Tenofovir Disoproxil Fumarate Prevents Mother-to-Child Transmission of Hepatitis B Virus: A Comprehensive Assessment from the Systematic Review and Meta-Analysis

Abstract

Context: Chronic Hepatitis B virus (HBV) infection affects 260 million people globally, causing 900,000 deaths annually due to cirrhosis and hepatocellular carcinoma (HCC). Mother-to-child transmission (MTCT) is a major contributor to this burden. While birth dose vaccination and Hepatitis B immunoglobulin (HBIG) are key prevention strategies, they are insufficient for mothers with high viral loads. Objectives: Tenofovir disoproxil fumarate (TDF) has emerged as an effective intervention to prevent MTCT of HBV. Data Sources: This systematic review and meta-analysis evaluated the efficacy of TDF in preventing MTCT of HBV. A comprehensive search was conducted across PubMed, Embase, and the Cochrane Library. Study Selection: The inclusion criteria focused on randomized controlled trials (RCTs) assessing TDF in pregnant women with HBV. Quality assessment was performed using the adapted Newcastle–Ottawa Scale. Data Extraction: The DerSimonian and Laird random-effects model was employed to determine pooled effect sizes, with heterogeneity assessed using Cochran’s Q and I2 statistics. All analyses were conducted using Stata/MP 17.0. Results: The search identified 1909 records, with 160 studies meeting the inclusion criteria after rigorous screening and quality assessment. The meta-analysis included 43 studies on TDF's effectiveness in preventing MTCT of HBV based on HBsAg detection. The pooled odds ratio (OR) from the random-effects model indicated a significant reduction in HBV transmission with TDF treatment compared to control groups. Moderate heterogeneity was observed (I2 = 52.48%), but the overall effect remained statistically significant [OR = 0.38, 95% onfidence interval (CI): 0.29 - 0.50, P < 0.001]. Additionally, analysis based on the trimester of TDF administration showed consistent effectiveness with no observed heterogeneity (I2 = 0.00%). For studies focusing on HBV DNA levels, significant heterogeneity was noted (I2 = 80.94%), yet TDF treatment consistently showed a significant reduction in transmission (OR = 0.25, 95% CI: 0.18 - 0.36, P < 0.001). Conclusions: The TDF is effective in reducing MTCT of HBV, supporting its use in maternal health programs. Further research should refine treatment protocols and address specific populations to enhance prevention strategies.