Study of Bulevirtide in Participants With Chronic Hepatitis D Infection

Key Inclusion Criteria:

• Individuals who have been diagnosed with chronic hepatitis D virus (HDV) infectionfor at least 6 months before study enrollment, confirmed by respective documentationin the individuals' medical records.

• Must have the ability to understand and sign a written informed consent form, whichmust be obtained prior to initiation of study procedures.

• Must be willing and able to comply with the visit schedule and study requirements.

• Cohort 1 only: Must have participated in study MYR-Reg-02.

• Cohort 2 only: Individuals scheduled to receive bulevirtide (BLV) according to theapproved label or for whom the decision to start treatment with BLV according to theapproved label has been made and treatment initiation is planned.

Key Exclusion Criteria:

• Individuals currently enrolled in BLV clinical treatment studies and/or otherinterventional clinical studies with an investigational agent.

• History or current presence of clinically significant illness or any other majormedical disorder that may interfere with individual follow-up, assessments, orcompliance 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, ultrasoundor computed tomography scan) performed within 4 months prior to Day 1 forindividuals with cirrhosis and within 6 months prior to Day 1 for individualswithout 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 officialorder.

• Individuals deemed by the study investigator to be inappropriate for studyparticipation for any reason not otherwise listed. This includes persons dependenton the sponsor, investigator, or trial site.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.