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NCT05461170 (VIR-2218 VIR-3434 in Chronic Hepatitis D Infection): BVCT ex-ante prediction vs. reported outcome

On 14 Aug 2024, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 19 Nov 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient.

Clinical Trial

NCTID
NCT05461170
Acronym
SOLSTICE
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 D Infection
Human Patients
124
Sponsor
Vir Biotechnology
Phase
Phase 2

Prediction of , index 445

Prospective Prediction
Prediction Index
445
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in HDV RNA suppression non-superior to SoC)
Technical Prediction
SUCCESS (statistically significant clinical benefit in HDV RNA suppression against placebo for which VIR-2218 is non-superior-non-inferior to bepirovirsen)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
97 days in advance
Readout Data Interpretation
elebsiran + tobevibart achieved 41% HDV RNA TND at week 24; which is inferior to 46% HDV RNA TND at week 24 achieved by 10-mg bulevirtide + PEG IFN-alfa-2a (DOI- 10.1056/NEJMoa2314134)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient
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 Efficacy, Safety and Tolerability of VIR-2218 and VIR-3434 in Participants With Chronic Hepatitis D Virus Infection (SOLSTICE)
Phase
Phase 2
Status
Active not recruiting
Enrollment
95
Lead sponsor
Vir Biotechnology, Inc.
Conditions
Hepatitis D, Chronic
Interventions
DRUG: VIR-2218; DRUG: VIR-3434; DRUG: NRTI
Design
Randomized · Sequential · None
Primary purpose
Treatment
Start
2022-09-17
Primary completion
2031-11
Completion
2032-05
Primary outcomes
  • Proportion of participants with undetectable HDV RNA (< limit of detection [LOD]) or ≥ 2 log10 decrease in HDV RNA from baseline and alanine aminotransferase (ALT) normalization (ALT < upper limit of normal [ULN]) at Week 24 (Up to 24 Weeks)
  • Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) (Up to 360 Weeks)

NCT05461170 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials