Tenofovir alafenamide (TAF) is a new prodrug of tenofovir developed to treat patients with chronic hepatitis B virus (HBV) infection. Whereas, the long-term effect of TAF to liver fibrosis is still unknown. Here, we enrolled treatment naive CHB patients with biopsy-proven significant fibrosis (METAVIR fibrosis stage ≥ F2). All enrolled subjects will be treated with TAF monotherapy for 96 weeks. After 96 weeks of therapy, the second liver biopsy will be performed to evaluate the rate of liver fibrosis regression. During this study, all subjects will be assessed for laboratory tests, imaging examination at baseline, first 12-week and every 24-week during follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Subjects will be treated for 96 weeks with TAF \[Vemlidy® 25mg QD\] monotherapy
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Shuguang Hospital
Shanghai, Shanghai Municipality, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Ruijin Hospital
Shanghai, Shanghai Municipality, China
Proportion of patients with fibrosis regression
Fibrosis stage decrease at least 1 point by Ishak score or "Predominantly Regressive" by "Beijing classification"
Time frame: Week 96
HBV DNA undetectable rate
Serum HBV DNA \<20 IU/mL
Time frame: Week 96
Percentage of liver stiffness decrease >= 30%
Proportion of patients with liver stiffness decrease \>= 30% from baseline to week 48 and 96
Time frame: Week 48 and Week 96
HBV DNA undetectable rate
HBV DNA undetectable rate at week 24, 48, and 72
Time frame: Week 24, Week 48 and Week 72
ALT normalization rate
Proportion of patients with ALT \<= 1.0xULN
Time frame: Week 48 and Week 96
HBeAg and HBsAg loss and seroconversion rate
Proportions of patients with HBsAg loss and seroconversion to anti-HBs, and proportions of patients with HBeAg loss and seroconversion to anti-HBe.
Time frame: Week 48 and Week 96
Changes in renal function
Changes of eGFR (estimated Glomerular Filtration rate) from baseline to week 48 and 96
Time frame: Week 48 and Week 96
Changes of bone mineral density
Percentage changes in spine BMD and hip BMD from baseline to week 48 and 96
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Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality, China
Tianjin Second People's Hospital
Tianjin, Tianjin Municipality, China
Time frame: Week 48 and Week 96
Incidence of liver-related endpoint events
liver-related endpoint events: decompensation, HCC, liver transplantation, liver-related death
Time frame: Week 96