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    Clinical Trial Results:
    A phase IIIb, open-label, multicentre, international randomised controlled trial of simplified treatment monitoring for 8 weeks glecaprevir (300mg)/pibrentasvir (120mg) in chronic HCV treatment naïve patients without cirrhosis

    Summary
    EudraCT number
    		 2017-000694-37
    Trial protocol
    		 GB   FR  
    Global end of trial date
    14 Dec 2018

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

    Trial information

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    Trial identification
    Sponsor protocol code
    VHCRP1701
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03117569
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of New South Wales Sydney
    Sponsor organisation address
    UNSW Sydney, Sydney, Australia,
    Public contact
    Philippa Marks, University of New South Wales Sydney, 61 293850886, pmarks@kirby.unsw.edu.au
    Scientific contact
    Gregory Dore, University of New South Wales Sydney, 61 293850900, gdore@kirby.unsw.edu.au
    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
    04 Mar 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Dec 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Dec 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the proportion of participants with undetectable hepatitis C virus load in their blood (HCV RNA less than the lower limit of quantification- LLOQ) at 12 weeks post-treatment (SVR12); following 8 weeks treatment with glecaprevir (300mg)/pibrentasvir (120mg); in people infected with hepatitis C without liver scarring (HCV treatment naïve non-cirrhosis chronic HCV patients), who have received a standard versus simplified schedule of safety and virological monitoring.
    Protection of trial subjects
    Participants received a telephone call from the nurse 4 weekly while on treatment to assess safety and adherence.
    Background therapy
    		 Participants received a direct acting antiviral hepatitis C treatment in the form of a oral once-daily fixed dose of glecaprevir (300mg)/pibrentasvir (120mg).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Aug 2017
    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
    United Kingdom: 24
    Country: Number of subjects enrolled
    France: 42
    Country: Number of subjects enrolled
    Germany: 41
    Country: Number of subjects enrolled
    Australia: 45
    Country: Number of subjects enrolled
    Canada: 86
    Country: Number of subjects enrolled
    New Zealand: 86
    Country: Number of subjects enrolled
    Switzerland: 23
    Country: Number of subjects enrolled
    United States: 33
    Worldwide total number of subjects
    380
    EEA total number of subjects
    107
    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)
    342
    From 65 to 84 years
    38
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 From 21 August 2017 to 16 July 2018, participants were screened and enrolled at 33 sites in Australia (n=6), Canada (n=7), France (n=3), Germany (n=4), New Zealand (n=4), Switzerland (n=2), United Kingdom (n=3), and United States (n=4).

    Pre-assignment
    Screening details
    		 Eligible participants were at last 18 years of age with chronic HCV, HCV treatment-naive and without cirrhosis. Participants who required additional treatment adherence support, self-reported injecting drug use within the previous six months, positive urinary drug screen or acute/chronic hepatitis B co-infection were excluded.

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Simplified monitoring
    Arm description
    		 Scheduled clinic study visits were only undertaken at screening, baseline and post-treatment week 12.
    Arm type
    		 Simplified Monitoring

    Investigational medicinal product name
    glecaprevir (300mg)/pibrentasvir (120mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    glecaprevir (300mg)/pibrentasvir (120mg) once daily for 8 weeks

    Arm title
    		 Standard monitoring
    Arm description
    		 Scheduled clinic study visits were undertaken at screening, baseline, treatment weeks four and eight (end of treatment), and post-treatment week 12.
    Arm type
    		 Standard Monitoring

    Investigational medicinal product name
    glecaprevir (300mg)/pibrentasvir (120mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    glecaprevir (300mg)/pibrentasvir (120mg) once daily for 8 weeks

    Number of subjects in period 1
    		Simplified monitoring Standard monitoring
    Started
    253
    127
    Completed
    253
    127
    Period 2
    Period 2 title
    Completed treatment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Simplified monitoring
    Arm description
    		 In the simplified arm, scheduled clinic study visits were undertaken at baseline and post-treatment week 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    glecaprevir (300mg)/pibrentasvir (120mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    glecaprevir (300mg)/pibrentasvir (120mg) daily for 8 weeks

    Arm title
    		 Standard monitoring
    Arm description
    		 In the standard arm, scheduled clinic study visits were undertaken at baseline, treatment weeks four and eight (end of treatment), and post-treatment week 12.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    glecaprevir (300mg)/pibrentasvir (120mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    glecaprevir (300mg)/pibrentasvir (120mg) daily for 8 weeks

    Number of subjects in period 2
    		Simplified monitoring Standard monitoring
    Started
    253
    127
    Completed
    249
    127
    Not completed
    4
    0
         Adverse event, non-fatal
    1
    -
         Lost to follow-up
    2
    -
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Simplified monitoring
    Reporting group description
    		 Scheduled clinic study visits were only undertaken at screening, baseline and post-treatment week 12.

    Reporting group title
    Standard monitoring
    Reporting group description
    		 Scheduled clinic study visits were undertaken at screening, baseline, treatment weeks four and eight (end of treatment), and post-treatment week 12.

