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    Clinical Trial Results:
    An Open-Label Study to Explore the Clinical Efficacy of GS-7977 with Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant

    Summary
    EudraCT number
    		 2012-000637-39
    Trial protocol
    		 ES  
    Global end of trial date
    20 Oct 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jul 2016
    First version publication date
    02 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    P7977-2025
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01559844
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
    Scientific contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Oct 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to determine if the administration of a combination of sofosbuvir (SOF; GS-7977) and ribavirin (RBV) to HCV-infected subjects with hepatocellular carcinoma (HCC) meeting the MILAN criteria prior to undergoing liver transplantation could prevent post-transplant re-infection as determined by a sustained post-transplant virological response (HCV RNA < lower limit of quantitation [LLOQ]) at 12 weeks post-transplant.
    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 Mar 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    New Zealand: 1
    Country: Number of subjects enrolled
    United States: 55
    Worldwide total number of subjects
    61
    EEA total number of subjects
    5
    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)
    53
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in the United States, Spain, and New Zealand. The first participant was screened on 27 March 2012. The last study visit occurred on 20 October 2014.

    Pre-assignment
    Screening details
    		 92 participants were screened.

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

    Arms
    Arm title
    		 SOF+RBV
    Arm description
    		 SOF+RBV for up to 48 weeks or until time of transplant, whichever occured first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    Sovaldi®, GS-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sofosbuvir (SOF) 400 mg administered once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin (RBV) administered in a divided daily dose based on weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

    Number of subjects in period 1
    		SOF+RBV
    Started
    61
    Completed
    36
    Not completed
    25
         Death
    5
         Efficacy Failure
    10
         No Longer A Transplant Candidate
    3
         Consent Withdrawn
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SOF+RBV
    Reporting group description
    		 SOF+RBV for up to 48 weeks or until time of transplant, whichever occured first.

    Reporting group values
    		 SOF+RBV Total
    Number of subjects
    		 61 61
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59 ( 5.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 49 49
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 12 12
        Not Hispanic or Latino
    		 49 49
    Race
    Units: Subjects
        White
    		 55 55
        Black or African American
    		 6 6
    Prior Hepatitis C Virus (HCV) Treatment
    Units: Subjects
        Yes
    		 46 46
        No
    		 15 15
    Response to Last Prior HCV Treatment Regimen
    Units: Subjects
        Non-Responder: Null
    		 11 11
        Non-Responder: Partial
    		 11 11
        Responder: Breakthrough
    		 3 3
        Responder: Relapser
    		 9 9
        Unknown
    		 12 12
        Had Not Received Prior Treatment
    		 15 15
    Baseline HCV RNA Category
    Units: Subjects
        < 6 log10 IU/mL
    		 20 20
        ≥ 6 and < 7 log10 IU/mL
    		 38 38
        ≥ 7 log10 IU/mL
    		 3 3
    HCV Genotype
    There are variations of HCV which are all similar enough to be called HCV, but are distinct enough to be referred to as HCV genotypes.
    Units: Subjects
        Genotype 1a
    		 24 24
        Genotype 1b
    		 21 21
        Genotype 2a
    		 1 1
        Genotype 2b
    		 7 7
        Genotype 3a
    		 7 7
        Genotype 4a
    		 1 1
    IL28b Status
    CC, CT, and TT alleles are different forms of the IL28b gene.
    Units: Subjects
        CC
    		 13 13
        CT
    		 39 39
        TT
    		 8 8
        Missing
    		 1 1
    Baseline Child-Pugh Turcotte (CPT) Score
    CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.
    Units: Subjects
        CPT Score = 5
    		 26 26
        CPT Score = 6
    		 18 18
        CPT Score = 7
    		 14 14
        CPT Score = 8
    		 3 3
    Baseline Model For End-Stage Liver Disease (MELD) Score
    MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.
    Units: Subjects
        MELD Score = 6
    		 5 5
        MELD Score = 7
    		 18 18
        MELD Score = 8
    		 12 12
        MELD Score = 9
    		 9 9
        MELD Score = 10
    		 6 6
        MELD Score = 11
    		 8 8
        MELD Score = 13
    		 2 2
        MELD Score = 14
    		 1 1
    Days on Transplant Waitlist
    Units: days
        arithmetic mean (standard deviation)
    		 266 ( 488.8 ) -
    Baseline HCV RNA
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    		 6.14 ( 0.633 ) -

    End points

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    End points reporting groups
    Reporting group title
    SOF+RBV
    Reporting group description
    		 SOF+RBV for up to 48 weeks or until time of transplant, whichever occured first.

