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    Clinical Trial Results:
    A Long-Term Follow-up Study of Subjects Who Participated in a Clinical Trial in Which Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) was Administered for the Treatment of Chronic Hepatitis C

    Summary
    EudraCT number
    		 2011-005287-21
    Trial protocol
    		 DE   IE   SE   IT   GB   DK   ES  
    Global end of trial date
    16 Mar 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Apr 2022
    First version publication date
    18 Apr 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    AI444-046
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01492504
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.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
    03 May 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the durability of virologic response in subjects previously treated with asunaprevir and/or daclatasvir who achieved Sustained Virologic Response (SVR12) in the previous study.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Feb 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 54
    Country: Number of subjects enrolled
    Australia: 54
    Country: Number of subjects enrolled
    Brazil: 9
    Country: Number of subjects enrolled
    Canada: 110
    Country: Number of subjects enrolled
    Denmark: 16
    Country: Number of subjects enrolled
    France: 270
    Country: Number of subjects enrolled
    Germany: 52
    Country: Number of subjects enrolled
    Ireland: 12
    Country: Number of subjects enrolled
    Italy: 50
    Country: Number of subjects enrolled
    Japan: 246
    Country: Number of subjects enrolled
    Korea, Republic of: 29
    Country: Number of subjects enrolled
    Mexico: 16
    Country: Number of subjects enrolled
    Poland: 11
    Country: Number of subjects enrolled
    Puerto Rico: 18
    Country: Number of subjects enrolled
    Spain: 74
    Country: Number of subjects enrolled
    Sweden: 23
    Country: Number of subjects enrolled
    Taiwan: 15
    Country: Number of subjects enrolled
    United Kingdom: 19
    Country: Number of subjects enrolled
    United States: 628
    Worldwide total number of subjects
    1706
    EEA total number of subjects
    508
    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)
    1426
    From 65 to 84 years
    280
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 1706 participants completed the follow up period from the parent study and were eligible for AI444046

    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
    		 DCV 3DAA +/- R
    Arm description
    		 Daclatasvir (DCV) in combination with asunaprevir (ASV) and beclabuvir (BCV), BMS-791325, NS5B Polymerase Inhibitor) with or without ribavirin (RBV). (Parent studies AI443014, AI443102, AI443113, and AI443123)
    Arm type
    		 No Intervention

    Investigational medicinal product name
    No Intervention
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    No intervention - System limitation pharmaceutical form and route of administration must be filled in below. Capsule and oral administration used as placeholder.

