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    Clinical Trial Results:
    A Phase 3b, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults with Chronic HCV Infection

    Summary
    EudraCT number
    		 2015-000690-13
    Trial protocol
    		 EE  
    Global end of trial date
    30 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 May 2017
    First version publication date
    25 May 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-337-1463
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02472886
    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 Trials Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
    Scientific contact
    Clinical Trials 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 Jun 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2016
    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 antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in adults with chronic hepatitis C virus (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
    17 Jun 2015
    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
    Estonia: 18
    Country: Number of subjects enrolled
    Russian Federation: 135
    Worldwide total number of subjects
    153
    EEA total number of subjects
    18
    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)
    149
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Russia and Estonia. The first participant was screened on 17 June 2015. The last study visit occurred on 30 June 2016.

    Pre-assignment
    Screening details
    		 169 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
    		 LDV/SOF 8 Weeks (TN, HCV-monoinfected [Group 1])
    Arm description
    		 Ledipasvir/sofosbuvir (LDV/SOF; Harvoni®) (90/400 mg) fixed dose combination (FDC) tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    LDV/SOF, GS-5885/GS-7977, Harvoni®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    90/400 mg FDC once daily for 8 weeks

    Arm title
    		 LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected [Group 2])
    Arm description
    		 LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naïve participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    LDV/SOF, GS-5885/GS-7977, Harvoni®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    90/400 mg FDC once daily for 8 weeks

    Arm title
    		 LDV/SOF+RBV 12 Wks (TE,SOF-treated,HCV-monoinfected [Group 3])
    Arm description
    		 LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve sustained virologic response (SVR) in a previous Gilead sofosbuvir (SOF) study
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    LDV/SOF, GS-5885/GS-7977, Harvoni®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    90/400 mg FDC once daily for 12 weeks

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    RBV
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Weight based RBV (1000-1200 mg in a divided daily dose) for 12 weeks

    Number of subjects in period 1
    		LDV/SOF 8 Weeks (TN, HCV-monoinfected [Group 1]) LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected [Group 2]) LDV/SOF+RBV 12 Wks (TE,SOF-treated,HCV-monoinfected [Group 3])
    Started
    67
    59
    27
    Completed
    67
    57
    26
    Not completed
    0
    2
    1
         Lack of efficacy
    -
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LDV/SOF 8 Weeks (TN, HCV-monoinfected [Group 1])
    Reporting group description
    		 Ledipasvir/sofosbuvir (LDV/SOF; Harvoni®) (90/400 mg) fixed dose combination (FDC) tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis

    Reporting group title
    LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected [Group 2])
    Reporting group description
    		 LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naïve participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1

    Reporting group title
    LDV/SOF+RBV 12 Wks (TE,SOF-treated,HCV-monoinfected [Group 3])
    Reporting group description
    		 LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve sustained virologic response (SVR) in a previous Gilead sofosbuvir (SOF) study

    Reporting group values
    		 LDV/SOF 8 Weeks (TN, HCV-monoinfected [Group 1]) LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected [Group 2]) LDV/SOF+RBV 12 Wks (TE,SOF-treated,HCV-monoinfected [Group 3]) Total
    Number of subjects
    		 67 59 27 153
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42 ± 12.6 34 ± 5.5 47 ± 11.2 -
    Gender categorical
    Units: Subjects
        Female
    		 33 25 9 67
        Male
    		 34 34 18 86
    Race
    Units: Subjects
        White
    		 66 59 27 152
        Asian
    		 1 0 0 1
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 67 59 27 153
    IL28b Status
    The CC, CT, and TT alleles are different forms of the IL28b gene.
    Units: Subjects
        CC
    		 17 9 7 33
        CT
    		 41 41 18 100
        TT
    		 9 9 2 20
    HCV RNA Category
    Units: Subjects
        < 800,000 IU/mL
    		 29 23 8 60
        ≥ 800,000 IU/mL
    		 38 36 19 93
    Cirrhosis Status
    Units: Subjects
        No
    		 67 59 17 143
        Yes
    		 0 0 10 10
    HCV RNA
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    		 5.9 ± 0.72 6.1 ± 0.54 6.3 ± 0.67 -

    End points

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    End points reporting groups
    Reporting group title
    LDV/SOF 8 Weeks (TN, HCV-monoinfected [Group 1])
    Reporting group description
    		 Ledipasvir/sofosbuvir (LDV/SOF; Harvoni®) (90/400 mg) fixed dose combination (FDC) tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis

    Reporting group title
    LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected [Group 2])
    Reporting group description
    		 LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naïve participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1

    Reporting group title
    LDV/SOF+RBV 12 Wks (TE,SOF-treated,HCV-monoinfected [Group 3])
    Reporting group description
    		 LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve sustained virologic response (SVR) in a previous Gilead sofosbuvir (SOF) study

    Subject analysis set title
    LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected, ARV-Naive)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1. These participants did not receive any prior ARV therapy. Participant in the Safety analysis set (without any prior ARV treatment) with available data were analyzed.

