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    Clinical Trial Results:
    A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Ledipasvir/Sofosbuvir in Subjects with Genotype 1, 4, 5 and 6 Chronic HCV Infection Who are on Dialysis for End Stage Renal Disease

    Summary
    EudraCT number
    		 2016-003489-25
    Trial protocol
    		 BE   IT  
    Global end of trial date
    14 Feb 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Dec 2019
    First version publication date
    02 Dec 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-337-4063
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03036839
    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
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@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
    14 Feb 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Oct 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Feb 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study was to evaluate the safety, efficacy and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) in adults with chronic hepatitis C virus (HCV) infection who were on dialysis for end stage renal disease (ESRD).
    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
    27 Jun 2017
    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
    Belgium: 3
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Italy: 16
    Country: Number of subjects enrolled
    United States: 8
    Country: Number of subjects enrolled
    Taiwan: 60
    Worldwide total number of subjects
    95
    EEA total number of subjects
    27
    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)
    56
    From 65 to 84 years
    39
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Taiwan, Italy, Germany, the United States, and Belgium. The first participant was screened on 27 June 2017. The last study visit occurred on 14 February 2019.

    Pre-assignment
    Screening details
    		 124 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 for 8 Weeks
    Arm description
    		 Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) fixed-dose combination (FDC) tablet once daily orally with or without food for 8 weeks.
    Arm type
    		 Experimental

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

    Arm title
    		 LDV/SOF for 12 Weeks
    Arm description
    		 Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
    Arm type
    		 Experimental

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

    Arm title
    		 LDV/SOF for 24 Weeks
    Arm description
    		 Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    GS-5885/GS-7977, Harvoni®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    90/400 mg FDC administered once daily for 24 weeks.

    Number of subjects in period 1
    		LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
    Started
    45
    31
    19
    Completed
    42
    31
    14
    Not completed
    3
    0
    5
         Withdrew Consent
    -
    -
    1
         Death
    3
    -
    3
         Adverse event
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LDV/SOF for 8 Weeks
    Reporting group description
    		 Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) fixed-dose combination (FDC) tablet once daily orally with or without food for 8 weeks.

    Reporting group title
    LDV/SOF for 12 Weeks
    Reporting group description
    		 Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.

    Reporting group title
    LDV/SOF for 24 Weeks
    Reporting group description
    		 Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.

    Reporting group values
    		 LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks Total
    Number of subjects
    		 45 31 19 95
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60 ± 12.0 59 ± 10.1 65 ± 7.1 -
    Gender categorical
    Units: Subjects
        Female
    		 16 19 4 39
        Male
    		 29 12 15 56
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 0 2 2
        Not Hispanic or Latino
    		 45 31 17 93
        Unknown or Not Reported
    		 0 0 0 0
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 21 29 11 61
        Native Hawaiian or Other Pacific Islander
    		 1 0 0 1
        Black or African American
    		 3 0 2 5
        White
    		 20 2 6 28
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0
    IL28b Status
    The CC, CT, and TT alleles are different forms of the IL28b gene
    Units: Subjects
        CC
    		 24 24 9 57
        CT
    		 12 5 9 26
        TT
    		 9 2 1 12
    HCV RNA Category
    Units: Subjects
        < 800,000 IU/mL
    		 24 14 10 48
        ≥ 800,000 IU/mL
    		 21 17 9 47
    Cirrhosis Status
    Units: Subjects
        Yes
    		 0 0 19 19
        No
    		 45 31 0 76
    HCV Genotype
    Units: Subjects
        Genotype 1
    		 45 8 15 68
        Genotype 2
    		 0 19 2 21
        Genotype 4
    		 0 0 2 2
        Genotype 5
    		 0 1 0 1
        Genotype 6
    		 0 2 0 2
        Indeterminate
    		 0 1 0 1
    HCV RNA
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    		 5.8 ± 0.80 5.9 ± 0.95 5.9 ± 0.63 -

    End points

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    End points reporting groups
    Reporting group title
    LDV/SOF for 8 Weeks
    Reporting group description
    		 Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) fixed-dose combination (FDC) tablet once daily orally with or without food for 8 weeks.

    Reporting group title
    LDV/SOF for 12 Weeks
    Reporting group description
    		 Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.

    Reporting group title
    LDV/SOF for 24 Weeks
    Reporting group description
    		 Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.

