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    Summary
    EudraCT Number:2021-001033-39
    Sponsor's Protocol Code Number:VIR-2218-1006
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-07-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2021-001033-39
    A.3Full title of the trial
    A Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of Regimens Containing VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects with Chronic Hepatitis B Virus Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of Regimens Containing VIR -2218, VIR-3434, and/or PEG-IFNα in Subjects with Chronic Hepatitis B Virus Infection
    A.4.1Sponsor's protocol code numberVIR-2218-1006
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04856085
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorVir Biotechnology, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportVir Biotechnology, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation Pharmaceutical Product Development -PPD
    B.5.2Functional name of contact pointGarrett Mohr
    B.5.3 Address:
    B.5.3.1Street Address1208 Viola Street
    B.5.3.2Town/ citySmithville
    B.5.3.3Post code64089
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1910558 5343
    B.5.5Fax number+1816509 4026
    B.5.6E-mailgarrett.mohr@ppd.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code VIR-2218
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codeALN-81890 or AD-81890
    D.3.9.3Other descriptive nameVIR-2218
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code VIR-3434
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codeVIR-3434
    D.3.9.3Other descriptive nameWBP2166B, 2166B, or WBP2166
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Pegasys
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePegasys
    D.3.2Product code NA
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEGINTERFERON ALFA-2A
    D.3.9.1CAS number 198153-51-4
    D.3.9.3Other descriptive namePEGINTERFERON ALFA-2A
    D.3.9.4EV Substance CodeSUB16452MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic HBV infection.
    E.1.1.1Medical condition in easily understood language
    Chronic infection of Hepatitis B Virus.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10008910
    E.1.2Term Chronic hepatitis B
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To evaluate the safety and tolerability of regimens containing VIR-2218 +, VIR-3434, and/or PEG IFNα
    - To evaluate the efficacy of regimens containing VIR-2218 +, VIR-3434, and/or PEG-IFNα
    E.2.2Secondary objectives of the trial
    - To assess the effect of regimens containing VIR-2218 +, VIR-3434, and/or PEG-IFNα on serum hepatitis B surface antigen (HBsAg)
    - To assess the effect of regimens containing VIR-2218, VIR-3434, and/or PEG-IFNα on serum HBV DNA
    - For hepatitis B e antigen (HBeAg)-) positive subjects: to assess the effect of regimens containing VIR- 2218 +, VIR-3434, and/or PEG-IFNα
    on HBeAg and anti-HBe
    - To assess the effect of regimens containing VIR-2218, VIR-3434, and/or PEG-IFNα on anti-HBs
    - To characterize the pharmacokinetics (PK) of VIR-3434
    - To assess the immunogenicity of VIR-3434
    - To evaluate proportion of subjects meeting criteria for nucleos(t)ide reverse transcriptase inhibitor (NRTI) discontinuation or retreatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 (or age of legal consent, whichever is older) to < 66 years
    2. Body Mass Index (BMI) ≥ 18 kg/m2 to ≤ 35 kg/m2
    3. Chronic HBV infection defined as a positive serum HBsAg, HBV DNA, or HBeAg on 2 occasions at least 6 months apart based on previous or
    current laboratory documentation (any combination of these tests performed 6 months apart is acceptable)
    4. On continuous NRTI therapy for at least 2 months prior to screening
    5. HBV DNA < 100 IU/mL at screening
    6. HBsAg > the lower limit of detection
    7. Negative anti-HBs at screening
    8. Besides chronic infection with HBV, must be in good health, determined from medical history, and no clinically significant findings from physical examination, vital signs, and laboratory values
    9. Female subjects must have a negative pregnancy test or confirmation of postmenopausal status. Post-menopausal status is defined as 12 months with no menses without an alternative medical cause. Women of child-bearing potential (WOCBP) must have a negative blood pregnancy
    test at screening and a negative urine pregnancy test on Day 1, cannot be breast feeding, and must be willing to use highly effective methods of
    contraception (Section 6.4) 14 days before study drug administration through 48 weeks after the last dose of study drug.
