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    Clinical Trial Results:
    A Long Term Follow-up Registry of Subjects Who Did Not Achieve Sustained Virologic Response in Gilead-Sponsored Trials in Subjects with Chronic Hepatitis C Infection

    Summary
    EudraCT number
    		 2011-000946-39
    Trial protocol
    		 DE   GB   FR   CZ   HU   PL   IT   AT   SE   ES   EE   NL   BE  
    Global end of trial date
    09 Apr 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Apr 2019
    First version publication date
    20 Apr 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-248-0123
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01457768
    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
    09 Apr 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Apr 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Apr 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate hepatitis C virus (HCV) viral sequences and the persistence or evolution of treatment-emergent viral mutations in participants who fail to achieve a sustained viral response (SVR) after treatment with a Gilead oral antiviral (OAV) containing regimen in a previous Gilead-sponsored hepatitis C study.
    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
    19 Dec 2011
    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
    United States: 403
    Country: Number of subjects enrolled
    Australia: 38
    Country: Number of subjects enrolled
    Canada: 33
    Country: Number of subjects enrolled
    Puerto Rico: 16
    Country: Number of subjects enrolled
    New Zealand: 15
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    United Kingdom: 8
    Country: Number of subjects enrolled
    Czech Republic: 3
    Country: Number of subjects enrolled
    Estonia: 1
    Country: Number of subjects enrolled
    France: 11
    Country: Number of subjects enrolled
    Germany: 22
    Country: Number of subjects enrolled
    Italy: 2
    Worldwide total number of subjects
    567
    EEA total number of subjects
    62
    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)
    530
    From 65 to 84 years
    37
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in the United States, Australia, Canada, New Zealand, and Europe. The first participant was screened on 19 December 2011. The last study visit occurred on 09 April 2018.

    Pre-assignment
    Screening details
    		 570 participants consented to participate the study. Three participants who did not have at least 1 postenrollment visit were excluded from all analyses.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SOF+RBV±PEG
    Arm description
    		 Participants previously received sofosbuvir (SOF) + ribavirin (RBV) with or without pegylated interferon (PEG).
    Arm type
    		 Observational

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    SOF, Sovaldi®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    No treatment was administered in this observational study. Participants received SOF in a previous Gilead-sponsored study.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    RBV
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    No treatment was administered in this observational study. Participants received RBV in a previous Gilead-sponsored study.

    Investigational medicinal product name
    Pegylated interferon
    Investigational medicinal product code
    Other name
    PEG
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    No treatment was administered in this observational study. Participants received PEG in a previous Gilead-sponsored study.

    Arm title
    		 LDV/SOF±RBV
    Arm description
    		 Participants previously received ledipasvir/sofosbuvir (LDV/SOF) with or without RBV.
    Arm type
    		 Observational

    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
    No treatment was administered in this observational study. Participants received LDV/SOF in a previous Gilead-sponsored study.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    RBV
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    No treatment was administered in this observational study. Participants received RBV in a previous Gilead-sponsored study.

    Arm title
    		 SOF/VEL±RBV
    Arm description
    		 Participants previously received sofosbuvir/velpatasvir (SOF/VEL) with or without RBV.
    Arm type
    		 Observational

    Investigational medicinal product name
    Sofosbuvir/velpatasvir
    Investigational medicinal product code
    Other name
    SOF/VEL, Epclusa®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    No treatment was administered in this observational study. Participants received SOF/VEL in a previous Gilead-sponsored study.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    RBV
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    No treatment was administered in this observational study. Participants received RBV in a previous Gilead-sponsored study.

    Arm title
    		 SOF/VEL/VOX
    Arm description
    		 Participants previously received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX).
    Arm type
    		 Observational

    Investigational medicinal product name
    Sofosbuvir/velpatasvir/voxilaprevir
    Investigational medicinal product code
    Other name
    SOF/VEL/VOX, Vosevi®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    No treatment was administered in this observational study. Participants received SOF/VEL/VOX in a previous Gilead-sponsored study.

