Efficacy and Safety of Switching to Vemliver From Entecavir in Chronic Hepatitis B Patients Previously Treated With Entecavir

Inclusion Criteria:

1. Participants aged 19 years and older as of the date of written consent.

2. Individuals with a positive HBsAg for at least 24 weeks prior to screening or ahistory of chronic hepatitis B.

3. Individuals with chronic hepatitis B who have been receiving ETV 0.5 mg asmonotherapy for at least 24 weeks and have expressed the intention to switch toBarakros tablets or Bemeliver tablets.

4. Participants with good adherence to ETV 0.5 mg monotherapy confirmed throughquestionnaire (≥80%).

5. Participants who have demonstrated viral suppression efficacy (HBV DNA <69 IU/mL)and are deemed to require monotherapy with Tenofovir alafenamide or ETV for at least 48 weeks.

6. Individuals who voluntarily agree to participate in the clinical trial and havesigned the informed consent form.

Exclusion Criteria: Medical history or surgical (treatment) history at the time of screening visit:

① Individuals diagnosed with substance abuse or alcohol addiction within the pastyear of screening.

• Confirmed diagnosis of malignant tumors, including liver cancer, within thepast 5 years.
• Organ or bone marrow transplant recipients. Coexisting conditions at the time of screening visit:

① Non-selective clinical signs/symptoms in non-selective liver disease.

• Galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.
• Kidney disease patients requiring hemodialysis or peritoneal dialysis. ④Other clinically significant cardiovascular, respiratory, neurological, orpsychiatric conditions considered inappropriate for participation in theclinical trial according to the participant's judgment. Laboratory test results at the time of screening visit:

① Co-infection with HCV and HIV.

• Hemoglobin <8 g/dL.

• Impaired renal function. ④ ALT >3 × ULN. Anticipated use of the following drugs during the specified period: During the clinical trial period:

• Immunosuppressants.

• Systemic corticosteroids administered at a dose equal to or greater than arestricted dose for more than 2 weeks.

• Drugs affecting renal excretion, drugs with renal or hepatictoxicity. ④ Anti-HBV drugs other than investigational medicinalproducts. ⑤ Hepatotonics.