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VIR-3434

Phase 1

Chronic Hepatitis B | Monoclonal antibody | Infectious Disease |Vir Biotechnology, Inc.|Last Updated: Feb 9, 2026

Target and mechanism

Molecular targethepatitis B surface antigen
Target classProtein
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment113

FDA Designations

No designations recorded

Clinical trial landscape

VIR-3434 · 2 trials · 2 indications

Phase 1 2
NCT05612581A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B InfectionHepatitis B, Chronic
COMPLETED33 Analytics
NCT04423393Study of VIR-3434 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus InfectionChronic Hepatitis B
COMPLETED113 Analytics
PHASE1COMPLETED
A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection
Hepatitis B, Chronic
NCT0561258133
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PHASE1COMPLETED
Study of VIR-3434 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection
Chronic Hepatitis B
NCT04423393113
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Study Endpoints

Primary Endpoints

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
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
Number of Participants With Clinical Laboratory Abnormalities
Up to 280 days post-dose

Secondary Endpoints

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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
STRIVE: Cohort 1a (VIR-3434 + TDF)EXPERIMENTALParticipants will receive combination therapy with VIR-3434 + TDF for 44 weeks total
STRIVE: Cohort 2a (VIR-3434 + TDF)EXPERIMENTALParticipants will receive combination therapy with VIR-3434 + TDF for 44 weeks total
STRIVE: Cohort 3a (VIR-3434 + TDF)EXPERIMENTALParticipants will receive combination therapy with VIR-3434 + TDF for 36 or 40 weeks total
STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF)EXPERIMENTALParticipants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 20 or 44 weeks total
STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα)EXPERIMENTALParticipants will receive combination therapy with VIR-3434 + VIR-2218 +TDF + PEG-IFNα for 48 weeks total
THRIVE: Cohort 1b (VIR-3434 + TDF)EXPERIMENTALParticipants will receive combination therapy with VIR-3434 + TDF for 44 weeks
THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF)EXPERIMENTALParticipants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 44 weeks total
VIR-3434EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
VIR-3434DRUGVIR-3434 given by subcutaneous injection
VIR-2218DRUGVIR-2218 given by subcutaneous injection
TDFDRUGTDF given orally
PEG-IFNαDRUGPEG-IFNα given by subcutaneous injection
PlaceboOTHERSterile normal saline (0.9% NaCl) given by subcutaneous injection or intravenous infusion.
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Eligibility Criteria

Age Range18 Years to 66 Years
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * 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 negat...

Countries:FranceHong KongMoldovaRomaniaSouth KoreaUnited KingdomGermanyNew ZealandSingapore
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Frequently asked questions about VIR-3434

What is VIR-3434 used for in chronic hepatitis B?

VIR-3434 is an investigational monoclonal antibody being developed for chronic hepatitis B and hepatitis B virus infection. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with chronic hepatitis B to evaluate its safety and potential therapeutic effects.

What does VIR-3434 target?

VIR-3434 targets the hepatitis B surface antigen, a protein found on the surface of the hepatitis B virus. By binding to this antigen, the antibody is designed to interfere with the virus's ability to infect cells and replicate. This mechanism is being investigated as a potential treatment approach for chronic hepatitis B infection.

Who makes VIR-3434?

VIR-3434 is being developed by Vir Biotechnology, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol VIR. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational monoclonal antibody for the treatment of chronic hepatitis B.

What phase is VIR-3434 in?

VIR-3434 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received approval from regulatory agencies such as the FDA. The Phase 1 trials are designed to assess the drug's safety, tolerability, and pharmacokinetics in healthy volunteers and patients with chronic hepatitis B.

What clinical trials is VIR-3434 in?

VIR-3434 has been studied in two clinical trials. The first, NCT04423393, was a Phase 1 study in healthy volunteers and patients with chronic hepatitis B, enrolling 113 participants across multiple countries. The second, NCT05612581, was a Phase 1 platform study evaluating investigational therapies in chronic hepatitis B, enrolling 33 participants. Both trials have been completed.

Is VIR-3434 the same as other hepatitis B treatments?

VIR-3434 is a distinct investigational monoclonal antibody targeting the hepatitis B surface antigen. It is not the same as other approved hepatitis B treatments, which typically include nucleoside analogs or interferons. VIR-3434 represents a novel approach being studied in clinical trials for its potential to treat chronic hepatitis B.