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Objectives: We aimed to determine epidemiological characteristics and serologic markers among chronically hepatitis B virus (HBV)-infected pregnant women during the assessment of tenofovir disoproxil fumarate (TDF) prescription in Vietnam. Methods: We consecutively recruited 375 pregnant women with chronic HBV (cHBV) infection at week 25±2 of pregnancy, at which time they were assessed for TDF use as pre-prophylaxis and/or pre-treatment at the Hospital for Tropical Diseases in southern Vietnam during December 2019-April 2021. Demographic characteristics, serological biomarkers, and prenatal liver ultrasounds were obtained through interviews and reviews of medical records. Results: The median age of pregnant women was 29 years (interquartile range: 26-32). More than half of pregnant women (208/375; 55.5%) started TDF for prevention of mother-to-child transmission of HBV and/or treatment of chronic hepatitis B (CHB). Among the pregnant women initiating TDF, 96.1% (198/206) tested positive for hepatitis B e antigen, and 21.6% (45/208) had quantitative hepatitis B surface antigen (qHBsAg) ≤104 IU/mL. A relatively strong correlation between qHBsAg and HBV deoxyribonucleic acid (DNA) (r = 0.81; 95% CI: 0.76-0.85) was observed in pregnant women starting TDF. Conclusions: Our results demonstrate the high need for TDF prescription for prevention and/or treatment purposes in pregnant women with cHBV infection. Pregnant women with qHBsAg levels ≤104 IU/mL may prioritize HBV DNA testing over qHBsAg to decide on TDF prescription.
RESUMEN
INTRODUCTION: Using tenofovir disoproxil fumarate (TDF) is recommended in the 3rd trimester for pregnant women with HBV DNA ≥ 200,000 IU/mL to prevent mother-to-child transmission (MTCT) of hepatitis B virus (HBV). However, HBV DNA quantification is unavailable in many resource-limited areas worldwide, hence prophylaxis is often missed. The aim of this study was to determine whether HBeAg or qHBsAg is a better alternative to HBV DNA testing in HBV-infected pregnant women. METHODOLOGY: In this prospective cohort study, pregnant women with HBV infection were recruited in 3 hospitals from October 2019 to November 2020. Socio-demographic and clinical data were collected. Blood samples were taken for qHBsAg and HBV DNA testing. HBeAg results were collected from the medical records of the participants who visited a doctor during the study. RESULTS: 465 pregnant women met the study criteria. 41.9% were HBeAg positive, 33.3% had high qHBsAg levels (> 104 IU/mL), 38.3% had high HBV DNA levels (≥ 200,000 IU/mL). Pregnant women with high qHBsAg levels were 27 times more likely to have high HBV DNA levels (aOR = 27.0, 95% CI: 11.1-65.5, p < 0.001). Participants who were HBeAg positive were 57.5 times more likely to have high HBV DNA levels (aOR = 57.5, 95% CI: 23.0-140.0, p < 0.001). The sensitivity of qHBsAg and HBeAg was 80% and 94%, respectively; and specificity was 95% and 90%, respectively. CONCLUSIONS: HBeAg testing should be considered over qHBsAg assay as an alternative to HBV DNA assay because of its technical simplicity, lower cost, and fewer missed treatments.