Abstract: Objective The aim of this study was to evaluate the safety of tenofovir disoproxil fumarate (TDF) therapy in pregnant women. Methods 120 pregnant female HBV carriers delivered in Beijing You'an Hospital, Capital Medical University,between July 1, 2018 and June 30, 2019. 40 carriers (group A) started taking TDF within one year before pregnancy until the delivery, 40 carriers (group B) taking at 24 to 28 weeks of pregnancy, and 40 carriers (group C) did not taking antiviral medicine. All pregnant women took blood and urine routine examination at the 12th and 36th weeks of pregnancy to evaluate the renal functions, such as serum phosphorus (P), glomerular filtration rate (GFR), creatinine (sCr), creatine kinase (CK) and urinary protein (uPRO). We also record the physical development indexes of newborns at birth, such as head circumference, body length and body mass. The adverse events of newborns recorded such as neonatal clavicle fracture, birth defect and neonatal death. Results At 36th week of gestation, serum P, GFR, sCr, CK and uPRO in group A were(1.2±0.1)mmol/L,(120.9±7.9)mL/(min·1.73 m²),(52.1±7.9)μmol/L, (57.7±21.8)U/L and 6 cases (15.0%) positive, in group B were (1.2±0.1)mmol/L, (119.5±9.4)mL/(min·1.73 m²), (50.6±7.7)μmol/L, (56.6±18.8)U/L and 5 cases (12.5%), and in group C were (1.2±0.1)mmol/L, (125.7±8.7)mL/(min·1.73 m²), (48.9±7.2)μmol/L, (53.9±16.1)U/L and 4 cases(10.0%), not significantly different among them (P>0.05); the height, head circumference and birth weight of newborns in group A were (50.0±1.1)cm, (333.6±5.1)cm and(3383±319)g, in group B were (49.9±1.2)cm, (333.9±5.1)cm and 3215±327)g, and in group C were (50.1±1.1) cm, (332.9±5.7)cm and(3284±328)g, not significantly different among them (P>0.05); only one neonatal had clavicular fracture in group C in our series. Conclusion TDF has no untoward effects on renal function tests and fetal growth in pregnant women with HBV infection. It might be administered safely during pregnancy.

Key words: Hepatitis B viral carriers, Tenofovir disoproxil fumarate, Pregnant women, fetus