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    Clinical Trial Results:
    A multi-centre single-arm study to evaluate the efficacy and safety of BOCEPREVIR 44 weeks in addition to standard of care (SOC) in previously treatment failure (relapser, non-responders, both partial and null) patients with chronic hepatitis C genotype 1 (G1) and cirrhosis (F4 Metavir). (MK-3034-105)

    Summary
    EudraCT number
    		 2012-002772-13
    Trial protocol
    		 IT  
    Global end of trial date
    17 Nov 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Oct 2016
    First version publication date
    16 Oct 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MK-3034-105
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01756079
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp, ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp, ClinicalTrialsDisclosure@merck.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
    17 Nov 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Nov 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Nov 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study was done to find out if the addition of boceprevir to standard of care (SOC) treatment with peginterferon alfa-2b (PegIFN-2b) + ribavirin (RBV) is effective for participants with chronic hepatitis C (CHC) genotype 1 and cirrhosis who were not successfully treated by previous SOC. All participants were to receive treatment with SOC alone for 4 weeks and then boceprevir was to be added to the treatment regimen for 44 additional weeks of combined treatment.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research. The following additional measure defined for this individual study was in place for the protection of trial participants: A participant was to be discontinued from all study therapy if they met the per-protocol criteria for virologic failure.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Feb 2013
    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
    Italy: 58
    Worldwide total number of subjects
    58
    EEA total number of subjects
    58
    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)
    38
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study enrolled adult participants with hepatitis C (CHC) genotype 1 and cirrhosis who failed a prior treatment with peginterferon alpha (PegIFN-2b) and ribavirin (RBV). Other inclusion and exclusion criteria applied.

    Pre-assignment
    Screening details
    		 A total of 130 participants were screened. Sixty participants passed screening, but 2 of these participants were excluded before assignment because standard of care treatment was not received during the Lead-in Period.

    Period 1
    Period 1 title
    Lead-in: Day 0 to Week 4
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Overall Participants
    Arm description
    		 Participants received PegIFN-2b (once weekly, 1.5 μg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 μg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ribivirin
    Investigational medicinal product code
    Other name
    Rebetol, RBV
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Ribivirin oral capsule weight-based dose from 800-1400 mg/day divided into two daily doses throughout the study

    Investigational medicinal product name
    Pegintron
    Investigational medicinal product code
    Other name
    Peginterferon alfa-2b (PegIFN-2b)
    Pharmaceutical forms
    Powder and solvent for solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PegIFN-2b 1.5 μg/kg subcutaneous injection once weekly throughout the study

    Number of subjects in period 1
    		Overall Participants
    Started
    58
    Completed
    58
    Period 2
    Period 2 title
    Treatment/Follow-up: Week 4 to Week 72
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Overall Participants
    Arm description
    		 Participants received PegIFN-2b (once weekly, 1.5 μg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 μg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pegintron
    Investigational medicinal product code
    Other name
    Peginterferon alfa-2b (PegIFN-2b)
    Pharmaceutical forms
    Powder and solvent for solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PegIFN-2b 1.5 μg/kg subcutaneous injection once weekly throughout the study

    Investigational medicinal product name
    Ribivirin
    Investigational medicinal product code
    Other name
    Rebetol, RBV
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Ribivirin oral capsule weight-based dose from 800-1400 mg/day divided into two daily doses throughout the study

    Investigational medicinal product name
    Boceprevir
    Investigational medicinal product code
    Other name
    Victrelis, BOC
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Boceprevir 800 mg oral capsule three times daily during the Treatment Period (Week 4 to Week 48)

    Number of subjects in period 2
    		Overall Participants
    Started
    58
    Treated in Treatment Period
    54
    Completed
    23
    Not completed
    35
         Consent withdrawn by subject
    4
         Adverse event, non-fatal
    5
         No information available
    2
         No boceprevir during Treatment Period
    4
         Lack of efficacy
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lead-in: Day 0 to Week 4
    Reporting group description
    		 -

    Reporting group values
    		 Lead-in: Day 0 to Week 4 Total
    Number of subjects
    		 58 58
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    		 38 38
        From 65-84 years
    		 20 20
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.3 ( 9.2 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 19 19
        Male
    		 39 39

    End points

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    End points reporting groups
    Reporting group title
    Overall Participants
    Reporting group description
    		 Participants received PegIFN-2b (once weekly, 1.5 μg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 μg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
    Reporting group title
    Overall Participants
    Reporting group description
    		 Participants received PegIFN-2b (once weekly, 1.5 μg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 μg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.

    Subject analysis set title
    ITT Set: Participants Treated in the Treatment Period
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received PegIFN-2b (once weekly, 1.5 μg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 μg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.

    Subject analysis set title
    Safety Set 2: Participants Treated in the Treatment Period
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received PegIFN-2b (once weekly, 1.5 μg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 μg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.

