Chronic hepatitis B
Conditions
Interventions
experimental group:switching to TAF (25 mg/d) therapy
control group:continuing ETV (0.5 mg/d) therapy
Sponsors
The Fifth Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) aged over 18 years; (2) serum positive for both HBsAg and HBV DNA; (3) ETV-treated patients who received ETV for >48 weeks and experienced LLV (HBV DNA 20-2000 IU/mL).
Exclusion criteria
Exclusion criteria: (1) treated with other nucleos(t)ide analogues (NUCs) or pegylated interferon-a (IFN-a); (2) poor clinical compliance; (3) coinfected with either hepatitis C virus or human immunodeficiency virus; (4) combined with other liver disease including autoimmune liver disease, drug-induced liver injury, etc.; (5) had decompensated cirrhosis (eg, complicated with obvious ascites, variceal haemorrhage or encephalopathy); (6) any cancers; (7) women with pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete virological response (CVR) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Degree of serum HBV DNA levels decreased;ALT normalization;Degree of qHBsAg decline;HBeAg loss and seroconversion;changes in liver fibrosis as measured by LSM, APRI and FIB-4; | — |
Countries
China
Contacts
Public ContactJi Dong
Senior Department of Hepatology, the Fifth Medical Center of PLA General Hospital
Outcome results
None listed