    Arm title
    		 DCV + ASV
    Arm description
    		 Daclatasvir (DCV) in combination with asunaprevir (ASV). (Parent studies AI444026, AI447011, AI447017, AI447026, and AI447028)
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 DCV + ASV + P/R
    Arm description
    		 Daclatasvir/asunaprevir (DCV/ASV) plus peginterferon a-2a (pegIFNa-2a)/ ribavirin (RBV). (Parent study AI444026, AI447011, and AI447029); includes DCV/ASV plus RBV (Group B3 in parent study AI447011, N = 4)
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 DCV + SOF +/- R
    Arm description
    		 Daclatasvir (DCV) in combination with sofosbuvi (SOF) (with or without ribavirin (RBV)) (Parent study AI444040, AI444215, AI444216, and AI444218)
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 DCV + P/R
    Arm description
    		 Daclatasvir (DCV) plus pegIFNa-2a/ribavirin (RBV) (Parent studies AI444010, AI444011, AI444014, AI444026, AI444031, AI444038, AI444042, AI444043, and AI444052)
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 ASV + P/R
    Arm description
    		 Asunaprevir (ASV) plus pegIFNa-2a/ribavirin (RBV) (Parent study AI447016)
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Comparator + P/R
    Arm description
    		 Comparator/pegIFNa-2a/ribavirin (RBV) (Parent studies AI444010, AI444011, AI444014, AI444031, AI444042, and AI447016) Comparator includes placebo (PBO) or telaprevir (TVR)
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Rescue/Re-trt
    Arm description
    		 Rescue therapy (daclatasvir/asunaprevir (DCV/ASV) plus pegIFNa-2a or pegIFNa-2b/ribavirin (RBV) after virologic non-response to DCV/ASV. (Parent studies AI444040, AI447011, AI447026, and AI447028 or DCV/ASV/RBV [Group B3 in parent study AI447011, N = 3] therapy administered for a subset of subjects.)
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		DCV 3DAA +/- R DCV + ASV DCV + ASV + P/R DCV + SOF +/- R DCV + P/R ASV + P/R Comparator + P/R Rescue/Re-trt
    Started
    265
    389
    199
    263
    410
    94
    63
    23
    Completed
    196
    351
    158
    177
    294
    76
    44
    13
    Not completed
    69
    38
    41
    86
    116
    18
    19
    10
         Participant No Longer Meets Study Criteria
    3
    6
    7
    9
    43
    4
    2
    4
         Other Reasons
    13
    2
    2
    5
    7
    1
    5
    2
         Death
    2
    7
    2
    4
    5
    2
    -
    -
         Lost to follow-up
    21
    10
    9
    25
    33
    9
    6
    -
         Participant Withdrew Consent
    29
    13
    21
    23
    28
    2
    6
    1
         Administrative Reason by Sponsor
    1
    -
    -
    20
    -
    -
    -
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DCV 3DAA +/- R
    Reporting group description
    		 Daclatasvir (DCV) in combination with asunaprevir (ASV) and beclabuvir (BCV), BMS-791325, NS5B Polymerase Inhibitor) with or without ribavirin (RBV). (Parent studies AI443014, AI443102, AI443113, and AI443123)

    Reporting group title
    DCV + ASV
    Reporting group description
    		 Daclatasvir (DCV) in combination with asunaprevir (ASV). (Parent studies AI444026, AI447011, AI447017, AI447026, and AI447028)

    Reporting group title
    DCV + ASV + P/R
    Reporting group description
    		 Daclatasvir/asunaprevir (DCV/ASV) plus peginterferon a-2a (pegIFNa-2a)/ ribavirin (RBV). (Parent study AI444026, AI447011, and AI447029); includes DCV/ASV plus RBV (Group B3 in parent study AI447011, N = 4)

    Reporting group title
    DCV + SOF +/- R
    Reporting group description
    		 Daclatasvir (DCV) in combination with sofosbuvi (SOF) (with or without ribavirin (RBV)) (Parent study AI444040, AI444215, AI444216, and AI444218)

    Reporting group title
    DCV + P/R
    Reporting group description
    		 Daclatasvir (DCV) plus pegIFNa-2a/ribavirin (RBV) (Parent studies AI444010, AI444011, AI444014, AI444026, AI444031, AI444038, AI444042, AI444043, and AI444052)

    Reporting group title
    ASV + P/R
    Reporting group description
    		 Asunaprevir (ASV) plus pegIFNa-2a/ribavirin (RBV) (Parent study AI447016)

    Reporting group title
    Comparator + P/R
    Reporting group description
    		 Comparator/pegIFNa-2a/ribavirin (RBV) (Parent studies AI444010, AI444011, AI444014, AI444031, AI444042, and AI447016) Comparator includes placebo (PBO) or telaprevir (TVR)

    Reporting group title
    Rescue/Re-trt
    Reporting group description
    		 Rescue therapy (daclatasvir/asunaprevir (DCV/ASV) plus pegIFNa-2a or pegIFNa-2b/ribavirin (RBV) after virologic non-response to DCV/ASV. (Parent studies AI444040, AI447011, AI447026, and AI447028 or DCV/ASV/RBV [Group B3 in parent study AI447011, N = 3] therapy administered for a subset of subjects.)

