This study evaluates generic emtricitabine(FTC) in Chinese naive chronic hepatitis B patients. Patients were divided into 2 groups: HBeAg positive Chronic hepatitis B(CHB)group and HBeAg negative Chronic hepatitis B(CHB)group.
Generic emtricitabine(FTC) has been approved for treatment of naive chronic hepatitis B(CHB) patients in China. Yet data are limited for this agent. The investigators design this trial to test the effect of FTC in Chinese CHB which including naive HBeAg positive and Negative CHB patients. Response guided therapy strategy is adopted for patients who can not achieve HBV DNA negativity at week 24 FTC treatment, which means FTC and adefovir are combined for these patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,000
emtricitabine were given to each patients at baseline and respoonse guided therapy was adopted according HBV DNA level at week 24
virological response rate
HBV DNA \< 500 copies/ml
Time frame: week 96
HBV DNA decrease level
HBV DNA decrease compared with baseline(log10 copies/ml)
Time frame: week24, 48, 72 and 96
HBV DNA negativity rate
HBV DNA \< 500 copies/ml
Time frame: week 24, 48 and 72
biochemical response
ALT normalization
Time frame: week 24,48,72 and 96
HBeAg loss
HBeAg loss in HBeAg positive group
Time frame: week 24,48,72 and 96
HBeAg seroconversion
HBeAg seroconversion in HBeAg positive group
Time frame: week 24,48,72 and 96
HBeAg reversion
HBeAg positive in Baseline HBeAg negativie group patients
Time frame: week 24,48,72 and 96
HBsAg loss
HBsAg loss in both group
Time frame: week 24,48,72 and 96
HBsAg seroconversion
HBsAg loss and anti-HBs positive
Time frame: week 24,48,72 and 96
adverse event
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type and rate of adverse events;type and rate of severe adverse event;
Time frame: week 24,48,72 and 96
HBV genetic resistance to emtricitabine and adefovir
HBV genetic resistance to emtricitabine and adefovir
Time frame: week 24,48,72 and 96