Efficacy and safety of tenofovir disoproxil fumarate or telbivudine used throughout pregnancy for the prevention of mother-to-child transmission of hepatitis B virus: A cohort study.

OBJECTIVE

Tenofovir disoproxil fumarate (TDF) use compared with telbivudine (LdT) use throughout pregnancy has not been adequately investigated. To compare the efficacy and safety of TDF and LdT for the prevention of mother-to-child transmission (MTCT) of hepatitis B from highly viremic mothers throughout pregnancy in real-world settings.

STUDY

DESIGN

This was a single-center, retrospective cohort study. From January 1, 2013, to December 31, 2018, we retrospectively enrolled 602 mothers with chronic hepatitis B (CHB) who received antiviral treatment throughout pregnancy at Beijing Ditan Hospital. A total of 562 mothers met the inclusion criteria, with 167 in the TDF group and 395 in the LdT group. Mothers and infants were followed for 28 weeks postpartum. The primary endpoint was the MTCT rate of HBV. The secondary endpoints were the safety profiles in mothers and infants.

RESULTS

The MTCT rates were 0 % in both the TDF and LdT groups. The rates of neonatal congenital abnormalities were similar between the TDF and LdT groups (1.2 % vs 1.8 %, P = 0.896). There were no significant differences in perinatal complications between the two groups (all P > 0.05). There were also no significant differences in gestational age or infant height, weight, Apgar score. The level of HBV DNA at 28 weeks postpartum was an independent risk factor for postpartum alanine aminotransferase (ALT) flares (OR = 2.348, 95 % CI: 1.100-5.016, P = 0.027).

CONCLUSION

TDF and LdT treatments throughout pregnancy in mothers with CHB were equally effective in preventing MTCT and safe.