This study evaluates generic emtricitabine(FTC) efficacy and safety in Chinese naive pregnant chronic hepatitis B patients. Single group patients were enrolled to receive emtricitabine till 48 weeks after delivery.
Single group patients were enrolled to receive emtricitabine till 48 weeks after delivery, which include HBeAg positive and negative patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
emtricitabine were given to each patients at baseline till 48 weeks after delivery
virological response rate
HBV DNA \< 500 copies/ml
Time frame: week 48 after delivery
HBV DNA decrease level
HBV DNA decrease compared with baseline(log10 copies/ml)
Time frame: week 24 and 48 after delivery
virological response rate
HBV DNA \< 500 copies/ml
Time frame: week 24 after delivery
biochemical response
ALT normalization
Time frame: week 24 and 48 after delivery
HBeAg loss
HBeAg loss in HBeAg positive group
Time frame: week 24 and 48 after delivery
HBeAg seroconversion
HBeAg seroconversion in HBeAg positive group
Time frame: week 24 and 48 after delivery
HBeAg reversion
HBeAg positive in Baseline HBeAg negativie group patients
Time frame: week 24 and 48 after delivery
HBsAg loss
HBsAg loss
Time frame: week 24 and 48 after delivery
HBsAg seroconversion
HBsAg loss and anti-HBs positive
Time frame: week 24 and 48 after delivery
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HBV genetic resistance to emtricitabine
HBV genetic resistance to emtricitabine
Time frame: week 24 and 48 after delivery
adverse event
type and rate of adverse events;type and rate of severe adverse event;
Time frame: week 24 and 48 after delivery
birth defect in newborns
birth defect in newborns
Time frame: 0 weeks, week24 and week48 after delivery
HBsAg positive rate in newborns
HBsAg positive rate in newborns
Time frame: 0 weeks, week24 and week48 after delivery