Phase 2
N=33
A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection
Hepatitis B, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT05612581 ↗Enrolled (actual)
33
Serious AEs
3.0%
Results posted
Nov 2025
Primary outcome: Primary: STRIVE and THRIVE: Proportion of Participants Achieving Suppression of HBV DNA (< LLOQ) With HBsAg Loss (< 0.05 IU/mL) at the End of Treatment — 1; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VIR-3434 (Drug); VIR-2218 (Drug); TDF (Drug); PEG-IFNα (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vir Biotechnology, Inc.
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY STRIVE and THRIVE: Proportion of Participants Achieving Suppression of HBV DNA (< LLOQ) With HBsAg Loss (< 0.05 IU/mL) at the End of Treatment |
1; 4 | — |
| SECONDARY STRIVE and THRIVE: Proportion of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
— | — |
| SECONDARY STRIVE and THRIVE: Proportion of Participants With Serum HBsAg ≤ 10 IU/mL at End of Treatment |
— | — |
| SECONDARY STRIVE and THRIVE: Proportion of Participants With Serum HBsAg ≤ 10 IU/mL at 24 Weeks Post-end of Treatment |
— | — |
| SECONDARY STRIVE and THRIVE: Serum HBsAg Levels and Change From Baseline Across Timepoints in the Study |
— | — |
| SECONDARY STRIVE and THRIVE: Serum HBsAg Level at Nadir During the Study |
— | — |
| SECONDARY STRIVE and THRIVE: Time to Achieve Nadir of Serum HBsAg During the Study |
— | — |
| SECONDARY STRIVE and THRIVE: Time to Achieve Serum HBsAg Loss (< 0.05 IU/mL) |
— | — |
| SECONDARY STRIVE and THRIVE: Proportion of Participants With HBsAg Loss With Anti-HBs Seroconversion at End of Treatment and at 24 Weeks Post-end of Treatment |
— | — |
| SECONDARY STRIVE: Proportion of Participants Achieving Sustained Suppression of HBV DNA (< LLOQ) With HBsAg Loss (< 0.05 IU/mL) After Discontinuation of All Treatment at 24 Weeks and at the F48 Follow-Up Visit |
— | — |
| SECONDARY STRIVE: Proportion of Participants With HBsAg Loss (<0.05 IU/mL) at End of Treatment and at 24 Weeks Post-end of Treatment |
— | — |
| SECONDARY STRIVE: Proportion of Participants Achieving Sustained Suppression of HBV DNA (< LLOQ) After Discontinuation of All Treatment at 24 Weeks and at the F48 Follow-Up Visit |
— | — |
| SECONDARY STRIVE: For HBeAg-positive Participants: Proportion of Participants With HBeAg Loss (Undetectable HBeAg) and/or Anti-HBe Seroconversion |
— | — |
| SECONDARY STRIVE: Incidence and Titers of Anti-drug Antibodies (ADA; if Applicable) to VIR-3434 |
— | — |
| SECONDARY STRIVE: Mean Change in Serum HBsAg Level From Baseline Across Timepoints in the Study |
— | — |
| SECONDARY STRIVE: Proportion of Participants Achieving HBV DNA (< LLOQ) Across Timepoints in the Study |
— | — |
| SECONDARY STRIVE: Proportion of Participants Achieving ALT ≤ ULN Across Timepoints in the Study |
— | — |
| SECONDARY THRIVE: Proportion of Participants Achieving Sustained Suppression of HBV DNA (< LLOQ) With HBsAg Loss (< 0.05 IU/mL) After Discontinuation of All Treatment at 24 Weeks and at 48 Weeks |
— | — |
| SECONDARY THRIVE: Proportion of Participants Achieving HBsAg Loss (< 0.05 IU/mL) at End of Treatment and at 24 Weeks Post-end of Treatment |
— | — |
| SECONDARY THRIVE: Proportion of Participants Achieving Sustained Suppression of HBV DNA (< LLOQ) After Discontinuation of All Treatment at 24 Weeks and at 48 Weeks |
— | — |
| SECONDARY THRIVE: Incidence and Titers of ADA (if Applicable) to VIR-3434 |
— | — |
| SECONDARY THRIVE: Mean Change in Serum HBsAg Level From Baseline Across Timepoints in the Study |
— | — |
| SECONDARY THRIVE: Proportion of Participants Achieving HBV DNA (< LLOQ) |
— | — |
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.
Eligibility Criteria
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 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05612581). 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.