    Subject analysis set title
    LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected, ARV-Experienced)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1. These participants were on a stable ARV regimen for at least 8 weeks prior to screening. Participant in the Safety analysis set (who received prior ARV treatment) with available data were analyzed

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

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    End point title
    		 Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) [1]
    End point description
    Full Analysis Set (FAS) included participants who were enrolled into the study and received at least 1 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 statistical comparison was planned or performed.
    End point values
    		 LDV/SOF 8 Weeks (TN, HCV-monoinfected [Group 1]) LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected [Group 2]) LDV/SOF+RBV 12 Wks (TE,SOF-treated,HCV-monoinfected [Group 3])
    Number of subjects analysed
    67
    59
    27
    Units: percentage of participants
        number (confidence interval 95%)
    100 (94.6 to 100)
    96.6 (88.3 to 99.6)
    96.3 (81 to 99.9)
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Discontinued Study Drug Due to Any Adverse Event (AE)

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    End point title
    		 Percentage of Participants Who Discontinued Study Drug Due to Any Adverse Event (AE) [2]
    End point description
    Safety Analysis Set included all participants who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Up to 12 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 comparison was planned or performed.
    End point values
    		 LDV/SOF 8 Weeks (TN, HCV-monoinfected [Group 1]) LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected [Group 2]) LDV/SOF+RBV 12 Wks (TE,SOF-treated,HCV-monoinfected [Group 3])
    Number of subjects analysed
    67
    59
    27
    Units: percentage of participants
        number (not applicable)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Sustained Virologic Response (SVR) 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 (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
    End point description
    SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Posttreatment Weeks 4 and 24
    End point values
    		 LDV/SOF 8 Weeks (TN, HCV-monoinfected [Group 1]) LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected [Group 2]) LDV/SOF+RBV 12 Wks (TE,SOF-treated,HCV-monoinfected [Group 3])
    Number of subjects analysed
    67
    59
    27
    Units: percentage of participants
    number (confidence interval 95%)
        SVR4
    100 (94.6 to 100)
    96.6 (88.3 to 99.6)
    96.3 (81 to 99.9)
        SVR24
    100 (94.6 to 100)
    96.6 (88.3 to 99.6)
    96.3 (81 to 99.9)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HCV RNA < LLOQ on Treatment

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    End point title
    		 Percentage of Participants With HCV RNA < LLOQ on Treatment
    End point description
    1) Full Analysis Set 2) 999 = Treatment for this group was 8 weeks only.
    End point type
    Secondary
    End point timeframe
    Up to 12 weeks
    End point values
    		 LDV/SOF 8 Weeks (TN, HCV-monoinfected [Group 1]) LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected [Group 2]) LDV/SOF+RBV 12 Wks (TE,SOF-treated,HCV-monoinfected [Group 3])
    Number of subjects analysed
    67
    59
    27
    Units: percentage of participants
    number (confidence interval 95%)
        Week 1
    20.9 (11.9 to 32.6)
    39 (26.5 to 52.6)
    3.7 (0.1 to 19)
        Week 2
    65.7 (53.1 to 76.8)
    69.5 (56.1 to 80.8)
    59.3 (38.8 to 77.6)
        Week 4
    100 (94.6 to 100)
    96.6 (88.3 to 99.6)
    88.9 (70.8 to 97.6)
        Week 8
    100 (94.6 to 100)
    98.3 (90.9 to 100)
    100 (87.2 to 100)
        Week 12
    999 (999 to 999)
    999 (999 to 999)
    100 (87.2 to 100)
    No statistical analyses for this end point

    Secondary: HCV RNA Change From Day 1

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    End point title
    		 HCV RNA Change From Day 1
    End point description
    1) Participants in Full Analysis Set with available data were analyzed. 2) 999 = Treatment for this group was 8 weeks only.
    End point type
    Secondary
    End point timeframe
    Up to 12 weeks
    End point values
    		 LDV/SOF 8 Weeks (TN, HCV-monoinfected [Group 1]) LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected [Group 2]) LDV/SOF+RBV 12 Wks (TE,SOF-treated,HCV-monoinfected [Group 3])
    Number of subjects analysed
    67
    59
    27
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Wk 1(Group 1: N = 65;Group 2 = 58; Group 3: N =27)
    -3.97 ± 0.675
    -4.34 ± 0.626
    -4.12 ± 0.582
        Wk 2(Group 1: N = 67;Group 2 = 58; Group 3: N =27)
    -4.5 ± 0.687
    -4.76 ± 0.522
    -4.83 ± 0.63
        Wk 4
    -4.74 ± 0.723
    -4.89 ± 0.534
    -5.08 ± 0.642
        Wk 8
    -4.74 ± 0.723
    -4.91 ± 0.536
    -5.11 ± 0.671
        Wk 12
    999 ± 999
    999 ± 999
    -5.11 ± 0.671
    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
    1) Full Analysis Set 2) Virologic failure was defined as • On-treatment virologic failure • confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough), • confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound), HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie, nonresponse) • Relapse • 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
    Up to Posttreatment Week 24
    End point values
    		 LDV/SOF 8 Weeks (TN, HCV-monoinfected [Group 1]) LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected [Group 2]) LDV/SOF+RBV 12 Wks (TE,SOF-treated,HCV-monoinfected [Group 3])
    Number of subjects analysed
    67
    59
    27
    Units: percentage of participants
        number (not applicable)
    0
    3.4
    3.7
    No statistical analyses for this end point

    Secondary: Percentage of HIV/HCV-Coinfected Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4

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    End point title
    		 Percentage of HIV/HCV-Coinfected Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4 [3]
    End point description
    Participants in the Safety Analysis Set (who had HIV RNA < 50 Copies/mL at baseline) with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to Posttreatment Week 4
    Notes
    [3] - 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: This secondary endpoint was not analyzed for Group 1 and 3.
    End point values
    		 LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected [Group 2])
    Number of subjects analysed
    45
    Units: percentage of participants
    number (not applicable)
        Week 4
    100
        Week 8 (N= 43)
    100
        Posttreatment Week 4 (N= 36)
    97.2
    No statistical analyses for this end point

    Secondary: For HIV/HCV-Coinfected Participants, Change From Baseline in CD4 T-cell Count at the End of Treatment and Posttreatment Week 4

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    End point title
    		 For HIV/HCV-Coinfected Participants, Change From Baseline in CD4 T-cell Count at the End of Treatment and Posttreatment Week 4
    End point description
    Participant in the Safety analysis set (with or without prior ARV treatment) with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to Posttreatment Week 4
    End point values
    		 LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected, ARV-Naive) LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected, ARV-Experienced)
    Number of subjects analysed
    44
    9
    Units: cells/µL
    arithmetic mean (standard deviation)
        Wk 4 (ARV-Naive: N=43; ARV-Exp: N=9)
    47 ± 120.5
    159 ± 114.9
        Wk 8 (ARV-Naive: N=44; ARV-Exp: N=9)
    45 ± 122.7
    202 ± 178.1
        FU-Wk 4 (ARV-Naive: N=35; ARV-Exp: N=5)
    74 ± 117.8
    172 ± 114.1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 12 weeks plus 30 days
    Adverse event reporting additional description
    Safety Analysis Set included all participants who received at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    LDV/SOF 8 Weeks (TN, HCV-monoinfected)
    Reporting group description
    		 LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis

    Reporting group title
    LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)
    Reporting group description
    		 LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1

    Reporting group title
    LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)
    Reporting group description
    		 LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study

    Serious adverse events
    		 LDV/SOF 8 Weeks (TN, HCV-monoinfected) LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected) LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 59 (0.00%)
    0 / 27 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 LDV/SOF 8 Weeks (TN, HCV-monoinfected) LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected) LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 67 (7.46%)
    2 / 59 (3.39%)
    8 / 27 (29.63%)
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 59 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 67 (5.97%)
    0 / 59 (0.00%)
    4 / 27 (14.81%)
         occurrences all number
    4
    0
    4
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 59 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    1
    0
    2
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 59 (1.69%)
    2 / 27 (7.41%)
         occurrences all number
    1
    1
    2
    Dyspepsia
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 59 (0.00%)
    3 / 27 (11.11%)
         occurrences all number
    0
    0
    3
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 59 (1.69%)
    2 / 27 (7.41%)
         occurrences all number
    0
    1
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jun 2015
    • Added Amiodarone to the “Agents Disallowed” list based on risk of symptomatic bradycardia with coadministration of amiodarone with ledipasvir/sofosbuvir. Postmarketing cases of symptomatic bradycardia were reported in patients receiving amiodarone who were coadministered Harvoni® (ledipasvir/sofosbuvir), or Sovaldi® (sofosbuvir) in combination with another direct acting antiviral. • Added information from the GS-US-337-0115 ( ION-4) study (LDV/SOF in HCV/HIV co-infected subjects) • Added abacavir/lamivudine and dolutegravir as acceptable HIV ARV medications • Added optional additional testing to differentiate HIV-1 and HIV-2 infection to the laboratory tests to be performed as needed • Clarified inclusion/exclusion criteria related to Group 3 subjects (ie, subjects who failed to achieve SVR12 in study GS-US-334-0119) to o Allow enrolment of subjects who do not meet all laboratory requirements upon approval by the Gilead Medical Monitor or Study Director o Explicitly excluded subjects who did not participate in or who achieved SVR12 study GS-US-334-0119

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

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