Overview
This is a phase 2 trial in which participants with chronic hepatitis D virus (HDV) infection will receive VIR-2218 and/or VIR-3434 and be assessed for safety, tolerability, and efficacy
Description
Participants may be enrolled into Cohort 1 (1a and 1b) or Cohort 2 (2a, 2b1 or 2b2, 2c), 3, 4, and 5.
Eligibility
Inclusion Criteria:
- Male or female ages 18 to < 70 years at screening
- Chronic HDV infection for >/= 6 months
- On NRTI therapy for at least 12 weeks prior to day 1
- ALT>ULN and < 5x ULN
- Anti-HBs >10 mIU/mL at screening if only adding a select set of EC
- Non-cirrhotic and CPT-A cirrhotic
Exclusion Criteria:
- 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
- History or evidence of alcohol or drug abuse
- Prior or concomitant therapy with an immunomodulatory agent, IFN-alpha, cytotoxic or chemotherapeutic agent, or chronic corticosteroids.