Study of VIR-2218 With or Without Pegylated Interferon Al... | NCT04412863 | Trialant
NCT04412863
Sponsor
Vir Biotechnology, Inc.
Status
Completed
Last Update Posted
Apr 16, 2026Actual
Enrollment
84Actual
Phase
Phase 2
Conditions
Chronic Hepatitis B
Interventions
VIR-2218
pegylated interferon-alfa 2a
Countries
Australia
Hong Kong
Malaysia
New Zealand
South Korea
Thailand
Protocol Section
Identification Module
NCT ID
NCT04412863
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
VIR-2218-1001-PEG-IFNα
Secondary IDs
Not provided
Brief Title
Study of VIR-2218 With or Without Pegylated Interferon Alpha-2a for Treatment of Chronic Hepatitis B Virus Infection
Official Title
A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-2218 Alone or in Combination With Pegylated Interferon Alpha-2a
Acronym
Not provided
Organization
Vir Biotechnology, Inc.INDUSTRY
Status Module
Record Verification Date
Mar 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 3, 2020Actual
Primary Completion Date
Mar 25, 2024Actual
Completion Date
Mar 25, 2024Actual
First Submitted Date
May 29, 2020
First Submission Date that Met QC Criteria
May 29, 2020
First Posted Date
Jun 2, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Mar 25, 2025
Results First Submitted that Met QC Criteria
Mar 27, 2026
Results First Posted Date
Apr 16, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 27, 2026
Last Update Posted Date
Apr 16, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Vir Biotechnology, Inc.INDUSTRY
Collaborators
Name
Class
Alnylam Pharmaceuticals
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a phase 2 study in which subjects with chronic hepatitis B virus (HBV) infection will receive VIR-2218 alone or in combination with pegylated interferon alfa-2a and will be assessed for safety, tolerability, pharmacokinetics, and antiviral activity.
Detailed Description
Not provided
Conditions Module
Conditions
Chronic Hepatitis B
Keywords
Hepatitis B Virus
Chronic Hepatitis B
HBV
Hepatitis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
84Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1d
Experimental
VIR-2218 given by subcutaneous injection
Drug: VIR-2218
Cohort 2d
Experimental
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Drug: VIR-2218
Drug: pegylated interferon-alfa 2a
Cohort 3d
Experimental
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Drug: VIR-2218
Drug: pegylated interferon-alfa 2a
Cohort 1e
Experimental
VIR-2218 given by subcutaneous injection
Drug: VIR-2218
Cohort 2e
Experimental
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Drug: VIR-2218
Drug: pegylated interferon-alfa 2a
Cohort 3e
Experimental
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Interventions
Name
Type
Description
Arm Group Labels
Other Names
VIR-2218
Drug
VIR-2218 given by subcutaneous injection
Cohort 1d
Cohort 1e
Cohort 1f
Cohort 2d
Cohort 2e
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Subjects With Adverse Events as Assessed by CTCAE v5.0
Up to 148 Weeks
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Up to 148 Weeks
Secondary Outcomes
Measure
Description
Time Frame
Mean Maximum Reduction of Serum HBsAg at Any Timepoint
Up to 148 Weeks
Proportion of Subjects With Serum HBsAg Loss (Undetectable HBsAg) at Any Timepoint
Up to 148 Weeks
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female of ages 18 - 65
Chronic HBV infection for >/= 6 months
Exclusion Criteria:
Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
Significant fibrosis or cirrhosis
History or evidence of drug or alcohol abuse
History of intolerance to SC injection
History of chronic liver disease from any cause other than chronic HBV infection
History of hepatic decompensation
Any prior receipt of an interferon product
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
65 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Investigative Site
Birtinya
Queensland
4575
Australia
Investigative Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Phase 1 Part1 A-C data results are posted on clinicaltrials.gov in NCT03672188.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks
FG001
Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Dec 2, 2021
Mar 25, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: VIR-2218
Drug: pegylated interferon-alfa 2a
Cohort 1f
Experimental
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Drug: VIR-2218
Drug: pegylated interferon-alfa 2a
Cohort 2f
Experimental
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Drug: VIR-2218
Drug: pegylated interferon-alfa 2a
Cohort 3f
Experimental
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Drug: VIR-2218
Drug: pegylated interferon-alfa 2a
Cohort 2f
Cohort 3d
Cohort 3e
Cohort 3f
Elebsiran
pegylated interferon-alfa 2a
Drug
pegylated interferon-alfa 2a given by subcutaneous injection
Cohort 1f
Cohort 2d
Cohort 2e
Cohort 2f
Cohort 3d
Cohort 3e
Cohort 3f
pegylated interferon alpha-2a
PEG-IFNα
Proportion of Subjects With Sustained Serum HBsAg Loss (Undetectable HBsAg) for Greater Than 6 Months
Up to 148 Weeks
Proportion of Subjects With Anti-HBs Seroconversion at Any Timepoint
Anti-HBs seroconversion is defined as Anti-HBs quantitative value changed from baseline <LLOQ (5 mIU/mL) to post-baseline>=LLOQ.
