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    Clinical Trial Results:
    A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects

    Summary
    EudraCT number
    		 2012-004154-28
    Trial protocol
    		 GB   DE   IT   ES  
    Global end of trial date
    10 Jul 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Mar 2016
    First version publication date
    06 Aug 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-334-0124
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01783678
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
    Scientific contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Jul 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV infection who are co-infected with HIV-1.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jan 2013
    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
    Spain: 57
    Country: Number of subjects enrolled
    United Kingdom: 47
    Country: Number of subjects enrolled
    Germany: 48
    Country: Number of subjects enrolled
    Italy: 49
    Country: Number of subjects enrolled
    Australia: 38
    Country: Number of subjects enrolled
    France: 36
    Worldwide total number of subjects
    275
    EEA total number of subjects
    237
    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)
    269
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at a total of 39 study sites in Australia and Europe. The first participant was screened on 18 January 2013. The last study visit occurred on 10 July 2014.

    Pre-assignment
    Screening details
    		 346 participants were screened.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Genotype 2 Treatment-naive
    Arm description
    		 Sofosbuvir (SOF) + ribavirin (RBV) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    Sovaldi®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg tablet administered orally once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

    Arm title
    		 Genotype 1 Treatment-naive
    Arm description
    		 SOF + RBV for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    Sovaldi®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg tablet administered orally once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

    Arm title
    		 Genotype 2 Treatment-experienced
    Arm description
    		 SOF + RBV for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    Sovaldi®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg tablet administered orally once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

    Arm title
    		 Genotype 3 Treatment-naive
    Arm description
    		 SOF + RBV for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    Sovaldi®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg tablet administered orally once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

    Arm title
    		 Genotype 3 Treatment-experienced
    Arm description
    		 SOF + RBV for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    Sovaldi®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg tablet administered orally once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

    Arm title
    		 Genotype 4 Treatment-naive
    Arm description
    		 SOF + RBV for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    Sovaldi®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg tablet administered orally once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

    Number of subjects in period 1 [1]
    		Genotype 2 Treatment-naive Genotype 1 Treatment-naive Genotype 2 Treatment-experienced Genotype 3 Treatment-naive Genotype 3 Treatment-experienced Genotype 4 Treatment-naive
    Started
    19
    112
    6
    57
    49
    31
    Completed
    17
    94
    5
    50
    42
    26
    Not completed
    2
    18
    1
    7
    7
    5
         Withdrew Consent
    1
    1
    -
    2
    -
    -
         Lost to follow-up
    -
    4
    -
    2
    1
    -
         Lack of efficacy
    1
    13
    1
    3
    6
    5
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: One participant who was enrolled but not treated is not included in the subject disposition table.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Genotype 2 Treatment-naive
    Reporting group description
    		 Sofosbuvir (SOF) + ribavirin (RBV) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection

    Reporting group title
    Genotype 1 Treatment-naive
    Reporting group description
    		 SOF + RBV for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection

    Reporting group title
    Genotype 2 Treatment-experienced
    Reporting group description
    		 SOF + RBV for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection

    Reporting group title
    Genotype 3 Treatment-naive
    Reporting group description
    		 SOF + RBV for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection

    Reporting group title
    Genotype 3 Treatment-experienced
    Reporting group description
    		 SOF + RBV for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection

    Reporting group title
    Genotype 4 Treatment-naive
    Reporting group description
    		 SOF + RBV for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection

