A Perspective Study of the Antiviral Efficacy and Safety of Switching to TAF Treatment in CHB Adults With Suboptimal Response (SOR) and Intolerant to Entecavir

Exclusion Criteria

• •1. Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study;
• •2. Co-infection with HCV, HIV, or HDV;
• •3. Any history of, or current evidence of, clinical hepatic decompensation (i.e., moderate-severe ascites, encephalopathy or variceal hemorrhage);
• •4. Evidence of hepatocellular carcinoma (e.g. as evidenced by recent imaging);
• •5. Abnormal hematological and biochemical parameters, including: Hemoglobin \< 10 g/dl, Absolute neutrophil count \< 0.75×109/L, Platelets ≤ 50×109/L, AST or ALT \> 10 × ULN, Total bilirubin \> 2.5 × ULN, Albumin \< 3.0 g/dl, INR \> 1.5 × ULN;
• •6. Received solid organ or bone marrow transplant;
• •7. Recent history of pancreatitis (within 24 weeks prior to the first dose of study medication);
• •8. Evidence of other autoimmune or metabolic liver diseases (except non-alcoholic fatty liver disease);
• •9. Significant renal, cardiovascular, pulmonary, or neurological disease in the opinion of the investigator;
• •11. Known hypersensitivity to study drugs, metabolites, or formulation excipients;
• •12. Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance;
• •13. Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements.