A Study Evaluating ABI-H0731+ NUC vs NUC Alone for the Treatment of Viremic HBeAg-positive, CHB Patients

This is a Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating
ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Patients
With Chronic Hepatitis B

Key Inclusion Criteria:

- Male or female between ages 18 and 70 years

- HBeAg-positive at screening

- In good general health except for chronic HBV infection

- HBV viral load ≥2×105 IU/mL

- HBsAg >1000 IU/mL at screening

Key Exclusion Criteria:

- Any prior treatment with lamivudine or telbivudine, previous treatment with an
investigational agent for HBV other than ABI-H0731; or any other SOC treatment for >4
weeks

- Co-infection with HIV, HCV, HEV or 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 subject 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 HCC

- Females who are lactating or pregnant or wish to become pregnant are excluded from the
study

- Exclusionary laboratory parameters at screening:

- Platelet count <100,000/mm3

- Albumin
- Direct bilirubin >1.2×ULN

- ALT >10×ULN at screening

- Serum alpha fetoprotein (AFP) ≥100 ng/mL. If AFP at Screening is >ULN but <100
ng/mL, subject is eligible if a hepatic imaging study prior to the initiation of
study drug reveals no lesions suspicious of possible HCC

- International Normalized Ratio (INR) >1.5×ULN

- Glomerular filtration rate (GFR) <60 mL/min/1.73 m2 by CKD-EPI equation