A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide

Launched by VIR BIOTECHNOLOGY, INC. · Aug 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new combination treatment called tobevibart plus elebsiran for people with chronic hepatitis D virus (HDV) infection who have not responded well to their current treatment with bulevirtide. HDV is a type of viral hepatitis that affects the liver, and this study aims to see if adding these new medicines can better control the virus in the body.

People who might be eligible to join are adults between 18 and 70 years old who have a certain level of HDV virus in their blood and have been on bulevirtide treatment for at least 24 weeks without full virus control. Participants should have liver disease that is either non-cirrhotic or cirrhosis that is still compensated, meaning the liver is damaged but still working. They also need to be on treatment for hepatitis B virus (HBV), as these two viruses often occur together. During the study, participants will receive the new combination treatment and be closely monitored to see how well it works and to ensure safety. This trial is currently recruiting participants, and people with certain other health conditions or allergies to the study drugs may not be able to join.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female ages 18 to 70 years at screening
• • 2. HDV RNA ≥ 500 IU/mL at screening
• • 3. Receiving BLV 2 mg SC QD for ≥ 24 weeks at Day 1
• • 4. Noncirrhotic or compensated cirrhotic liver disease at screening
• • 5. On NRTI therapy against HBV for at least 12 weeks prior to day 1 or have HBV DNA \< 20 IU/ml at screening, currently on locally approved NRTI therapy
• Exclusion Criteria:
• • 1. Serum ALT ≥ 5 × ULN
• • 2. Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation.
• • 3. History of significant liver disease from non-HBV or non-HDV etiology
• • 4. History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients.
• • 5. History of anaphylaxis
• • 6. History of immune complex disease
• • 7. History of autoimmune disorder
• • 8. Current therapy or therapy within 24 weeks of screening with an immunomodulatory agent, immune checkpoint inhibitors, immunosuppressants, cytotoxic or chemotherapeutic agent, or chronic systemic corticosteroids.