    Reporting group values
    		 Genotype 2 Treatment-naive Genotype 1 Treatment-naive Genotype 2 Treatment-experienced Genotype 3 Treatment-naive Genotype 3 Treatment-experienced Genotype 4 Treatment-naive Total
    Number of subjects
    		 19 112 6 57 49 31 274
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55 ( 8.2 ) 45 ( 7.6 ) 55 ( 10.2 ) 47 ( 5.4 ) 49 ( 6.2 ) 47 ( 5.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 12 0 19 11 7 53
        Male
    		 15 100 6 38 38 24 221
    Race
    Units: Subjects
        Black or African American
    		 0 1 1 0 0 1 3
        White
    		 18 104 5 54 49 29 259
        Asian
    		 0 5 0 2 0 0 7
        American Indian/Alaska Native/ First Nations
    		 1 0 0 0 0 0 1
        Other
    		 0 1 0 1 0 0 2
        Not Permitted
    		 0 1 0 0 0 1 2
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 3 4 0 3 5 1 16
        Not Hispanic or Latino
    		 16 106 6 54 44 29 255
        Not Permitted
    		 0 2 0 0 0 1 3
    Cirrhosis Status
    Units: Subjects
        No
    		 18 95 4 54 26 23 220
        Yes
    		 1 17 2 3 23 8 54
    IB28b Status
    CC, CT, and TT alleles are different forms of the IL28b gene.
    Units: Subjects
        CC
    		 12 48 3 30 25 9 127
        CT
    		 5 45 1 21 20 14 106
        TT
    		 2 18 2 6 4 8 40
        Missing
    		 0 1 0 0 0 0 1
    Hepatitis C Virus (HCV) RNA
    Units: Subjects
        < 6 log10 IU/mL
    		 2 33 1 21 12 12 81
        ≥ 6 log10 IU/mL
    		 17 79 5 36 37 19 193

    End points

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    End points reporting groups
    Reporting group title
    Genotype 2 Treatment-naive
    Reporting group description
    		 Sofosbuvir (SOF) + ribavirin (RBV) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection

    Reporting group title
    Genotype 1 Treatment-naive
    Reporting group description
    		 SOF + RBV for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection

    Reporting group title
    Genotype 2 Treatment-experienced
    Reporting group description
    		 SOF + RBV for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection

    Reporting group title
    Genotype 3 Treatment-naive
    Reporting group description
    		 SOF + RBV for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection

    Reporting group title
    Genotype 3 Treatment-experienced
    Reporting group description
    		 SOF + RBV for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection

    Reporting group title
    Genotype 4 Treatment-naive
    Reporting group description
    		 SOF + RBV for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection

    Subject analysis set title
    Genotype 1a Treatment-naive
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)

    Subject analysis set title
    Genotype 1b Treatment-naive
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)

    Subject analysis set title
    Genotype 2 Treatment-naive
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    SOF + RBV for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection

    Subject analysis set title
    Genotype 2/3 Treatment-experienced
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    SOF + RBVfor 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 or 3 HCV coinfection

    Subject analysis set title
    Genotype 1/3/4 Treatment-naive
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    SOF + RBVfor 24 weeks in treatment-naive participants with HIV-1 and genotype 1, 3, or 4 HCV coinfection

    Primary: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)

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    End point title
    		 Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) [1]
    End point description
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks following the last dose of study drug.
    End point type
    Primary
    End point timeframe
    Posttreatment 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: No intergroup analysis or analysis against a historic rate was planned or performed.
    End point values
    		 Genotype 2 Treatment-naive Genotype 1 Treatment-naive Genotype 2 Treatment-experienced Genotype 3 Treatment-naive Genotype 3 Treatment-experienced Genotype 4 Treatment-naive Genotype 1a Treatment-naive Genotype 1b Treatment-naive
    Number of subjects analysed
    19
    112
    6
    57
    49
    31
    100
    11
    Units: percentage of participants
        number (not applicable)
    89.5
    84.8
    83.3
    91.2
    85.7
    83.9
    84
    90.9
    No statistical analyses for this end point

    Primary: Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

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    End point title
    		 Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) [2]
    End point description
    The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.
    End point type
    Primary
    End point timeframe
    Up to 24 weeks
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned or performed.
    End point values
    		 Genotype 2 Treatment-naive Genotype 2/3 Treatment-experienced Genotype 1/3/4 Treatment-naive
    Number of subjects analysed
    19
    55
    200
    Units: percentage of participants
        number (not applicable)
    0
    1.8
    3.5
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