    Primary: Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12

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    End point title
    		 Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12 [1]
    End point description
    pTVR was defined as HCV RNA < the lower limit of quantification (LLOQ, ie, 25 mL/IU) at Week 12 after transplant. Participants in the Full Analysis Set (enrolled and received at least 1 dose of study drug) who underwent liver transplantation, and who had HCV RNA < LLOQ at last measurement prior to transplant were analyzed.
    End point type
    Primary
    End point timeframe
    Posttransplant 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
    		 SOF+RBV
    Number of subjects analysed
    43 [2]
    Units: percentage of participants
    number (not applicable)
        Transplant after ≥ 12 weeks of treatment (n=32)
    75
        Transplant after any duration of treatment (n=43)
    69.8
    Notes
    [2] - Participants who had liver transplantation & HCV RNA < LLOQ at last measurement prior to transplant
    No statistical analyses for this end point

    Primary: Percentage of Participants Experiencing Any Adverse Event Leading to Permanent Discontinuation of Sofosbuvir Prior to Receiving Transplant

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    End point title
    		 Percentage of Participants Experiencing Any Adverse Event Leading to Permanent Discontinuation of Sofosbuvir Prior to Receiving Transplant [3]
    End point description
    End point type
    Primary
    End point timeframe
    Up to 48 weeks prior to transplant
    Notes
    [3] - 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
    Number of subjects analysed
    61 [4]
    Units: percentage of participants
        number (not applicable)
    3.3
    Notes
    [4] - Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
    No statistical analyses for this end point

    Primary: Percentage of Participants With Graft Loss Following Transplant

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    End point title
    		 Percentage of Participants With Graft Loss Following Transplant [5]
    End point description
    End point type
    Primary
    End point timeframe
    Up to 48 weeks following transplant
    Notes
    [5] - 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
    Number of subjects analysed
    46 [6]
    Units: percentage of participants
        number (not applicable)
    6.5
    Notes
    [6] - Participants in the Safety Analysis Set who underwent liver transplantation were analyzed.
    No statistical analyses for this end point

    Primary: Number of Participants Who Died

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    End point title
    		 Number of Participants Who Died [7]
    End point description
    • Treatment-emergent deaths were those that occurred while taking study drug or to the minimum of 1) date of transplantation, 2) retreatment 1st dose date, or 3) last dose date + 30 days. • Only those participants who underwent liver transplantation were analyzed for death post-transplantation.
    End point type
    Primary
    End point timeframe
    Up to 48 weeks following transplant
    Notes
    [7] - 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
    Number of subjects analysed
    61 [8]
    Units: participants
        All Deaths
    5
        Treatment-Emergent Death (n = 61)
    1
        Death Following Transplant (n = 46)
    3
        Death Not Meeting Either Criteria (n = 61)
    1
    Notes
    [8] - Safety Analysis Set
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Posttransplant Virologic Response (pTVR) Through Posttransplant Week 48

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    End point title
    		 Percentage of Participants With Posttransplant Virologic Response (pTVR) Through Posttransplant Week 48
    End point description
    pTVR was defined as HCV RNA < the lower limit of quantification (LLOQ, ie, 25 mL/IU) at the relevant time point after transplant. Participants in the Full Analysis Set who underwent liver transplantation and who had ≥ 12 weeks treatment and HCV RNA < LLOQ at last measurement prior to transplant were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 48 weeks following transplant
    End point values
    		 SOF+RBV
    Number of subjects analysed
    32 [9]
    Units: percentage of participants
    number (not applicable)
        Posttransplant Week 1 (n = 32)
    87.5
        Posttransplant Week 2 (n = 32)
    81.3
        Posttransplant Week 4 (n = 32)
    75
        Posttransplant Week 8 (n = 32)
    75
        Posttransplant Week 24 (n = 32)
    75
        Posttransplant Week 48 (n = 30)
    66.7
    Notes
    [9] - Had liver transplant, ≥ 12 weeks treatment, & HCV RNA<LLOQ at last measurement before transplant
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HCV RNA < LLOQ (ie, 25 mL/IU) During Treatment Through Week 48

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    End point title
    		 Percentage of Participants With HCV RNA < LLOQ (ie, 25 mL/IU) During Treatment Through Week 48
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 48 weeks prior to transplant
    End point values
    		 SOF+RBV
    Number of subjects analysed
    61 [10]
    Units: percentage of participants
    number (not applicable)
        Week 1 (n = 61)
    13.1
        Week 2 (n = 61)
    57.4
        Week 3 (n = 60)
    81.7
        Week 4 (n = 58)
    93.1
        Week 8 (n = 54)
    90.7
        Week 12 (n = 48)
    93.8
        Week 24 (n = 30)
    100
        Week 36 (n = 9)
    100
        Week 48 (n = 8)
    100
    Notes
    [10] - Participants in the Full Analysis Set with available data were analyzed.
    No statistical analyses for this end point

    Secondary: HCV RNA and Change From Baseline in HCV RNA Through Week 8

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    End point title
    		 HCV RNA and Change From Baseline in HCV RNA Through Week 8
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 8 weeks prior to transplant
    End point values
    		 SOF+RBV
    Number of subjects analysed
    61 [11]
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Week 1 (n = 59)
    -3.87 ( 0.7 )
        Week 2 (n = 61)
    -4.43 ( 0.771 )
        Week 3 (n = 60)
    -4.64 ( 0.67 )
        Week 4 (n = 58)
    -4.69 ( 0.686 )
        Week 8 (n = 53)
    -4.66 ( 0.708 )
    Notes
    [11] - Participants in the Full Analysis Set with available data were analyzed.
    No statistical analyses for this end point

    Secondary: Proportion of Participants With Virologic Failure Prior to Transplant

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    End point title
    		 Proportion of Participants With Virologic Failure Prior to Transplant
    End point description
    Virologic failure (VF) in the pretransplant phase was defined by: • Breakthrough (HCV RNA ≥ 25 IU/ml after having previously had HCV RNA < 25 IU/ml, while on treatment), • Rebound (breakthrough or > 1 log10 IU/ml increase in HCV RNA from nadir while on treatment), • Non-response (HCV RNA ≥ 25 IU/ml through 8 weeks of treatment), • Pre-transplant relapse (HCV RNA ≥ 25 IU/ml during the Pre-Transplant off-treatment follow-up period after having achieved HCV RNA < 25 IU/ml at last observed HCV RNA on treatment). Analysis Population Descriptions: On-treatment VF: Full Analysis Set. Posttreatment/Pretransplant VF - 24 Weeks or 48 Weeks: Participants who completed 24 or 48 weeks of treatment and had an observed or imputed Week 4 posttreatment follow-up HCV RNA value relapsed during posttreatment follow-up were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 48 weeks prior to transplant
    End point values
    		 SOF+RBV
    Number of subjects analysed
    61 [12]
    Units: percentage of participants
    number (not applicable)
        On-treatment VF (n = 61)
    8.2
        Posttreatment/Pretransplant VF - 24 Weeks (n = 15)
    73.3
        Posttreatment/Pretransplant VF - 48 Weeks (n = 8)
    37.5
    Notes
    [12] - See End point description for more information on Analysis Population Descriptions.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 48 weeks plus 30 days
    Adverse event reporting additional description
    Safety Analysis Set
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    SOF+RBV
    Reporting group description
    		 SOF+RBV for up to 48 weeks or until time of transplant, whichever occured first.

    Serious adverse events
    		 SOF+RBV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 61 (18.03%)
         number of deaths (all causes)
    5
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatocellular carcinoma
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tumour thrombosis
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Hepatic encephalopathy
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Umbilical hernia, obstructive
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal strangulated hernia
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mesenteric artery thrombosis
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc degeneration
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peritonitis bacterial
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Sepsis
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 SOF+RBV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    49 / 61 (80.33%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    14 / 61 (22.95%)
         occurrences all number
    15
    Dizziness
         subjects affected / exposed
    4 / 61 (6.56%)
         occurrences all number
    4
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    13 / 61 (21.31%)
         occurrences all number
    15
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    23 / 61 (37.70%)
         occurrences all number
    24
    Oedema peripheral
         subjects affected / exposed
    4 / 61 (6.56%)
         occurrences all number
    4
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    10 / 61 (16.39%)
         occurrences all number
    10
    Constipation
         subjects affected / exposed
    6 / 61 (9.84%)
         occurrences all number
    6
    Diarrhoea
         subjects affected / exposed
    4 / 61 (6.56%)
         occurrences all number
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 61 (11.48%)
         occurrences all number
    8
    Dyspnoea
         subjects affected / exposed
    7 / 61 (11.48%)
         occurrences all number
    7
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    9 / 61 (14.75%)
         occurrences all number
    10
    Pruritus
         subjects affected / exposed
    6 / 61 (9.84%)
         occurrences all number
    7
    Alopecia
         subjects affected / exposed
    4 / 61 (6.56%)
         occurrences all number
    4
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    7 / 61 (11.48%)
         occurrences all number
    7
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    4 / 61 (6.56%)
         occurrences all number
    7
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    4 / 61 (6.56%)
         occurrences all number
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Feb 2012
    The sponsor information was updated to Gilead Sciences, Inc. (Gilead) throughout the document. Section numbers were updated to reflect the Gilead protocol template. The study design and study assessments were clarified. A pharmacogenomic substudy was added to the protocol for subjects who provided their separate and specific consent. The retreatment substudy was added for subjects who experienced posttreatment virologic relapse during the pretransplant treatment phase so they could start a new course of SOF+RBV therapy (after confirmation of no resistance-conferring mutations) for up to an additional 24 weeks of treatment or until transplantation, whichever occurred first. Toxicity management of elevated bilirubin values was added at the request of the US Food and Drug Administration (FDA).
    22 Mar 2012
    Updated the monitoring of adverse events (AEs) and serious AEs (SAEs) to occur during the primary treatment period through 30 days after the last dose of study drug. Updated the duration of collection of concomitant medications and vital signs from through posttransplant follow-up Week 48 to 30 days after the last dose of study drug. Updated and clarified reporting requirements and procedures for AEs and SAEs. Added the definition and reporting procedures for special situations. Special situations were defined in the clinical study protocol as pregnancy reports, reports of medication error, abuse, misuse, or overdose, lack of effect reports, reports of adverse reactions in infants following exposure from breastfeeding, and reports of adverse reactions associated with product complaints. However, due to implementation issues, only pregnancy reports and overdose were collected during the study.
    21 Aug 2012
    Updated birth control inclusion/exclusion criteria per FDA request. Clarified collection of safety laboratories and assessments 30 days after the last dose of study drug. Updated background information according to available data. Removed requirement for study drug dosing in the clinic on days of study visits after the baseline/Day 1 visit.
    22 Jan 2013
    Allowed subjects to continue therapy for up to 48 weeks or until the time of transplant, whichever occurred first. Subjects who had not received a transplant (except those who discontinued study treatment for safety or virologic reasons) at approval of protocol Amendment 4 participated in the pretransplant retreatment phase, which was formerly named the retreatment substudy. Replaced the SOF 200-mg tablets with a single tablet formulation of the SOF 400-mg dose if the supply of 200-mg tablets was depleted. However, the SOF 400-mg tablet was not needed during the study. Removed prohibition of rifaximin (a concomitant medication commonly used to manage the symptoms of hepatic encephalopathy), which is not absorbed when taken orally and, therefore, has a low possibility of interaction with 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.
    There were no limitations affecting the analysis or results.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/25261839
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