Korean J Intern Med.  2021 Jan;36(1):76-85. 10.3904/kjim.2018.465.

Role of tenofovir disoproxil fumarate in prevention of perinatal transmission of hepatitis B virus from mother to child: a systematic review and metaanalysis

• Lee YS
• Lee HS
• Kim JH
• Chang SW
• Hyun MH
• Bak H
• Kim S
• Lee Mj
• Lee CU
• Jung YK
• Seo YS
• Yim HJ
• Yeon JE
• Um SH
• Byun KS

• KMID: 2509795
• DOI: http://doi.org/10.3904/kjim.2018.465

Abstract

Background/Aims
To prevent the perinatal transmission of hepatitis B virus (HBV) from mother to child, administration of an antiviral agent during pregnancy has been attempted in women who are either hepatitis B e antigen positive or have a high viral load. In this systematic review and meta-analysis with randomized controlled trials, we analyzed the efficacy and safety of tenofovir disoproxil fumarate (TDF) in preventing the perinatal transmission of HBV in pregnant women who have high HBV DNA titers.
Methods
Multiple comprehensive databases (PubMed, EMBASE, and Cochrane databases) were searched for studies evaluating the efficacy of TDF for the prevention of perinatal transmission of HBV.
Results
Two studies (one open label study and one double blind study) were included and analyzed. Intention-to-treat analysis (527 pregnancies) showed that the preventive effect of TDF was not significant (odds ratio [OR], 0.53; 95% confidence interval[CI], 0.13 to 2.17; p = 0.38, I² = 81%). However, the per-protocol analysis showed that TDF significantly reduced perinatal transmission (OR, 0.10; 95% CI, 0.01 to 0.77; p = 0.03, I² = 0%). There was no significant difference between the TDF group and the control group with respect to maternal and fetal safety outcomes.
Conclusions
In pregnant women who have high HBV DNA titers, TDF can reduce the perinatal transmission from mother to child without significant adverse events.

Keyword

Hepatitis B virus; Tenofovir; Pregnancy; Transmission