
    -0.0955 ± 0.03323
    -0.1125 ± 0.00636
        Hematocrit; Week 36; n=12, 7, 1, 2
    -0.0567 ± 0.05031
    -0.069 ± 0.04724
    -0.087 ± 99999
    -0.0895 ± 0.00354
        Hematocrit; Week 42; n=10, 6, 2, 2
    -0.0623 ± 0.05449
    -0.0802 ± 0.0562
    -0.0535 ± 0.07
    -0.111 ± 0.00566
        Hematocrit; Week 48; n=9, 6, 1, 2
    -0.0624 ± 0.06203
    -0.0753 ± 0.05285
    -0.047 ± 99999
    -0.1095 ± 0.03041
        Hematocrit; PT Week 4; n=32, 34, 11, 11
    -0.0293 ± 0.03575
    -0.0135 ± 0.03178
    -0.0362 ± 0.02907
    -0.0354 ± 0.0358
    Notes
    [124] - Safety Population
    [125] - Safety Population
    [126] - Safety Population
    [127] - Safety Population
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in mean corpuscle volume at the indicated time points after Week 12

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    End point title
    Mean change from Baseline in mean corpuscle volume at the indicated time points after Week 12
    End point description
    Blood samples were collected for the measurement of mean corpuscle volume at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the mean corpuscle volume values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population. The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of 99999 indicates NA for the mean and the standard deviation).
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [128]
    40 [129]
    17 [130]
    13 [131]
    Units: Femtoliters
    arithmetic mean (standard deviation)
        Mean Corpuscle Volume ; Week 18; n=38, 34, 13, 12
    7.5 ± 6.37
    6.2 ± 8.19
    8.5 ± 5.78
    5.3 ± 5.28
        Mean Corpuscle Volume ; Week 24; n=35, 33, 12, 11
    8.5 ± 6.14
    7.5 ± 8.89
    7.6 ± 5.9
    5.8 ± 5.08
        Mean Corpuscle Volume ; Week 30; n=13, 10, 2, 2
    7.8 ± 7.24
    9.5 ± 12.02
    11.5 ± 7.78
    3 ± 2.83
        Mean Corpuscle Volume ; Week 36; n=12, 7, 1, 2
    8.1 ± 5.92
    11.4 ± 13.6
    2 ± 99999
    5.5 ± 2.12
        Mean Corpuscle Volume ; Week 42; n=10, 6, 2, 2
    6.9 ± 5.7
    10.7 ± 14.47
    1 ± 2.83
    4 ± 2.83
        Mean Corpuscle Volume ; Week 48; n=9, 6, 1, 2
    5.2 ± 5.76
    9 ± 14.04
    -1 ± 99999
    5 ± 1.41
        Mean Corpuscle Volume; PT Week 4; n=32, 34, 11, 11
    6.1 ± 5.56
    5.1 ± 4.86
    5.8 ± 3.79
    5.3 ± 5.1
    Notes
    [128] - Safety Population
    [129] - Safety Population
    [130] - Safety Population
    [131] - Safety Population
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in albumin at the indicated time points after Week 12

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    End point title
    Mean change from Baseline in albumin at the indicated time points after Week 12
    End point description
    Blood samples were collected for the measurement of albumin at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the albumin values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population. The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of 99999 indicates NA for the mean and the standard deviation).
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [132]
    40 [133]
    17 [134]
    13 [135]
    Units: Grams per liter
    arithmetic mean (standard deviation)
        Albumin; Week 18; n=38, 34, 13, 12
    -2.3 ± 2.78
    -1.4 ± 2.65
    -1.8 ± 2.86
    -1 ± 2.89
        Albumin; Week 24; n=35, 33, 12, 11
    -2.1 ± 3.08
    -1.6 ± 2.82
    -2.3 ± 2.81
    -1.1 ± 2.81
        Albumin; Week 30; n=13, 10, 3, 2
    -1.8 ± 2.09
    -0.7 ± 4.22
    -3 ± 2.65
    -4.5 ± 0.71
        Albumin; Week 36; n=10, 7, 2, 2
    -1.7 ± 3.92
    -1.1 ± 2.85
    2 ± 1.41
    -2 ± 0
        Albumin; Week 42; n=9, 6, 1, 2
    -1.3 ± 2.5
    -1.3 ± 1.63
    -1 ± 99999
    -3 ± 0
        Albumin; Week 48; n=6, 6, 0, 2
    -1.3 ± 3.61
    -0.3 ± 2.16
    99999 ± 99999
    -4 ± 1.41
        Albumin; PT Week 4; n=33, 34, 11, 11
    -0.7 ± 3.93
    -0.2 ± 2.84
    0.5 ± 2.3
    -0.7 ± 1.79
    Notes
    [132] - Safety Population
    [133] - Safety Population
    [134] - Safety Population
    [135] - Safety Population
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase at the indicated time points after Week 12

