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. 2020 Dec 17;71(10):e587-e593.
doi: 10.1093/cid/ciaa282.

Hepatitis B e Antigen (HBeAg) Rapid Test and Alanine Aminotransferase Level-Based Algorithm to Identify Pregnant Women at Risk of HBV Mother-to-Child Transmission: The ANRS 12345 TA PROHM Study

Olivier Segeral  1 , Bunnet Dim  2 , Christine Durier  3 , Sophearot Prak  4 , Kearena Chhim  5 , Chanlina Vong  6 , Sothy Pech  7 , Say Tiv  8 , Bunthoeun Nem  9 , Kay Hout  10 , Janin Nouhin  3   11 , Samsorphea Chhun  5 , Laurence Borand  2
Affiliations

Hepatitis B e Antigen (HBeAg) Rapid Test and Alanine Aminotransferase Level-Based Algorithm to Identify Pregnant Women at Risk of HBV Mother-to-Child Transmission: The ANRS 12345 TA PROHM Study

Olivier Segeral et al. Clin Infect Dis. .

Abstract

Background: The paucity of hepatitis B virus (HBV) DNA measurement in low-/middle-income countries hinders the identification of HBV-infected pregnant women at risk of perinatal transmission. This study evaluates the validity of an algorithm selecting HBeAg-positive women and HBeAg-negative women with alanine aminotransferase (ALT) ≥40 IU/L as a predictor of high HBV DNA level.

Methods: All women with reactive samples for hepatitis B surface antigen (HBsAg) were assessed with an SD BIOLINE HBeAg rapid test and HBV DNA quantification was performed. Validities of HBeAg and of the algorithm to identify HBV DNA >2 thresholds (5.3 and 7.3 log10 IU/mL) were evaluated.

Results: For the 515 HBsAg-positive women, median age was 29 years, 92 (17.9%) were HBeAg positive, 47 (9.1%) were HBeAg negative with ALT ≥40 IU/L, and 144 (28.0%) had an HBV DNA >5.3 log10 IU/mL. Sensitivity and specificity of HBeAg were 61.8% and 99.2% for HBV DNA >5.3 log10 IU/mL and 81.3% and 96.7% for HBV DNA >7.3 log10 IU/mL. For the algorithm, sensitivity and specificity were 79.2% and 93.3% for HBV DNA level >5.3 log10 IU/mL and 92.7% and 88.1% for HBV DNA >7.3 log10 IU/mL. The AUCs for the algorithm (0.92 and 0.94 for HBV DNA >5.3 and 7.3, respectively) were significantly greater (P < .001) than the AUCs for HBeAg (0.81 and 0.89 for HBV DNA >5.3 and 7.3, respectively).

Conclusions: An algorithm using HBeAg and ALT level could be an effective strategy to identify HBV-infected pregnant women at risk of perinatal transmission in countries where HBV DNA quantification is not routinely available.

Keywords: HBeAg rapid test; Western-Pacific area; hepatitis B; mother-to-child transmission; public health.

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Figures

Figure 1.
Figure 1.
Description of the evaluated algorithm. Abbreviations: ALT, alanine aminotransferase; ELISA, enzyme-linked immunoassay; HBeAg, hepatitis B e antigen; HBsAg, hepatitis B surface antigen; RDT, rapid diagnosis test; TDF, tenofovir disoproxil fumarate; WA, weeks of amenorrhea.
Figure 2.
Figure 2.
HBV DNA serum levels and ALT values in HBeAg-positive and -negative women (N = 515). Reference lines at HBV DNA = 5.3 and 7.3 log10 IU/mL and ALT = 40 IU/L. Abbreviations: ALT, alanine aminotransferase; HBeAg, hepatitis B e antigen; HBV, hepatitis B virus.
Figure 3.
Figure 3.
ROC curves for (A) the current algorithm (HBeAg only) and the novel algorithm (HBeAg and ALT) for HBV DNA >5.3 log10 IU/mL, (B) for HBV DNA >7.3 log10 IU/mL, (C) for the novel algorithm (HBeAg and ALT) for HBV DNA >5.3 log10 IU/mL, and (D) for HBV DNA >7.3 log10. Points are labeled with HBeAg positivity and ALT. Abbreviations: algo, algorithm; ALT, alanine aminotransferase; HBeAg, hepatitis B e antigen; HBV, hepatitis B virus; ROC, receiver operating characteristic.
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