This study is to investigate the clinical efficacy and safety of Nucleoside (acid) analogues treatment in patients with normal Alanine Aminotransferase and positive Hepatitis B virus DNA.
Hepatitis b virus infection has always been a global public health problem that endangers national health. Current clinical guidelines do not recommend antiviral therapy for people with positive hepatitis b-DNA and normal Alanine Aminotransferase, but studies have found that viral replication is associated with an increased risk of cirrhosis and liver tumors. Nucleoside (acid) analogues can effectively inhibit viral reverse transcriptase, reduce HBV viral load in the blood, thereby reducing secondary inflammation, and contribute to liver cell regeneration and disease recovery. And its side effect is small, adverse reaction rate is low, use safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Patients would receive treatment of oral Tenofovir alafenamide Fumarate（TAF）once per day.
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGhepatitis b s antigen decrease from baseline
Magnitude of decrease in hepatitis B antigen quantification from baseline to week 144.
Time frame: 48 week, 96 week, 144 week
hepatitis b e antigen loss rate
Hepatitis b e antigen would be tested to know the ratio of patients with negative hepatitis B e antigen.
Time frame: 48 week, 96 week, 144 week
hepatitis b virus(HBV) DNA undetectable rate
Hepatitis b virus DNA would not be detected if it below the upper limit of test value
Time frame: 48 week, 96 week, 144 week
hepatitis b virus(HBV) RNA undetectable rate
Hepatitis b virus RNA would not be detected if it below the upper limit of test value
Time frame: 48 week, 96 week, 144 week
hepatitis b s antigen loss rate
Hepatitis b s antigen become negative and quantitative analysis below the upper limit of test value
Time frame: 48 week, 96 week, 144 week
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