This study evaluates generic emtricitabine(FTC) efficacy and safety in Chinese naive pregnant HBsAg positive patients in prevention of HBV vertical transmission. Single group patients were enrolled to receive emtricitabine till 24 weeks after delivery.
Single group patients were enrolled to receive emtricitabine till 24 weeks after delivery, which include HBeAg positive patients. Patients and their newborns were followed till 48 weeks after delivery to evaluate the efficacy of prevention of vertical transmission.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
200
emtricitabine were given to each patients from week 28 pregnancy to 24 weeks after delivery
HBsAg positive rate in newborns
HBsAg positive rate in newborns
Time frame: week48 after delivery
birth defect in newborns
birth defect in newborns
Time frame: 0 weeks, week24 and week48 after delivery
virological response rate
HBV DNA \< 500 copies/ml
Time frame: week 24 after delivery
HBV DNA decrease level
HBV DNA decrease compared with baseline(log10 copies/ml)
Time frame: week 24 after delivery
biochemical response
ALT normalization
Time frame: week 24 after delivery
HBeAg loss
HBeAg loss in HBeAg positive patients
Time frame: week 24 after delivery
HBeAg seroconversion
HBeAg seroconversion in HBeAg positive group
Time frame: week 24 after delivery
HBV genetic resistance to emtricitabine
HBV genetic resistance to emtricitabine
Time frame: week 24 after delivery
adverse event
type and rate of adverse events;type and rate of severe adverse event
Time frame: week 24 after delivery
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