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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/- Ribavirin for 12 and 24 Weeks in Treatment-Naive Subjects with Chronic Genotype 1 HCV Infection.

    Summary
    EudraCT number
    		 2012-003387-43
    Trial protocol
    		 GB   DE   ES   FR  
    Global end of trial date
    30 Apr 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

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    Trial identification
    Sponsor protocol code
    GS-US-337-0102
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01701401
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences, Inc.
    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
    30 Apr 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.
    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
    26 Sep 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 55
    Country: Number of subjects enrolled
    United Kingdom: 55
    Country: Number of subjects enrolled
    Germany: 84
    Country: Number of subjects enrolled
    Italy: 96
    Country: Number of subjects enrolled
    France: 63
    Country: Number of subjects enrolled
    United States: 512
    Worldwide total number of subjects
    865
    EEA total number of subjects
    353
    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)
    793
    From 65 to 84 years
    72
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at a total of 100 study sites in the United States and Europe. The first participant was screened on 26 September 2012. The last study visit occurred on 30 April 2014.

    Pre-assignment
    Screening details
    		 1015 participants were screened.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LDV/SOF 12 weeks
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    LDV/SOF, Harvoni®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LDV/SOF 90/400 mg fixed-dose combination (FDC) tablet administered orally once daily

    Arm title
    		 LDV/SOF+RBV 12 weeks
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    LDV/SOF, Harvoni®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LDV/SOF 90/400 mg fixed-dose combination (FDC) tablet administered orally once daily

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

    Arm title
    		 LDV/SOF 24 weeks
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    LDV/SOF, Harvoni®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LDV/SOF 90/400 mg fixed-dose combination (FDC) tablet administered orally once daily

    Arm title
    		 LDV/SOF+RBV 24 weeks
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    LDV/SOF, Harvoni®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LDV/SOF 90/400 mg fixed-dose combination (FDC) tablet administered orally once daily

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

    Number of subjects in period 1
    		LDV/SOF 12 weeks LDV/SOF+RBV 12 weeks LDV/SOF 24 weeks LDV/SOF+RBV 24 weeks
    Started
    214
    217
    217
    217
    Completed
    207
    209
    212
    212
    Not completed
    7
    8
    5
    5
         Protocol violation
    -
    -
    1
    -
         Non-treatment emergent death
    1
    -
    -
    -
         Lost to follow-up
    5
    5
    1
    3
         Withdrew consent
    -
    3
    1
    2
         Lack of efficacy
    1
    -
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LDV/SOF 12 weeks
    Reporting group description
    		 -

    Reporting group title
    LDV/SOF+RBV 12 weeks
    Reporting group description
    		 -

    Reporting group title
    LDV/SOF 24 weeks
    Reporting group description
    		 -

    Reporting group title
    LDV/SOF+RBV 24 weeks
    Reporting group description
    		 -

    Reporting group values
    		 LDV/SOF 12 weeks LDV/SOF+RBV 12 weeks LDV/SOF 24 weeks LDV/SOF+RBV 24 weeks Total
    Number of subjects
    		 214 217 217 217 865
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 52 ± 10.7 52 ± 11.5 53 ± 10.3 53 ± 9.9 -
    Gender, Male/Female
    Units: participants
        Female
    		 87 89 78 98 352
        Male
    		 127 128 139 119 513
    Race
    Units: Subjects
        Black or African American
    		 24 26 32 26 108
        White
    		 187 188 177 183 735
        Asian
    		 1 0 5 5 11
        American Indian/Alaska Native
    		 0 1 0 1 2
        Hawaiian or Pacific Islander
    		 0 0 1 0 1
        Other
    		 2 1 2 1 6
        Not Disclosed
    		 0 1 0 1 2
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 26 20 29 26 101
        Not Hispanic or Latino
    		 187 197 188 190 762
        Not Disclosed
    		 1 0 0 1 2
    HCV RNA Category
    Units: Subjects
        < 800,000 IU/mL
    		 45 44 49 44 182
        ≥ 800,000 IU/mL
    		 169 173 168 173 683
    HCV Genotype
    There are variations of HCV which are all similar enough to be called HCV, but are distinct enough to be referred to as HCV genotypes.
    Units: Subjects
        Genotype 1a
    		 144 148 146 143 581
        Genotype 1b
    		 66 68 68 71 273
        Genotype 1 (no confirmed subtype)
    		 1 1 1 1 4
        Genotype 4
    		 1 0 0 1 2
        Missing
    		 2 0 2 1 5
    IL28b Status
    CC, CT, and TT alleles are different forms of the IL28b gene.
    Units: Subjects
        CC
    		 55 76 52 73 256
        CT
    		 113 107 119 112 451
        TT
    		 46 34 46 32 158
    Hepatitis C Virus (HCV) RNA
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    		 6.4 ± 0.69 6.4 ± 0.64 6.3 ± 0.68 6.3 ± 0.65 -

    End points

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    End points reporting groups
    Reporting group title
    LDV/SOF 12 weeks
    Reporting group description
    		 -

    Reporting group title
    LDV/SOF+RBV 12 weeks
    Reporting group description
    		 -

    Reporting group title
    LDV/SOF 24 weeks
    Reporting group description
    		 -

    Reporting group title
    LDV/SOF+RBV 24 weeks
    Reporting group description
    		 -

    Primary: Percentage of participants with sustained virologic response (SVR) 12 weeks after discontinuation of study drug (SVR12)

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    End point title
    		 Percentage of participants with sustained virologic response (SVR) 12 weeks after discontinuation of study drug (SVR12) [1]
    End point description
    SVR12 was defined as HCV RNA level < the lower limit of quantification (LLOQ, ie, < 25 copies/mL) 12 weeks after 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 was planned or performed.
    End point values
    		 LDV/SOF 12 weeks LDV/SOF+RBV 12 weeks LDV/SOF 24 weeks LDV/SOF+RBV 24 weeks
    Number of subjects analysed
    214
    217
    217
    217
    Units: percentage of participants
        number (not applicable)
    98.6
    97.2
    98.2
    99.1
    No statistical analyses for this end point

    Primary: Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug

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    End point title
    		 Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug [2]
    End point description
    The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug 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 intergroup analysis was planned or performed.
    End point values
    		 LDV/SOF 12 weeks LDV/SOF+RBV 12 weeks LDV/SOF 24 weeks LDV/SOF+RBV 24 weeks
    Number of subjects analysed
    214
    217
    217
    217
    Units: percentage of participants
        number (not applicable)
    0
    0.5
    1.8
    3.7
    No statistical analyses for this end point

    Secondary: Percentage of participants with SVR at 4 and 24 weeks after discontinuation of study drug

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    End point title
    		 Percentage of participants with SVR at 4 and 24 weeks after discontinuation of study drug
    End point description
    SVR4 and SVR24 were defined as HCV RNA level < LLOQ at 4 and 24 weeks after discontinuation of study drug, respectively.
    End point type
    Secondary
    End point timeframe
    Posttreatment Weeks 4 and 24
    End point values
    		 LDV/SOF 12 weeks LDV/SOF+RBV 12 weeks LDV/SOF 24 weeks LDV/SOF+RBV 24 weeks
    Number of subjects analysed
    214
    217
    217
    217
    Units: percentage of participants
    number (not applicable)
        SVR4
    98.6
    98.2
    99.1
    99.1
        SVR24
    98.6
    97.2
    98.2
    99.1
    No statistical analyses for this end point

    Secondary: Percentage of participants with HCV RNA < LLOQ at Week 2

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    End point title
    		 Percentage of participants with HCV RNA < LLOQ at Week 2
    End point description
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    		 LDV/SOF 12 weeks LDV/SOF+RBV 12 weeks LDV/SOF 24 weeks LDV/SOF+RBV 24 weeks
    Number of subjects analysed
    213
    217
    216
    217
    Units: percentage of participants
        number (not applicable)
    82.2
    83.4
    82.9
    82.9
    No statistical analyses for this end point

    Secondary: Percentage of participants with HCV RNA < LLOQ at Week 4

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    End point title
    		 Percentage of participants with HCV RNA < LLOQ at Week 4
    End point description
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 LDV/SOF 12 weeks LDV/SOF+RBV 12 weeks LDV/SOF 24 weeks LDV/SOF+RBV 24 weeks
    Number of subjects analysed
    213
    217
    216
    217
    Units: percentage of participants
        number (not applicable)
    100
    99.1
    100
    100
    No statistical analyses for this end point

    Secondary: Percentage of participants with HCV RNA < LLOQ at Week 8

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    End point title
    		 Percentage of participants with HCV RNA < LLOQ at Week 8
    End point description
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 LDV/SOF 12 weeks LDV/SOF+RBV 12 weeks LDV/SOF 24 weeks LDV/SOF+RBV 24 weeks
    Number of subjects analysed
    213
    215
    215
    217
    Units: percentage of participants
        number (not applicable)
    99.5
    100
    99.5
    100
    No statistical analyses for this end point

    Secondary: Change from baseline in HCV RNA at Week 2

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    End point title
    		 Change from baseline in HCV RNA at Week 2
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline; Week 2
    End point values
    		 LDV/SOF 12 weeks LDV/SOF+RBV 12 weeks LDV/SOF 24 weeks LDV/SOF+RBV 24 weeks
    Number of subjects analysed
    213
    217
    216
    216
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    -4.9 ± 0.657
    -4.94 ± 0.633
    -4.86 ± 0.67
    -4.89 ± 0.648
    No statistical analyses for this end point

    Secondary: Change from baseline in HCV RNA at Week 4

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    End point title
    		 Change from baseline in HCV RNA at Week 4
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline; Week 4
    End point values
    		 LDV/SOF 12 weeks LDV/SOF+RBV 12 weeks LDV/SOF 24 weeks LDV/SOF+RBV 24 weeks
    Number of subjects analysed
    213
    216
    216
    217
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    -4.99 ± 0.697
    -5.02 ± 0.623
    -4.93 ± 0.678
    -4.96 ± 0.651
    No statistical analyses for this end point

    Secondary: Change from baseline in HCV RNA at Week 8

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    End point title
    		 Change from baseline in HCV RNA at Week 8
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline; Week 8
    End point values
    		 LDV/SOF 12 weeks LDV/SOF+RBV 12 weeks LDV/SOF 24 weeks LDV/SOF+RBV 24 weeks
    Number of subjects analysed
    213
    215
    216
    217
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    -4.99 ± 0.696
    -5.02 ± 0.625
    -4.91 ± 0.702
    -4.96 ± 0.651
    No statistical analyses for this end point

    Secondary: Percentage of participants with virologic failure

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    End point title
    		 Percentage of participants with virologic failure
    End point description
    On-treatment virologic failure was defined as: - Breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow- up values, OR - Rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow-up values, OR - Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment Virologic relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement
    End point type
    Secondary
    End point timeframe
    Baseline to posttreatment Week 24
    End point values
    		 LDV/SOF 12 weeks LDV/SOF+RBV 12 weeks LDV/SOF 24 weeks LDV/SOF+RBV 24 weeks
    Number of subjects analysed
    214
    217
    217
    217
    Units: percentage of participants
    number (not applicable)
        On-treatment virologic failure
    0
    0
    0.5
    0
        Virologic relapse
    0.5
    0
    0.5
    0
    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
    Adverse event reporting additional description
    Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    LDV/SOF 12 weeks
    Reporting group description
    		 LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks

    Reporting group title
    LDV/SOF+RBV 12 weeks
    Reporting group description
    		 LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks

    Reporting group title
    LDV/SOF 24 weeks
    Reporting group description
    		 LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks

    Reporting group title
    LDV/SOF+RBV 24 weeks
    Reporting group description
    		 LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks

    Serious adverse events
    		 LDV/SOF 12 weeks LDV/SOF+RBV 12 weeks LDV/SOF 24 weeks LDV/SOF+RBV 24 weeks
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 214 (0.47%)
    7 / 217 (3.23%)
    18 / 217 (8.29%)
    7 / 217 (3.23%)
         number of deaths (all causes)
    1
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 214 (0.00%)
    0 / 217 (0.00%)
    0 / 217 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Hand fracture
         subjects affected / exposed
    0 / 214 (0.00%)
    0 / 217 (0.00%)
    2 / 217 (0.92%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    0 / 214 (0.00%)
    0 / 217 (0.00%)
    0 / 217 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 214 (0.00%)
    0 / 217 (0.00%)
    0 / 217 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 214 (0.00%)
    0 / 217 (0.00%)
    1 / 217 (0.46%)
    0 / 217 (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
    Foot fracture
         subjects affected / exposed
    0 / 214 (0.00%)
    0 / 217 (0.00%)
    1 / 217 (0.46%)
    0 / 217 (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
    Lower limb fracture
         subjects affected / exposed
    0 / 214 (0.00%)
    0 / 217 (0.00%)
    1 / 217 (0.46%)
    0 / 217 (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
    Rib fracture
         subjects affected / exposed
    0 / 214 (0.00%)
    0 / 217 (0.00%)
    0 / 217 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 214 (0.00%)
    1 / 217 (0.46%)
    0 / 217 (0.00%)
    0 / 217 (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
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 214 (0.00%)
    1 / 217 (0.46%)
    0 / 217 (0.00%)
    0 / 217 (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
    Nervous system disorders
    Carotid artery stenosis
         subjects affected / exposed
    0 / 214 (0.00%)
    0 / 217 (0.00%)
    0 / 217 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 214 (0.00%)
    0 / 217 (0.00%)
    1 / 217 (0.46%)
    0 / 217 (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
    Migraine
         subjects affected / exposed
    0 / 214 (0.00%)
    1 / 217 (0.46%)
    0 / 217 (0.00%)
    0 / 217 (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
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 214 (0.00%)
    1 / 217 (0.46%)
    0 / 217 (0.00%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Factor VIII inhibition
         subjects affected / exposed
    0 / 214 (0.00%)
    0 / 217 (0.00%)
    1 / 217 (0.46%)
    0 / 217 (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
    Lymphadenopathy
         subjects affected / exposed
    0 / 214 (0.00%)
    0 / 217 (0.00%)
    0 / 217 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 214 (0.47%)
    0 / 217 (0.00%)
    1 / 217 (0.46%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 214 (0.00%)
    1 / 217 (0.46%)
    1 / 217 (0.46%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 214 (0.00%)
    0 / 217 (0.00%)
    1 / 217 (0.46%)
    0 / 217 (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
    Colitis
         subjects affected / exposed
    0 / 214 (0.00%)
    0 / 217 (0.00%)
    1 / 217 (0.46%)
    0 / 217 (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
    Mesenteric vein thrombosis
         subjects affected / exposed
    0 / 214 (0.00%)
    0 / 217 (0.00%)
    1 / 217 (0.46%)
    0 / 217 (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
    Reproductive system and breast disorders
    Breast mass
         subjects affected / exposed
    0 / 214 (0.00%)
    0 / 217 (0.00%)
    1 / 217 (0.46%)
    0 / 217 (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
    Psychiatric disorders
    Alcohol withdrawal syndrome
         subjects affected / exposed
    0 / 214 (0.00%)
    0 / 217 (0.00%)
    0 / 217 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 214 (0.00%)
    0 / 217 (0.00%)
    0 / 217 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Substance abuse
         subjects affected / exposed
    0 / 214 (0.00%)
    0 / 217 (0.00%)
    0 / 217 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus ureteric
         subjects affected / exposed
    0 / 214 (0.00%)
    0 / 217 (0.00%)
    0 / 217 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 214 (0.00%)
    1 / 217 (0.46%)
    0 / 217 (0.00%)
    0 / 217 (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
    Lumbar spinal stenosis
         subjects affected / exposed
    0 / 214 (0.00%)
    0 / 217 (0.00%)
    1 / 217 (0.46%)
    0 / 217 (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
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 214 (0.00%)
    0 / 217 (0.00%)
    1 / 217 (0.46%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 214 (0.00%)
    0 / 217 (0.00%)
    2 / 217 (0.92%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 214 (0.00%)
    1 / 217 (0.46%)
    0 / 217 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Progressive multifocal leukoencephalopathy
         subjects affected / exposed
    0 / 214 (0.00%)
    0 / 217 (0.00%)
    1 / 217 (0.46%)
    0 / 217 (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
    Salpingitis
         subjects affected / exposed
    0 / 214 (0.00%)
    0 / 217 (0.00%)
    1 / 217 (0.46%)
    0 / 217 (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
    Urinary tract infection
         subjects affected / exposed
    0 / 214 (0.00%)
    0 / 217 (0.00%)
    1 / 217 (0.46%)
    0 / 217 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 LDV/SOF 12 weeks LDV/SOF+RBV 12 weeks LDV/SOF 24 weeks LDV/SOF+RBV 24 weeks
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    140 / 214 (65.42%)
    168 / 217 (77.42%)
    149 / 217 (68.66%)
    189 / 217 (87.10%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    54 / 214 (25.23%)
    50 / 217 (23.04%)
    54 / 217 (24.88%)
    66 / 217 (30.41%)
         occurrences all number
    65
    58
    66
    75
    Dizziness
         subjects affected / exposed
    11 / 214 (5.14%)
    10 / 217 (4.61%)
    14 / 217 (6.45%)
    18 / 217 (8.29%)
         occurrences all number
    12
    11
    15
    18
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 214 (0.00%)
    25 / 217 (11.52%)
    0 / 217 (0.00%)
    22 / 217 (10.14%)
         occurrences all number
    0
    25
    0
    22
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    46 / 214 (21.50%)
    79 / 217 (36.41%)
    53 / 217 (24.42%)
    84 / 217 (38.71%)
         occurrences all number
    52
    80
    63
    88
    Asthenia
         subjects affected / exposed
    14 / 214 (6.54%)
    23 / 217 (10.60%)
    20 / 217 (9.22%)
    26 / 217 (11.98%)
         occurrences all number
    14
    24
    23
    35
    Irritability
         subjects affected / exposed
    11 / 214 (5.14%)
    17 / 217 (7.83%)
    17 / 217 (7.83%)
    24 / 217 (11.06%)
         occurrences all number
    11
    17
    17
    25
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    24 / 214 (11.21%)
    37 / 217 (17.05%)
    29 / 217 (13.36%)
    32 / 217 (14.75%)
         occurrences all number
    25
    41
    36
    35
    Diarrhoea
         subjects affected / exposed
    24 / 214 (11.21%)
    18 / 217 (8.29%)
    24 / 217 (11.06%)
    14 / 217 (6.45%)
         occurrences all number
    28
    18
    27
    16
    Constipation
         subjects affected / exposed
    13 / 214 (6.07%)
    12 / 217 (5.53%)
    15 / 217 (6.91%)
    10 / 217 (4.61%)
         occurrences all number
    13
    12
    16
    11
    Dyspepsia
         subjects affected / exposed
    7 / 214 (3.27%)
    11 / 217 (5.07%)
    14 / 217 (6.45%)
    12 / 217 (5.53%)
         occurrences all number
    7
    14
    15
    14
    Abdominal pain
         subjects affected / exposed
    12 / 214 (5.61%)
    9 / 217 (4.15%)
    7 / 217 (3.23%)
    8 / 217 (3.69%)
         occurrences all number
    13
    11
    7
    10
    Vomiting
         subjects affected / exposed
    7 / 214 (3.27%)
    9 / 217 (4.15%)
    6 / 217 (2.76%)
    12 / 217 (5.53%)
         occurrences all number
    7
    9
    8
    13
    Abdominal pain upper
         subjects affected / exposed
    5 / 214 (2.34%)
    11 / 217 (5.07%)
    7 / 217 (3.23%)
    9 / 217 (4.15%)
         occurrences all number
    5
    11
    8
    10
    Gastrooesophageal reflux disease
         subjects affected / exposed
    4 / 214 (1.87%)
    7 / 217 (3.23%)
    3 / 217 (1.38%)
    11 / 217 (5.07%)
         occurrences all number
    4
    7
    3
    11
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 214 (2.80%)
    22 / 217 (10.14%)
    16 / 217 (7.37%)
    25 / 217 (11.52%)
         occurrences all number
    6
    22
    17
    25
    Dyspnoea
         subjects affected / exposed
    3 / 214 (1.40%)
    18 / 217 (8.29%)
    5 / 217 (2.30%)
    15 / 217 (6.91%)
         occurrences all number
    3
    18
    5
    16
    Dyspnoea exertional
         subjects affected / exposed
    3 / 214 (1.40%)
    9 / 217 (4.15%)
    2 / 217 (0.92%)
    11 / 217 (5.07%)
         occurrences all number
    3
    9
    2
    11
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    16 / 214 (7.48%)
    21 / 217 (9.68%)
    16 / 217 (7.37%)
    26 / 217 (11.98%)
         occurrences all number
    18
    24
    17
    29
    Pruritus
         subjects affected / exposed
    11 / 214 (5.14%)
    22 / 217 (10.14%)
    8 / 217 (3.69%)
    20 / 217 (9.22%)
         occurrences all number
    11
    22
    8
    22
    Dry skin
         subjects affected / exposed
    2 / 214 (0.93%)
    14 / 217 (6.45%)
    3 / 217 (1.38%)
    13 / 217 (5.99%)
         occurrences all number
    2
    14
    3
    14
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    17 / 214 (7.94%)
    45 / 217 (20.74%)
    26 / 217 (11.98%)
    46 / 217 (21.20%)
         occurrences all number
    17
    45
    27
    49
    Anxiety
         subjects affected / exposed
    7 / 214 (3.27%)
    9 / 217 (4.15%)
    12 / 217 (5.53%)
    19 / 217 (8.76%)
         occurrences all number
    7
    9
    12
    21
    Depression
         subjects affected / exposed
    5 / 214 (2.34%)
    6 / 217 (2.76%)
    5 / 217 (2.30%)
    11 / 217 (5.07%)
         occurrences all number
    5
    6
    5
    11
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    9 / 214 (4.21%)
    14 / 217 (6.45%)
    21 / 217 (9.68%)
    13 / 217 (5.99%)
         occurrences all number
    9
    14
    23
    14
    Myalgia
         subjects affected / exposed
    9 / 214 (4.21%)
    13 / 217 (5.99%)
    12 / 217 (5.53%)
    12 / 217 (5.53%)
         occurrences all number
    10
    13
    12
    12
    Back pain
         subjects affected / exposed
    12 / 214 (5.61%)
    5 / 217 (2.30%)
    12 / 217 (5.53%)
    14 / 217 (6.45%)
         occurrences all number
    12
    5
    12
    14
    Muscle spasms
         subjects affected / exposed
    7 / 214 (3.27%)
    14 / 217 (6.45%)
    9 / 217 (4.15%)
    12 / 217 (5.53%)
         occurrences all number
    7
    15
    10
    16
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    14 / 214 (6.54%)
    9 / 217 (4.15%)
    13 / 217 (5.99%)
    19 / 217 (8.76%)
         occurrences all number
    15
    9
    13
    21
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    10 / 214 (4.67%)
    12 / 217 (5.53%)
    8 / 217 (3.69%)
    9 / 217 (4.15%)
         occurrences all number
    10
    12
    8
    10

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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/24725239
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