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NCT04856085 (VIR-2218 VIR-3434 in Chronic hepatitis B viral infection): BVCT ex-ante prediction vs. reported outcome

On 14 Aug 2024, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. 2 readouts followed: 15 Nov 2024, True Positive (TP); 9 May 2025, True Negative (TN).

Clinical Trial

NCTID
NCT04856085
Acronym
MARCH
Drug Name
VIR-2218 (elebsiran) VIR-3434 (tobevibart)
Drug MoA
anti-HBx-HBV siRNA and anti-HBsAg mAb inhibitor
Drug Modality
siRNA and monoclonal antibody (mAb)
Drug Class
First-In-Class
Therapeutic Area
Infections
Indication
Chronic hepatitis B viral infection
Human Patients
244
Sponsor
Vir Biotechnology
Phase
Phase 2

Prediction of , index 444

Prospective Prediction
Prediction Index
444
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in HBV DNA suppression non-superior to SoC)
Technical Prediction
SUCCESS (statistically significant clinical benefit in TEAE and HBsAg against placebo for which VIR-2218 is non-superior-non-inferior to bepirovirsen)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
93 days in advance
Readout Data Interpretation
elebsiran + tobevibart achieved 16% HBsAg loss and elebsiran + tobevibart + PEG-IFNalpha achieved 22% HBsAg loss; of which elebsiran's about 7% HBsAg loss (see the data in the add link) is non-superior to bepirovirsen's 9-10% HBsAg loss (N Engl J Med DOI- 10.1056/NEJMoa2210027)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (HBsAg loss) and commercially TBD (pending HBV DNA suppression data)
Prediction Classification
True Positive (TP)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
268 days in advance
Readout Data Interpretation
VIR2218 + VIR3434 achieved functional cure (HBsAg absence and HBV DNA absence) in 4% participants at week 24; inferior to bepirovirsen that achieved functional cure in 10% participants at week 24 (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially probably insufficient (non-superior to bepirovirsen)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of Regimens Containing VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection
Phase
Phase 2
Status
Completed
Enrollment
244
Lead sponsor
Vir Biotechnology, Inc.
Conditions
Hepatitis B, Chronic
Interventions
DRUG: VIR-2218; DRUG: VIR-3434; DRUG: PEG-IFNα
Design
Non randomized · Parallel · None
Primary purpose
Treatment
Start
2021-07-11
Primary completion
2026-03-16
Completion
2026-03-16
Primary outcomes
  • 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)

NCT04856085 on ClinicalTrials.gov

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