    Female subjects must also agree to refrain from egg donation and in vitro fertilization from the time of study drug administration through 48
    weeks after the last dose of study drug
    10. Male subjects with female partners of child-bearing potential must agree to meet 1 of the following contraception requirements from the time of study drug administration through 48 weeks after the last dose of study drug: documentation of vasectomy or azoospermia, or male condom use plus partner use of 1 of the contraceptive options listed for contraception for WOCBP (Section 6.4).
    Male subjects must also agree to not donate sperm from the time of first study drug administration through 48 weeks after the last dose of study
    drug.
    11. Willing to comply with the study requirements and able to provide written informed consent
    12. Cohort 2b only: Previously enrolled in Cohort 1d of the VIR-2218-1001 study and completed the Treatment Period
    E.4Principal exclusion criteria
    1. Significant fibrosis or cirrhosis as defined by having either a FibroScan result of > 8.5 kPa at screening or a liver biopsy within 1 year with Metavir F3 fibrosis or F4 cirrhosis.
    2. History of clinically significant liver disease from non-HBV etiology
    3. History of hepatic decompensation, including ascites, hepatic encephalopathy, and/or esophageal or gastric varices
    4. History of immune complex disease
    5. History of an autoimmune disorder
    6. History of HBV-related extrahepatic disease, including but not limited to HBV-related rash, arthritis, or glomerulonephritis
    7. History of allergic reactions hypersensitivity, or intolerance to monoclonal antibodies, antibody fragments or any excipients of VIR-3434
    8. History of anaphylaxis
    9. History of malignancy diagnosed or treated within 5 years (localized treatment of squamous or non-invasive basal cell skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to screening); subjects under evaluation for malignancy are not eligible.
    10. History of bone marrow or solid organ transplant
    11. Known active infection other than chronic HBV infection or any clinically significant acute condition such as fever (> 38 C) or acute respiratory illness within 7 days prior to Day 1
    12. Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (subjects with HDV) Subjects who are
    HCV antibody or HDV antibody positive but have a documented negative HCV , RNA or HDV RNA, respectively, are eligble.
    13. Creatinine clearance (CLcr) < 60 mL/min as calculated by the Cockcroft-Gault formula at screening
    14. Subject has the following laboratory parameters at screening by laboratory testing:
    a. ALT or aspartate aminotransferase (AST) > 3x ULN
    b. direct bilirubin or INR > ULN
    c. platelets < the lower limit of normal (LLN)
    Screening laboratory tests may be repeated (eg, for values thought to be erroneous) with Sponsor medical monitor approval.
    15. Regular consumption of more than 10 units of alcohol per week (1 unit = 1 glass of wine [125 mL] = 1 measure of spirits [30 mL] = one-half pint of beer [284 mL]), or more than 2 units of alcohol per day
    16. History or clinical evidence of alcohol or drug abuse within the 12 months before screening or a positive drug screen at screening unless it can be explained by a prescribed
    medication (the diagnosis and prescription must be approved by the investigator). Note: cannabis use is permitted
    17. Use of any of the following systemic medications within 14 days before study drug
    administration and throughout the study:
    a. Paracetamol (acetaminophen) ≥ 3 g/day
    b. Isoniazid
    c. Systemic steroids (prednisone equivalent of > 10 mg/day) or other immunosuppressive agents
    d. Parts A and C only: theophylline
    e. Parts A and C only: methadone
    18. Received an investigational agent within 90 days or 5 half-lives (if known), whichever is
    longer, before study drug administration or are active in the follow-up phase of another clinical study involving interventional treatment. Subjects must also agree not to take part in any other interventional study at any time during their participation in this study, inclusive of the Follow-Up Period and NRTI Discontinuation Monitoring Period.
    19. Receipt of an oligonucleotide (eg, siRNA, antisense oligonucleotide) with activity against HBV within 48 weeks before study drug administration
    20. Receipt of VIR-2218 or VIR-3434 within 24 weeks prior to Day 1
    21. Any clinically significant medical or psychiatric condition that may
    interfere with study treatment, assessment, or compliance with the
    protocol or otherwise makes the subject unsuitable for participation in
    the study, as determined by the investigator.