Up to 148 Weeks
For HBeAg-positive Patients: Proportion of Subjects With HBeAg Loss (Undetectable HBeAg) and/or Anti-HBe Seroconversion at Any Timepoint
Up to 148 weeks
Fitzroy
Victoria
3168
Australia
Investigative site
Hong Kong
Hong Kong
Investigative Site
Batu Caves
68100
Malaysia
Investigative Site
Kajang
43000
Malaysia
Investigative Site
Kuala Lumpur
59100
Malaysia
Investigative Site
Kuantan
25100
Malaysia
Investigative Site
Auckland
1010
New Zealand
Investigative Site
Auckland
2025
New Zealand
Investigative Site
Busan
49241
South Korea
Investigative Site
Chuncheon
24253
South Korea
Investigative Site
Daegu
41944
South Korea
Investigative Site
Seoul
03080
South Korea
Investigative Site
Seoul
05505
South Korea
Investigative Site
Yangsan
50612
South Korea
Investigative Site
Bangkok
10330
Thailand
Investigative Site
Bangkok
10400
Thailand
Investigative Site
Bangkok
10700
Thailand
Investigative Site
Chiang Mai
50200
Thailand
Investigative Site
Hat Yai
90110
Thailand
Investigative Site
Khlong Luang
12120
Thailand
Investigative Site
Khon Kaen
40002
Thailand
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks and 12 doses of 180 µg of PEG-IFN once every week starting at Week 12 for 12 weeks
FG002
Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI
All participants in this arm received 3 doses of 200 mg of VIR-2218 once every 4 weeks for 8 weeks with 12 doses of 180 µg of PEG-IFNα once every week for 12 weeks
FG003
Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with 24 doses of 180 µg of PEG-IFNα once every week for 24 weeks
FG004
Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with up to 48 doses of 180 µg of PEG-IFNα once every week for up to 48 weeks
FG005
Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI
All participants in this arm received up to 13 doses of 200 mg of VIR-2218 once every 4 weeks for up to 48 weeks with up to 44 doses of 180 µg of PEG-IFNα once every week for up to 44 weeks
FG00015 subjects
FG00115 subjects
FG0025 subjects
FG00318 subjects
FG00418 subjects
FG00513 subjects
COMPLETED
FG0009 subjects
FG00115 subjects
FG0025 subjects
FG00317 subjects
FG00416 subjects
FG00513 subjects
NOT COMPLETED
FG0006 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0042 subjects
FG0050 subjects
Type
Comment
Reasons
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Rolled over to another study
FG0006 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks
BG001
Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks and 12 doses of 180 µg of PEG-IFN once every week starting at Week 12 for 12 weeks
BG002
Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI
All participants in this arm received 3 doses of 200 mg of VIR-2218 once every 4 weeks for 8 weeks with 12 doses of 180 µg of PEG-IFNα once every week for 12 weeks
BG003
Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with 24 doses of 180 µg of PEG-IFNα once every week for 24 weeks
BG004
Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with up to 48 doses of 180 µg of PEG-IFNα once every week for up to 48 weeks
BG005
Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI
All participants in this arm received up to 13 doses of 200 mg of VIR-2218 once every 4 weeks for up to 48 weeks with up to 44 doses of 180 µg of PEG-IFNα once every week for up to 44 weeks
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00015
BG00115
BG0025
BG00318
BG00418
BG00513
BG00684
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00050.3± 8.62
BG00146.6± 7.80
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
New Zealand
Title
Measurements
BG0006
BG0013
BG002
Hepatitis B surface antigen (Log10 IU/mL)
Mean
Standard Deviation
Log10 IU/mL
Title
Denominators
Categories
Title
Measurements
BG0003.44± 0.447
BG0013.20± 0.676
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Subjects With Adverse Events as Assessed by CTCAE v5.0
Posted
Count of Participants
Participants
Up to 148 Weeks
ID
Title
Description
OG000
Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks
OG001
Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks and 12 doses of 180 µg of PEG-IFN once every week starting at Week 12 for 12 weeks
OG002
Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI
All participants in this arm received 3 doses of 200 mg of VIR-2218 once every 4 weeks for 8 weeks with 12 doses of 180 µg of PEG-IFNα once every week for 12 weeks
OG003
Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with 24 doses of 180 µg of PEG-IFNα once every week for 24 weeks
OG004
Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with up to 48 doses of 180 µg of PEG-IFNα once every week for up to 48 weeks
OG005
Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI
All participants in this arm received up to 13 doses of 200 mg of VIR-2218 once every 4 weeks for up to 48 weeks with up to 44 doses of 180 µg of PEG-IFNα once every week for up to 44 weeks
Units
Counts
Participants
OG00015
OG00115
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0009
OG00113
OG0023
OG003
Primary
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
All participants that received at least one dose of any study intervention were included in this analysis.
Posted
Count of Participants
Participants
Up to 148 Weeks
ID
Title
Description
OG000
Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks
OG001
Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 12 weeks and 12 doses of 180 µg of PEG-IFN once every week starting at Week 12 for 12 weeks
OG002
Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI
All participants in this arm received 3 doses of 200 mg of VIR-2218 once every 4 weeks for 8 weeks with 12 doses of 180 µg of PEG-IFNα once every week for 12 weeks
OG003
Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI
Secondary
Mean Maximum Reduction of Serum HBsAg at Any Timepoint
Posted
Mean
Standard Deviation
Log 10 IU/mL
Up to 148 Weeks
ID
Title
Description
OG000
Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks
OG001
Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks and 12 doses of 180 µg of PEG-IFN once every week starting at Week 12 for 12 weeks
OG002
Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI
All participants in this arm received 3 doses of 200 mg of VIR-2218 once every 4 weeks for 8 weeks with 12 doses of 180 µg of PEG-IFNα once every week for 12 weeks
OG003
Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with 24 doses of 180 µg of PEG-IFNα once every week for 24 weeks
Secondary
Proportion of Subjects With Serum HBsAg Loss (Undetectable HBsAg) at Any Timepoint
Posted
Count of Participants
Participants
Up to 148 Weeks
ID
Title
Description
OG000
Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks
OG001
Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks and 12 doses of 180 µg of PEG-IFN once every week starting at Week 12 for 12 weeks
OG002
Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI
All participants in this arm received 3 doses of 200 mg of VIR-2218 once every 4 weeks for 8 weeks with 12 doses of 180 µg of PEG-IFNα once every week for 12 weeks
OG003
Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with 24 doses of 180 µg of PEG-IFNα once every week for 24 weeks
Secondary
Proportion of Subjects With Sustained Serum HBsAg Loss (Undetectable HBsAg) for Greater Than 6 Months
Posted
Count of Participants
Participants
Up to 148 Weeks
ID
Title
Description
OG000
Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks
OG001
Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks and 12 doses of 180 µg of PEG-IFN once every week starting at Week 12 for 12 weeks
OG002
Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI
All participants in this arm received 3 doses of 200 mg of VIR-2218 once every 4 weeks for 8 weeks with 12 doses of 180 µg of PEG-IFNα once every week for 12 weeks
OG003
Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with 24 doses of 180 µg of PEG-IFNα once every week for 24 weeks
Secondary
Proportion of Subjects With Anti-HBs Seroconversion at Any Timepoint
Anti-HBs seroconversion is defined as Anti-HBs quantitative value changed from baseline <LLOQ (5 mIU/mL) to post-baseline>=LLOQ.