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    End point title
    		 Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
    End point description
    SVR4 and SVR24 were defined as HCV RNA < the lower limit of quantitation (LLOQ) 4 weeks and 24 weeks following the last dose of study drug, respectively.
    End point type
    Secondary
    End point timeframe
    Posttreatment Weeks 4 and 24
    End point values
    		 Genotype 2 Treatment-naive Genotype 1 Treatment-naive Genotype 2 Treatment-experienced Genotype 3 Treatment-naive Genotype 3 Treatment-experienced Genotype 4 Treatment-naive Genotype 1a Treatment-naive Genotype 1b Treatment-naive
    Number of subjects analysed
    19
    112
    6
    57
    48
    31
    100
    11
    Units: percentage of participants
    number (not applicable)
        SVR4
    89.5
    87.5
    83.3
    91.2
    87.8
    90.3
    87.5
    90.9
        SVR24
    89.5
    83
    83.3
    91.2
    83.7
    80.6
    82
    90.9
    No statistical analyses for this end point

    Secondary: HCV RNA Change From Baseline at Week 1

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    End point title
    		 HCV RNA Change From Baseline at Week 1
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline; Week 1
    End point values
    		 Genotype 2 Treatment-naive Genotype 1 Treatment-naive Genotype 2 Treatment-experienced Genotype 3 Treatment-naive Genotype 3 Treatment-experienced Genotype 4 Treatment-naive Genotype 1a Treatment-naive Genotype 1b Treatment-naive
    Number of subjects analysed
    19
    112
    6
    54
    48
    31
    100
    11
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    -4.72 ( 0.573 )
    -4.54 ( 0.776 )
    -4.34 ( 0.575 )
    -4.41 ( 0.498 )
    -4.33 ( 0.667 )
    -4.21 ( 0.665 )
    -4.57 ( 0.777 )
    -4.35 ( 0.752 )
    No statistical analyses for this end point

    Secondary: HCV RNA Change From Baseline at Week 2

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    End point title
    		 HCV RNA Change From Baseline at Week 2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline; Week 2
    End point values
    		 Genotype 2 Treatment-naive Genotype 1 Treatment-naive Genotype 2 Treatment-experienced Genotype 3 Treatment-naive Genotype 3 Treatment-experienced Genotype 4 Treatment-naive Genotype 1a Treatment-naive Genotype 1b Treatment-naive
    Number of subjects analysed
    19
    111
    6
    55
    47
    30
    99
    11
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    -5.29 ( 0.681 )
    -4.92 ( 0.717 )
    -4.98 ( 0.633 )
    -4.86 ( 0.677 )
    -4.89 ( 0.776 )
    -4.52 ( 0.843 )
    -4.97 ( 0.674 )
    -4.55 ( 0.928 )
    No statistical analyses for this end point

    Secondary: HCV RNA Change From Baseline at Week 4

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    End point title
    		 HCV RNA Change From Baseline at Week 4
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline; Week 4
    End point values
    		 Genotype 2 Treatment-naive Genotype 1 Treatment-naive Genotype 2 Treatment-experienced Genotype 3 Treatment-naive Genotype 3 Treatment-experienced Genotype 4 Treatment-naive Genotype 1a Treatment-naive Genotype 1b Treatment-naive
    Number of subjects analysed
    19
    109
    6
    57
    49
    31
    97
    11
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    -5.33 ( 0.655 )
    -4.95 ( 0.72 )
    -5.05 ( 0.618 )
    -4.89 ( 0.708 )
    -4.84 ( 0.895 )
    -4.57 ( 0.846 )
    -5.01 ( 0.674 )
    -4.55 ( 0.928 )
    No statistical analyses for this end point

    Secondary: HCV RNA Change From Baseline at Week 6

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    End point title
    		 HCV RNA Change From Baseline at Week 6
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline; Week6
    End point values
    		 Genotype 2 Treatment-naive Genotype 1 Treatment-naive Genotype 2 Treatment-experienced Genotype 3 Treatment-naive Genotype 3 Treatment-experienced Genotype 4 Treatment-naive Genotype 1a Treatment-naive Genotype 1b Treatment-naive
    Number of subjects analysed
    19
    109
    6
    57
    49
    31
    97
    11
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    -5.33 ( 0.655 )
    -4.95 ( 0.718 )
    -5.05 ( 0.618 )
    -4.89 ( 0.71 )
    -4.91 ( 0.789 )
    -4.57 ( 0.846 )
    -5.01 ( 0.672 )
    -4.55 ( 0.928 )
    No statistical analyses for this end point