    Arm title
    		 Other
    Arm description
    		 Participants previously received other HCV treatment. Other HCV treatment included SOF and products other than those in above arms.
    Arm type
    		 Observational

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		SOF+RBV±PEG LDV/SOF±RBV SOF/VEL±RBV SOF/VEL/VOX Other
    Started
    254
    34
    52
    22
    205
    Completed
    29
    1
    2
    0
    56
    Not completed
    225
    33
    50
    22
    149
         Subject withdrew consent
    14
    4
    4
    2
    21
         Signed consent but did not meet eligibility
    2
    -
    -
    -
    -
         Death
    2
    1
    1
    -
    1
         Study discontinued
    2
    -
    -
    -
    3
         Investigator decision
    1
    -
    -
    2
    1
         Started anti-viral therapy for HCV
    183
    23
    44
    17
    103
         Lost to follow-up
    21
    5
    1
    1
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SOF+RBV±PEG
    Reporting group description
    		 Participants previously received sofosbuvir (SOF) + ribavirin (RBV) with or without pegylated interferon (PEG).

    Reporting group title
    LDV/SOF±RBV
    Reporting group description
    		 Participants previously received ledipasvir/sofosbuvir (LDV/SOF) with or without RBV.

    Reporting group title
    SOF/VEL±RBV
    Reporting group description
    		 Participants previously received sofosbuvir/velpatasvir (SOF/VEL) with or without RBV.

    Reporting group title
    SOF/VEL/VOX
    Reporting group description
    		 Participants previously received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX).

    Reporting group title
    Other
    Reporting group description
    		 Participants previously received other HCV treatment. Other HCV treatment included SOF and products other than those in above arms.

    Reporting group values
    		 SOF+RBV±PEG LDV/SOF±RBV SOF/VEL±RBV SOF/VEL/VOX Other Total
    Number of subjects
    		 254 34 52 22 205 567
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 52 ± 8.5 59 ± 6.7 57 ± 6.1 58 ± 7.1 55 ± 7.2 -
    Gender categorical
    Units: Subjects
        Female
    		 45 1 9 5 65 125
        Male
    		 209 33 43 17 140 442
    Race
    Units: Subjects
        Black or African American
    		 26 9 5 3 30 73
        White
    		 213 24 46 18 171 472
        Asian
    		 6 0 0 0 4 10
        American Indian or Alaska Native
    		 5 0 0 0 0 5
        Native Hawaiian or Pacific Islander
    		 2 1 0 0 0 3
        Other
    		 2 0 1 1 0 4
        Not Disclosed
    		 0 0 0 0 0 0
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 33 2 7 2 21 65
        Not Hispanic or Latino
    		 220 32 45 20 182 499
        Not Reported
    		 1 0 0 0 2 3

    End points

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    End points reporting groups
    Reporting group title
    SOF+RBV±PEG
    Reporting group description
    		 Participants previously received sofosbuvir (SOF) + ribavirin (RBV) with or without pegylated interferon (PEG).

    Reporting group title
    LDV/SOF±RBV
    Reporting group description
    		 Participants previously received ledipasvir/sofosbuvir (LDV/SOF) with or without RBV.

    Reporting group title
    SOF/VEL±RBV
    Reporting group description
    		 Participants previously received sofosbuvir/velpatasvir (SOF/VEL) with or without RBV.

    Reporting group title
    SOF/VEL/VOX
    Reporting group description
    		 Participants previously received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX).

    Reporting group title
    Other
    Reporting group description
    		 Participants previously received other HCV treatment. Other HCV treatment included SOF and products other than those in above arms.

    Subject analysis set title
    SOF+RBV±PEG: Cirrhotic Participants
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who previously received SOF+RBV±PEG and had cirrhosis at the parent study baseline were included in this analysis set.

    Subject analysis set title
    LDV/SOF±RBV: Cirrhotic Participants
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who previously received LDV/SOF±RBV and had cirrhosis at the parent study baseline were included in this analysis set.

    Subject analysis set title
    SOF/VEL±RBV: Cirrhotic Participants
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who previously received SOF/VEL±RBV and had cirrhosis at the parent study baseline were included in this analysis set.

    Subject analysis set title
    SOF/VEL/VOX: Cirrhotic Participants
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who previously received SOF/VEL/VOX and had cirrhosis at the parent study baseline were included in this analysis set.

