Patients with chronic hepatitis B should maximize the inhibition of HBV replication, which could reduce the incidence of liver cancer and liver disease-related complications. However, after 96 weeks of treatment with the first-line drugs, entecavir or tenofovir disoproxil fumarate, a certain proportion of patients still had low levels of HBV replication. Tenofovir alafenamide fumarate is a newly marketed anti-hepatitis B drug that is currently considered to be non-inferior to tenofovir disoproxil fumarate and safer bone and renal effects. Therefore, this research was put forward to investigate whether tenofovir alafenamide fumarate replacement for hepatitis B had a higher virological response rate and safety in patients with low levels of virus after 48 weeks of treatment with entecavir and tenofovir disoproxil fumarate.
Patients who meet the inclusion and exclusion criteria will be enrolled into the research. The participants will voluntarily choose to enter the experimental group or the control group with full informed consent. The control group will continue with the original regimen, while the study group will switch to tenofovir alafenamide fumarate antiviral therapy. Each group will enroll 100 participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Patients would take tenofovir alafenamide fumarate, 25mg，once per day
Patients would take entecavir 0.5 mg once per day, or tenofovir disoproxil fumarate 300 mg once per day
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGRatio of patients with undetectable hepatitis b virus DNA after treatment
Hepatitis b virus DNA would be tested to know the ratio of patients with undetectable hepatitis b virus DNA at 24 week after treatment.
Time frame: 24 week
The changes of glomerular filtration rate
Glomerular filtration rate will be tested to know the changes after treatment
Time frame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
The changes of bone mineral density in lumbar spine and hip
Bone mineral density in lumbar spine and hip were tested after treatment
Time frame: 0 week, 48 week, 96 week, 144 week.
Ratio of patients with undetectable hepatitis b virus DNA after treatment
Hepatitis b virus DNA would be tested at 6 time points.
Time frame: 12 week, 48 week, 72 week, 96 week, 120 week, 144 week
The changes of HBsAg
The levels of HBsAg were tested at each time point.
Time frame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
The changes of the degree of liver fibrosis
Fibroscan would be conducted once every 48 weeks
Time frame: 0 week, 48 week, 96 week, 144 week.
Differences in symptoms
Symptoms would be evaluated at each time point
Time frame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
The changes of HBeAg
The levels of HBeAg were tested at each time point.
Time frame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
The changes of alanine aminotransferase
The levels of alanine aminotransferase were tested at each time point.
Time frame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Differences in body weight
Body weight would be evaluated at each time point
Time frame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Differences in proteinuria, albuminuria and urinary β2-microglobulin
Proteinuria, albuminuria and urinary β2-microglobulin would be evaluated at each time point
Time frame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Differences in osmotic pressure
The levels of osmotic pressure would be evaluated at each time point
Time frame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Differences in blood calcium and phosphorus
The levels of blood calcium and phosphorus would be evaluated at each time point
Time frame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Differences in blood lipid
The levels of blood lipid would be evaluated at each time point
Time frame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Differences in serum creatine kinase
The levels of creatine kinase would be evaluated at each time point
Time frame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
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