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    Clinical Trial Results:
    Four weeks treatment for chronic hepatitis C in patients under 50 years of age with no significant liver fibrosis

    Summary
    EudraCT number
    		 2017-005179-21
    Trial protocol
    		 DK  
    Global end of trial date
    11 Aug 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Sep 2022
    First version publication date
    17 Sep 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    4RIBC-2018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Clinical Institute, University of Southern Denmark
    Sponsor organisation address
    J.B. Winsløwsvej 4, Indgang 18, Penthous, Odense C, Denmark, 5000
    Public contact
    Deparment of infectious Diseases, Odense University Hospital, 0045 28834681, lone.wulff.madsen@rsyd.dk
    Scientific contact
    Deparment of infectious Diseases, Odense University Hospital, lone.wulff.madsen@rsyd.dk
    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
    22 Feb 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Aug 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Aug 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To compare the percentage of subjects achieving a 12-week sustained virological response, SVR 12 (HCV RNA below lower limit of quantification at week 12 after end of treatment) after 4 weeks of treatment (including forward moving arm from phase 1) compared to 8 weeks of treatment in the intention to treat population including all subjects taking at least one dose of study medication.
    Protection of trial subjects
    because of the study criteria, no one suffered from severe liver disease, and based on previous retreatment studies after short treatment, the likelihood of cure after retreatment was high. All patients who experienced treatment failure have been offered retreatment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 May 2018
    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
    Denmark: 61
    Worldwide total number of subjects
    61
    EEA total number of subjects
    61
    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)
    61
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first 33 patients were all included at the outpatient clinic at Odense University hospital. The 28 last patients were included at outreach clinics at drug treatment centers and at the outpatient clinic at Odense University hospital.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 61
    Number of subjects completed
    		 53

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Protocol deviation: 2
    Reason: Number of subjects
    		 Consent withdrawn by subject: 6
    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intervention
    Arm description
    		 Glecaprevir/Pibrentasvir was given with ribavirin for 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Maviret
    Investigational medicinal product code
    Other name
    Glecaprevir/Pibrentasvir
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100mg glecaprevir and 40 mg pibrentasvir, 3 tablets once daily at the same time with food.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Moderiba/copegus/
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    15mg/kg with a maximum of 1400mg. Dosed twice daily for the first 15 patients and for the rest in this intervention group once daily

    Arm title
    		 Intervention 2
    Arm description
    		 Glecaprevir/pibrentasvir given for 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Maviret
    Investigational medicinal product code
    Other name
    Glecaprevir/pibrentasvir
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100mg glecaprevir/40 mg pibrentasvir, 3 tablets once daily with food

    Arm title
    		 GLE/PIB for 8 weeks
    Arm description
    		 Standard of care with GLE/PIB for 8 weeks for treatment of chronic hepatitis C
    Arm type
    		 standard of care

    Investigational medicinal product name
    Maviret
    Investigational medicinal product code
    Other name
    Glecaprevir/Pibrentasvir
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100mg glecaprevir and 40 mg pibrentasvir, 3 tablets once daily at the same time with food.

    Number of subjects in period 1 [1]
    		Intervention Intervention 2 GLE/PIB for 8 weeks
    Started
    28
    17
    8
    Completed
    28
    17
    8
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 61 patients were enrolled. A total of 53 patients started treatment divided at the three treatment arms.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Glecaprevir/Pibrentasvir was given with ribavirin for 4 weeks

    Reporting group title
    Intervention 2
    Reporting group description
    		 Glecaprevir/pibrentasvir given for 4 weeks

    Reporting group title
    GLE/PIB for 8 weeks
    Reporting group description
    		 Standard of care with GLE/PIB for 8 weeks for treatment of chronic hepatitis C

    Reporting group values
    		 Intervention Intervention 2 GLE/PIB for 8 weeks Total
    Number of subjects
    		 28 17 8 53
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 28 17 8 53
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 43 (39 to 45) 41 (33 to 48) 36 (33.5 to 43.5) -
    Gender categorical
    Units: Subjects
        Female
    		 7 3 4 14
        Male
    		 21 14 4 39

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Glecaprevir/Pibrentasvir was given with ribavirin for 4 weeks

    Reporting group title
    Intervention 2
    Reporting group description
    		 Glecaprevir/pibrentasvir given for 4 weeks

    Reporting group title
    GLE/PIB for 8 weeks
    Reporting group description
    		 Standard of care with GLE/PIB for 8 weeks for treatment of chronic hepatitis C

    Primary: SVR12

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    End point title
    		 SVR12
    End point description
    How many were cured of hepatitis C
    End point type
    Primary
    End point timeframe
    12 weeks after end of treatment
    End point values
    		 Intervention Intervention 2 GLE/PIB for 8 weeks
    Number of subjects analysed
    27 [1]
    17
    7 [2]
    Units: %
    67
    59
    100
    Notes
    [1] - one patient lost to follow up
    [2] - one patient lost to follow up
    Statistical analysis title
    		 percent
    Comparison groups
    Intervention v Intervention 2 v GLE/PIB for 8 weeks
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.749 [4]
    Method
    		 Fisher exact
    Parameter type
    		 Mean difference (final values)
    Confidence interval
    Notes
    [3] - The study closed prematurely due to the low number of included patients due to the COVID-19 pandemic.
    [4] - 4 weeks treatment with maviret + ribavirin compared to maviret for 4 weeks

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 weeks after end of treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    4 weeks maviret+ ribavirin
    Reporting group description
    		 -

    Reporting group title
    maviret 4 weeks
    Reporting group description
    		 -

    Reporting group title
    maviret 8 weeks
    Reporting group description
    		 -

    Serious adverse events
    		 4 weeks maviret+ ribavirin maviret 4 weeks maviret 8 weeks
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 17 (0.00%)
    1 / 8 (12.50%)
         number of deaths (all causes)
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    drug use
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 17 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 4 weeks maviret+ ribavirin maviret 4 weeks maviret 8 weeks
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 28 (89.29%)
    15 / 17 (88.24%)
    8 / 8 (100.00%)
    Nervous system disorders
    headache
         subjects affected / exposed
    10 / 28 (35.71%)
    11 / 17 (64.71%)
    5 / 8 (62.50%)
         occurrences all number
    10
    11
    5
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    18 / 28 (64.29%)
    13 / 17 (76.47%)
    5 / 8 (62.50%)
         occurrences all number
    18
    13
    5
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    5 / 28 (17.86%)
    7 / 17 (41.18%)
    3 / 8 (37.50%)
         occurrences all number
    5
    7
    3
    diarrhea
         subjects affected / exposed
    5 / 28 (17.86%)
    4 / 17 (23.53%)
    1 / 8 (12.50%)
         occurrences all number
    5
    4
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    5 / 28 (17.86%)
    3 / 17 (17.65%)
    1 / 8 (12.50%)
         occurrences all number
    5
    3
    1
    Pruritus
         subjects affected / exposed
    5 / 28 (17.86%)
    4 / 17 (23.53%)
    1 / 8 (12.50%)
         occurrences all number
    5
    4
    1

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/34154034
    http://www.ncbi.nlm.nih.gov/pubmed/35337021
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