    Reporting group values
    		 Simplified monitoring Standard monitoring Total
    Number of subjects
    		 253 127 380
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Median Age
    Units: years
        median (full range (min-max))
    		 52 (22 to 73) 50 (24 to 79) -
    Gender categorical
    Units: Subjects
        Female
    		 96 53 149
        Male
    		 157 72 229
        Transgender
    		 0 2 2
    HCV Genotype
    HCV Genotype
    Units: Subjects
        Genotype 1
    		 118 61 179
        Genotype 2
    		 35 17 52
        Genotype 3
    		 80 41 121
        Genotype 4
    		 14 4 18
        Genotype 5
    		 0 1 1
        Genotype 6
    		 5 3 8
        Genotype indeterminate
    		 1 0 1
    Fibrosis Stage
    Units: Subjects
        No or mild fibrosis (F0/F1)
    		 190 93 283
        Moderate fibrosis (F2)
    		 49 29 78
        Severe fibrosis (F3)
    		 14 5 19
    HIV Infection
    HIV Infection
    Units: Subjects
        HIV infection
    		 14 13 27
        No HIV Infection
    		 239 114 353
    Ethnicity
    Ethnicity
    Units: Subjects
        White
    		 194 97 291
        Asian
    		 22 12 34
        Black
    		 13 7 20
        Other
    		 24 11 35
    Opioid Substitution Therapy (OST)
    Opioid Substitution Therapy (OST)
    Units: Subjects
        Opioid Substitution Therapy (OST)
    		 21 17 38
        No OST
    		 232 110 342
    Body Mass Index (BMI)
    Body Mass Index (BMI)
    Units: kg/m2
        median (full range (min-max))
    		 25.3 (17.8 to 41.7) 24.7 (18.2 to 51.5) -
    HCV RNA
    HCV RNA
    Units: Log10 IU/mL
        median (full range (min-max))
    		 6.27 (2.49 to 7.74) 6.29 (2.85 to 7.71) -

    End points

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    End points reporting groups
    Reporting group title
    Simplified monitoring
    Reporting group description
    		 Scheduled clinic study visits were only undertaken at screening, baseline and post-treatment week 12.

    Reporting group title
    Standard monitoring
    Reporting group description
    		 Scheduled clinic study visits were undertaken at screening, baseline, treatment weeks four and eight (end of treatment), and post-treatment week 12.
    Reporting group title
    Simplified monitoring
    Reporting group description
    		 In the simplified arm, scheduled clinic study visits were undertaken at baseline and post-treatment week 12.

    Reporting group title
    Standard monitoring
    Reporting group description
    		 In the standard arm, scheduled clinic study visits were undertaken at baseline, treatment weeks four and eight (end of treatment), and post-treatment week 12.

    Primary: SVR12

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    End point title
    		 SVR12
    End point description
    End point type
    Primary
    End point timeframe
    Twelve weeks post-treatment.
    End point values
    		 Simplified monitoring Standard monitoring
    Number of subjects analysed
    239
    123
    Units: Number of participants
        number (not applicable)
    233
    121
    Statistical analysis title
    		 Primary endpoint
    Comparison groups
    Simplified monitoring v Standard monitoring
    Number of subjects included in analysis
    362
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 88
         upper limit
    		 95
    Notes
    [1] - The non-inferiority margin of 6% was selected in accordance with the principles outlined in guidance on conducting non-inferiority trials; the choice of margin ensured minimal to no loss of efficacy.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment emergent adverse events up to 30 days after last dose
    Adverse event reporting additional description
    Collected at clinic visits and during 4-weekly telephone call with the nurse while on treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Simplified monitoring
    Reporting group description
    		 In the simplified arm, scheduled clinic study visits were undertaken at baseline and post-treatment week 12. Adverse events were also collected during the 4-weekly on-treatment telephone calls with the nurse. Adverse events are reported up to 30 days after last dose.

    Reporting group title
    Standard monitoring
    Reporting group description
    		 In the standard arm, scheduled clinic study visits were undertaken at baseline, treatment weeks four and eight (end of treatment), and post-treatment week 12. Adverse events were also collected during the 4-weekly on-treatment telephone calls with the nurse. Adverse events are reported up to 30 days after last dose.

    Serious adverse events
    		 Simplified monitoring Standard monitoring
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 253 (1.19%)
    0 / 127 (0.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    1 / 253 (0.40%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Lung adenocarcinoma
         subjects affected / exposed
    1 / 253 (0.40%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Psychiatric disorders
    Acute psychosis
         subjects affected / exposed
    1 / 253 (0.40%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Simplified monitoring Standard monitoring
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    133 / 253 (52.57%)
    70 / 127 (55.12%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    43 / 253 (17.00%)
    26 / 127 (20.47%)
         occurrences all number
    43
    26
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    52 / 253 (20.55%)
    30 / 127 (23.62%)
         occurrences all number
    52
    30
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    17 / 253 (6.72%)
    25 / 127 (19.69%)
         occurrences all number
    17
    25

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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