Effectiveness of TAF in Reducing Clinical Events in CHB Patients Beyond Treatment Indications by Current Guidelines

Prior treatment

• Abusing alcohol (more than 60 g/day) or illicit drugs

Other illness

• Co-infection with HCV, HDV, HIV (Confirmed by nucleic acid tests)
• Patients with history of hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage)
  • 4-1) Evidence of cirrhosis, including any of follows:
• Evidence of clinically significant portal hypertension

Lab values

• Platelet count \<100,000/mm3
• Fibroscan ≥ 12.0 kPa (If the test was done in 3 months before the time of screening.) and confirmed to have liver cirrhosis by an investigator
  • 4-2) 40≤ALT levels\<70 IU/L (males) or 40≤ ALT levels\<50 IU/L (females) with evidence of significant fibrosis(F2; ≥7.2 kPa) as measured by either liver biopsy, Fibroscan or MR elastograpy performed within 3 months.
  • 5\. Received interferon or other immunomodulatory treatment for HBV infection in the 12 months before screening for this study
  • 6\. Medical condition that requires concurrent use of systemic corticosteroid or other immunosuppressive agents
  • 7\. Received solid organ or bone marrow transplant
  • 8\. Known hypersensitivity to study drugs, metabolites, or formulation excipients
  • 9\. Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the patient unsuitable for the study or unable to comply with dosing requirements
  • 10\. Use of investigational agents within 6 months of screening, unless allowed by the Sponsor or Investigator
  • 11\. Significant renal, cardiovascular, pulmonary, or neurological disease in the opinion of the Investigator
  • 12\. Any malignant tumor in the preceding five years. However, a history of treated malignancy (other than HCC) is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding three years
  • 13\. Pregnant or breastfeeding or willing to be pregnant
  • 14\. Participating in other clinical trials to administer medication. However, it is possible to participate if it is not an antiviral agent or immunosuppressant related clinical trial.

Other

• Esophagogastric varices on endoscopy

• Patient must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures
• Male or female, 40 to 80 years of age
• Positive for HBsAg or HBV DNA for at least 6 months or more
• HBeAg positive or negative
• No evidence of liver cirrhosis (platelet count ≥100,000/mm3)
• serum HBV DNA ≥ 4 log10 IU/mL and ≤ 8 log10 IU/mL
• Serum ALT level \<70 if male, \<50 if female
• Estimated creatinine clearance ≥ 30 ml/min based on serum creatinine as measured at the screening evaluation
• Patient is willing and able to comply with all study requirements