The goal of this observational study is to explore the efficacy and safety of Tenofovir Amibufenamide (TMF) in Entecavir (ETV) treated chronic hepatitis B patients with low-level viraemia. The main question it aims to answer is: * The efficacy and safety of TMF in chronic hepatitis B patients with low-level viraemia. * What is the appropriate treatment for ETV treated chronic hepatitis B patients with low-level viraemia. Participants will choose to maintain their original regimen (ETV) or switch to TMF After being fully informed of the benefits and risks of treatment. Researchers will compare ETV and TMF to see if there is a difference in the efficacy of the two drugs in chronic hepatitis B patients with low-level viraemia.
Study Type
OBSERVATIONAL
Enrollment
204
switch ETV to TMF
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGChongqing University Three Gorges Central Hospital
Chongqing, China
NOT_YET_RECRUITINGAffiliated Hospital of Guangxi Medical University
Guangxi, China
NOT_YET_RECRUITINGHepatobiliary disease of Jilin Province
Jilin City, China
NOT_YET_RECRUITINGThe First People's Hospital of Yunnan Province
Kunming, China
NOT_YET_RECRUITINGthe Second People's Hospital of Yunnan Province
Kunming, China
NOT_YET_RECRUITINGNanjing Second Hospital
Nanjing, China
NOT_YET_RECRUITINGThe Second Hospital of Ningbo
Ningbo, China
RECRUITINGShanghai East Hospital
Shanghai, China
RECRUITINGShuguang Hospital, Shanghai, China.
Shanghai, China
NOT_YET_RECRUITING...and 3 more locations
The proportions of undetectable HBV DNA in patients treated with ETV and TMF at week 48.
Undetectable HBV DNA is defined as below 20 IU/mL.
Time frame: 48 weeks
The proportions of undetectable HBV DNA in patients treated with ETV and TMF at week 24.
Undetectable HBV DNA is defined as below 20 IU/mL.
Time frame: 24 weeks
The proportions of ALT normalization in patients treated with ETV and TMF at week 24 and 48.
There are two criteria for ALT normalization. Criteria1: below 40 U/L. Criteria2: Males: ALT\<30U/L, female: ALT\<19U/L.
Time frame: 24 weeks and 48 weeks
Comparing pgRNA levels from baseline at week 24 and 48.
Time frame: 24 weeks and 48 weeks
Comparing HBcrAg levels from baseline at week 24 and 48.
Time frame: 24 weeks and 48 weeks
The proportions of undetectable pgRNA in patients treated with ETV and TMF at week 24 and 48.
Undetectable pgRNA is defined as below 100 pg/mL.
Time frame: 24 weeks and 48 weeks
The proportions of undetectable HBcrAg in patients treated with ETV and TMF at week 24 and 48.
Time frame: 24 weeks and 48 weeks
Comparing degree of liver fibrosis from baseline at week 24 and 48.
Evaluation of liver fibrosis including Fibroscan, APRI and FIB-4.
Time frame: 24 weeks and 48 weeks
Comparing the change of creatinine clearance rate from baseline at week 24 and 48.
Time frame: 24 weeks and 48 weeks
The types, incidence and severity of adverse events and serious adverse events during treatment were evaluated in both groups
Time frame: Week 48
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