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    End point title
    Mean change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase at the indicated time points after Week 12
    End point description
    Blood samples were collected for the measurement of Alkaline Phosphatase (ALP) , Alanine Amino Transferase (ALT) , Aspartate Amino Transferase (AST) , Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the ALP, ALT, AST, CK and GGT values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population. System value of 99999 indicates NA (too few participants).
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [136]
    40 [137]
    17 [138]
    13 [139]
    Units: International units per liter
    arithmetic mean (standard deviation)
        ALP; Week 18; n=38, 34, 13, 12
    2.5 ± 17.25
    1.1 ± 16.95
    2.2 ± 21.77
    6.4 ± 20.08
        ALP; Week 24; n=35, 33, 12, 11
    0.8 ± 19.71
    3.3 ± 18.83
    2.1 ± 20.24
    4.5 ± 22.82
        ALP; Week 30; n=13, 10, 3, 2
    1.8 ± 15.79
    -6.4 ± 18.62
    -8 ± 8.54
    22.5 ± 14.85
        ALP; Week 36; n=10, 7, 2, 2
    2 ± 17.49
    2.7 ± 9.45
    2.5 ± 0.71
    18 ± 7.07
        ALP; Week 42; n=9, 6, 1, 2
    5.3 ± 13.4
    3.3 ± 8.45
    -2 ± 99999
    17.5 ± 2.12
        ALP; Week 48; n=6, 6, 0, 2
    9.8 ± 17.36
    4.2 ± 9.62
    99999 ± 99999
    30 ± 24.04
        ALP; PT Week 4; n=33, 34, 11, 11
    -4.9 ± 19.71
    -6.3 ± 17.88
    -7 ± 17.93
    -3.9 ± 22.15
        ALT; Week 18; n=38, 34, 13, 12
    -38.9 ± 61.39
    -22.9 ± 61.65
    -38.6 ± 40.89
    -38.4 ± 32.63
        ALT; Week 24; n=35, 33, 12, 11
    -43.9 ± 62.25
    -31.3 ± 56.12
    -39.7 ± 38.19
    -41.7 ± 28.32
        ALT; Week 30; n=13, 10, 3, 2
    -34.8 ± 30.82
    -45.1 ± 95.76
    -57.7 ± 58.31
    -26 ± 22.63
        ALT; Week 36; n=10, 7, 2, 2
    -30.2 ± 28.15
    -16.6 ± 13.7
    -69 ± 74.95
    -20.5 ± 16.26
        ALT; Week 42; n=9, 6, 1, 2
    -34.3 ± 35.15
    -14.3 ± 20.07
    -122 ± 99999
    -28 ± 25.46
        ALT; Week 48; n=6, 6, 0, 2
    -38.8 ± 42.1
    -10.8 ± 27.11
    99999 ± 99999
    -26.5 ± 26.16
        ALT; PT Week 4; n=33, 34, 11, 11
    -45.5 ± 62.76
    -33.3 ± 56.81
    -31.5 ± 22.68
    -43.9 ± 27.71
        AST; Week 18; n=38, 34, 13, 12
    -13.1 ± 27.49
    -3.5 ± 37.25
    -18.8 ± 27.32
    -16.3 ± 15.11
        AST; Week 24; n=35, 33, 12, 11
    -16.5 ± 26.86
    -11.8 ± 30.51
    -23.8 ± 26.91
    -15.7 ± 18.91
        AST; Week 30; n=13, 10, 3, 2
    -15.1 ± 17.35
    -18.7 ± 43.89
    -27.7 ± 20.13
    -6.5 ± 7.78
        AST; Week 36; n=10, 7, 2, 2
    -11.8 ± 13.81
    -7.3 ± 9.5
    -27.5 ± 31.82
    -2.5 ± 2.12
        AST; Week 42; n=9, 6, 1, 2
    -14.2 ± 16.81
    -5.8 ± 10.03
    -54 ± 99999
    -9 ± 7.07
        AST; Week 48; n=6, 6, 0, 2
    -12.8 ± 18.65
    -2.2 ± 13.61
    99999 ± 99999
    -6.5 ± 9.19
        AST; PT Week 4; n=33, 34, 11, 11
    -19.5 ± 26.41
    -15.6 ± 34.38
    -17.7 ± 14.67
    -16 ± 31.8
        CK; Week 18; n=38, 34, 13, 12
    -44 ± 55.77
    -28.3 ± 36.59
    -38.7 ± 45.46
    -60.7 ± 75.8
        CK; Week 24; n=35, 33, 12, 11
    -34.5 ± 66.48
    -18.7 ± 77.24
    -39 ± 36.68
    60.1 ± 475.39
        CK; Week 30; n=13, 10, 3, 2
    -33 ± 83.25
    -15.8 ± 51.92
    -30 ± 24.27
    -78.5 ± 55.86
        CK; Week 36; n=10, 7, 2, 2
    -18.9 ± 34.18
    -26.7 ± 32.22
    -37.5 ± 6.36
    -69 ± 53.74
        CK; Week 42; n=9, 6, 1, 2
    -0.2 ± 51.5
    -29.7 ± 43.42
    -32 ± 99999
    -81 ± 57.98
        CK; Week 48; n=6, 6, 0, 2
    10.5 ± 71.39
    22.3 ± 77.32
    99999 ± 99999
    -82.5 ± 70
        CK; PT Week 4; n=33, 34, 11, 11
    -17.9 ± 48.82
    -26.4 ± 49.42
    -21.7 ± 42.62
    258.7 ± 994.88
        GGT; Week 18; n=38, 34, 13, 12
    -37.3 ± 71.19
    -12.3 ± 60.35
    -30.2 ± 42.04
    -34.2 ± 56.52
        GGT; Week 24; n=35, 33, 12, 11
    -38.3 ± 72.79
    -12.5 ± 86.73
    -37.4 ± 45.44
    -35.7 ± 59.63
        GGT; Week 30; n=13, 10, 3, 2
    -44.2 ± 41.3
    -32.8 ± 31.81
    -38.7 ± 36.02
    -12 ± 4.24
        GGT; Week 36; n=10, 7, 2, 2
    -51.5 ± 45.03
    -19.7 ± 24.52
    -40.5 ± 33.23
    -10 ± 4.24
        GGT; Week 42; n=9, 6, 1, 2
    -44.6 ± 46.61
    -19.7 ± 25.06
    -17 ± 99999
    -9 ± 1.41
        GGT; Week 48; n=6, 6, 0, 2
    -37.8 ± 28.74
    -16.8 ± 24.38
    99999 ± 99999
    -9.5 ± 6.36
        GGT; PT Week 4; n=33, 34, 11, 11
    -43.4 ± 78.29
    -17.7 ± 78.22
    -30.7 ± 41.91
    -41.4 ± 61.06
    Notes
    [136] - Safety Population
    [137] - Safety Population
    [138] - Safety Population
    [139] - Safety Population
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in total bilirubin and creatinine at the indicated time points after Week 12

