Chronic hepatitis B
Conditions
Interventions
treated group:TAF first, then decide if need ETV+TAF
Initial treatment group:initiate TAF
Sponsors
Guangdong General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Cohort 1: Initial treatment cohort 1. HBsAg positive for more than 6 months; 2. No gender limitation; 3. HBV DNA > 20 IU/ml; 4. ALT normal or ALT abnormal for 1-3 months (ALT normal means that ALT is checked at least once every 3 months within 6 months, all of which are normal; ALT abnormalities were included as the baseline value with the highest value in the examination results within 1-3 months.); 5. Aged >= 30 years; 6. A family history of liver cancer or cirrhosis; 7. Voluntarily signed the informed consent for this study and the informed consent for antiviral treatment. Cohort 2: treated cohorts 1. Age >= 18 years, gender unlimited; 2. Confirmed chronic hepatitis B/compensatory cirrhosis, currently treated with NA (except TAF) for more than 48 weeks; 3. HBV DNA > 20 IU/ml; 4. Voluntarily signed the informed consent for this study and the informed consent for antiviral treatment
Exclusion criteria
Exclusion criteria: Initial treatment cohort: 1. Pregnant women, women who are breastfeeding or who believe they may become pregnant during the course of the study; Reproductive potential men and women who were unwilling to use effective contraceptive methods during the study period; 2. Complicated HIV/HCV infection; 3. Participating in other clinical studies/unable to follow up; 4. Diagnosis of liver fibrosis, cirrhosis or newly diagnosed history of HCC/HCC; 5. Being taking drugs that have significant drug interactions with TAF (carbamazepine, oxcarbazepine, phenobarbital, phenytoin, itraconazole, ketoconazole, rifampicin, rifapentine, rifambutine, St. John's wort, etc.)or within 30 days; 6. Allergic to the active ingredients or excipients of TAF; 7. eGFR < 15 ml/min. 8. Diagnosis of severe fatty liver (severe fatty liver is determined by liver B-ultrasound or liver hardness), alcoholic liver or autoimmune hepatitis; 9.For other reasons, researchers consider it unsuitable to participate in the study. Treatment cohort: 1. Hypoviremia caused by non-compliance; 2. Pregnant women, women who are breastfeeding or who believe they may become pregnant during the course of the study; Reproductive potential men and women who were unwilling to use effective contraceptive methods during the study period; 3. Combined with HIV/HCV infection; 4. Participating in other clinical studies/unable to follow up; 5. Newly diagnosed history of HCC/HCC; 6. Being taking drugs that have significant drug interactions with TAF (carbamazepine, oxcarbazepine, phenobarbital, phenytoin, itraconazole, ketoconazole, rifampicin, rifapentine, rifambutine, St. John's wort, etc.)or within 30 days; 7. Allergic to the active ingredients or excipients of TAF; 8. eGFR < 15 ml/min. 9. Participants with decompensated cirrhosis, liver failure;(Child-Pugh grade B cirrhosis participants were enrolled by the investigator based on the participant's comprehensive status.Child-Pugh Grade C participants will be excluded) 10. Diagnosis of severe fatty liver (severe fatty liver is determined by liver B-ultrasound or liver hardness), alcoholic liver or autoimmune hepatitis; 11. For other reasons, researchers consider it unsuitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV DNA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood Cell Count;qHBsAg;HBeAg quantity;ALT, AST;TBIL,DBIL;AFP;Cr, eGFR;Ca, P;TC,TG,HDL, LDL;Glu;CK,CK-MB;Urine renal tubular marker;Fibroscan;BMD(Spine and hip);YKL-40;HBV pg RNA;Liver biopsy; | — |
Countries
China
Contacts
Public ContactChen Xuefu
Guangdong General Hospital
Outcome results
None listed