Chronic Hepatitis BPhase 2NCT04412863

Study of VIR-2218 With or Without Pegylated Interferon Alpha-2a for Treatment of Chronic Hepatitis B Virus Infection

A Phase 2 study testing VIR-2218 and pegylated interferon-alfa 2a in people with Chronic Hepatitis B, run by Vir Biotechnology, Inc. at 22 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Hepatitis B
What is being tested?: VIR-2218 and pegylated interferon-alfa 2a
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 22 sitesin 6 countries
Study dates: 3 Jul 2020to 25 Mar 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female of ages 18 - 65
Chronic HBV infection for >/= 6 months

Who cannot join

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

Trial locations and contacts

22 sites in 6 countries.

Country

City, postcode or hospital

22 sites in 6 countries

Thailand7 sites

Investigative Site
Bangkok, 10330
Investigative Site
Bangkok, 10400
Investigative Site
Bangkok, 10700
Investigative Site
Chiang Mai, 50200
Investigative Site
Hat Yai, 90110
Investigative Site
Khlong Luang, 12120
Investigative Site
Khon Kaen, 40002

Other trials in Thailand

South Korea6 sites

Investigative Site
Busan, 49241
Investigative Site
Chuncheon, 24253
Investigative Site
Daegu, 41944
Investigative Site
Seoul, 03080
Investigative Site
Seoul, 05505
Investigative Site
Yangsan, 50612

Other trials in South Korea

Malaysia4 sites

Investigative Site
Batu Caves, 68100
Investigative Site
Kajang, 43000
Investigative Site
Kuala Lumpur, 59100
Investigative Site
Kuantan, 25100

Other trials in Malaysia

Australia2 sites

Investigative Site
Birtinya, Queensland, 4575
Investigative Site
Fitzroy, Victoria, 3168

Other trials in Australia

New Zealand2 sites

Investigative Site
Auckland, 1010
Investigative Site
Auckland, 2025

Other trials in New Zealand

Hong Kong1 site

Investigative site
Hong Kong

Other trials in Hong Kong

About this study

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

Conditions: Chronic Hepatitis B
Being tested: VIR-2218, pegylated interferon-alfa 2a
Keywords: Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis
Medical subject headings: Hepatitis B, Chronic, Hepatitis B, Hepatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VIR-2218Drug
Also called Elebsiran
VIR-2218 given by subcutaneous injection
pegylated interferon-alfa 2aDrug
Also called pegylated interferon alpha-2a, PEG-IFNα
pegylated interferon-alfa 2a given by subcutaneous injection

Study groups in NCT04412863
Study group	Role	What they receive
Cohort 1d	Experimental	VIR-2218 given by subcutaneous injection Receives: Drug: VIR-2218
Cohort 2d	Experimental	VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection Receives: Drug: VIR-2218; Drug: pegylated interferon-alfa 2a
Cohort 3d	Experimental	VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection Receives: Drug: VIR-2218; Drug: pegylated interferon-alfa 2a
Cohort 1e	Experimental	VIR-2218 given by subcutaneous injection Receives: Drug: VIR-2218
Cohort 2e	Experimental	VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection Receives: Drug: VIR-2218; Drug: pegylated interferon-alfa 2a
Cohort 3e	Experimental	VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection Receives: Drug: VIR-2218; Drug: pegylated interferon-alfa 2a
Cohort 1f	Experimental	VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection Receives: Drug: VIR-2218; Drug: pegylated interferon-alfa 2a
Cohort 2f	Experimental	VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection Receives: Drug: VIR-2218; Drug: pegylated interferon-alfa 2a
Cohort 3f	Experimental	VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection Receives: Drug: VIR-2218; Drug: pegylated interferon-alfa 2a

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Adverse Events as Assessed by CTCAE v5.0
Measured: Up to 148 Weeks
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Measured: Up to 148 Weeks

Secondary outcomes (5)

Mean Maximum Reduction of Serum HBsAg at Any Timepoint
Measured: Up to 148 Weeks
Proportion of Subjects With Serum HBsAg Loss (Undetectable HBsAg) at Any Timepoint
Measured: Up to 148 Weeks
Proportion of Subjects With Sustained Serum HBsAg Loss (Undetectable HBsAg) for Greater Than 6 Months
Measured: 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.
Measured: Up to 148 Weeks
For HBeAg-positive Patients: Proportion of Subjects With HBeAg Loss (Undetectable HBeAg) and/or Anti-HBe Seroconversion at Any Timepoint
Measured: Up to 148 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jul 202025 Mar 2024

First posted2 Jun 2020
Study start3 Jul 2020
Primary completion25 Mar 2024
Study completion25 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04412863
Sponsor's protocol ID: VIR-2218-1001-PEG-IFNα
Status last verified: Mar 2026
First submitted: 29 May 2020
Last updated: 16 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

All Chronic Hepatitis B trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04412863
Acronym / sponsor ID: VIR-2218-1001-PEG-IFNα
Conditions: Chronic Hepatitis B
Keywords: Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: Vir Biotechnology, Inc.Industry (pharma, biotech, devices)
Collaborators: Alnylam Pharmaceuticals
Study start: 3 Jul 2020 (actual)
Primary completion: 25 Mar 2024 (actual)
Study completion: 25 Mar 2024 (actual)
First posted: 2 Jun 2020 (actual)
Results: Posted 16 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 9

