Title: Tenofovir Disoproxil Fumarate for prevention of mother-to-child transmission of Hepatitis B virus: A systematic review and meta-analysis of randomized control trials

Abstract

Background: Hepatitis B virus (HBV) infection caused by mother-to-child transmission (MTCT) continues to pose challenges to global health. This study aimed to assess the efficacy and safety of tenofovir disoproxil fumarate (TDF) for preventing HBV MTCT. Method: PubMed and the Cochrane Central Register of Controlled Trials were searched through August 2020. Randomized controlled trials (RCTs) were selected that evaluated the efficacy and safety of TDF for preventing MTCT of HBV compared with the standard of care, placebo, or other HBV therapies. The primary outcomes were HBV MTCT rate and maternal HBV DNA level. Secondary outcomes were infant and maternal safety outcomes. The review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Guidelines, and prospectively registered on PROSPERO (CRD42020186275). Results: Of 240 citations, three RCTs that involved 651 participants were included. The pooled result showed that TDF can reduce the risk of HBV MTCT after 6 months postpartum by 80% (risk ratio RR=0.2, 95% CI [0.06- 0.7], n=584) with low heterogeneity (I2=0%). TDF demonstrated HBV DNA suppression at delivery, though there was heterogeneity among individual studies, (RR=0.13, 95% CI [0.08-0.20] and (RR=0.36, 95% CI [0.27- 0.49]). Maternal and infant safety outcomes were comparable among treated and untreated mothers and infants born to them. The quality of evidence varied from high to very low. Conclusion: There is evidence that TDF effectively interrupted MTCT of HBV and suppressed HBV DNA level. Available studies on safety are very limited and heterogeneous, emphasizing the need for additional RCTs with complete safety indicators.

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