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    End point title
    Mean change from Baseline in total bilirubin and creatinine at the indicated time points after Week 12
    End point description
    Blood samples were collected for the measurement of total bilirubin and creatinine at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the direct bilirubin, total bilirubin and creatinine values are summarized for each post-Baseline assessment afterl Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population. The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of 99999 indicates NA for the mean and the standard deviation).
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [140]
    40 [141]
    17 [142]
    13 [143]
    Units: Micromoles per liter
    arithmetic mean (standard deviation)
        Total bilirubin; Week 18; n=38, 34, 13, 12
    0.5 ± 5.01
    1.7 ± 5.32
    -1.4 ± 11.37
    0.6 ± 6.49
        Total bilirubin; Week 24; n=35, 33, 12, 11
    -0.1 ± 5.73
    1 ± 4.08
    -1.3 ± 11.9
    1.3 ± 6.26
        Total bilirubin; Week 30; n=13, 10, 3, 2
    -0.2 ± 5.99
    0.8 ± 4.76
    -2.3 ± 9.29
    -4 ± 5.66
        Total bilirubin; Week 36; n=10, 7, 2, 2
    0 ± 4.29
    1.9 ± 4.95
    -3 ± 11.31
    -3 ± 7.07
        Total bilirubin; Week 42; n=9, 6, 1, 2
    0.1 ± 5.11
    1.5 ± 5.79
    -14 ± 99999
    -4 ± 5.66
        Total bilirubin; Week 48; n=6, 6, 0, 2
    -0.7 ± 4.72
    3.5 ± 7.2
    99999 ± 99999
    -4 ± 2.83
        Total bilirubin PT Week 4; n=33, 34, 11, 11
    -4.6 ± 3.57
    -2.4 ± 3.3
    -0.4 ± 5.68
    -2.2 ± 2.71
        Creatinine; Week 18; n=38, 34, 13, 12
    -2.24 ± 9.186
    -1.97 ± 9.65
    -1.75 ± 9.874
    0.09 ± 10.668
        Creatinine; Week 24; n=35, 33, 12, 11
    -1.55 ± 9.507
    -2.4 ± 8.413
    -3.12 ± 9.408
    1.31 ± 10.377
        Creatinine; Week 30; n=13, 10, 3, 2
    0.66 ± 4.603
    2.82 ± 8.123
    -8.47 ± 8.693
    -8.85 ± 3.748
        Creatinine; Week 36; n=10, 7, 2, 2
    2.33 ± 11.096
    2.99 ± 8.179
    -5.5 ± 16.829
    -8 ± 1.273
        Creatinine; Week 42; n=9, 6, 1, 2
    1.23 ± 10.32
    4.97 ± 11.697
    -14.3 ± 99999
    -7.55 ± 5.586
        Creatinine; Week 48; n=6, 6, 0, 2
    -2.35 ± 4.222
    10.07 ± 17.173
    99999 ± 99999
    -7.1 ± 1.273
        Creatinine; PT Week 4; n=33, 34, 11, 11
    1.23 ± 8.22
    -0.34 ± 7.624
    -1.7 ± 6.897
    -1.25 ± 6.228
    Notes
    [140] - Safety Population
    [141] - Safety Population
    [142] - Safety Population
    [143] - Safety Population
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in systolic blood pressure and diastolic blood pressure at the indicated time points after Week 12

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    End point title
    Mean change from Baseline in systolic blood pressure and diastolic blood pressure at the indicated time points after Week 12
    End point description
    Blood pressure measurements were taken to observe vital signs and included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. As defined in the Reporting Analysis Plan (RAP) for this protocol, the supplemental final data package generated for this study after Week 12 only provided graphical displays of vital signs (e.g., change from baseline for heart rate and blood pressure) to facilitate clinical interpretation and data summarization. All abnormal values were also provided in separate by-subject data listings. Therefore, no statistical summary table is available after week 12.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    0 [144]
    0 [145]
    0 [146]
    0 [147]
    Units: Millimeters of mercury (mmHg)
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [144] - Safety Population
    [145] - Safety Population
    [146] - Safety Population
    [147] - Safety Population
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in heart rate at the indicated time points after Week 12

