Phase 2 N=84 Treatment

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

Chronic Hepatitis B

Bottom Line

View on ClinicalTrials.gov: NCT04412863 ↗

Enrolled (actual)

Serious AEs

3.6%

Results posted

Apr 2026

Primary outcome: Primary: Number of Subjects With Adverse Events as Assessed by CTCAE v5.0 — 9; 13; 3; 16 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: VIR-2218 (Drug); pegylated interferon-alfa 2a (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vir Biotechnology, Inc.
Primary completion: Mar 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With Adverse Events as Assessed by CTCAE v5.0	9; 13; 3; 16; 17; 13	—
PRIMARY Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings	2; 12; 2; 12; 14; 9	—
SECONDARY Mean Maximum Reduction of Serum HBsAg at Any Timepoint	-1.96; -2.15; -1.73; -2.52; -2.48; -2.99	—
SECONDARY Proportion of Subjects With Serum HBsAg Loss (Undetectable HBsAg) at Any Timepoint	0; 1; 0; 2; 6; 4	—
SECONDARY Proportion of Subjects With Sustained Serum HBsAg Loss (Undetectable HBsAg) for Greater Than 6 Months	0; 1; 0; 1; 4; 2	—
SECONDARY Proportion of Subjects With Anti-HBs Seroconversion at Any Timepoint	9; 8; 3; 7; 4; 3	—
SECONDARY For HBeAg-positive Patients: Proportion of Subjects With HBeAg Loss (Undetectable HBeAg) and/or Anti-HBe Seroconversion at Any Timepoint	1; 1; 0; 3; 3; 1	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04412863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.