    Reporting group values
    		 DCV 3DAA +/- R DCV + ASV DCV + ASV + P/R DCV + SOF +/- R DCV + P/R ASV + P/R Comparator + P/R Rescue/Re-trt Total
    Number of subjects
    		 265 389 199 263 410 94 63 23 1706
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    		 229 239 180 230 383 84 60 21 1426
        From 65-84 years
    		 36 150 19 33 27 10 3 2 280
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55.8 ± 9.16 60.3 ± 10.88 53.7 ± 8.94 55.9 ± 9.22 51.4 ± 9.38 50.8 ± 10.18 51.3 ± 8.23 57.7 ± 7.37 -
    Gender Categorical
    Units: Subjects
        Female
    		 85 235 60 88 143 30 21 11 673
        Male
    		 180 154 139 175 267 64 42 12 1033
    Race
    Units: Subjects
        White
    		 229 103 162 216 352 83 58 11 1214
        Black/African American
    		 28 11 22 34 30 6 3 4 138
        Asian Indian
    		 0 0 0 3 2 0 0 0 5
        Chinese
    		 1 15 0 0 3 0 0 0 19
        Japanese
    		 0 238 0 0 1 0 0 8 247
        Korean
    		 0 15 14 1 0 0 0 0 30
        Asian Other
    		 3 3 0 4 8 2 1 0 21
        American Indian/ Alaskan Native
    		 2 0 0 1 1 0 1 0 5
        Native Hawaiian/ Other Pacific
    		 1 0 0 1 0 0 0 0 2
        Other
    		 1 4 1 3 13 3 0 0 25
    Ethnicity
    Units: Subjects
        Hispanic/ Latino
    		 26 5 16 54 55 24 9 2 191
        Not Hispanic/ Latino
    		 235 348 178 209 350 65 47 21 1453
        Not Reported
    		 4 36 5 0 5 5 7 0 62

    End points

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    End points reporting groups
    Reporting group title
    DCV 3DAA +/- R
    Reporting group description
    		 Daclatasvir (DCV) in combination with asunaprevir (ASV) and beclabuvir (BCV), BMS-791325, NS5B Polymerase Inhibitor) with or without ribavirin (RBV). (Parent studies AI443014, AI443102, AI443113, and AI443123)

    Reporting group title
    DCV + ASV
    Reporting group description
    		 Daclatasvir (DCV) in combination with asunaprevir (ASV). (Parent studies AI444026, AI447011, AI447017, AI447026, and AI447028)

    Reporting group title
    DCV + ASV + P/R
    Reporting group description
    		 Daclatasvir/asunaprevir (DCV/ASV) plus peginterferon a-2a (pegIFNa-2a)/ ribavirin (RBV). (Parent study AI444026, AI447011, and AI447029); includes DCV/ASV plus RBV (Group B3 in parent study AI447011, N = 4)

    Reporting group title
    DCV + SOF +/- R
    Reporting group description
    		 Daclatasvir (DCV) in combination with sofosbuvi (SOF) (with or without ribavirin (RBV)) (Parent study AI444040, AI444215, AI444216, and AI444218)

    Reporting group title
    DCV + P/R
    Reporting group description
    		 Daclatasvir (DCV) plus pegIFNa-2a/ribavirin (RBV) (Parent studies AI444010, AI444011, AI444014, AI444026, AI444031, AI444038, AI444042, AI444043, and AI444052)

    Reporting group title
    ASV + P/R
    Reporting group description
    		 Asunaprevir (ASV) plus pegIFNa-2a/ribavirin (RBV) (Parent study AI447016)

    Reporting group title
    Comparator + P/R
    Reporting group description
    		 Comparator/pegIFNa-2a/ribavirin (RBV) (Parent studies AI444010, AI444011, AI444014, AI444031, AI444042, and AI447016) Comparator includes placebo (PBO) or telaprevir (TVR)

    Reporting group title
    Rescue/Re-trt
    Reporting group description
    		 Rescue therapy (daclatasvir/asunaprevir (DCV/ASV) plus pegIFNa-2a or pegIFNa-2b/ribavirin (RBV) after virologic non-response to DCV/ASV. (Parent studies AI444040, AI447011, AI447026, and AI447028 or DCV/ASV/RBV [Group B3 in parent study AI447011, N = 3] therapy administered for a subset of subjects.)