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    End point title
    Mean change from Baseline in heart rate at the indicated time points after Week 12
    End point description
    Vital sign monitoring included heart rate, measured at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. As defined in the Reporting Analysis Plan (RAP) for this protocol, the supplemental final data package generated for this study after Week 12 only provided graphical displays of vital signs (e.g., change from Baseline for heart rate and blood pressure) to facilitate clinical interpretation and data summarization. All abnormal values were also provided in separate by-subject data listings. Therefore, no statistical summary table is available after week 12.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    0 [148]
    0 [149]
    0 [150]
    0 [151]
    Units: Beats per minute
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [148] - Safety Population
    [149] - Safety Population
    [150] - Safety Population
    [151] - Safety Population
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in ECG heart rate values at the indicated time points after Week 12

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    End point title
    Mean change from Baseline in ECG heart rate values at the indicated time points after Week 12
    End point description
    The electrocardiographic (ECG) data was only collected “Perform as needed”, therefore, no such summary table was generated.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    0 [152]
    0 [153]
    0 [154]
    0 [155]
    Units: Beats per minute
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [152] - Safety Population
    [153] - Safety Population
    [154] - Safety Population
    [155] - Safety Population
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in PR interval, QRS duration, uncorrected QT interval, QTcB, QTcF values at the indicated time points after Week 12

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    End point title
    Mean change from Baseline in PR interval, QRS duration, uncorrected QT interval, QTcB, QTcF values at the indicated time points after Week 12
    End point description
    The electrocardiographic (ECG) data was only collected “Perform as needed”, therefore, no such summary table was generated.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    0 [156]
    0 [157]
    0 [158]
    0 [159]
    Units: Milliseconds
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [156] - Safety Population
    [157] - Safety Population
    [158] - Safety Population
    [159] - Safety Population
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/Bun at the indicated time points after Week 12

