A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection

NCT05612581 | Completed Phase 1 Results FDA Drug

• 1 other identifier: VIR-MHB1-V200
• Study Type: interventional
• Target: 33
• Locations: 6 countries
• Sites: 15

Brief Summary

This is a Phase 1b/2 platform study framework to evaluate the safety and efficacy of investigational candidate(s) and their combinations as potential treatments for adults with chronic hepatitis B virus infection.

Conditions

Hepatitis B, Chronic

Keywords

Hepatitis B Virus; Chronic Hepatitis B; HBV; Hepatitis

Outcome Measures

Primary Outcomes (1)

• STRIVE and THRIVE: Proportion of Participants Achieving Suppression of HBV DNA (< LLOQ) With HBsAg Loss (< 0.05 IU/mL) at the End of Treatment

  Up to 48 weeks

Secondary Outcomes (22)

• STRIVE and THRIVE: Proportion of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Up to 96 weeks

• STRIVE and THRIVE: Proportion of Participants With Serum HBsAg ≤ 10 IU/mL at End of Treatment

  Up to 48 weeks

• STRIVE and THRIVE: Proportion of Participants With Serum HBsAg ≤ 10 IU/mL at 24 Weeks Post-end of Treatment

  Up to 72 weeks

• STRIVE and THRIVE: Serum HBsAg Levels and Change From Baseline Across Timepoints in the Study

  Up to 96 weeks

• STRIVE and THRIVE: Serum HBsAg Level at Nadir During the Study

  Up to 96 weeks

Study Arms (7)

STRIVE: Cohort 1a (VIR-3434 + TDF)

EXPERIMENTAL

Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total

Drug: VIR-3434; Drug: TDF

STRIVE: Cohort 2a (VIR-3434 + TDF)

EXPERIMENTAL

Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total

Drug: VIR-3434; Drug: TDF

STRIVE: Cohort 3a (VIR-3434 + TDF)

EXPERIMENTAL

Participants will receive combination therapy with VIR-3434 + TDF for 36 or 40 weeks total

Drug: VIR-3434; Drug: TDF

STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF)

EXPERIMENTAL

Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 20 or 44 weeks total

Drug: VIR-3434; Drug: VIR-2218; Drug: TDF

STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα)

EXPERIMENTAL

Participants will receive combination therapy with VIR-3434 + VIR-2218 +TDF + PEG-IFNα for 48 weeks total

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

THRIVE: Cohort 1b (VIR-3434 + TDF)

EXPERIMENTAL

Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks

Drug: VIR-3434; Drug: TDF

THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF)

EXPERIMENTAL

Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 44 weeks total

Drug: VIR-3434; Drug: VIR-2218; Drug: TDF

Interventions

VIR-3434 DRUG

VIR-3434 given by subcutaneous injection

Also known as: Tobevibart

STRIVE: Cohort 1a (VIR-3434 + TDF); STRIVE: Cohort 2a (VIR-3434 + TDF); STRIVE: Cohort 3a (VIR-3434 + TDF); STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF); STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα); THRIVE: Cohort 1b (VIR-3434 + TDF); THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF)

VIR-2218 DRUG

VIR-2218 given by subcutaneous injection

Also known as: Elebsiran

STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF); STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα); THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF)

TDF DRUG

TDF given orally

STRIVE: Cohort 1a (VIR-3434 + TDF); STRIVE: Cohort 2a (VIR-3434 + TDF); STRIVE: Cohort 3a (VIR-3434 + TDF); STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF); STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα); THRIVE: Cohort 1b (VIR-3434 + TDF); THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF)

PEG-IFNα DRUG

PEG-IFNα given by subcutaneous injection

STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα)

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ages 18 or older
• Chronic HBV infection for \>/= 6 months
• 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
• STRIVE: HBeAg positive or negative, HBV DNA \> 2,000 IU/mL, ALT \> ULN and ≤ 5x ULN
• THRIVE: Must be/have the following, within the 1-year period prior to screening: HBeAg negative, HBV DNA ≤ 2,000 IU/mL, ALT ≤ ULN

You may not qualify if:

• Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation
• History of clinically significant liver disease from non-HBV etiology
• History or current evidence of hepatic decompensation
• Co-infection with human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or hepatitis E virus (HEV).
• History or clinical evidence of alcohol or drug abuse
• STRIVE and THRIVE: Significant fibrosis or cirrhosis
• STRIVE and THRIVE: History of immune complex disease
• STRIVE and THRIVE: History of autoimmune disorder
• STRIVE and THRIVE: History of allergic reactions, hypersensitivity, or intolerance to monoclonal antibodies, antibody fragments, or any excipients of VIR-3434
• STRIVE: Prior NRTI or PEG-IFN therapy
• STRIVE: History of known contraindication to any interferon product
• THRIVE: Prior NRTI therapy \< 24 weeks of study or any prior PEG-IFN therapy

Sponsors & Collaborators

• Vir Biotechnology, Inc.: lead

Study Sites (15)

Investigative Site

Clichy, 92110, France

Location

Investigative Site

Nice, 06200, France

Location

Investigative Site

Rennes, 35000, France

Location

Investigative Site

Toulouse, 31000, France

Location

Investigative Site

Hong Kong, Sha Tin, Hong Kong

Location

Investigative Site

Hong Kong, Hong Kong

Location

Investigative Site

Chisinau, MD 2025, Moldova

Location

Investigative Site

Bucharest, 021105, Romania

Location

Investigative Site

Busan, 49241, South Korea

Location

Investigative Site

Seoul, 5505, South Korea

Location

Investigative Site

Yangsan, 50612, South Korea

Location

Investigative Site

Glasgow, G4 0SF, United Kingdom

Location

Investigative Site

London, EC1A 7BE, United Kingdom

Location

Investigative Site

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

Results Point of Contact

• Title: Study Inquiry
• Organization: Vir Biotechnology, Inc.

clinicaltrials@vir.bio

415-654-5281

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 10, 2022
• Study Start: May 10, 2023
• Primary Completion: October 15, 2024
• Study Completion: August 19, 2025
• Last Updated: February 9, 2026
• Results First Posted: November 26, 2025

Record last verified: 2025-10

Locations

RO (1); FR (4); MO (1); KR (3); GB (4); HK (2)