Study of VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection

NCT04856085 | Completed Phase 2 FDA Drug

• 1 other identifier: VIR-2218-1006
• Study Type: interventional
• Target: 244
• Locations: 12 countries
• Sites: 37

Brief Summary

This is a phase 2 study in which participants with chronic hepatitis B virus (HBV) infection will receive VIR-2218, VIR-3434 and/or PEG-IFNα and be assessed for safety, tolerability, and efficacy

Conditions

Hepatitis B, Chronic

Keywords

Hepatitis B Virus; Chronic Hepatitis B; HBV; Hepatitis

Outcome Measures

Primary Outcomes (4)

• Proportion of participants with treatment-emergent adverse events (TEAEs)

  Up to 72 weeks

• Proportion of participants with serious adverse events (SAEs)

  Up to 72 weeks

• Proportion of participants with hepatitis B surface antigen (HBsAg) loss (defined as undetectable HBsAg) at end of treatment

  Up to 48 weeks

• Proportion of participants with HBsAg loss (defined as undetectable HBsAg) at 24 weeks post-end of treatment

  Up to 72 weeks

Secondary Outcomes (18)

• Absolute serum HBsAg and change from baseline across all timepoints in the study

  Up to 110 weeks

• Nadir and maximum reduction of serum HBsAg from baseline

  Up to 110 weeks

• Proportion of participants achieving sustained suppression of HBV DNA (< lower limit of quantification (LLOQ) for >= 24 weeks after discontinuation of all treatment, including NRTIs)

  Up to 110 weeks

• For hepatitis B e-antigen (HBeAg)-positive participants: Proportion of participants with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepoint

  Up to 110 weeks

• For HBeAg-positive participants: Time to HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion

  Up to 110 weeks

Study Arms (13)

Cohort 1a (VIR-2218 + VIR-3434)

EXPERIMENTAL

Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total

Drug: VIR-2218; Drug: VIR-3434

Cohort 2a (VIR-2218 + VIR-3434)

EXPERIMENTAL

Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total

Drug: VIR-2218; Drug: VIR-3434

Cohort 3a (VIR-2218 + VIR-3434)

EXPERIMENTAL

Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks

Drug: VIR-2218; Drug: VIR-3434

Cohort 4a (VIR-2218 + VIR-3434)

EXPERIMENTAL

Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks

Drug: VIR-2218; Drug: VIR-3434

Cohort 5a (VIR-2218 + VIR-3434)

EXPERIMENTAL

Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks

Drug: VIR-2218; Drug: VIR-3434

Cohort 6a (VIR-2218 + VIR-3434)

EXPERIMENTAL

Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks

Drug: VIR-2218; Drug: VIR-3434

Cohort 7a (VIR-2218 + VIR-3434)

EXPERIMENTAL

Participants will receive multiple doses of VIR-2218 + VIR-3434 for 44 weeks

Drug: VIR-2218; Drug: VIR-3434

Cohort 8a (VIR-2218 + VIR-3434)

EXPERIMENTAL

Participants will receive multiple doses of VIR-2218 + VIR-3434 for 20 weeks

Drug: VIR-2218; Drug: VIR-3434

Cohort 1b (VIR-3434)

EXPERIMENTAL

Participants will receive multiple doses of VIR-3434 for 44 weeks

Drug: VIR-3434

Cohort 2b (VIR-3434)

EXPERIMENTAL

Participants will receive multiple doses of VIR-3434 for 20 weeks

Drug: VIR-3434

Cohort 1c (VIR-2218 + VIR-3434 + PEG-IFNα)

EXPERIMENTAL

Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 24 weeks

Drug: VIR-2218; Drug: VIR-3434; Drug: PEG-IFNα

Cohort 2c (VIR-2218 + VIR-3434 + PEG-IFNα)

EXPERIMENTAL

Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 48 weeks

Drug: VIR-2218; Drug: VIR-3434; Drug: PEG-IFNα

Cohort 1d (VIR-3434 + PEG-IFNα)

EXPERIMENTAL

Participants will receive multiple doses of VIR-3434 + PEG-IFNα for 48 weeks

Drug: VIR-3434; Drug: PEG-IFNα

Interventions

VIR-2218 DRUG

VIR-2218 given by subcutaneous injection

Also known as: Elebsiran

Cohort 1a (VIR-2218 + VIR-3434); Cohort 1c (VIR-2218 + VIR-3434 + PEG-IFNα); Cohort 2a (VIR-2218 + VIR-3434); Cohort 2c (VIR-2218 + VIR-3434 + PEG-IFNα); Cohort 3a (VIR-2218 + VIR-3434); Cohort 4a (VIR-2218 + VIR-3434); Cohort 5a (VIR-2218 + VIR-3434); Cohort 6a (VIR-2218 + VIR-3434); Cohort 7a (VIR-2218 + VIR-3434); Cohort 8a (VIR-2218 + VIR-3434)