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    End point title
    Mean change from Baseline in chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/Bun at the indicated time points after Week 12
    End point description
    Blood samples were collected for the measurement of Chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/bun at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Bun values are summarized for each post-Baseline assessment after Week 12. . Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. System value of 99999 indicates NA (too few participants).
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [160]
    40 [161]
    17 [162]
    13 [163]
    Units: Millimoles per liter
    arithmetic mean (standard deviation)
        Chloride; Week 18; n=38, 34, 13, 12
    1.9 ± 2.75
    1 ± 2.5
    1.8 ± 2.41
    0.5 ± 2.94
        Chloride; Week 24; n=35, 33, 12, 11
    2 ± 2.33
    0.7 ± 2.73
    2.9 ± 2.81
    -0.2 ± 3.52
        Chloride; Week 30; n=13, 10, 3, 2
    1.9 ± 2.72
    0.3 ± 2.87
    5.3 ± 3.21
    3 ± 0
        Chloride; Week 36; n=10, 7, 2, 2
    1.3 ± 2.11
    -0.1 ± 2.54
    4.5 ± 6.36
    1 ± 0
        Chloride; Week 42; n=9, 6, 1, 2
    1.3 ± 2.78
    0 ± 2
    10 ± 99999
    0.5 ± 0.71
        Chloride; Week 48; n=6, 6, 0, 2
    1.3 ± 2.34
    -1 ± 3.16
    99999 ± 99999
    0 ± 0
        Chloride; PT Week 4; n=33, 34, 11, 11
    0.5 ± 2.69
    0.2 ± 2.54
    0.6 ± 2.29
    -1.5 ± 2.25
        Bicarbonate; Week 18; n=38, 34, 13, 12
    -0.3 ± 2.18
    -1 ± 2.16
    -1.2 ± 2.27
    0 ± 2.95
        Bicarbonate; Week 24; n=35, 33, 12, 11
    -1 ± 2.41
    -1.2 ± 2.21
    -1.8 ± 2.41
    -0.4 ± 3.35
        Bicarbonate; Week 30; n=13, 10, 3, 2
    0.4 ± 2.33
    -2.2 ± 4.02
    -1.3 ± 1.53
    -2 ± 2.83
        Bicarbonate; Week 36; n=10, 7, 2, 2
    -0.9 ± 2.92
    0.1 ± 1.86
    -2.5 ± 2.12
    -1.5 ± 2.12
        Bicarbonate; Week 42; n=9, 6, 1, 2
    -0.7 ± 1.73
    -0.2 ± 2.04
    -4 ± 99999
    -1 ± 2.83
        Bicarbonate; Week 48; n=6, 6, 0, 2
    -1 ± 1.67
    -1.3 ± 2.66
    99999 ± 99999
    -0.5 ± 3.54
        Bicarbonate; PT Week 4; n=33, 34, 11, 11
    -0.7 ± 2.1
    -0.5 ± 2.46
    -0.9 ± 2.43
    1 ± 3.07
        Glucose; Week 18; n=38, 34, 13, 12
    -0.28 ± 1.326
    -0.13 ± 1.188
    -0.06 ± 0.702
    -0.23 ± 2.134
        Glucose; Week 24; n=35, 33, 12, 11
    -0.33 ± 1.552
    0.27 ± 2.986
    -0.23 ± 0.672
    -0.22 ± 1.349
        Glucose; Week 30; n=13, 10, 3, 2
    0.03 ± 1.383
    -0.26 ± 0.587
    -0.13 ± 0.252
    0.9 ± 0.707
        Glucose; Week 36; n=10, 7, 2, 2
    -0.38 ± 0.758
    -0.37 ± 1.09
    -0.1 ± 0.99
    -0.7 ± 0.283
        Glucose; Week 42; n=9, 6, 1, 2
    -0.28 ± 1.663
    -0.12 ± 0.794
    0.4 ± 99999
    -0.15 ± 0.919
        Glucose; Week 48; n=6, 6, 0, 2
    0.25 ± 1.358
    -0.3 ± 0.867
    99999 ± 99999
    4.55 ± 4.596
        Glucose; PT Week 4; n=33, 34, 11, 11
    0.24 ± 3.122
    0.18 ± 0.684
    -0.12 ± 0.735
    -0.07 ± 1.234
        Potassium; Week 18; n=38, 34, 13, 12
    -0.19 ± 0.399
    -0.24 ± 0.376
    -0.41 ± 0.236
    -0.2 ± 0.424
        Potassium; Week 24; n=35, 33, 12, 11
    -0.13 ± 0.452
    -0.12 ± 0.459
    -0.34 ± 0.403
    -0.32 ± 0.494
        Potassium; Week 30; n=13, 10, 3, 2
    -0.03 ± 0.48
    -0.23 ± 0.377
    -0.1 ± 0.2
    -0.1 ± 0.424
        Potassium; Week 36; n=10, 7, 2, 2
    0.24 ± 0.599
    -0.1 ± 0.365
    0.15 ± 0.071
    0.2 ± 0.424
        Potassium; Week 42; n=9, 6, 1, 2
    -0.1 ± 0.555
    -0.2 ± 0.415
    -0.1 ± 99999
    0.1 ± 0.566
        Potassium; Week 48; n=6, 6, 0, 2
    0.1 ± 0.566
    -0.3 ± 0.322
    99999 ± 99999
    0.05 ± 0.495
        Potassium; PT Week 4; n=33, 34, 11, 11
    -0.16 ± 0.382
    -0.13 ± 0.398
    -0.25 ± 0.532
    -0.1 ± 0.316
        Sodium; Week 18; n=38, 34, 13, 12
    0.7 ± 2.04
    0.1 ± 2.27
    0.7 ± 2.32
    0.4 ± 3.37
        Sodium; Week 24; n=35, 33, 12, 11
    0.4 ± 1.86
    -0.1 ± 2.61
    1.5 ± 2.24
    0.4 ± 3.53
        Sodium; Week 30; n=13, 10, 3, 2
    1.1 ± 3.25
    -1.4 ± 2.72
    1.3 ± 1.53
    0 ± 1.41
        Sodium; Week 36; n=10, 7, 2, 2
    0.4 ± 2.67
    -0.7 ± 1.98
    2 ± 2.83
    -0.5 ± 0.71
        Sodium; Week 42; n=9, 6, 1, 2
    0.4 ± 2.07
    -0.5 ± 1.38
    3 ± 99999
    -1.5 ± 0.71
        Sodium; Week 48; n=6, 6, 0, 2
    -0.2 ± 2.14
    -1.2 ± 2.79
    99999 ± 99999
    -2.5 ± 3.54
        Sodium; PT Week 4; n=33, 34, 11, 11
    -0.1 ± 2.3
    0.1 ± 2.45
    1.1 ± 2.47
    -0.5 ± 2.7
        Inorganic phosphorus; Week 18; n=38, 34, 13, 12
    -0.161 ± 0.1971
    -0.13 ± 0.1928
    -0.092 ± 0.1537
    -0.111 ± 0.2648
        Inorganic phosphorus; Week 24; n=35, 33, 12, 11
    -0.139 ± 0.2268
    -0.13 ± 0.2354
    -0.119 ± 0.1991
    -0.107 ± 0.2205
        Inorganic phosphorus; Week 30; n=13, 10, 3, 2
    -0.156 ± 0.1644
    -0.118 ± 0.2071
    -0.267 ± 0.2023
    -0.225 ± 0.1768
        Inorganic phosphorus; Week 36; n=10, 7, 2, 2
    -0.121 ± 0.2564
    -0.167 ± 0.1906
    -0.195 ± 0.0495
    -0.125 ± 0.2475
        Inorganic phosphorus; Week 42; n=9, 6, 1, 2
    -0.08 ± 0.2248
    -0.108 ± 0.0794
    -0.15 ± 99999
    -0.1 ± 0.3536
        Inorganic phosphorus; Week 48; n=6, 6, 0, 2
    -0.167 ± 0.1715
    -0.108 ± 0.1665
    99999 ± 99999
    -0.35 ± 0.0707
        Inorganic phosphorus; PT Week 4; n=33, 34, 11, 11
    -0.084 ± 0.2375
    -0.003 ± 0.2162
    0.009 ± 0.0798
    -0.085 ± 0.2247
        Urea/BUN; Week 18; n=38, 34, 13, 12
    -0.19 ± 1.166
    -0.23 ± 1.403
    -0.49 ± 1.233
    -0.25 ± 1.688
        Urea/BUN; Week 24; n=35, 33, 12, 11
    -0.22 ± 1.263
    -0.55 ± 1.252
    -0.43 ± 1.106
    0.02 ± 2.007
        Urea/BUN; Week 30; n=13, 10, 3, 2
    0.69 ± 1.107
    -0.16 ± 1.027
    -0.5 ± 1.082
    -0.5 ± 0
        Urea/BUN; Week 36; n=10, 7, 2, 2
    0.65 ± 1.775
    0.04 ± 1.172
    -0.15 ± 0.636
    -0.25 ± 1.061
        Urea/BUN; Week 42; n=9, 6, 1, 2
    0.34 ± 1.65
    0.5 ± 1.239
    0.5 ± 99999
    -0.5 ± 1.414
        Urea/BUN; Week 48; n=6, 6, 0, 2
    0.67 ± 1.353
    0.4 ± 1.607
    99999 ± 99999
    -0.5 ± 0.707
        Urea/BUN; PT Week 4; n=33, 34, 11, 11
    0.35 ± 1.284
    -0.19 ± 1.311
    -0.62 ± 1.012
    -0.47 ± 0.969
    Notes
    [160] - Safety Population
    [161] - Safety Population
    [162] - Safety Population
    [163] - Safety Population
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in creatinine clearance at the indicated time points after Week 12