    Primary: Percentage of Participants who Achieve Sustained Virological Response at Follow-up Week 24 (SVR24)

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    End point title
    		 Percentage of Participants who Achieve Sustained Virological Response at Follow-up Week 24 (SVR24) [1]
    End point description
    Hepatitis C Virus (HCV) ribonucleic acid (RNA) was measured using a polymerase chain reaction assay. SVR24 was defined as HCV RNA less than the Limit of Quantification (<25 International Units (IU)/mL) 24 weeks after the end of the Treatment Period. The Intent to Treat population included all participants who received at least 1 administration of boceprevir during the Treatment Period.
    End point type
    Primary
    End point timeframe
    Week 72 (24 weeks after end of treatment)
    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 analysis was planned for Percentage of Participants who Achieve Sustained Virological Response at Follow-up Week 24 (SVR24)
    End point values
    		 ITT Set: Participants Treated in the Treatment Period
    Number of subjects analysed
    54
    Units: Percentage of participants
        number (confidence interval 95%)
    35.2 (22.7 to 49.4)
    No statistical analyses for this end point

    Primary: Percentage of Participants with One or More Adverse Events

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    End point title
    		 Percentage of Participants with One or More Adverse Events [2]
    End point description
    Adverse events were monitored during the Lead-in and Treatment Periods. Safety Analysis Set 2 included all participants who received boceprevir during the Treatment Period.
    End point type
    Primary
    End point timeframe
    Up to 48 weeks (Lead-in and Treatment Periods)
    Notes
    [2] - 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 analysis was planned for Percentage of Participants with One or More Adverse Events
    End point values
    		 Safety Set 2: Participants Treated in the Treatment Period
    Number of subjects analysed
    54
    Units: Percentage of participants
        number (not applicable)
    98.1
    No statistical analyses for this end point

    Primary: Percentage of Participants with an Adverse Event Leading to Discontinuation of Study Medication

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    End point title
    		 Percentage of Participants with an Adverse Event Leading to Discontinuation of Study Medication [3]
    End point description
    Adverse events were monitored during the Lead-in and Treatment Periods. Safety Analysis Set 2 included all participants who received boceprevir during the Treatment Period.
    End point type
    Primary
    End point timeframe
    Up to 48 weeks (Lead-in and Treatment Periods)
    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 analysis was planned for Percentage of Participants with an Adverse Event Leading to Discontinuation of Study Medication
    End point values
    		 Safety Set 2: Participants Treated in the Treatment Period
    Number of subjects analysed
    54
    Units: Percentage of participants
        number (not applicable)
    9.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods)
    Adverse event reporting additional description
    Safety Analysis Set 1 included all participants who received PegIFN-2b + RBV during the Lead-in Period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Safety Set 1: Participants Treated in the Lead-in Period
    Reporting group description
    		 Participants received PegIFN-2b (once weekly, 1.5 μg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 μg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.

    Serious adverse events
    		 Safety Set 1: Participants Treated in the Lead-in Period
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 58 (17.24%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatocellular carcinoma
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Encephalopathy
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Headache
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences causally related to treatment / all
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyperpyrexia
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal impairment
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Parathyroid fever
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety Set 1: Participants Treated in the Lead-in Period
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    56 / 58 (96.55%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    11 / 58 (18.97%)
         occurrences all number
    11
    Asthenia
         subjects affected / exposed
    35 / 58 (60.34%)
         occurrences all number
    42
    Fatigue
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Influenza like illness
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    12
    Pyrexia
         subjects affected / exposed
    15 / 58 (25.86%)
         occurrences all number
    35
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    15 / 58 (25.86%)
         occurrences all number
    15
    Dyspnoea
         subjects affected / exposed
    7 / 58 (12.07%)
         occurrences all number
    7
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    7 / 58 (12.07%)
         occurrences all number
    7
    Irritability
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    5
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    14 / 58 (24.14%)
         occurrences all number
    15
    Headache
         subjects affected / exposed
    6 / 58 (10.34%)
         occurrences all number
    8
    Syncope
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    44 / 58 (75.86%)
         occurrences all number
    82
    Leukopenia
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    5
    Neutropenia
         subjects affected / exposed
    16 / 58 (27.59%)
         occurrences all number
    22
    Thrombocytopenia
         subjects affected / exposed
    7 / 58 (12.07%)
         occurrences all number
    8
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Abdominal distension
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    4
    Diarrhoea
         subjects affected / exposed
    7 / 58 (12.07%)
         occurrences all number
    7
    Dry mouth
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    5
    Dyspepsia
         subjects affected / exposed
    7 / 58 (12.07%)
         occurrences all number
    9
    Nausea
         subjects affected / exposed
    12 / 58 (20.69%)
         occurrences all number
    13
    Vomiting
         subjects affected / exposed
    6 / 58 (10.34%)
         occurrences all number
    10
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Dry skin
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    6
    Rash
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Pruritus generalized
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Renal and urinary disorders
    Nocturia
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Pollakiuria
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    6
    Myalgia
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    5
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    12 / 58 (20.69%)
         occurrences all number
    13

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Dec 2013
    Amendment 1: The visit window was changed from 2 to 3 days; the limit for diagnosis of cirrhosis by elastography was changed from 0.20 to 0.30; details on contraception with reference to boceprevir were added; details on exclusion based on oesophageal varices were added as replacement of a former exclusion criterion; details on exclusion for limits of total bilirubin were added and direct bilirubin was replaced by total bilirubin; exclusion criterion applicable to use of prohibited medications was added; criteria for assignment of screening number and treatment number were detailed; storage procedures for ribavirin were changed; procedures for co-administration of boceprevir with an oral contraceptive were detailed; duration of post-study contraception for males and females was added; rules for dose modification of ribavirin were added; other minor or typographic changes were made effective.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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