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

• Published in: Clinical infectious diseases Vol. 71; no. 10; pp. e587 - e593
• Main Authors: Segeral, Olivier, Dim, Bunnet, Durier, Christine, Prak, Sophearot, Chhim, Kearena, Vong, Chanlina, Pech, Sothy, Tiv, Say, Nem, Bunthoeun, Hout, Kay, Nouhin, Janin, Chhun, Samsorphea, Borand, Laurence
• Format: Journal Article
• Language: English
• Published: US Oxford University Press 17.12.2020
• Subjects: Adult; Alanine Transaminase; Algorithms; Child; DNA, Viral; Female; Hepatitis B e Antigens; Hepatitis B Surface Antigens; Hepatitis B virus - genetics; Hepatitis B, Chronic - diagnosis; Humans; Infectious Disease Transmission, Vertical; Mothers; Online Only; Pregnancy; Pregnancy Complications, Infectious - diagnosis; Pregnant Women; HBeAg rapid test; hepatitis B; Western-Pacific area; public health; mother-to-child transmission
• ISSN: 1058-4838; 1537-6591; 1537-6591
• DOI: 10.1093/cid/ciaa282

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. An algorithm selecting Hepatitis B e Antigen (HBeAG)-positive and HBeAg-negative women with ALT ≥40 IU/L could be an effective strategy to identify pregnant women with hepatitis B virus (HBV) eligible for antiviral preventive treatment in countries where HBV DNA quantification is not routinely available.