    Primary: Durability of Virologic Response

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    End point title
    		 Durability of Virologic Response [1]
    End point description
    The durability of virologic response, as assessed by the time to loss of virologic response among BMS-treated subjects who achieved a sustained virologic Response at post-treatment at week 12 (SVR12) in the previous study. The principal analysis of this endpoint is estimating the probability of maintaining a durable virologic response through long-term follow-up using the Kaplan-Meier approach. Subjects are considered to be in response until a hepatitis C virus (HCV) RNA >/= limit of quantitation (LOQ) (confirmed or last available) is observed. Eligible subjects who achieved SVR12 and who discontinue from the long-term study before having an event will be censored at the time of the latest HCV RNA. Eligible subjects who achieved SVR12 and have not had the event at the time of an analysis will be censored at the time of the last HCV RNA.
    End point type
    Primary
    End point timeframe
    Up to 144 weeks following SVR12 in parent study
    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: Only summary statistics planned for this endpoint
    End point values
    		 DCV 3DAA +/- R DCV + ASV DCV + ASV + P/R DCV + SOF +/- R DCV + P/R ASV + P/R Comparator + P/R Rescue/Re-trt
    Number of subjects analysed
    3
    1
    3
    0 [2]
    6
    3
    1
    2
    Units: Years
        median (full range (min-max))
    0.39 (0.23 to 1.196)
    0.52 (0.52 to 0.52)
    0.23 (0.23 to 0.747)
    ( to )
    0.23 (0.23 to 1.175)
    0.42 (0.23 to 0.474)
    0.60 (0.60 to 0.60)
    0.23 (0.23 to 0.233)
    Notes
    [2] - No eligible subjects with relapse
    No statistical analyses for this end point

    Secondary: Frequency of Viral Genotypic Substitutions

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    End point title
    		 Frequency of Viral Genotypic Substitutions [3]
    End point description
    The number of viral genotypic substitutions at analysis intervals among subjects previously treated with asunaprevir and/or daclatasvir who did not achieve or did not maintain a sustained virologic response at post-treatment at week 12 (SVR12) in the previous study.
    End point type
    Secondary
    End point timeframe
    Screening/ Day 1 participation up to 144 weeks
    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: Endpoint specific to participants previously treated with asunaprevir and/or daclatasvir. Missing arm is comprised of participants not previously treated with asunaprevir and/or daclatasvir
    End point values
    		 DCV 3DAA +/- R DCV + ASV DCV + ASV + P/R DCV + SOF +/- R DCV + P/R ASV + P/R Rescue/Re-trt
    Number of subjects analysed
    265
    389
    199
    263
    410
    94
    23
    Units: Genotypic Substitutions
        Week 24
    9
    35
    11
    0
    101
    11
    12
        Week 48
    6
    35
    12
    0
    87
    11
    12
        Week 72
    1
    5
    3
    0
    40
    5
    2
        Week 96
    4
    25
    2
    1
    73
    8
    12
        Week 120
    0
    0
    0
    0
    10
    2
    4
        Week 144
    3
    25
    2
    0
    45
    4
    7
    No statistical analyses for this end point

    Secondary: Frequency of Hepatic Disease Progression

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    End point title
    		 Frequency of Hepatic Disease Progression
    End point description
    The number of hepatic disease progression events diagnosed after end of therapy. (events include: hepatic cirrhosis, esophageal varices, bleeding esophageal varices, ascites, hepatic encephalopathy, hepatocellular carcinoma, spontaneous bacterial peritonitis, gastric varices, bleeding gastric varices, hepatorenal syndrome, liver transplant)
    End point type
    Secondary
    End point timeframe
    Screening/ Day 1 participation up to 144 weeks
    End point values
    		 DCV 3DAA +/- R DCV + ASV DCV + ASV + P/R DCV + SOF +/- R DCV + P/R ASV + P/R Comparator + P/R Rescue/Re-trt
    Number of subjects analysed
    265
    389
    199
    263
    410
    94
    63
    23
    Units: Events
    19
    17
    9
    8
    18
    2
    2
    3
    No statistical analyses for this end point

    Secondary: The Number of Participants that Died During the Long Term Follow Up

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    End point title
    		 The Number of Participants that Died During the Long Term Follow Up
    End point description
    The number of participants that died during the long term follow up
    End point type
    Secondary
    End point timeframe
    Screening/ Day 1 participation up to 144 weeks
    End point values
    		 DCV 3DAA +/- R DCV + ASV DCV + ASV + P/R DCV + SOF +/- R DCV + P/R ASV + P/R Comparator + P/R Rescue/Re-trt
    Number of subjects analysed
    265
    389
    199
    263
    410
    94
    63
    23
    Units: Participants
    3
    7
    2
    4
    5
    2
    0
    0
    No statistical analyses for this end point

    Secondary: The Number of Participants with Liver-Related Death During the Long Term Follow Up

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    End point title
    		 The Number of Participants with Liver-Related Death During the Long Term Follow Up
    End point description
    The number of participants with liver-related death during the long term follow Up
    End point type
    Secondary
    End point timeframe
    Screening/ Day 1 participation up to 144 weeks
    End point values
    		 DCV 3DAA +/- R DCV + ASV DCV + ASV + P/R DCV + SOF +/- R DCV + P/R ASV + P/R Comparator + P/R Rescue/Re-trt
    Number of subjects analysed
    265
    389
    199
    263
    410
    94
    63
    23
    Units: Participants
    0
    2
    1
    0
    1
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From screening/ Day 1 participation up to 144 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    DCV 3DAA +/- R
    Reporting group description
    		 Daclatasvir (DCV) in combination with asunaprevir (ASV) and beclabuvir (BCV), BMS-791325, NS5B Polymerase Inhibitor) with or without ribavirin (RBV). (Parent studies AI443014, AI443102, AI443113, and AI443123)

    Reporting group title
    DCV + ASV
    Reporting group description
    		 Daclatasvir (DCV) in combination with asunaprevir (ASV). (Parent studies AI444026, AI447011, AI447017, AI447026, and AI447028)

    Reporting group title
    DCV + ASV + P/R
    Reporting group description
    		 Daclatasvir/asunaprevir (DCV/ASV) plus peginterferon a-2a (pegIFNa-2a)/ ribavirin (RBV). (Parent study AI444026, AI447011, and AI447029); includes DCV/ASV plus RBV (Group B3 in parent study AI447011, N = 4)

    Reporting group title
    DCV + SOF +/- RBV
    Reporting group description
    		 Daclatasvir (DCV) in combination with sofosbuvi (SOF) (with or without ribavirin (RBV)) (Parent study AI444040, AI444215, AI444216, and AI444218)

    Reporting group title
    DCV + P/R
    Reporting group description
    		 Daclatasvir (DCV) plus pegIFNa-2a/ribavirin (RBV) (Parent studies AI444010, AI444011, AI444014, AI444026, AI444031, AI444038, AI444042, AI444043, and AI444052)

    Reporting group title
    ASV + P/R
    Reporting group description
    		 Asunaprevir (ASV) plus pegIFNa-2a/ribavirin (RBV) (Parent study AI447016)

    Reporting group title
    COMPARATOR + P/R
    Reporting group description
    		 Comparator/pegIFNa-2a/ribavirin (RBV) (Parent studies AI444010, AI444011, AI444014, AI444031, AI444042, and AI447016) Comparator includes placebo (PBO) or telaprevir (TVR)

    Reporting group title
    RESCUE/RE-TRT
    Reporting group description
    		 Rescue therapy (daclatasvir/asunaprevir (DCV/ASV) plus pegIFNa-2a or pegIFNa-2b/ribavirin (RBV) after virologic non-response to DCV/ASV. (Parent studies AI444040, AI447011, AI447026, and AI447028 or DCV/ASV/RBV [Group B3 in parent study AI447011, N = 3] therapy administered for a subset of subjects.)

