A Study to Evaluate Tobevibart+Elebsiran Versus Bulevirtide in Chronic HDV Infection

Inclusion criteria

• Male or female ages 18 to 70 years at screening
• Positive HDV antibody or positive HDV RNA PCR result for at least 6 months prior to screening and HDV RNA ≥ 500 IU/mL at screening
• Noncirrhotic or compensated cirrhotic liver disease at screening
• On NRTI therapy against HBV for at least 12 weeks prior to day 1 or have HBV DNA < 10 IU/ml at screening, currently on locally approved NRTI therapy

Exclusion criteria

• Serum ALT ≥ 5 × ULN
• Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation.
• History of significant liver disease from non-HBV or non-HDV etiology
• History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients.
• History of anaphylaxis
• History of immune complex disease
• History of autoimmune disorder
• 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.
• Any previous treatment with Bulivertide