The safety and efficacy of tenofovir disoproxil fumarate used throughout pregnancy for mothers with chronic hepatitis B

BACKGROUND: Antiviral therapy throughout pregnancy in women with chronic hepatitis B (CHB) during pregnancy has been suggested; however, the data of tenofovir disoproxil fumarate (TDF) are limited. The aim of this study was to evaluate the safety and efficiency in women with CHB. METHODS: It was a single-center, retrospectively study. Eighty-one women received TDF 300 mg/day before pregnancy. Sixty-three women did not receive antiviral treatment. All infants in both groups received immunoprophylaxis. Mothers and infants were followed at least postpartum 7 months. The primary endpoint was the safety of mothers and infants. The secondary endpoints were mother-to-child transmission (MTCT) rate and hepatitis B virus (HBV) DNA suppression. RESULTS: TDF was well tolerated in the mothers. The rates of neonatal congenital abnormalities were similar between the two groups (3.7% or 3/81 versus 3.3% or 2/63, P = 1.000). There were also no significant differences in infant length and weight, Apgar score (1 minute), rate of low birth weight, gestational age, or rate of cesarean section between the two groups. TDF significantly reduced the viral load (3.4 +/- 0.5 log IU/mL versus 6.3 +/- 1.5 log IU/mL, P < 0.001) and the ALT levels (19.9 +/- 10.2 versus 46.8 +/- 44.8 U/L, P < 0.001) before delivery. At 7-month postpartum, the MTCT rate was 0% in the TDF-treated group when compared with 6.3% (4/63) in the untreated group (P = 0.035). CONCLUSION: TDF used throughout pregnancy can safely reduce the rate of MTCT.