Recent TAF has introduced to have more safe profiles than TDF in clinical trials. Especially, TDF has the renal safety issue in high risk group including HIV, decompensated cirrhosis (ascites), uncontrolled DM etc. However, there is no available cohort data for treatment efficacy and safety in TDF-TAF switch therapy in treatment-naïve chronic hepatitis B. The aim of this study is to evaluate safety and efficacy of TAF switch therapy in patients with chronic hepatitis B who have been treated with TDF.
Study Type
OBSERVATIONAL
Enrollment
400
To evaluate of efficacy and safety in patients with TDF-TAF switch therapy
The Catholic University of Korea, Daejeon St.Mary's Hosptial
Junggu, Daejeon, South Korea
RECRUITINGComplete Virological response
Portion of subjects with plasma HBV DNA levels below 116 copies/mL
Time frame: at Week 96.
Incidence of of elevation of serum creatinine as a measure of renal safety
Incidence of elevation of serum creatinine (\>0.5mg/dL) from baseline creatinine
Time frame: at Week 96
Incidence of osteopenia and osteoporosis as a measure of bone safety
Incidence of osteopenia and osteoporosis according to Bone Mineral Density
Time frame: at Week 96
Biochemical response
ALT normalization (Male \<30 IU/L, Female \<19 IU/L)
Time frame: at Week 48 and 96
Serologic response
loss rate of HBeAg in HBeAg positive patients
Time frame: at Week 48 and 96
Serologic response
seroconversion rate in HBeAg positive patients
Time frame: at Week 48 and 96
Incidence of treatment-emergent adverse events
all adverse events during tenofovir treatment
Time frame: at Week 48 and 96
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