    Secondary: HCV RNA Change From Baseline at Week 8

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    End point title
    		 HCV RNA Change From Baseline at Week 8
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline; Week 8
    End point values
    		 Genotype 2 Treatment-naive Genotype 1 Treatment-naive Genotype 2 Treatment-experienced Genotype 3 Treatment-naive Genotype 3 Treatment-experienced Genotype 4 Treatment-naive Genotype 1a Treatment-naive Genotype 1b Treatment-naive
    Number of subjects analysed
    19
    109
    6
    56
    49
    31
    97
    11
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    -5.33 ( 0.655 )
    -4.95 ( 0.722 )
    -5.05 ( 6.618 )
    -4.88 ( 0.708 )
    -4.86 ( 0.876 )
    -4.57 ( 0.846 )
    -5.01 ( 0.676 )
    -4.55 ( 0.928 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing Virologic Failure

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    End point title
    		 Percentage of Participants Experiencing Virologic Failure
    End point description
    On-treatment virologic failure was defined as either: - Virologic breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or - Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or - Nonresponse (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment). Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period, having achieved HCV RNA < LLOQ at last on-treatment visit.
    End point type
    Secondary
    End point timeframe
    Baseline up to Posttreatment Week 24
    End point values
    		 Genotype 2 Treatment-naive Genotype 1 Treatment-naive Genotype 2 Treatment-experienced Genotype 3 Treatment-naive Genotype 3 Treatment-experienced Genotype 4 Treatment-naive Genotype 1a Treatment-naive Genotype 1b Treatment-naive
    Number of subjects analysed
    19
    112
    6
    57
    49
    31
    100
    11
    Units: percentage of participants
    number (not applicable)
        On-Treatment Virologic Failure
    0
    0
    0
    0
    2
    0
    0
    0
        Virologic Relapse
    5.3
    12.5
    16.7
    7
    12.5
    16.1
    13
    9.1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 24 weeks plus 30 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Genotype 2 Treatment-naive
    Reporting group description
    		 SOF + RBV for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection

    Reporting group title
    Genotype 2/3 Treatment-experienced
    Reporting group description
    		 SOF + RBV for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 or 3 HCV coinfection

    Reporting group title
    Genotype 1/3/4 Treatment-naive
    Reporting group description
    		 SOF + RBV for 24 weeks in treatmentnaive participants with HIV-1 and genotype 1, 3, or 4 HCV coinfection