    Subject analysis set title
    Other: Cirrhotic Participants
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who previously received other HCV treatment and had cirrhosis at the parent study baseline were included in this analysis set.

    Subject analysis set title
    All Cirrhotic Participants
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who had cirrhosis at the parent study baseline were included in this analysis set.

    Subject analysis set title
    SOF+RBV±PEG: Non-Cirrhotic Participants
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who previously received SOF+RBV±PEG and did not have cirrhosis (including participants with unknown cirrhosis status) at the parent study baseline were included in this analysis set.

    Subject analysis set title
    LDV/SOF±RBV: Non-Cirrhotic Participants
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who previously received LDV/SOF±RBV and did not have cirrhosis (including participants with unknown cirrhosis status) at the parent study baseline were included in this analysis set.

    Subject analysis set title
    SOF/VEL±RBV: Non-Cirrhotic Participants
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who previously received SOF/VEL±RBV and did not have cirrhosis (including participants with unknown cirrhosis status) at the parent study baseline were included in this analysis set.

    Subject analysis set title
    SOF/VEL/VOX: Non-Cirrhotic Participants
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who previously received SOF/VEL/VOX and did not have cirrhosis (including participants with unknown cirrhosis status) at the parent study baseline were included in this analysis set.

    Subject analysis set title
    Other: Non-Cirrhotic Participants
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who previously received other HCV treatment and did not have cirrhosis (including participants with unknown cirrhosis status) at the parent study baseline were included in this analysis set.

    Subject analysis set title
    All Non-Cirrhotic Participants
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who did not have cirrhosis (including participants with unknown cirrhosis status) at the parent study baseline were included in this analysis set.

    Primary: Percentage of Participants With at Least 1 Resistance-Associated Variant (RAV) Loss

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    End point title
    		 Percentage of Participants With at Least 1 Resistance-Associated Variant (RAV) Loss [1]
    End point description
    The RAV count was defined as the count of any RAV that was not detected at baseline of the parent study for a participant, but was detected in any other visit. The total RAV count was defined as the sum of the RAV counts across all 3 HCV genes (NS5A, NS5B, and NS3) for a visit. The cumulative RAV count was defined as the union of the RAV counts across all visits from relapse for an HCV gene. The total cumulative RAV count was defined as the sum of the cumulative RAV counts across all 3 HCV genes. RAV loss was defined as the cumulative RAV count minus the last RAV count with value of ≥ 0. Participants in the Virological Analysis Set (participants with virology data from time of failure in the most recent treatment protocol [including participants with attempted sequencing but failed, and participants who are indicated as with no data available at a specific time point]) with total cumulative RAV count ≥ 1 and RAV count ≥ 0 in at least 1 of the HCV genes were included in the analysis.
    End point type
    Primary
    End point timeframe
    Enrollment to End of Study (up to 3 years)
    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
    		 SOF+RBV±PEG LDV/SOF±RBV SOF/VEL±RBV SOF/VEL/VOX Other
    Number of subjects analysed
    10
    18
    23
    2
    165
    Units: Percentage of Participants
        number (not applicable)
    70.0
    22.2
    30.4
    50.0
    75.2
    No statistical analyses for this end point