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

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    End point title
    		 Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [1]
    End point description
    SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. The exact 95% confidence interval (CI) for the percentage within treatment group was based on the Clopper-Pearson method. The Full Analysis Set (FAS) included participants who were enrolled into the study and received at least 1 dose of study drug. Participants were grouped within the Full Analysis Set by genotype and treatment group to which they were enrolled.
    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 for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
    Number of subjects analysed
    45
    31
    19
    Units: percentage of participants
        number (confidence interval 95%)
    93.3 (81.7 to 98.6)
    100.0 (88.8 to 100.0)
    84.2 (60.4 to 96.6)
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event

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    End point title
    		 Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event [2]
    End point description
    The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
    End point type
    Primary
    End point timeframe
    First dose date up to Week 24
    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 for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
    Number of subjects analysed
    45
    31
    19
    Units: percentage of participants
        number (not applicable)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)

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    End point title
    		 Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
    End point description
    SVR4 was defined as HCV RNA < LLOQ (ie, 15 IU/mL) at 4 weeks after stopping study treatment. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Posttreatment Week 4
    End point values
    		 LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
    Number of subjects analysed
    45
    31
    19
    Units: percentage of participants
        number (confidence interval 95%)
    97.8 (88.2 to 99.9)
    100.0 (88.8 to 100.0)
    84.2 (60.4 to 96.6)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)

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    End point title
    		 Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
    End point description
    SVR24 was defined as HCV RNA < LLOQ (ie, 15 IU/mL) at 24 weeks after stopping study treatment. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Posttreatment Week 24
    End point values
    		 LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
    Number of subjects analysed
    45
    31
    19
    Units: percentage of participants
        number (confidence interval 95%)
    93.3 (81.7 to 98.6)
    100.0 (88.8 to 100.0)
    84.2 (60.4 to 96.6)
    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
    The total number of participants with HCV RNA < LLOQ was the sum of the number of participants with HCV RNA “< LLOQ detected” plus the number of subjects with HCV RNA “< LLOQ target not detected (TND)”. LLOQ was 15 IU/mL. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method. Participants in the Full Analysis Set with available data were analyzed. Here "n" signified number of participants analyzed for the specific timepoint and "99999"signified data were not applicable to be reported, since no participant was analyzed in the specific timepoint for the respective arm.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, 8, 12, 16, 20, 24
    End point values
    		 LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
    Number of subjects analysed
    45
    31
    19
    Units: percentage of participants
    number (confidence interval 95%)
        Week 2 (n= 45, 31, 19)
    84.4 (70.5 to 93.5)
    90.3 (74.2 to 98.0)
    84.2 (60.4 to 96.6)
        Week 4 (n= 44, 31, 19)
    100.0 (92.0 to 100.0)
    100.0 (88.8 to 100.0)
    100.0 (82.4 to 100.0)
        Week 6 (n= 44, 31, 19)
    100.0 (92.0 to 100.0)
    100.0 (88.8 to 100.0)
    94.7 (74.0 to 99.9)
        Week 8 (n= 44, 31, 18)
    100.0 (92.0 to 100.0)
    100.0 (88.8 to 100.0)
    100.0 (81.5 to 100.0)
        Week 12 (n= 0, 31, 17)
    99999 (99999 to 99999)
    100.0 (88.8 to 100.0)
    100.0 (80.5 to 100.0)
        Week 16 (n= 0, 0, 17)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    100.0 (80.5 to 100.0)
        Week 20 (n= 0, 0, 17)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    100.0 (80.5 to 100.0)
        Week 24 (n= 0, 0, 16)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    100.0 (79.4 to 100.0)
    No statistical analyses for this end point