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    End point title
    Mean change from Baseline in creatinine clearance at the indicated time points after Week 12
    End point description
    Blood samples were collected for the measurement of estimated creatinine clearance by Cockcroft-Gault formula at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the estimated creatinine clearance values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. The mean and standard deviation could not be determined (not reached) because too few participants experienced the event (system value of 99999 indicates NA for the mean and the standard deviation).
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Number of subjects analysed
    41 [164]
    40 [165]
    17 [166]
    13 [167]
    Units: mL/min
    arithmetic mean (standard deviation)
        Creatinine clearance; Week 18; n=38, 34, 13, 12
    -0.1 ± 17.36
    -1.1 ± 20.69
    -2.5 ± 16.25
    -4.3 ± 19.37
        Creatinine clearance; Week 24; n=35, 33, 12, 11
    -1.9 ± 16.77
    -1 ± 18.53
    -4.1 ± 15.11
    -6.1 ± 19.05
        Creatinine clearance; Week 30; n=13, 10, 3, 2
    -4.8 ± 13.91
    -10.4 ± 14.41
    -3.7 ± 13.58
    7 ± 0
        Creatinine clearance; Week 36; n=10, 7, 2, 2
    -11 ± 23.3
    -8.1 ± 13.28
    -1 ± 29.7
    1.5 ± 9.19
        Creatinine clearance; Week 42; n=9, 6, 1, 2
    -6.1 ± 16.86
    -13.3 ± 16.13
    9 ± 99999
    -1.5 ± 0.71
        Creatinine clearance; Week 48; n=6, 6, 0, 2
    3.2 ± 10.23
    -15.8 ± 16.18
    99999 ± 99999
    -4 ± 11.31
        Creatinine clearance; PT Week 4; n=33, 34, 11, 11
    -1.5 ± 34.53
    -1.3 ± 23.85
    -2.7 ± 11.38
    -5.3 ± 13.95
    Notes
    [164] - Safety Population
    [165] - Safety Population
    [166] - Safety Population
    [167] - Safety Population
    No statistical analyses for this end point

    Secondary: Correlation of individual GSK2336805 dose with Week 4 Plasma AUC(0-tau) versus eRVR Status

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    End point title
    Correlation of individual GSK2336805 dose with Week 4 Plasma AUC(0-tau) versus eRVR Status [168]
    End point description
    Correlation of individual GSK2336805 40 mg and 60 mg with Week 4 plasma AUC(0-tau) versus eRVR Status (eRVR and no eRVE) was performed. eRVR is defined as plasma HCV RNA <LLOQ and target not detected at Weeks 4 and 12. AUC (0-tau) is area under the concentration-time curve over the dosing interval. As defined in the Reporting Analysis Plan (RAP) for this protocol, correlations between GSK2336805 dose, and selected pharmacokinetic parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-subject data listings. Therefore, no statistical summary tables are available.
    End point type
    Secondary
    End point timeframe
    Week 4 and Week 12
    Notes
    [168] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
    Number of subjects analysed
    0 [169]
    0 [170]
    Units: hr*ng/mL
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [169] - Intensive PK Population
    [170] - Intensive PK Population
    No statistical analyses for this end point

    Secondary: Correlation of Individual GSK2336805 dose with Week 4 Plasma Cmax, Ctau, C0 versus eRVR status

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    End point title
    Correlation of Individual GSK2336805 dose with Week 4 Plasma Cmax, Ctau, C0 versus eRVR status [171]
    End point description
    Correlation of Individual GSK2336805 40 mg and 60 mg dose with Week 4 maximum plasma concentration (Cmax), pre-dose concentration (C0), concentration at the end of the dosing interval (Ctau) versus eRVR status (eRVR and no eRVR) was performed. eRVR is defined as plasma HCV RNA <LLOQ and target not detected at Weeks 4 and 12. As defined in the Reporting Analysis Plan (RAP) for this protocol, correlations between GSK2336805 dose, and selected pharmacokinetic parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-subject data listings. Therefore, no statistical summary tables are available.
    End point type
    Secondary
    End point timeframe
    Week 4 and Week 12
    Notes
    [171] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
    Number of subjects analysed
    0 [172]
    0 [173]
    Units: ng/mL
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [172] - Intensive PK Population
    [173] - Intensive PK Population
    No statistical analyses for this end point

    Secondary: Correlation of individual GSK2336805 dose with Week 4 Plasma AUC(0-tau) versus RVR Status

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    End point title
    Correlation of individual GSK2336805 dose with Week 4 Plasma AUC(0-tau) versus RVR Status [174]
    End point description
    Correlation of individual GSK2336805 40 mg and 60 mg with Week 4 plasma AUC(0-tau) versus eRVR Status (RVR and no eVE) was performed. RVR is defined as plasma HCV RNA <LLOQ and target not detected 4 weeks after initiation of therapy. AUC (0-tau) is area under the concentration-time curve over the dosing interval. As defined in the Reporting Analysis Plan (RAP) for this protocol, correlations between GSK2336805 dose, and selected pharmacokinetic parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-subject data listings. Therefore, no statistical summary tables are available..
    End point type
    Secondary
    End point timeframe
    Week 4
    Notes
    [174] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
    Number of subjects analysed
    0 [175]
    0 [176]
    Units: hr*ng/mL
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [175] - Intensive PK Population
    [176] - Intensive PK Population
    No statistical analyses for this end point

    Secondary: Correlation of Individual GSK2336805 dose with Week 4 Plasma Cmax, Ctau, C0 versus RVR status

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    End point title
    Correlation of Individual GSK2336805 dose with Week 4 Plasma Cmax, Ctau, C0 versus RVR status [177]
    End point description
    Correlation of Individual GSK2336805 40 mg and 60 mg dose with Week 4 maximum plasma concentration (Cmax), pre-dose concentration (C0), concentration at the end of the dosing interval (Ctau) versus RVR status (RVR and no RVR) was performed. RVR is defined as plasma HCV RNA <LLOQ and target not detected 4 weeks after initiation of therapy. As defined in the Reporting Analysis Plan (RAP) for this protocol, correlations between GSK2336805 dose, and selected pharmacokinetic parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-subject data listings. Therefore, no statistical summary tables are available.
    End point type
    Secondary
    End point timeframe
    Week 4
    Notes
    [177] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
    Number of subjects analysed
    0 [178]
    0 [179]
    Units: ng/mL
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [178] - Intensive PK Population
    [179] - Intensive PK Population
    No statistical analyses for this end point

    Secondary: Correlation of Individual GSK2336805 dose with pre-dose plasma concentration at Week 4 and Week 12 versus eRVR status

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    End point title
    Correlation of Individual GSK2336805 dose with pre-dose plasma concentration at Week 4 and Week 12 versus eRVR status [180]
    End point description
    Correlation of individual GSK2336805 dose with pre-dose plasma concentration at Week 4 and Week 12 versus eRVR status was performed. eRVR is defined as plasma HCV RNA <LLOQ and target not detected at Weeks 4 and 12. The PK/Pharmacodynamic (PD) analysis population comprised of all participants with available PD measures (e.g., safety and/or efficacy data) and with evaluable GSK2336805 plasma concentration data considered suitable for investigation of relationship with the PD measures. As defined in the Reporting Analysis Plan (RAP) for this protocol, correlations between GSK2336805 dose, and selected pharmacokinetic parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-subject data listings. Therefore, no statistical summary tables are available.
    End point type
    Secondary
    End point timeframe
    Week 4 and Week 12
    Notes
    [180] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
    Number of subjects analysed
    0 [181]
    0 [182]
    Units: ng/mL
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [181] - PK/PD Analysis Population
    [182] - PK/PD Analysis Population
    No statistical analyses for this end point

    Secondary: Correlation GSK2336805 pre-dose plasma concentration on Day 2 versus reduction in HCV RNA on Day 2

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    End point title
    Correlation GSK2336805 pre-dose plasma concentration on Day 2 versus reduction in HCV RNA on Day 2 [183]
    End point description
    Correlation GSK2336805 pre-dose plasma concentration (ng/mL) on Day 2 versus reduction in HCV RNA (log IU/mL) on Day 2 was performed. As defined in the Reporting Analysis Plan (RAP) for this protocol, correlations between GSK2336805 dose, and selected pharmacokinetic parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-subject data listings. Therefore, no statistical summary tables are available.
    End point type
    Secondary
    End point timeframe
    Day 2
    Notes
    [183] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis is not applicable for this Outcome Measure.
    End point values
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV
    Number of subjects analysed
    0 [184]
    0 [185]
    Units: ng/mL
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [184] - PK/PD Analysis Population
    [185] - PK/PD Analysis Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment until the follow-up contact (up to 20 study weeks).
    Adverse event reporting additional description
    SAEs and non-SAEs were collected in participants of the ATS Population, comprised of all participants who had received at least one dose of study medication (GSK2336805 or telaprevir).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    GSK2336805 40 mg, Genotype 1 HCV
    Reporting group description
    Participants with chronic G1 HCV infection received GSK2336805 40 milligrams (mg) orally (20 mg x 2 tablets) once daily (OD) in the morning with food in combination with antiviral therapy (Pegylated Interferon Alfa-2a [PEG] + Ribavirin [RIBA]) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the extended rapid virologic response (eRVR) achievement. PEG dose was 180 micrograms (µg) once weekly subcutaneous (SC) injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kilogram [kg]) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken in 2 divided doses with food.

    Reporting group title
    GSK2336805 60 mg, Genotype 1 HCV
    Reporting group description
    Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2 divided doses with food.

    Reporting group title
    Telaprevir, Genotype 1 HCV
    Reporting group description
    Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2 divided doses with food.

    Reporting group title
    GSK2336805 60 mg, Genotype 4 HCV
    Reporting group description
    Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2 divided doses with food.