Arm	Type	Receives
Cohort 1d	Experimental	Drug: VIR-2218VIR-2218 given by subcutaneous injection
Cohort 2d	Experimental	Drug: VIR-2218, Drug: pegylated interferon-alfa 2aVIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Cohort 3d	Experimental	Drug: VIR-2218, Drug: pegylated interferon-alfa 2aVIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Cohort 1e	Experimental	Drug: VIR-2218VIR-2218 given by subcutaneous injection
Cohort 2e	Experimental	Drug: VIR-2218, Drug: pegylated interferon-alfa 2aVIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Cohort 3e	Experimental	Drug: VIR-2218, Drug: pegylated interferon-alfa 2aVIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Cohort 1f	Experimental	Drug: VIR-2218, Drug: pegylated interferon-alfa 2aVIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Cohort 2f	Experimental	Drug: VIR-2218, Drug: pegylated interferon-alfa 2aVIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Cohort 3f	Experimental	Drug: VIR-2218, Drug: pegylated interferon-alfa 2aVIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Male or female of ages 18 - 65
Chronic HBV infection for >/= 6 months

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VIR-2218Also: ElebsiranVIR-2218 given by subcutaneous injection	Drug	Cohort 1d, Cohort 1e, Cohort 1f, Cohort 2d, Cohort 2e, Cohort 2f, Cohort 3d, Cohort 3e, Cohort 3f
pegylated interferon-alfa 2aAlso: pegylated interferon alpha-2a, PEG-IFNαpegylated interferon-alfa 2a given by subcutaneous injection	Drug	Cohort 1f, Cohort 2d, Cohort 2e, Cohort 2f, Cohort 3d, Cohort 3e, Cohort 3f

Primary outcome

Number of Subjects With Adverse Events as Assessed by CTCAE v5.0
Time frame: Up to 148 Weeks
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Time frame: Up to 148 Weeks

5 secondary outcomes

Mean Maximum Reduction of Serum HBsAg at Any Timepoint
Time frame: Up to 148 Weeks
Proportion of Subjects With Serum HBsAg Loss (Undetectable HBsAg) at Any Timepoint
Time frame: Up to 148 Weeks
Proportion of Subjects With Sustained Serum HBsAg Loss (Undetectable HBsAg) for Greater Than 6 Months
Time frame: Up to 148 Weeks
Proportion of Subjects With Anti-HBs Seroconversion at Any Timepoint
Time frame: Up to 148 Weeks
For HBeAg-positive Patients: Proportion of Subjects With HBeAg Loss (Undetectable HBeAg) and/or Anti-HBe Seroconversion at Any Timepoint
Time frame: Up to 148 weeks

Results and safety

Results posted to the registry on 16 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI	15	9
Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI	15	15
Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI	5	5
Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI	18	17
Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI	18	16
Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI	13	13

Primary outcome: Number of Subjects With Adverse Events as Assessed by CTCAE v5.0

Time frame: Up to 148 Weeks. Count of participants. Unit: Participants

Measure	Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI n = 15	Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI n = 15	Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI n = 5	Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI n = 18	Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI n = 18	Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI n = 13
Value	9	13	3	16	17	13

Primary outcome: Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings

Time frame: Up to 148 Weeks. Count of participants. Unit: Participants

Measure	Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI n = 15	Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI n = 15	Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI n = 5	Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI n = 18	Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI n = 18	Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI n = 13
ALT Grade 1	2	12	2	12	14	9
ALT Grade 2	0	1	1	2	2	2
ALT Grade 3	0	0	0	1	1	0
Alkaline phosphatase Grade 1	0	0	0	0	0	1
AST Grade 1	2	11	4	14	16	10
AST Grade 2	0	2	0	2	0	0
AST Grade 3	0	0	0	0	1	0
Bilirubin Grade 1	4	0	0	0	4	0

Population analysed: All participants that received at least one dose of any study intervention were included in this analysis.

5 secondary outcomes are reported in the full results.

Adverse events

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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1d: VIR-2218 200 mg Q4W x 6 on NRTI	0 of 15 (0%)	9 of 15 (60%)	0 of 15
Cohort 2d: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 12 Starting at Week 12 on NRTI	0 of 15 (0%)	13 of 15 (86.7%)	0 of 15
Cohort 3d: VIR-2218 200 mg Q4W x 3 + PEG-IFNα 180 µg QW x 12 on NRTI	0 of 5 (0%)	3 of 5 (60%)	0 of 5
Cohort 1f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x 24 on NRTI	1 of 18 (5.6%)	16 of 18 (88.9%)	0 of 18
Cohort 2f: VIR-2218 200 mg Q4W x 6 + PEG-IFNα 180 µg QW x ≤ 48 on NRTI	1 of 18 (5.6%)	17 of 18 (94.4%)	0 of 18
Cohort 3f: VIR-2218 200 mg Q4W x ≤13 + PEG-IFNα 180 µg QW x ≤ 44 on NRTI	1 of 13 (7.7%)	13 of 13 (100%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Chronic Hepatitis B

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

22 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VIR-2218 and pegylated interferon-alfa 2a in people with Chronic Hepatitis B, run by Vir Biotechnology, Inc. at 22 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Thailand, South Korea, Malaysia, Australia, New Zealand and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Adverse Events as Assessed by CTCAE v5.0 (time frame: Up to 148 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04412863.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.