    Secondary: Change From Baseline in HCV RNA

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    End point title
    		 Change From Baseline in HCV RNA
    End point description
    Participants in the Full Analysis Set with available data were analyzed. Here "n" signified number of participants analyzed for the specific timepoint and "99999"signified data were not applicable to be reported, since no participant was analyzed in the specific timepoint for the respective arm.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, 8, 12, 16, 20, 24
    End point values
    		 LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
    Number of subjects analysed
    44
    31
    19
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Change at Week 2 (n= 42, 31, 19)
    -4.63 ± 0.799
    -4.71 ± 0.894
    -4.67 ± 0.631
        Change at Week 4 (n= 44, 31, 19)
    -4.61 ± 0.805
    -4.79 ± 0.950
    -4.71 ± 0.631
        Change at Week 6 (n= 44, 31, 18)
    -4.61 ± 0.805
    -4.79 ± 0.950
    -4.81 ± 0.474
        Change at Week 8 (n= 44, 31, 18)
    -4.61 ± 0.805
    -4.79 ± 0.950
    -4.81 ± 0.474
        Change at Week 12 (n= 0, 31, 17)
    99999 ± 99999
    -4.79 ± 0.950
    -4.79 ± 0.480
        Change at Week 16 (n= 0, 0, 17)
    99999 ± 99999
    99999 ± 99999
    -4.79 ± 0.480
        Change at Week 20 (n= 0, 0, 17)
    99999 ± 99999
    99999 ± 99999
    -4.79 ± 0.480
        Change at Week 24 (n= 0, 0, 16)
    99999 ± 99999
    99999 ± 99999
    -4.75 ± 0.466
    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
    Virologic failure was defined as: • On-treatment virologic failure: • 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 • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) • Virologic relapse: • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last ontreatment visit. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline up to Posttreatment Week 24
    End point values
    		 LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
    Number of subjects analysed
    45
    31
    19
    Units: percentage of participants
        number (not applicable)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Developed Resistance to LDV and SOF

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    End point title
    		 Percentage of Participants Who Developed Resistance to LDV and SOF
    End point description
    The Resistance Analysis Population was defined as all participants in the Safety Analysis Set with a virologic outcome and at least 1 gene sequenced. As no participant had a relapse in this study, this outcome could not be analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline up to Posttreatment Week 24
    End point values
    		 LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
    Number of subjects analysed
    0 [3]
    0 [4]
    0 [5]
    Units: percentage of participants
        number (not applicable)
    Notes
    [3] - Since no participants had virologic outcome, hence, no participants were analyzed for the endpoint.
    [4] - Since no participants had virologic outcome, hence, no participants were analyzed for the endpoint.
    [5] - Since no participants had virologic outcome, hence, no participants were analyzed for the endpoint.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK) Parameter: AUCtau of LDV

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    End point title
    		 Pharmacokinetics (PK) Parameter: AUCtau of LDV
    End point description
    AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval. The PK Analysis Set included all participants who took at least 1 dose of the study drug and had at least 1 nonmissing postdose concentration value for the corresponding analyte in plasma.
    End point type
    Secondary
    End point timeframe
    Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))
    End point values
    		 LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
    Number of subjects analysed
    44
    31
    19
    Units: h*ng/mL
        arithmetic mean (standard deviation)
    11923.9 ± 6319.41
    13632.7 ± 4648.74
    13542.5 ± 6322.88
    No statistical analyses for this end point

    Secondary: PK Parameter: AUCtau of SOF

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    End point title
    		 PK Parameter: AUCtau of SOF
    End point description
    AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval. Participants in the PK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))
    End point values
    		 LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
    Number of subjects analysed
    24
    23
    12
    Units: h*ng/mL
        arithmetic mean (standard deviation)
    2435.4 ± 452.83
    2296.6 ± 583.30
    2838.2 ± 438.93
    No statistical analyses for this end point

    Secondary: PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)

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    End point title
    		 PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)
    End point description
    AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval. Participants in the PK Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))
    End point values
    		 LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
    Number of subjects analysed
    44
    31
    19
    Units: h*ng/mL
        arithmetic mean (standard deviation)
    234980.1 ± 67648.52
    269050.3 ± 93600.65
    280829.5 ± 93618.16
    No statistical analyses for this end point

    Secondary: PK Parameter: Cmax of LDV

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    End point title
    		 PK Parameter: Cmax of LDV
    End point description
    Cmax is defined as the population PK derived maximum concentration of the drug. Participants in the PK Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))
    End point values
    		 LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
    Number of subjects analysed
    44
    31
    19
    Units: ng/mL
        arithmetic mean (standard deviation)
    544.2 ± 271.72
    618.4 ± 204.87
    607.0 ± 267.38
    No statistical analyses for this end point

    Secondary: PK Parameter: Cmax of SOF

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    End point title
    		 PK Parameter: Cmax of SOF
    End point description
    Cmax is defined as the population PK derived maximum concentration of the drug. Participants in the PK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))
    End point values
    		 LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
    Number of subjects analysed
    24
    23
    12
    Units: ng/mL
        arithmetic mean (standard deviation)
    1059.8 ± 251.74
    1005.8 ± 204.54
    1052.5 ± 295.06
    No statistical analyses for this end point

    Secondary: PK Parameter: Cmax of GS-331007 (Metabolite of SOF)

