Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B
Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B
To compare the efficacy and renal safety of tenofovir alafenamide (TAF) versus entecavir
 (ETV) in the chronic hepatitis B patients.
With high antiviral potency and low drug resistance rate, both ETV and tenofovir disoproxil
 fumarate (TDF) have been recommended as the first-line antiviral therapy for chronic
 hepatitis B (CHB). However, risk of renal dysfunction remains an issue in TDF long-term
 therapy. Tenofovir alafenamide (TAF) is a novel prodrug of tenofovir and is formulated to
 deliver the active metabolite to target cells more efficiently than TDF at lower doses,
 thereby reducing systemic exposure to tenofovir. Importantly, TAF had improved renal safety
 as compared to TDF. TAF has been approved for treating CHB since 2017; however, it is still
 unknown whether the efficacy and renal safety of TAF is compatible to those of ETV. The
 investigators aim to conduct an open label, randomized controlled trial comparing TAF with
 ETV for assessing their efficacy and renal safety in CHB patients. The eligible CHB patients
 are randomly assigned (1:1) to receive TAF or ETV. After allocation to TAF group or ETV
 group, study subjects will receive therapy for 3 years (144 weeks).
Inclusion Criteria:

 1. Patients more than 20 years old

 2. Chronic hepatitis B patients

 3. Patients who were indicated for hepatitis B virus antiviral therapy

 Exclusion Criteria:

 1. Decompensated liver disease (Child-Pugh B &C)

 2. End stage renal disease (eGRF < 15 ml/min/1.73m2)

 3. Prior use of nucleot(s)ide analogues for chronic hepatitis B

 4. Prior use of interferon for chronic hepatitis B within six months

 5. Known history of human immunodeficiency virus or hepatitis C virus co-infection

 6. Concurrent other uncontrolled malignancy

 7. Women in pregnancy or lactation

 8. Cannot conform to the study protocol of this study