    22. Parts A and C only: Known hypersensitivity or contraindication to an
    interferon product
    23. Parts A and C only: Current or prior history of psychosis, bipolar
    disorder, schizophrenia, moderate-severe depression, suicide ideation,
    attempt, or gesture, or high risk for suicide
    24. Parts A and C only: Current or prior history of clinically significant
    retinal disease
    25. Parts A and C only: Current or prior history of chronic uncontrolled
    hypoglycemia, or
    uncontrolled hyperglycemia/diabetes (defined as HbA1c ≥ 8%) at
    screening
    26. Parts A and C only: Current or prior history of colitis
    27. Parts A and C only: Serum lipase ≥ 2 times the ULN
    28. Parts A and C only: TSH and free T4 above the ULN or below the LLN
    29. Parts A and C only: platelets < 90,000 cells/mm3
    30. Parts A and C only: absolute neutrophil count < 1,500 cells/mm3
    31. Clinically significant abnormalities on 12-lead ECG at screening
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints are as follows:
    • Proportion of subjects with treatment-emergent adverse events (TEAEs)
    • Proportion of subjects with serious adverse events (SAEs)
    • Proportion of subjects with HBsAg loss at end of treatment
    • Proportion of subjects with HBsAg loss at 24 weeks post-end of treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Cohort 1a/2a: up to 88 weeks
    - Cohort 3/4a: Up to 72 weeks
    - Cohort 5a/6a: up to 79 weeks
    - Cohort 7a/1b: Up to 112 weeks
    - Cohort 8a/2b: up to 88 weeks
    - Cohort 1c: up to 92 weeks
    - Cohort 2c: up to 116 weeks
    E.5.2Secondary end point(s)
    • Proportion of subjects achieving functional cure (defined as undetectable HBsAg and sustained suppression of HBV DNA [target not detected (TND)] ≥ 24 weeks after discontinuation of all treatment,
    including NRTIs)
    • Proportion of subjects with serum HBsAg < 10 IU/mL at end of treatment
    • Proportion of subjects with serum HBsAg < 10 IU/mL at 24 weeks post-end of treatment
    • Absolute serum HBsAg and change from baseline across timepoints in the study
    • Nadir and maximum reduction of serum of HBsAg from baseline
    • Time to achieve nadir and maximum reduction of serum HBsAg from baseline
    • Time to achieve serum HBsAg loss
    • For HBeAg-positive subjects: proportion of subjects with HBeAg loss (undetectable HBeAg) and/or anti-Hbe seroconversion
    • For HBeAg-positive subjects: time to HBeAg loss (undetectable HBeAg) and/or anti-Hbe seroconversion
    • Proportion of subjects with anti-HBs seroconversion
    • VIR-3434 PK parameters
    • Incidence and titers of anti-drug antibodies (ADA; if applicable) to VIR-3434
    • Proportion of subjects meeting criteria for NRTI discontinuation
    • Proportion of subjects meeting criteria for NRTI retreatment
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Cohort 1a/2a: up to 88 weeks
    - Cohort 3/4a: Up to 72 weeks
    - Cohort 5a/6a: up to 79 weeks
    - Cohort 7a/1b: Up to 112 weeks
    - Cohort 8a/2b: up to 88 weeks
    - Cohort 1c: up to 92 weeks
    - Cohort 2c: up to 116 weeks
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Malaysia
    New Zealand
    United States
    Moldova, Republic of
    Ukraine
    Germany
    Romania
    Hong Kong
    Korea, Republic of
    Taiwan
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Assessments for the final visit of the Follow-Up Period for the assigned cohort (eg, Week 68 for Cohorts 1a/2a, Week 52 for Cohorts 3a/4a, Week 59 for Cohorts 5a/6a) should be performed.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 260
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 260
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Following completion of follow-up in VIR-2218-1006, patients will end their participation in the trial and resume routine care under their treating physician. Given that the combination of VIR-2218 and VIR-3434 is being developed as a finite regimen aimed at functional cure, these study drugs will not be provided after the completion of treatment.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-12
    P. End of Trial
    P.End of Trial StatusOngoing
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