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    End point title
    		 PK Parameter: Cmax of GS-331007 (Metabolite of SOF)
    End point description
    Cmax is defined as the population PK derived maximum concentration of the drug. Participants in the PK Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))
    End point values
    		 LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
    Number of subjects analysed
    44
    31
    19
    Units: ng/mL
        arithmetic mean (standard deviation)
    9956.3 ± 2846.07
    11392.7 ± 3938.33
    11882.4 ± 3951.04
    No statistical analyses for this end point

    Secondary: HCV-RNA

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    End point title
    		 HCV-RNA
    End point description
    Participants in the Full Analysis Set with available data were analyzed. Here "n" signified number of participants analyzed for the specific timepoint and "99999"signified data were not applicable to be reported, since no participant was analyzed in the specific timepoint for the respective arm.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, 8, 12, 16, 20, 24
    End point values
    		 LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
    Number of subjects analysed
    44
    31
    19
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Week 2 (n= 42, 31, 19)
    1.17 ± 0.107
    1.22 ± 0.261
    1.18 ± 0.098
        Week 4 (n= 44, 31, 19)
    1.15 ± 0.000
    1.15 ± 0.000
    1.15 ± 0.000
        Week 6 (n= 44, 31, 18)
    1.15 ± 0.000
    1.15 ± 0.000
    1.15 ± 0.000
        Week 8 (n= 44, 31, 18)
    1.15 ± 0.000
    1.15 ± 0.000
    1.15 ± 0.000
        Week 12 (n= 0, 31, 17)
    99999 ± 99999
    1.15 ± 0.000
    1.15 ± 0.000
        Week 16 (n= 0, 0, 17)
    99999 ± 99999
    99999 ± 99999
    1.15 ± 0.000
        Week 20 (n= 0, 0, 17)
    99999 ± 99999
    99999 ± 99999
    1.15 ± 0.000
        Week 24(n= 0, 0, 16)
    99999 ± 99999
    99999 ± 99999
    1.15 ± 0.000
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
    Adverse event reporting additional description
    The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    LDV/SOF for 8 Weeks
    Reporting group description
    		 Treatment-naive genotype 1 participants without cirrhosis received ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily orally with or without food for 8 weeks.

    Reporting group title
    LDV/SOF for 12 Weeks
    Reporting group description
    		 Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.

    Reporting group title
    LDV/SOF for 24 Weeks
    Reporting group description
    		 Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.

