eligibility_summary
Adults ≥18 with chronic HBV ≥6 months (positive HBsAg/HBV DNA/HBeAg on 2 tests ≥6 months apart). STRIVE: HBeAg ±, HBV DNA >2,000 IU/mL, ALT >ULN ≤5×ULN. THRIVE (past year): HBeAg−, HBV DNA ≤2,000, ALT ≤ULN. Exclude: significant illness, non-HBV liver disease, hepatic decomp, HIV/HAV/HCV/HDV/HEV, substance abuse, fibrosis/cirrhosis, immune complex/autoimmune disease, mAb/VIR-3434 allergy, STRIVE: prior NRTI/PEG-IFN or IFN contraindication, THRIVE: NRTI <24 wks or any PEG-IFN.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
NCT05612581 (PREVAIL) is a Phase 1b/2 platform in chronic HBV testing combinations of: 1) VIR-3434 (tobevibart): a human monoclonal antibody to HBsAg that neutralizes HBV virions/subviral particles and, via Fc engineering, enhances Fcγ receptor–mediated effector functions (ADCC/ADCP) to help clear HBsAg-expressing hepatocytes. 2) VIR-2218 (elebsiran): a GalNAc-conjugated siRNA targeting conserved HBV transcripts (incl. S/X), engaging hepatocyte RNAi (RISC) to lower HBsAg and other viral proteins. 3) Tenofovir disoproxil fumarate (TDF): an oral nucleotide reverse transcriptase inhibitor that blocks HBV polymerase and viral DNA synthesis. 4) Pegylated interferon-α (PEG-IFNα): an immunomodulatory cytokine activating JAK-STAT and ISGs, enhancing innate (NK) and adaptive (T cell) antiviral responses. Targets/pathways: HBsAg/entry neutralization, Fc effector clearance, hepatocyte RNAi, reverse transcription, and interferon-driven innate/adaptive immunity.