VIR-3434 DRUG

VIR-3434 given by subcutaneous injection

Also known as: Tobevibart

Cohort 1a (VIR-2218 + VIR-3434); Cohort 1b (VIR-3434); Cohort 1c (VIR-2218 + VIR-3434 + PEG-IFNα); Cohort 1d (VIR-3434 + PEG-IFNα); Cohort 2a (VIR-2218 + VIR-3434); Cohort 2b (VIR-3434); Cohort 2c (VIR-2218 + VIR-3434 + PEG-IFNα); Cohort 3a (VIR-2218 + VIR-3434); Cohort 4a (VIR-2218 + VIR-3434); Cohort 5a (VIR-2218 + VIR-3434); Cohort 6a (VIR-2218 + VIR-3434); Cohort 7a (VIR-2218 + VIR-3434); Cohort 8a (VIR-2218 + VIR-3434)

PEG-IFNα DRUG

PEG-IFNα given by subcutaneous injection

Cohort 1c (VIR-2218 + VIR-3434 + PEG-IFNα); Cohort 1d (VIR-3434 + PEG-IFNα); Cohort 2c (VIR-2218 + VIR-3434 + PEG-IFNα)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ages 18 - \<66 years
• Chronic HBV infection for \>/= 6 months
• On NRTI therapy for \>/= 2 months at the time of screening

You may not qualify if:

• Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation
• Significant fibrosis or cirrhosis
• History or evidence of drug or alcohol abuse
• History of chronic liver disease from any cause other than chronic HBV infection
• History of hepatic decompensation
• History of anaphylaxis
• History of allergic reactions, hypersensitivity, or intolerance to monoclonal antibodies, antibody fragments, or any excipients of VIR-3434
• History of immune complex disease
• History of known contraindication to any interferon product

Sponsors & Collaborators

• Vir Biotechnology, Inc.: lead

Study Sites (37)

Investigative Site

San Francisco, California, 94143, United States

Location

Investigative Site

Miami, Florida, 33136, United States

Location

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Orlando, Florida, 32803, United States

Location

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Baltimore, Maryland, 21218, United States

Location

Investigative Site

Hillsborough, New Jersey, 08844, United States

Location

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Toronto, 2C4, Canada

Location

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Toronto, 3M1, Canada

Location

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Vancouver, 2C7, Canada

Location

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Frankfurt, 60590, Germany

Location

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Hanover, 30625, Germany

Location

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Mannheim, 68167, Germany

Location

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Hong Kong, Shatin, Hong Kong

Location

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Hong Kong, Tai Po District, Hong Kong

Location

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Hong Kong, Hong Kong

Location

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Kuala Lumpur, 59100, Malaysia

Location

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Chisinau, MD 2025, Moldova

Location

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Auckland, 1010, New Zealand

Location

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Auckland, 2025, New Zealand

Location

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Hamilton, 3204, New Zealand

Location

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Tauranga, 3110, New Zealand

Location

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Wellington, 6021, New Zealand

Location

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Bucharest, 021105, Romania

Location

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Busan, 49421, South Korea

Location

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Seoul, 03080, South Korea

Location

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Seoul, 05505, South Korea

Location

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Yangsan, 50612, South Korea

Location

Investigative Site

Chiayi City, 60041, Taiwan

Location

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Kaohsiung City, 80756, Taiwan

Location

Investigative Site

Kaohsiung City, 83301, Taiwan

Location

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Taichung, 40705, Taiwan

Location

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Taipei, 100, Taiwan

Location

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Taoyuan, 33305, Taiwan

Location

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Kyiv, 01135, Ukraine

Location

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Birmingham, B15 2TH, United Kingdom

Location

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London, E11FR, United Kingdom

Location

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London, SE5 9RS, United Kingdom

Location

Investigative Site

Manchester, M8 5RB, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B; Hepatitis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 22, 2021
• Study Start: July 11, 2021
• Primary Completion: March 16, 2026
• Study Completion: March 16, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (6); MY (1); DE (3); NZ (5); RO (1); MO (1); HK (3); UA (1); CA (3); US (5); KR (4); GB (4)