    Serious adverse events
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 41 (4.88%)
    2 / 40 (5.00%)
    3 / 17 (17.65%)
    1 / 13 (7.69%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    0 / 17 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Haemorrhoids
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 40 (2.50%)
    0 / 17 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    1 / 17 (5.88%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    1 / 17 (5.88%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 40 (2.50%)
    0 / 17 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    1 / 17 (5.88%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 40 (2.50%)
    0 / 17 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injection site abscess
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 40 (2.50%)
    0 / 17 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis externa
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    0 / 17 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    GSK2336805 40 mg, Genotype 1 HCV GSK2336805 60 mg, Genotype 1 HCV Telaprevir, Genotype 1 HCV GSK2336805 60 mg, Genotype 4 HCV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    41 / 41 (100.00%)
    38 / 40 (95.00%)
    17 / 17 (100.00%)
    13 / 13 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 41 (7.32%)
    1 / 40 (2.50%)
    0 / 17 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    3
    1
    0
    0
    Hypotension
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    5 / 41 (12.20%)
    1 / 40 (2.50%)
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    7
    1
    0
    2
    Chills
         subjects affected / exposed
    5 / 41 (12.20%)
    0 / 40 (0.00%)
    1 / 17 (5.88%)
    1 / 13 (7.69%)
         occurrences all number
    5
    0
    1
    1
    Drug withdrawal syndrome
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    1 / 17 (5.88%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fatigue
         subjects affected / exposed
    9 / 41 (21.95%)
    12 / 40 (30.00%)
    7 / 17 (41.18%)
    4 / 13 (30.77%)
         occurrences all number
    9
    13
    8
    4
    Feeling hot
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Influenza like illness
         subjects affected / exposed
    8 / 41 (19.51%)
    9 / 40 (22.50%)
    3 / 17 (17.65%)
    8 / 13 (61.54%)
         occurrences all number
    16
    10
    3
    8
    Injection site bruising
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    1 / 17 (5.88%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    1
    Injection site erythema
         subjects affected / exposed
    6 / 41 (14.63%)
    3 / 40 (7.50%)
    1 / 17 (5.88%)
    0 / 13 (0.00%)
         occurrences all number
    7
    5
    2
    0
    Injection site pain
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    1
    Injection site pruritus
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 40 (5.00%)
    0 / 17 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Injection site reaction
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Injury associated with device
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Irritability
         subjects affected / exposed
    4 / 41 (9.76%)
    0 / 40 (0.00%)
    0 / 17 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    5
    0
    0
    2
    Mucosal dryness
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    1 / 17 (5.88%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pain
         subjects affected / exposed
    4 / 41 (9.76%)
    0 / 40 (0.00%)
    2 / 17 (11.76%)
    0 / 13 (0.00%)
         occurrences all number
    4
    0
    2
    0
    Pyrexia
         subjects affected / exposed
    11 / 41 (26.83%)
    8 / 40 (20.00%)
    5 / 17 (29.41%)
    2 / 13 (15.38%)
         occurrences all number
    17
    16
    7
    2
    Temperature intolerance
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    1 / 17 (5.88%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    5 / 41 (12.20%)
    3 / 40 (7.50%)
    1 / 17 (5.88%)
    1 / 13 (7.69%)
         occurrences all number
    6
    3
    1
    2
    Depressed mood
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Depression
         subjects affected / exposed
    4 / 41 (9.76%)
    3 / 40 (7.50%)
    1 / 17 (5.88%)
    0 / 13 (0.00%)
         occurrences all number
    4
    3
    1
    0
    Insomnia
         subjects affected / exposed
    7 / 41 (17.07%)
    8 / 40 (20.00%)
    0 / 17 (0.00%)
    3 / 13 (23.08%)
         occurrences all number
    7
    9
    0
    3
    Libido decreased
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Mood swings
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 40 (2.50%)
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    0
    1
    Nervousness
         subjects affected / exposed
    3 / 41 (7.32%)
    1 / 40 (2.50%)
    0 / 17 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    3
    1
    0
    0
    Nightmare
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    1 / 17 (5.88%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Panic attack
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 40 (2.50%)
    1 / 17 (5.88%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 40 (2.50%)
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    0
    1
    Injury, poisoning and procedural complications
    Gingival injury
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Laceration
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    1 / 17 (5.88%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Post procedural complication
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Procedural pain
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    2
    0
    0
    1
    Road traffic accident
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    1 / 17 (5.88%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Investigations
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    1 / 17 (5.88%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Body temperature increased
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    1 / 17 (5.88%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    International normalised ratio decreased
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    1 / 17 (5.88%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Weight decreased
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 40 (5.00%)
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    2
    0
    1
    White blood cell count increased
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    1 / 17 (5.88%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Tachycardia
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 41 (12.20%)
    3 / 40 (7.50%)
    2 / 17 (11.76%)
    2 / 13 (15.38%)
         occurrences all number
    5
    3
    3
    2
    Dyspnoea
         subjects affected / exposed
    1 / 41 (2.44%)
    3 / 40 (7.50%)
    1 / 17 (5.88%)
    1 / 13 (7.69%)
         occurrences all number
    1
    3
    1
    2
    Dyspnoea exertional
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    1
    Epistaxis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 40 (2.50%)
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    0
    2
    Oropharyngeal pain
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 40 (5.00%)
    0 / 17 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    2
    0
    1
    Wheezing
         subjects affected / exposed
    2 / 41 (4.88%)
    2 / 40 (5.00%)
    0 / 17 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Blood and lymphatic system disorders