    Secondary: Percentage of Participants with RAV Loss by Unit Category

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    End point title
    		 Percentage of Participants with RAV Loss by Unit Category
    End point description
    RAV loss was defined as the cumulative RAV count minus the last RAV count with value of equal to or greater than 0. Percentage of participants with at least X RAV loss = (number of participants with at least X RAV loss divided by the number of participants with cumulative RAV count ≥ X) multiplied by 100. Participants in the Virological Analysis Set with total cumulative RAV count ≥ 1 and RAV count ≥ 0 in at least 1 of the HCV genes and with available data were analyzed. The value 99999 signifies that no participants were evaluable in the specified unit category, for indicated arm.
    End point type
    Secondary
    End point timeframe
    Enrollment to End of Study (up to 3 years)
    End point values
    		 SOF+RBV±PEG LDV/SOF±RBV SOF/VEL±RBV SOF/VEL/VOX Other
    Number of subjects analysed
    10
    18
    23
    2
    165
    Units: Percentage of Participants
    number (not applicable)
        1 RAV Loss (n = 10, 18, 23, 2, 165)
    70.0
    22.2
    30.4
    50.0
    75.2
        2 RAV Loss (n = 0, 8, 5, 1, 151)
    99999
    25.0
    20.0
    0.0
    64.9
        3 RAV Loss (n = 0, 3, 0, 0, 114)
    99999
    0.0
    99999
    99999
    58.8
        4 RAV Loss (n = 0, 1, 0, 0, 97)
    99999
    0.0
    99999
    99999
    44.3
        5 RAV Loss (n = 0, 0, 0, 0, 65)
    99999
    99999
    99999
    99999
    29.2
        6 RAV Loss (n = 0, 0, 0, 0, 36)
    99999
    99999
    99999
    99999
    33.3
        7 RAV Loss (n = 0, 0, 0, 0, 21)
    99999
    99999
    99999
    99999
    42.9
        8 RAV Loss (n = 0, 0, 0, 0, 9)
    99999
    99999
    99999
    99999
    44.4
        9 RAV Loss (n = 0, 0, 0, 0, 7)
    99999
    99999
    99999
    99999
    14.3
        10 RAV Loss (n = 0, 0, 0, 0, 4)
    99999
    99999
    99999
    99999
    25.0
    No statistical analyses for this end point

    Secondary: Average Number of RAV Loss

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    End point title
    		 Average Number of RAV Loss
    End point description
    RAV loss was defined as the cumulative RAV count minus the last RAV count with value of ≥ 0. Average number of RAV loss = total number of RAV loss divided by number of participants with total cumulative RAV count ≥ 1 and RAV count ≥ 0 in at least 1 of the HCV genes. Participants in the Virological Analysis Set with total cumulative RAV count ≥ 1 and RAV count ≥ 0 in at least 1 of the HCV genes were analyzed.
    End point type
    Secondary
    End point timeframe
    Enrollment to End of Study (up to 3 years)
    End point values
    		 SOF+RBV±PEG LDV/SOF±RBV SOF/VEL±RBV SOF/VEL/VOX Other
    Number of subjects analysed
    10
    18
    23
    2
    165
    Units: RAV loss
        number (not applicable)
    0.7
    0.3
    0.3
    0.5
    2.3
    No statistical analyses for this end point

    Secondary: Liver Disease Progression, as Assessed by Percentage of Participants Experiencing Jaundice

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    End point title
    		 Liver Disease Progression, as Assessed by Percentage of Participants Experiencing Jaundice
    End point description
    Participants in the Full Analysis Set (all participants with at least 1 post-enrollment visit who have previously participated in a Gilead-sponsored HCV study, received at least 1 Gilead OAV and failed to achieve SVR, as defined in the original treatment protocol) with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 24, 36, 48, 96, and 144
    End point values
    		 All Cirrhotic Participants All Non-Cirrhotic Participants
    Number of subjects analysed
    140
    427
    Units: Percentage of Participants
    number (not applicable)
        Baseline (n = 139, 422)
    3.6
    0.0
        Week 12 (n = 108, 363)
    0.0
    0.0
        Week 24 (n = 102, 338)
    2.9
    0.0
        Week 36 (n = 71, 275)
    0.0
    0.0
        Week 48 (n = 55, 233)
    0.0
    0.0
        Week 96 (n = 17, 154)
    5.9
    0.0
        Week 144 (n = 10, 90)
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Liver Disease Progression, as Assessed by Percentage of Participants Experiencing Ascites

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    End point title
    		 Liver Disease Progression, as Assessed by Percentage of Participants Experiencing Ascites
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 24, 36, 48, 96, and 144
    End point values
    		 All Cirrhotic Participants All Non-Cirrhotic Participants
    Number of subjects analysed
    140
    427
    Units: Percentage of Participants
    number (not applicable)
        Baseline (n = 139, 422)
    5.8
    0.0
        Week 12 (n = 108, 363)
    6.5
    0.0
        Week 24 (n = 102, 338)
    4.9
    0.0
        Week 36 (n = 71, 275)
    2.8
    0.0
        Week 48 (n = 55, 233)
    5.5
    0.4
        Week 96 (n = 17, 154)
    11.8
    0.6
        Week 144 (n = 10, 90)
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Liver Disease Progression, as Assessed by Percentage of Participants Experiencing Hepatic Encephalopathy

