Tenofovir Alafenamide With Fine Needle Aspiration Biopsy in Chronic Hepatitis B:

Exclusion Criteria

• •• Treatment with any investigational drug within 60 days of entry into this protocol
• •* Immune-suppressive treatment within the previous 6 months
• •* History of decompensated cirrhosis (defined as direct (conjugated)
• •* bilirubin \> 1.2 × ULN,
• •* prothrombin time (PT) \> 1.2 × ULN
• •* platelets \< 100,000/mm3
• •* serum albumin \< 3.5 g/dL
• •* prior history of clinical hepatic decompensation (jaundice in the presence of cirrhosis, ascites, gastric bleeding, oesophageal varices or encephalopathy)
• •* Liver transplantation
• •* Co-infection with hepatitis C virus, hepatitis D virus or HIV
• •* Other significant liver disease: alcoholic liver disease, drug-related liver disease, auto-immune hepatitis, hemochromatosis, Wilson's disease or alpha-1 antitrypsin deficiency
• •* Estimated glomerular filtration rate \<50 mL/min/1.73m2 or any significant renal disease.
• •* Alpha-fetoprotein \> 50 ng/ml
• •* Pregnancy, breast-feeding
• •* Other significant medical illness that might interfere with this study: significant pulmonary dysfunction in previous 6 months, malignancy other than skin basocellular carcinoma in previous 5 years, immunodeficiency syndromes (e.g. HIV positivity, auto-immune diseases, organ transplants other than cornea and hair transplant)
• •* Substance abuse, such as alcohol (≥80 g/day), I.V. drugs and inhaled drugs in past 2 years. Current methadone usage is allowed.
• •* Any other condition which in the opinion of the investigator would make the patient unsuitable for enrolment, or could interfere with the patient participating in and completing the study