Posted
Count of Participants
Participants
Up to 148 Weeks
ID
Title
Description
OG000
Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks
OG001
Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks and 12 doses of 180 µg of PEG-IFN once every week starting at Week 12 for 12 weeks
OG002
Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI
All participants in this arm received 3 doses of 200 mg of VIR-2218 once every 4 weeks for 8 weeks with 12 doses of 180 µg of PEG-IFNα once every week for 12 weeks
OG003
Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI
Secondary
For HBeAg-positive Patients: Proportion of Subjects With HBeAg Loss (Undetectable HBeAg) and/or Anti-HBe Seroconversion at Any Timepoint
Cohort 3d: This outcome is 0 as it is only applicable to HBeAg positive participants, no HBeAg positive participants were assigned to cohort 3d.
Posted
Count of Participants
Participants
Up to 148 weeks
ID
Title
Description
OG000
Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks
OG001
Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks and 12 doses of 180 µg of PEG-IFN once every week starting at Week 12 for 12 weeks
OG002
Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI
All participants in this arm received 3 doses of 200 mg of VIR-2218 once every 4 weeks for 8 weeks with 12 doses of 180 µg of PEG-IFNα once every week for 12 weeks
OG003
Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI
Time Frame
Treatment emergent serious adverse events were defined as AEs reported between Part 1D/2D: Day 1 through Week 27, Part 3D; Day 1 through Week 15, Part 1F: Day 1 through Week 27, Part 2F: Day 1 through Week 51, Part 3F: Day 1 through Week 52.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks
0
15
0
15
9
15
EG001
Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks and 12 doses of 180 µg of PEG-IFN once every week starting at Week 12 for 12 weeks
0
15
0
15
13
15
EG002
Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI
All participants in this arm received 3 doses of 200 mg of VIR-2218 once every 4 weeks for 8 weeks with 12 doses of 180 µg of PEG-IFNα once every week for 12 weeks
0
5
0
5
3
5
EG003
Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with 24 doses of 180 µg of PEG-IFNα once every week for 24 weeks
0
18
1
18
16
18
EG004
Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with up to 48 doses of 180 µg of PEG-IFNα once every week for up to 48 weeks
0
18
1
18
17
18
EG005
Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI
All participants in this arm received up to 13 doses of 200 mg of VIR-2218 once every 4 weeks for up to 48 weeks with up to 44 doses of 180 µg of PEG-IFNα once every week for up to 44 weeks
0
13
1
13
13
13
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Biliary colic
Hepatobiliary disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG0030 affected18 at risk
EG0040 affected18 at risk
EG0051 affected13 at risk
Ankle fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Mania
Psychiatric disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Myalgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 affected15 at risk
EG0011 affected15 at risk
EG0021 affected5 at risk
EG0036 affected18 at risk
EG0043 affected18 at risk
EG0054 affected13 at risk
Headache
Nervous system disorders
Systematic Assessment
EG0001 affected15 at risk
EG0013 affected15 at risk
EG0020 affected5 at risk
EG003
Injection site erythema
Immune system disorders
Systematic Assessment
EG0001 affected15 at risk
EG0012 affected15 at risk
EG0021 affected5 at risk
EG003
Pyrexia
General disorders
Systematic Assessment
EG0000 affected15 at risk
EG0013 affected15 at risk
EG0020 affected5 at risk
EG003
Fatigue
General disorders
Systematic Assessment
EG0000 affected15 at risk
EG0015 affected15 at risk
EG0021 affected5 at risk
EG003
Neutrophil count decreased
Investigations
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0021 affected5 at risk
EG003
Influenza like illness
General disorders
Systematic Assessment
EG0000 affected15 at risk
EG0012 affected15 at risk
EG0020 affected5 at risk
EG003
COVID-19
Infections and infestations
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0003 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
Systematic Assessment
EG0001 affected15 at risk
EG0012 affected15 at risk
EG0020 affected5 at risk
EG003
Dyspepsia
Gastrointestinal disorders
Systematic Assessment
EG0001 affected15 at risk
EG0012 affected15 at risk
EG0020 affected5 at risk
EG003
Injection site pruritus
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Vaccination site pain
General disorders
Systematic Assessment
EG0001 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Injection site bruising
General disorders
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected15 at risk
EG0012 affected15 at risk
EG0020 affected5 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Erythema
General disorders
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Injection site pain
General disorders
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Injection site rash
General disorders
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Alanine aminotransferase increased
Investigations
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0002 affected15 at risk
EG0010 affected15 at risk
EG0021 affected5 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Depressed mood
Psychiatric disorders
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Malaise
General disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
Systematic Assessment
EG0000 affected15 at risk
EG0012 affected15 at risk
EG0020 affected5 at risk
EG003
Stomatitis
Gastrointestinal disorders
Systematic Assessment
EG0001 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Upper respiratory tract infection
Infections and infestations
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
White blood cell count decreased
Investigations
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0021 affected5 at risk
EG003
Abdominal distension
Gastrointestinal disorders
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Aspartate aminotransferase increased
Investigations
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Dizziness
Nervous system disorders
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Gastritis
Gastrointestinal disorders
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Insomnia
Psychiatric disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
Systematic Assessment
EG0000 affected15 at risk
EG0012 affected15 at risk
EG0020 affected5 at risk
EG003
Non-cardiac chest pain
General disorders
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Rash pruritic
General disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Retinopathy
Eye disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Seborrhoeic dermatitis
General disorders
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Visual impairment
Eye disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Weight decreased
Investigations
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Abscess limb
Infections and infestations
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0021 affected5 at risk
EG003
Asthenia
General disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Biliary colic
Hepatobiliary disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Cellulitis
Infections and infestations
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0021 affected5 at risk
EG003
Chalazion
Eye disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Chest discomfort
General disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Chest pain
General disorders
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Conjunctivitis
Infections and infestations
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Depression
Psychiatric disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Ear congestion
Ear and labyrinth disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Extrasystoles
Cardiac disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Eye pruritus
Eye disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Fall
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Gastritis erosive
Gastrointestinal disorders
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Gastroenteritis
Infections and infestations
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Haematuria
Renal and urinary disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Haemorrhoids thrombosed
Gastrointestinal disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Hyperthyroidism
Endocrine disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Injection site discolouration
General disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Injection site haematoma
General disorders
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Injection site induration
General disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Injection site irritation
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Injection site swelling
General disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Lethargy
Nervous system disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Mania
Psychiatric disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Myopathy
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Nasopharyngitis
Infections and infestations
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Nocturia
Renal and urinary disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Ocular hyperaemia
Eye disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Oral herpes
Infections and infestations
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Orchitis
Infections and infestations
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Pain
General disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Palpitations
Cardiac disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Paronychia
Infections and infestations
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Penile blister
Reproductive system and breast disorders
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Periorbital oedema
Eye disorders
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Pollakiuria
Renal and urinary disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Postoperative wound infection
Infections and infestations
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Rhinitis
Infections and infestations
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Sudden hearing loss
Ear and labyrinth disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Tendon discomfort
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Tremor
Nervous system disorders
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected5 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Vertigo
Ear and labyrinth disorders
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected5 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The study results in their entirety have been publicly disclosed by or with the consent of the Sponsor OR study has been completed at all investigative sites for at least 18 months provision of publication up to 60 days before planned submission to allow Sponsor to remove confidential information or identify Sponsor intellectual property.
Publication may be delayed as applicable, up to 120 days for Sponsor to file patent application(s).
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with 24 doses of 180 µg of PEG-IFNα once every week for 24 weeks
OG004
Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with up to 48 doses of 180 µg of PEG-IFNα once every week for up to 48 weeks
OG005
Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI
All participants in this arm received up to 13 doses of 200 mg of VIR-2218 once every 4 weeks for up to 48 weeks with up to 44 doses of 180 µg of PEG-IFNα once every week for up to 44 weeks
Units
Counts
Participants
OG00015
OG00115
OG0025
OG00318
OG00418
OG00513
Title
Denominators
Categories
ALT Grade 1
Title
Measurements
OG0002
OG00112
OG0022
OG00312
OG00414
OG0059
ALT Grade 2
Title
Measurements
OG0000
OG0011
OG0021
OG003
ALT Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Alkaline phosphatase Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST Grade 1
Title
Measurements
OG0002
OG00111
OG0024
OG003
AST Grade 2
Title
Measurements
OG0000
OG0012
OG0020
OG003
AST Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Bilirubin Grade 1
Title
Measurements
OG0004
OG0010
OG0020
OG003
Bilirubin Grade 2
Title
Measurements
OG0000
OG0011
OG0020
OG003
Prothrombin, Internalized Normalized Ratio (INR) Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hemoglobin, anemia (g/DL) grade 1
Title
Measurements
OG0000
OG0012
OG0020
OG003
Hemoglobin, anemia (g/DL) grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Leukocytes, White blood cell decreased (10^9/L), grade 1
Title
Measurements
OG0003
OG0016
OG0023
OG003
Leukocytes, White blood cell decreased (10^9/L), grade 2
Title
Measurements
OG0000
OG0016
OG0021
OG003
Leukocytes, White blood cell decreased (10^9/L), grade 3
Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with up to 48 doses of 180 µg of PEG-IFNα once every week for up to 48 weeks
OG005
Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI
All participants in this arm received up to 13 doses of 200 mg of VIR-2218 once every 4 weeks for up to 48 weeks with up to 44 doses of 180 µg of PEG-IFNα once every week for up to 44 weeks
Units
Counts
Participants
OG00015
OG00115
OG0025
OG00318
OG00418
OG00513
Title
Denominators
Categories
Title
Measurements
OG000-1.96± 0.29
OG001-2.15± 0.61
OG002-1.73± 0.37
OG003-2.52± 0.82
OG004-2.48± 1.41
OG005-2.99± 1.32
OG004
Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with up to 48 doses of 180 µg of PEG-IFNα once every week for up to 48 weeks
OG005
Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI
All participants in this arm received up to 13 doses of 200 mg of VIR-2218 once every 4 weeks for up to 48 weeks with up to 44 doses of 180 µg of PEG-IFNα once every week for up to 44 weeks
Units
Counts
Participants
OG00015
OG00115
OG0025
OG00318
OG00418
OG00513
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG0032
OG0046
OG0054
OG004
Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with up to 48 doses of 180 µg of PEG-IFNα once every week for up to 48 weeks
OG005
Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI
All participants in this arm received up to 13 doses of 200 mg of VIR-2218 once every 4 weeks for up to 48 weeks with up to 44 doses of 180 µg of PEG-IFNα once every week for up to 44 weeks
Units
Counts
Participants
OG00015
OG00115
OG0025
OG00318
OG00418
OG00513
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0044
OG0052
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with 24 doses of 180 µg of PEG-IFNα once every week for 24 weeks
OG004
Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with up to 48 doses of 180 µg of PEG-IFNα once every week for up to 48 weeks
OG005
Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI
All participants in this arm received up to 13 doses of 200 mg of VIR-2218 once every 4 weeks for up to 48 weeks with up to 44 doses of 180 µg of PEG-IFNα once every week for up to 44 weeks
Units
Counts
Participants
OG00013
OG00114
OG0025
OG00317
OG00414
OG00511
Title
Denominators
Categories
Title
Measurements
OG0009
OG0018
OG0023
OG0037
OG0044
OG0053
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with 24 doses of 180 µg of PEG-IFNα once every week for 24 weeks
OG004
Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI
All participants in this arm received 6 doses of 200 mg of VIR-2218 once every 4 weeks for 20 weeks with up to 48 doses of 180 µg of PEG-IFNα once every week for up to 48 weeks
OG005
Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI
All participants in this arm received up to 13 doses of 200 mg of VIR-2218 once every 4 weeks for up to 48 weeks with up to 44 doses of 180 µg of PEG-IFNα once every week for up to 44 weeks
Units
Counts
Participants
OG0001
OG0011
OG0020
OG0034
OG0045
OG0051
Title
Denominators
Categories
HBeAg loss at any time
Title
Measurements
OG0001
OG0011
OG0020
OG0033
OG0043
OG0051
HBeAg loss with anti-HBe seroconversion at any time