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    End point title
    		 Liver Disease Progression, as Assessed by Percentage of Participants Experiencing Hepatic Encephalopathy
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 24, 36, 48, 96, and 144
    End point values
    		 All Cirrhotic Participants All Non-Cirrhotic Participants
    Number of subjects analysed
    140
    427
    Units: Percentage of Participants
    number (not applicable)
        Baseline (n = 139, 422)
    4.3
    0.7
        Week 12 (n = 108, 363)
    5.6
    0.0
        Week 24 (n = 102, 338)
    5.9
    0.0
        Week 36 (n = 71, 275)
    4.2
    0.0
        Week 48 (n = 55, 233)
    7.3
    0.4
        Week 96 (n = 17, 154)
    11.8
    0.0
        Week 144 (n = 10, 90)
    10.0
    0.0
    No statistical analyses for this end point

    Secondary: Liver Disease Progression, as Assessed by Percentage of Participants Experiencing Varices

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    End point title
    		 Liver Disease Progression, as Assessed by Percentage of Participants Experiencing Varices
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 24, 36, 48, 96, and 144
    End point values
    		 All Cirrhotic Participants All Non-Cirrhotic Participants
    Number of subjects analysed
    140
    427
    Units: Percentage of Participants
    number (not applicable)
        Baseline (n = 139, 422)
    11.5
    0.0
        Week 12 (n = 108, 363)
    5.6
    0.0
        Week 24 (n = 102, 338)
    3.9
    0.0
        Week 36 (n = 71, 275)
    4.2
    0.4
        Week 48 (n = 55, 233)
    10.9
    0.0
        Week 96 (n = 17, 154)
    11.8
    1.3
        Week 144 (n = 10, 90)
    10.0
    0.0
    No statistical analyses for this end point

    Secondary: Liver Disease Progression, as Assessed by Percentage of Participants Experiencing Other Events Related to Liver Disease Progression Such as Transplantation

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    End point title
    		 Liver Disease Progression, as Assessed by Percentage of Participants Experiencing Other Events Related to Liver Disease Progression Such as Transplantation
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 24, 36, 48, 96, and 144
    End point values
    		 All Cirrhotic Participants All Non-Cirrhotic Participants
    Number of subjects analysed
    140
    427
    Units: Percentage of Participants
    number (not applicable)
        Baseline (n = 139, 422)
    0.0
    0.5
        Week 12 (n = 108, 363)
    0.0
    0.3
        Week 24 (n = 102, 338)
    0.0
    0.3
        Week 36 (n = 71, 275)
    0.0
    0.4
        Week 48 (n = 55, 233)
    1.8
    0.0
        Week 96 (n = 17, 154)
    0.0
    0.0
        Week 144 (n = 10, 90)
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Liver Disease Progression, as Assessed by Percentage of Participants Experiencing Clinically Meaningful Changes from Registry Baseline in Any Laboratory Parameters

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    End point title
    		 Liver Disease Progression, as Assessed by Percentage of Participants Experiencing Clinically Meaningful Changes from Registry Baseline in Any Laboratory Parameters
    End point description
    Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Enrollment to End of Study (up to 3 years)
    End point values
    		 All Cirrhotic Participants All Non-Cirrhotic Participants
    Number of subjects analysed
    140
    427
    Units: Percentage of Participants
        number (not applicable)
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Developed Hepatocellular Carcinoma (HCC) Through Week 144