    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: SAEs not related to the BMS product under study and non-serious AEs will not be reported as part of this study.
    Serious adverse events
    		 DCV 3DAA +/- R DCV + ASV DCV + ASV + P/R DCV + SOF +/- RBV DCV + P/R ASV + P/R COMPARATOR + P/R RESCUE/RE-TRT
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 265 (0.38%)
    3 / 389 (0.77%)
    1 / 199 (0.50%)
    4 / 263 (1.52%)
    5 / 410 (1.22%)
    2 / 94 (2.13%)
    0 / 63 (0.00%)
    0 / 23 (0.00%)
         number of deaths (all causes)
    1
    3
    1
    4
    5
    2
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cervix carcinoma
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 389 (0.00%)
    0 / 199 (0.00%)
    0 / 263 (0.00%)
    1 / 410 (0.24%)
    0 / 94 (0.00%)
    0 / 63 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 389 (0.26%)
    0 / 199 (0.00%)
    0 / 263 (0.00%)
    0 / 410 (0.00%)
    0 / 94 (0.00%)
    0 / 63 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 389 (0.00%)
    0 / 199 (0.00%)
    0 / 263 (0.00%)
    1 / 410 (0.24%)
    0 / 94 (0.00%)
    0 / 63 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 389 (0.00%)
    0 / 199 (0.00%)
    1 / 263 (0.38%)
    0 / 410 (0.00%)
    0 / 94 (0.00%)
    0 / 63 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 389 (0.00%)
    0 / 199 (0.00%)
    1 / 263 (0.38%)
    0 / 410 (0.00%)
    0 / 94 (0.00%)
    0 / 63 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Craniocerebral injury
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 389 (0.00%)
    0 / 199 (0.00%)
    0 / 263 (0.00%)
    0 / 410 (0.00%)
    1 / 94 (1.06%)
    0 / 63 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 389 (0.00%)
    0 / 199 (0.00%)
    0 / 263 (0.00%)
    0 / 410 (0.00%)
    0 / 94 (0.00%)
    0 / 63 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 389 (0.00%)
    1 / 199 (0.50%)
    0 / 263 (0.00%)
    0 / 410 (0.00%)
    1 / 94 (1.06%)
    0 / 63 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 389 (0.00%)
    0 / 199 (0.00%)
    0 / 263 (0.00%)
    1 / 410 (0.24%)
    0 / 94 (0.00%)
    0 / 63 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 389 (0.00%)
    0 / 199 (0.00%)
    0 / 263 (0.00%)
    1 / 410 (0.24%)
    0 / 94 (0.00%)
    0 / 63 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 389 (0.00%)
    0 / 199 (0.00%)
    1 / 263 (0.38%)
    0 / 410 (0.00%)
    0 / 94 (0.00%)
    0 / 63 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Liver disorder
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 389 (0.26%)
    0 / 199 (0.00%)
    0 / 263 (0.00%)
    0 / 410 (0.00%)
    0 / 94 (0.00%)
    0 / 63 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 389 (0.00%)
    0 / 199 (0.00%)
    1 / 263 (0.38%)
    0 / 410 (0.00%)
    0 / 94 (0.00%)
    0 / 63 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Chronic kidney disease
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 389 (0.00%)
    0 / 199 (0.00%)
    0 / 263 (0.00%)
    1 / 410 (0.24%)
    0 / 94 (0.00%)
    0 / 63 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Septic shock
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 389 (0.26%)
    0 / 199 (0.00%)
    0 / 263 (0.00%)
    0 / 410 (0.00%)
    0 / 94 (0.00%)
    0 / 63 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 DCV 3DAA +/- R DCV + ASV DCV + ASV + P/R DCV + SOF +/- RBV DCV + P/R ASV + P/R COMPARATOR + P/R RESCUE/RE-TRT
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 265 (0.00%)
    0 / 389 (0.00%)
    0 / 199 (0.00%)
    0 / 263 (0.00%)
    0 / 410 (0.00%)
    0 / 94 (0.00%)
    0 / 63 (0.00%)
    0 / 23 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Feb 2012
    Implements changes to the target patient population
    05 Apr 2012
    Implements reporting of serious adverse events (SAEs) related to the BMS product under study and clarifies the inclusion criteria.

    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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