Study of Bulevirtide in Participants With Chronic Hepatitis D Infection

Exclusion Criteria

• •Individuals currently enrolled in BLV clinical treatment studies and/or other interventional clinical studies with an investigational agent.
• •History or current presence of clinically significant illness or any other major medical disorder that may interfere with individual follow-up, assessments, or compliance with the protocol.
• •Coinfection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV) (Individuals with HCV antibodies can be enrolled if HCV RNA is negative).
• •Solid organ transplantation.
• •Any history, or current evidence of clinical hepatic decompensation (ie, ascites, encephalopathy, jaundice, or gastrointestinal bleeding (GIB)).
• •Presence of hepatocellular carcinoma (HCC) as evidenced by imaging (eg, ultrasound or computed tomography scan) performed within 4 months prior to Day 1 for individuals with cirrhosis and within 6 months prior to Day 1 for individuals without cirrhosis.
• •Pregnant or breastfeeding females.
• •Individuals with a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed by a positive polymerase chain reaction test result.
• •Known hypersensitivity or contraindication to BLV or formulation excipients.
• •Individuals who are committed to an institution by virtue of a court or official order.
• •Individuals deemed by the study investigator to be inappropriate for study participation for any reason not otherwise listed. This includes persons dependent on the sponsor, investigator, or trial site.