    Serious adverse events
    		 Genotype 2 Treatment-naive Genotype 2/3 Treatment-experienced Genotype 1/3/4 Treatment-naive
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 19 (0.00%)
    5 / 55 (9.09%)
    10 / 200 (5.00%)
         number of deaths (all causes)
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatic cancer
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cardiac disorders
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 200 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    1 / 200 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 200 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 200 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 200 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Petechiae
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 200 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcoholism
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug Abuse
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 200 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mania
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 200 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 200 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 200 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rhabdomyolysis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 200 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Atypical pneumonia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 200 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 200 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 200 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Genotype 2 Treatment-naive Genotype 2/3 Treatment-experienced Genotype 1/3/4 Treatment-naive
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 19 (89.47%)
    47 / 55 (85.45%)
    181 / 200 (90.50%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Seborrhoeic keratosis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    0 / 200 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 19 (5.26%)
    11 / 55 (20.00%)
    32 / 200 (16.00%)
         occurrences all number
    1
    11
    36
    Fatigue
         subjects affected / exposed
    5 / 19 (26.32%)
    11 / 55 (20.00%)
    40 / 200 (20.00%)
         occurrences all number
    5
    12
    45
    Influenza like illness
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    4 / 200 (2.00%)
         occurrences all number
    1
    0
    4
    Malaise
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    2 / 200 (1.00%)
         occurrences all number
    1
    0
    2
    Pyrexia
         subjects affected / exposed
    0 / 19 (0.00%)
    3 / 55 (5.45%)
    5 / 200 (2.50%)
         occurrences all number
    0
    3
    5
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 19 (0.00%)
    6 / 55 (10.91%)
    17 / 200 (8.50%)
         occurrences all number
    0
    6
    17
    Dysphonia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    0 / 200 (0.00%)
         occurrences all number
    1
    0
    0
    Dyspnoea
         subjects affected / exposed
    2 / 19 (10.53%)
    8 / 55 (14.55%)
    10 / 200 (5.00%)
         occurrences all number
    2
    8
    10
    Dyspnoea exertional
         subjects affected / exposed
    2 / 19 (10.53%)
    5 / 55 (9.09%)
    11 / 200 (5.50%)
         occurrences all number
    2
    5
    11
    Oropharyngeal discomfort
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    1 / 200 (0.50%)
         occurrences all number
    1
    0
    1
    Psychiatric disorders
    Abnormal dreams
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    1 / 200 (0.50%)
         occurrences all number
    1
    0
    1
    Anxiety
         subjects affected / exposed
    0 / 19 (0.00%)
    3 / 55 (5.45%)
    15 / 200 (7.50%)
         occurrences all number
    0
    3
    15
    Claustrophobia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    0 / 200 (0.00%)
         occurrences all number
    1
    0
    0
    Depressed mood
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 55 (0.00%)
    4 / 200 (2.00%)
         occurrences all number
    2
    0
    4
    Depression
         subjects affected / exposed
    0 / 19 (0.00%)
    5 / 55 (9.09%)
    9 / 200 (4.50%)
         occurrences all number
    0
    5
    10
    Insomnia
         subjects affected / exposed
    3 / 19 (15.79%)
    5 / 55 (9.09%)
    36 / 200 (18.00%)
         occurrences all number
    3
    5
    37
    Irritability
         subjects affected / exposed
    1 / 19 (5.26%)
    6 / 55 (10.91%)
    20 / 200 (10.00%)
         occurrences all number
    1
    6
    20
    Mood swings
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 55 (1.82%)
    2 / 200 (1.00%)
         occurrences all number
    1
    1
    2
    Sleep disorder
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 55 (1.82%)
    13 / 200 (6.50%)
         occurrences all number
    1
    1
    13
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    3 / 200 (1.50%)
         occurrences all number
    1
    0
    5
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 55 (3.64%)
    1 / 200 (0.50%)
         occurrences all number
    1
    3
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 19 (0.00%)
    5 / 55 (9.09%)
    9 / 200 (4.50%)
         occurrences all number
    0
    5
    10
    Headache
         subjects affected / exposed
    1 / 19 (5.26%)
    7 / 55 (12.73%)
    35 / 200 (17.50%)
         occurrences all number
    1
    8
    39
    Lethargy
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 55 (1.82%)
    15 / 200 (7.50%)
         occurrences all number
    1
    1
    15
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 19 (5.26%)
    3 / 55 (5.45%)
    16 / 200 (8.00%)
         occurrences all number
    1
    3
    16
    Ear and labyrinth disorders
    Ear discomfort
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    0 / 200 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 19 (5.26%)
    3 / 55 (5.45%)
    9 / 200 (4.50%)
         occurrences all number
    1
    3
    9
    Abdominal pain upper
         subjects affected / exposed
