A Study Evaluating ABI-H0731 as Adjunctive Therapy in Participants With Chronic Hepatitis B Infection

Exclusion Criteria

• •Co-infection with HIV, hepatitis C virus (HCV), hepatitis E virus (HEV) or hepatitis D virus (HDV)
• •History or evidence of hepatic decompensation (including gastrointestinal bleeding or esophageal varices) at any time prior to or at time of screening
• •Clinically significant cardiac or pulmonary disease, chronic or recurrent renal or urinary tract disease, liver disease other than HBV, endocrine disorder, autoimmune disorder, diabetes mellitus requiring treatment with insulin or hypoglycemic agents, neuromuscular, musculoskeletal, or mucocutaneous conditions requiring frequent treatment, seizure disorders requiring treatment, or other medical conditions requiring frequent medical management or pharmacologic or surgical treatment that in the opinion of the Investigator or the Sponsor makes the participant unsuitable for the study
• •Previous treatment with an investigational agent for HBV other than ABI-H0731 in the last 6 months before screening
• •History of hepatocellular carcinoma (HCC)
• •Females who are lactating or pregnant or wish to become pregnant are excluded from the study
• •Exclusionary laboratory parameters at screening include:
• •* Platelet count \<100,000/mm3
• •* Albumin \<lower limit of normal (LLN)
• •* Direct bilirubin \>1.2×upper limit of normal (ULN)
• •* Alanine aminotransferase (ALT) \>5×ULN at screening
• •* International Normalized Ratio (INR) \>1.5×ULN
• •* Glomerular filtration rate (GFR) \<60 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation