This is a multicenter, single arm, open label, historical control pilot Study to the antiviral efficacy and safety of Suboptimal Responders to Entecavir Switching to TAF Treatment at week 48 (investigate the rates of complete virological response on switching to TAF in patients with Suboptimal response or ETV intolerance to standard ETV= 0.5 mg monotherapy).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Tenofovir alafenamide (TAF) 25 mg QD, oral administration, 48 weeks;
Main efficacy endpoint
The primary efficacy endpoint is the proportion of subjects with plasma HBV DNA levels below 20 IU/ml at Week 48.
Time frame: Week 48
Key secondary efficacy endpoint
The proportion of subjects with plasma HBV DNA \< 20 IU/mL at Weeks 24
Time frame: Week 24
Key secondary efficacy endpoint
The change from baseline in plasma HBV DNA levels at Weeks 48
Time frame: Week 48
Key secondary efficacy endpoint
The proportion of subjects with ALT normalization at Weeks 24 and 48
Time frame: Week 24 and Week 48
Key secondary efficacy endpoint
The proportion of subjects with HBeAg seroconversion to anti-HBe at Weeks 48
Time frame: Week 48
Key secondary efficacy endpoint
The HBV DNA maintenance rate at week 48 in ETV intolerant pts.
Time frame: Week 48
Key secondary efficacy endpoint
The proportion of subjects with HBsAg seroconversion to anti-HBs at Weeks 48
Time frame: Week 48
Key secondary efficacy endpoint
The incidence of drug resistant mutations at Weeks 48
Time frame: Week 48
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