    Serious adverse events
    		 LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 45 (8.89%)
    2 / 31 (6.45%)
    6 / 19 (31.58%)
         number of deaths (all causes)
    3
    0
    3
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatocellular carcinoma
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 31 (3.23%)
    0 / 19 (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
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 31 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arteriovenous fistula site complication
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 31 (3.23%)
    0 / 19 (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
    Arteriovenous fistula thrombosis
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 31 (3.23%)
    0 / 19 (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
    Femur fracture
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 31 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Cardiac valve disease
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Gastrointestinal disorders
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 31 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic erosive gastritis
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         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
    Hepatitis acute
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Psychiatric disorders
    Mental status changes
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 31 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 31 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 31 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         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
    		 LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 45 (51.11%)
    28 / 31 (90.32%)
    15 / 19 (78.95%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 31 (3.23%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    1
    Hypotension
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 45 (6.67%)
    2 / 31 (6.45%)
    2 / 19 (10.53%)
         occurrences all number
    3
    2
    2
    Asthenia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 31 (0.00%)
    4 / 19 (21.05%)
         occurrences all number
    1
    0
    4
    Pyrexia
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 31 (3.23%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    1
    Chest discomfort
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 31 (3.23%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    3
    Chest pain
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 31 (3.23%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    1
    Influenza like illness
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 31 (3.23%)
    1 / 19 (5.26%)
         occurrences all number
    0
    2
    3
    Tenderness
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 45 (6.67%)
    3 / 31 (9.68%)
    0 / 19 (0.00%)
         occurrences all number
    3
    3
    0
    Dyspnoea
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 45 (2.22%)
    4 / 31 (12.90%)
    1 / 19 (5.26%)
         occurrences all number
    1
    4
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 45 (2.22%)
    2 / 31 (6.45%)
    3 / 19 (15.79%)
         occurrences all number
    2
    2
    3
    Fall
         subjects affected / exposed
    0 / 45 (0.00%)
    3 / 31 (9.68%)
    1 / 19 (5.26%)
         occurrences all number
    0
    3
    1
    Shunt occlusion
         subjects affected / exposed
    3 / 45 (6.67%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    3
    0
    4
    Limb injury
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 31 (3.23%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    2
    Muscle strain
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    1
    Concussion
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Ligament sprain
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Shunt stenosis
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 31 (3.23%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    1
    Atrial fibrillation
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Cardiac valve disease
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Myocardial ischaemia
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 45 (6.67%)
    3 / 31 (9.68%)
    2 / 19 (10.53%)
         occurrences all number
    4
    3
    2
    Dizziness
         subjects affected / exposed
    2 / 45 (4.44%)
    4 / 31 (12.90%)
    1 / 19 (5.26%)
         occurrences all number
    2
    5
    1
    Hypoaesthesia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 31 (3.23%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    2
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Conjunctival hyperaemia
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Glaucoma
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 45 (2.22%)
    4 / 31 (12.90%)
    1 / 19 (5.26%)
         occurrences all number
    1
    4
    2
    Nausea
         subjects affected / exposed
    4 / 45 (8.89%)
    1 / 31 (3.23%)
    1 / 19 (5.26%)
         occurrences all number
    5
    1
    1
    Vomiting
         subjects affected / exposed
    4 / 45 (8.89%)
    1 / 31 (3.23%)
    1 / 19 (5.26%)
         occurrences all number
    4
    1
    1
    Diarrhoea
         subjects affected / exposed
    2 / 45 (4.44%)
    2 / 31 (6.45%)
    0 / 19 (0.00%)
         occurrences all number
    2
    2
    0
    Abdominal distension
         subjects affected / exposed
    0 / 45 (0.00%)
    2 / 31 (6.45%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Hyperchlorhydria
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Large intestine polyp
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 45 (2.22%)
    3 / 31 (9.68%)
    3 / 19 (15.79%)
         occurrences all number
    1
    3
    4
    Rash
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 31 (3.23%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    1
    Ecchymosis
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    2
    Rash papular
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Skin exfoliation
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    1 / 45 (2.22%)
    7 / 31 (22.58%)
    4 / 19 (21.05%)
         occurrences all number
    1
    12
    5
    Arthralgia
         subjects affected / exposed
    2 / 45 (4.44%)
    1 / 31 (3.23%)
    1 / 19 (5.26%)
         occurrences all number
    2
    1
    1
    Arthritis
         subjects affected / exposed
    0 / 45 (0.00%)
    2 / 31 (6.45%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 31 (3.23%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Myalgia
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 45 (6.67%)
    7 / 31 (22.58%)
    1 / 19 (5.26%)
         occurrences all number
    3
    9
    1
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 45 (4.44%)
    3 / 31 (9.68%)
    0 / 19 (0.00%)
         occurrences all number
    2
    4
    0
    Cellulitis
         subjects affected / exposed
    0 / 45 (0.00%)
    2 / 31 (6.45%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    Shunt infection
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    1
    Clostridial infection
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Peritonitis bacterial
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 31 (3.23%)
    1 / 19 (5.26%)
         occurrences all number
    0
    2
    1
    Hyperkalaemia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 31 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Nov 2016
    - Update to the hemodialysis PK substudy design (removal of dialysate collection) - Clarification of the study drug dispensing schedules - Clarification of collection of information relating to PK samples, including time of prior dosing and time of prior dialysis. - Addition of an inclusion criterion that the most recent HCV treatment must have been completed at least 8 weeks prior to screening
    30 Jan 2017
    - Addition of hepatitis B core antibody (HBcAb) and hepatitis B surface antibody (HBsAb) testing at screening and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) testing for HBcAb+ participants at baseline/Day 1, every 4 weeks on-treatment and at posttreatment Weeks 4, 12 and 24 - Change and clarification for timing of Data Monitoring Committee (DMC) meetings: initial review of data after the first 12 subjects completed 8 weeks of treatment, or early termination, and every 3 months thereafter. These subsequent safety reviews were to alternate between: -A review by the DMC chair of all serious adverse events (SAEs) and deaths -A review of safety data by the DMC meeting as specified in the DMC charter - Addition of North America as a participating region, and an increase in the number of centers from approximately 35 to approximately 40 - Addition of ClinicalTrials.gov identifier and IND number to the protocol cover page and synopsis - Addition of the term ‘on dialysis for ESRD’ to the exploratory objectives to keep consistency with the protocol title
    02 Mar 2017
    -Communication to investigators the potential for hematologic toxicity associated with higher exposure of GS-331007, a metabolite of SOF.

    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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