This study evaluates generic emtricitabine(FTC) plus adefovir dipivoxil in Chinese naive HBV related cirrhosis patients. Patients were divided into 2 groups: compensated HBV related cirrhosis patients and decompensated HBV related cirrhosis patients.
Generic emtricitabine(FTC) has been approved for treatment of naive chronic hepatitis B(CHB) patients in China. Yet data are limited for this agent plus adefovir dipivoxil in cirrhosis patients. The investigators design this trial to test the effect of FTC plus adefovir dipivoxil in Chinese naive compensated and decompensated HBV related cirrhosis patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
emtricitabine plus adefovir dipivoxil were given to each patients for 96 weeks
virological response rate
HBV DNA \< 500 copies/ml
Time frame: week 96
HBV DNA negativity rate
HBV DNA \< 500 copies/ml
Time frame: week 24, 48 and 72
HBV DNA decrease level
HBV DNA decrease compared with baseline(log10 copies/ml)
Time frame: week24, 48, 72 and 96
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
HBV genetic resistance to emtricitabine and adefovir
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HBV genetic resistance to emtricitabine and adefovir
Time frame: week 24,48,72 and 96
adverse event
type and rate of adverse events;type and rate of severe adverse event
Time frame: week 24,48,72 and 96
incidence of HCC
incidence of HCC in both groups
Time frame: week 24,48,72 and 96
change of MELD score and Child-Pugh score
change of MELD score and Child-Pugh score in both groups
Time frame: week 24,48,72 and 96