    3 / 19 (15.79%)
    1 / 55 (1.82%)
    9 / 200 (4.50%)
         occurrences all number
    3
    1
    10
    Abdominal tenderness
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    1 / 200 (0.50%)
         occurrences all number
    1
    0
    1
    Constipation
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    10 / 200 (5.00%)
         occurrences all number
    0
    0
    10
    Diarrhoea
         subjects affected / exposed
    1 / 19 (5.26%)
    5 / 55 (9.09%)
    24 / 200 (12.00%)
         occurrences all number
    1
    7
    27
    Gastrointestinal pain
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    1 / 200 (0.50%)
         occurrences all number
    1
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    10 / 200 (5.00%)
         occurrences all number
    0
    0
    11
    Nausea
         subjects affected / exposed
    3 / 19 (15.79%)
    4 / 55 (7.27%)
    32 / 200 (16.00%)
         occurrences all number
    3
    4
    33
    Tongue ulceration
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    0 / 200 (0.00%)
         occurrences all number
    1
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    13 / 200 (6.50%)
         occurrences all number
    0
    2
    14
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    2 / 200 (1.00%)
         occurrences all number
    1
    0
    2
    Jaundice
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 55 (1.82%)
    5 / 200 (2.50%)
         occurrences all number
    1
    1
    5
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 19 (0.00%)
    3 / 55 (5.45%)
    5 / 200 (2.50%)
         occurrences all number
    0
    3
    5
    Dermatitis
         subjects affected / exposed
    2 / 19 (10.53%)
    1 / 55 (1.82%)
    4 / 200 (2.00%)
         occurrences all number
    2
    1
    4
    Dry skin
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 55 (3.64%)
    9 / 200 (4.50%)
         occurrences all number
    1
    2
    10
    Hair texture abnormal
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    0 / 200 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    2 / 200 (1.00%)
         occurrences all number
    1
    0
    2
    Pruritus
         subjects affected / exposed
    0 / 19 (0.00%)
    5 / 55 (9.09%)
    16 / 200 (8.00%)
         occurrences all number
    0
    6
    16
    Rash
         subjects affected / exposed
    2 / 19 (10.53%)
    3 / 55 (5.45%)
    15 / 200 (7.50%)
         occurrences all number
    4
    3
    17
    Urticaria
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    1 / 200 (0.50%)
         occurrences all number
    1
    0
    1
    Renal and urinary disorders
    Chromaturia
         subjects affected / exposed
    0 / 19 (0.00%)
    3 / 55 (5.45%)
    1 / 200 (0.50%)
         occurrences all number
    0
    3
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 55 (3.64%)
    11 / 200 (5.50%)
         occurrences all number
    1
    2
    11
    Back pain
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 55 (3.64%)
    13 / 200 (6.50%)
         occurrences all number
    1
    2
    13
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    2 / 200 (1.00%)
         occurrences all number
    1
    0
    2
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    2 / 200 (1.00%)
         occurrences all number
    1
    0
    2
    Myalgia
         subjects affected / exposed
    1 / 19 (5.26%)
    6 / 55 (10.91%)
    11 / 200 (5.50%)
         occurrences all number
    1
    7
    11
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    7 / 200 (3.50%)
         occurrences all number
    1
    0
    7
    Ear infection
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    1 / 200 (0.50%)
         occurrences all number
    1
    0
    1
    Influenza
         subjects affected / exposed
    0 / 19 (0.00%)
    3 / 55 (5.45%)
    4 / 200 (2.00%)
         occurrences all number
    0
    3
    4
    Localised infection
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    1 / 200 (0.50%)
         occurrences all number
    1
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    3 / 19 (15.79%)
    5 / 55 (9.09%)
    11 / 200 (5.50%)
         occurrences all number
    3
    6
    13
    Otitis media
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    1 / 200 (0.50%)
         occurrences all number
    1
    0
    1
    Pharyngitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    3 / 200 (1.50%)
         occurrences all number
    1
    0
    3
    Rhinitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    8 / 200 (4.00%)
         occurrences all number
    1
    0
    9
    Sinusitis
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 55 (1.82%)
    7 / 200 (3.50%)
         occurrences all number
    1
    1
    7
    Subcutaneous abscess
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    0 / 200 (0.00%)
         occurrences all number
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 55 (3.64%)
    13 / 200 (6.50%)
         occurrences all number
    1
    2
    15
    Urethritis gonococcal
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    0 / 200 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 55 (3.64%)
    17 / 200 (8.50%)
         occurrences all number
    1
    2
    17
    Hyperphagia
         subjects affected / exposed
    0 / 19 (0.00%)
    3 / 55 (5.45%)
    1 / 200 (0.50%)
         occurrences all number
    0
    3
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jan 2013
    • The assessment of adverse events (AEs) text was modified to clarify the assessment of causality for AEs.
    27 Feb 2013
    • The study design was updated to extend the treatment period for treatment-naive subjects with genotype 3 HCV infection from 12 weeks to 24 weeks. • The study design was revised to increase the number of treatment-naive subjects with genotype 2 and 3 HCV infection from 50 to 100.

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

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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/25659285
    For support, Contact us.
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