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    End point title
    		 Percentage of Participants who Developed Hepatocellular Carcinoma (HCC) Through Week 144
    End point description
    Percentage of participants who developed HCC was estimated by Kaplan-Meier estimate of the proportion of participants with HCC event by the time point. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 24, 36, 48, 96, and 144
    End point values
    		 SOF+RBV±PEG: Cirrhotic Participants LDV/SOF±RBV: Cirrhotic Participants SOF/VEL±RBV: Cirrhotic Participants SOF/VEL/VOX: Cirrhotic Participants Other: Cirrhotic Participants All Cirrhotic Participants SOF+RBV±PEG: Non-Cirrhotic Participants LDV/SOF±RBV: Non-Cirrhotic Participants SOF/VEL±RBV: Non-Cirrhotic Participants SOF/VEL/VOX: Non-Cirrhotic Participants Other: Non-Cirrhotic Participants All Non-Cirrhotic Participants
    Number of subjects analysed
    79
    18
    29
    11
    3
    140
    175
    16
    23
    11
    202
    427
    Units: Percentage of Participants
    number (not applicable)
        Baseline
    0.00
    0.00
    0.00
    0.00
    0.00
    0.00
    0.00
    0.00
    0.00
    0.00
    0.00
    0.00
        Week 12
    2.53
    5.56
    0.00
    0.00
    0.00
    2.14
    0.00
    0.00
    0.00
    0.00
    0.00
    0.00
        Week 24
    3.92
    5.56
    0.00
    0.00
    0.00
    2.98
    0.67
    0.00
    0.00
    0.00
    0.00
    0.27
        Week 36
    3.92
    5.56
    0.00
    0.00
    0.00
    2.98
    0.67
    0.00
    0.00
    0.00
    0.00
    0.27
        Week 48
    3.92
    5.56
    0.00
    0.00
    0.00
    2.98
    0.67
    0.00
    0.00
    0.00
    0.00
    0.27
        Week 96
    9.58
    5.56
    0.00
    0.00
    0.00
    6.71
    0.67
    0.00
    0.00
    0.00
    0.00
    0.27
        Week 144
    27.7
    5.56
    0.00
    0.00
    0.00
    20.0
    3.28
    0.00
    0.00
    0.00
    0.00
    0.98
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Participants were not provided study drug in this registry study. There were no treatment-emergent adverse events (AEs) or serious adverse events (SAEs).
    Adverse event reporting additional description
    Safety Analysis Set included all participants with at least 1 post-enrollment visit who have previously participated in a Gilead-sponsored HCV study, received at least 1 Gilead OAV and failed to achieve SVR, as defined in the original treatment protocol.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 No Dictionary
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    SOF+RBV±PEG
    Reporting group description
    		 Participants previously received sofosbuvir (SOF) + ribavirin (RBV) with or without pegylated interferon (PEG).

    Reporting group title
    LDV/SOF±RBV
    Reporting group description
    		 Participants previously received ledipasvir/sofosbuvir (LDV/SOF) with or without RBV.

    Reporting group title
    SOF/VEL±RBV
    Reporting group description
    		 Participants previously received sofosbuvir/velpatasvir (SOF/VEL) with or without RBV.

    Reporting group title
    SOF/VEL/VOX
    Reporting group description
    		 Participants previously received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX).

    Reporting group title
    Other
    Reporting group description
    		 Participants previously received other HCV treatment. Other HCV treatment included SOF and products other than those in above arms.

    Serious adverse events
    		 SOF+RBV±PEG LDV/SOF±RBV SOF/VEL±RBV SOF/VEL/VOX Other
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 254 (0.00%)
    0 / 34 (0.00%)
    0 / 52 (0.00%)
    0 / 22 (0.00%)
    0 / 205 (0.00%)
         number of deaths (all causes)
    2
    1
    1
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 SOF+RBV±PEG LDV/SOF±RBV SOF/VEL±RBV SOF/VEL/VOX Other
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 254 (0.00%)
    0 / 34 (0.00%)
    0 / 52 (0.00%)
    0 / 22 (0.00%)
    0 / 205 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Participants were not provided study drug in this registry study. There were no treatment-emergent adverse events (AEs) or serious adverse events (SAEs).

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Jun 2012
    In this amendment, a quality of life survey was added to all study visits in Study GS-US-248-0123. Also, it was clarified that the detection of a drug resistant mutation (DRM) is no longer an inclusion criterion and the absence of a DRM is no longer a discontinuation criterion.
    02 Dec 2014
    The purpose of this amendment was to provide clarification to the protocol text that individual participants may be discontinued at the sponsor’s discretion.

    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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