Study of Tenofovir Alafenamide in HBV-Infected Pregnant Women
Chronic Hepatitis b, Tenofovir Alafenamide Fumarate
About this trial
This is an interventional treatment trial for Chronic Hepatitis b focused on measuring pharmacokinetics, CHB, TAF, pregnancy, mother-to-child transmission
Eligibility Criteria
Inclusion Criteria: Age of 20-40 years; Positive for hepatitis B surface antigen (HBsAg) and hepatitis B virus e antigen (HBeAg); HBV DNA level >200 000 IU/mL during the 24th-32nd week of pregnancy; Willing to take TAF for mother-to-child blockade; Both husband and wife are willingly sign an informed consent. Exclusion Criteria: Co-infected with hepatitis C or HIV, or other chronic diseases; History of spontaneous abortion or congenital malformation; Decompensated cirrhosis and liver cancer; History of kidney injury, CCr <50ml/min and urine protein test positive (>300mg/L); Fetal malformations detected by B-ultrasound during pregnancy; ALT > 2×upper limit of normal (ULN); TBIL ≥ 1×ULN; Albumin (ALB) < 25 g/L.
Sites / Locations
- Hangzhou First People's HospitalRecruiting
Arms of the Study
Arm 1
Experimental
TAF antiviral therapy group
Eligible hepatitis B pregnant women are given TAF antiviral therapy (25mg, oral, 1/day) from week 28-32 of gestation until delivery