Accuracy of HBeAg to identify pregnant women at risk of transmitting hepatitis B virus to their neonates: a systematic review and meta-analysis

  • The Lancet Infectious Diseases, Volume 21, No. 1, Year 2021

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Study Justification:
– The study aimed to address the issue of inadequate access to assays to quantify HBV DNA levels in resource-poor settings.
– It aimed to identify the HBV DNA threshold for mother-to-child transmission (MTCT) of hepatitis B virus (HBV) and assess the accuracy of HBeAg testing in identifying pregnant women at risk of transmitting HBV to their neonates.
– The study was commissioned by the World Health Organization (WHO) to provide evidence-based recommendations for preventing MTCT of HBV.
Study Highlights:
– The risk of MTCT of HBV was found to be negligible below a maternal HBV DNA level of 5.30 log10 IU/mL (200,000 IU/mL) and increased above this threshold.
– HBeAg testing showed a high sensitivity (88.2%) in identifying pregnant women with HBV DNA levels of 5.30 log10 IU/mL or greater.
– HBeAg testing also had a high sensitivity (99.5%) in predicting cases of immunoprophylaxis failure for MTCT of HBV infection.
Study Recommendations for Lay Reader and Policy Maker:
– Maternal HBV DNA level of 5.30 log10 IU/mL or greater should be considered as the optimal threshold for MTCT of HBV infection despite infant immunoprophylaxis.
– HBeAg testing can accurately identify pregnant women with HBV DNA levels above the threshold and has high sensitivity in predicting cases of immunoprophylaxis failure.
– In areas where HBV DNA assays are unavailable, HBeAg testing can be used as an alternative to assess eligibility for antiviral prophylaxis.
Key Role Players:
– World Health Organization (WHO): Commissioned the study and can play a key role in disseminating the findings and implementing the recommendations.
– Healthcare Providers: Responsible for implementing the recommended testing and treatment strategies.
– Policy Makers: Responsible for incorporating the study findings into national guidelines and policies.
Cost Items for Planning Recommendations:
– Training and Capacity Building: Budget for training healthcare providers on HBeAg testing and interpretation of results.
– Testing Equipment and Supplies: Budget for procuring HBeAg testing kits and related supplies.
– Laboratory Facilities: Budget for establishing or upgrading laboratory facilities to perform HBeAg testing.
– Communication and Awareness: Budget for developing and implementing communication strategies to raise awareness among healthcare providers and pregnant women about the importance of HBeAg testing and its implications for MTCT of HBV.
Please note that the provided cost items are general categories and the actual cost estimation would require a detailed analysis based on the specific context and resources available.

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Background: Prevention of mother-to-child transmission (MTCT) of hepatitis B virus (HBV) involves neonatal immunoprophylaxis, with a birth dose of hepatitis B vaccine and immune globulin, and provision of peripartum antiviral prophylaxis in highly viraemic women. However, access to assays to quantify HBV DNA levels remains inadequate in resource-poor settings. This study was commissioned by WHO and aimed to identify the HBV DNA threshold for MTCT, to assess the sensitivity and specificity of hepatitis B e antigen (HBeAg) testing to identify pregnant women with HBV DNA levels above this threshold, and to predict MTCT of HBV infection on the basis of HBeAg testing. Methods: For this systematic review and meta-analysis, we searched the PubMed, EMBASE, Scopus, CENTRAL, CNKI, and Wanfang databases for studies of pregnant women with chronic HBV infection without concurrent antiviral therapy, published between Jan 1, 2000, and April 3, 2019. Studies were eligible for inclusion if MTCT in mother–child pairs could be stratified by different levels of maternal HBV DNA during pregnancy, if maternal HBeAg status could be stratified by HBV DNA level, and if the MTCT status of infants could be stratified by maternal HBeAg status during pregnancy. Studies that selected pregnant women on the basis of HBeAg serostatus or HBV DNA levels were excluded. Aggregate data were extracted from eligible studies by use of a pre-piloted form; study authors were contacted to clarify any uncertainties about potential duplication or if crucial information was missing. To pool sensitivities and specificities of maternal HBeAg to identify highly viraemic women and to predict MTCT events, we used the DerSimonian-Laird bivariate random effects model. This study is registered with PROSPERO, CRD42019138227. Findings: Of 9007 articles identified, 67 articles (comprising 66 studies) met the inclusion criteria. The risk of MTCT despite infant immunoprophylaxis was negligible (0·04%, 95% CI 0·00–0·25) below a maternal HBV DNA level of 5·30 log10 IU/mL (200 000 IU/mL) and increased above this threshold. The pooled sensitivity of HBeAg testing to identify HBV DNA levels of 5·30 log10 IU/mL or greater in pregnant women was 88·2% (83·9–91·5) and pooled specificity was 92·6% (90·0–94·5). The pooled sensitivity of HBeAg testing in predicting MTCT of HBV infection despite infant immunoprophylaxis was 99·5% (95% CI 91·7–100) and pooled specificity was 62·2% (55·2–68·7). Interpretation: Maternal HBV DNA of 5·30 log10 IU/mL or greater appears to be the optimal threshold for MTCT of HBV infection despite infant immunoprophylaxis. HBeAg is accurate to identify women with HBV DNA levels above this threshold and has high sensitivity to predict cases of immunoprophylaxis failure. In areas where HBV DNA assays are unavailable, HBeAg can be used as an alternative to assess eligibility for antiviral prophylaxis. Funding: World Health Organization.

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Based on the provided information, here are some potential innovations that could improve access to maternal health:

1. Development of affordable and portable HBV DNA testing kits: Creating low-cost and portable testing kits for HBV DNA levels would improve access to accurate diagnosis in resource-poor settings.

2. Telemedicine and remote consultations: Implementing telemedicine and remote consultations would allow pregnant women in remote areas to access healthcare professionals and receive guidance on HBV management without the need for physical travel.

3. Training programs for healthcare workers: Establishing training programs to educate healthcare workers in resource-poor settings about HBV management and the use of HBeAg testing would enhance their ability to identify and support pregnant women at risk of transmitting the virus.

4. Integration of HBV screening into routine antenatal care: Incorporating HBV screening into routine antenatal care would ensure that all pregnant women are tested for HBV infection, allowing for early identification and appropriate management.

5. Public awareness campaigns: Launching public awareness campaigns to educate communities about the importance of HBV screening during pregnancy and the availability of preventive measures would encourage more pregnant women to seek testing and treatment.

These innovations aim to improve access to maternal health by addressing the challenges related to HBV testing and management in resource-poor settings.
AI Innovations Description
The recommendation to improve access to maternal health based on the provided description is to utilize HBeAg testing as an alternative method to assess eligibility for antiviral prophylaxis in areas where HBV DNA assays are unavailable. This recommendation is supported by a systematic review and meta-analysis commissioned by the World Health Organization.

The study found that a maternal HBV DNA level of 5.30 log10 IU/mL or greater is the optimal threshold for mother-to-child transmission (MTCT) of HBV infection despite infant immunoprophylaxis. HBeAg testing was shown to accurately identify pregnant women with HBV DNA levels above this threshold, with a pooled sensitivity of 88.2% and specificity of 92.6%. Additionally, HBeAg testing had a high sensitivity of 99.5% in predicting cases of immunoprophylaxis failure.

By utilizing HBeAg testing as an alternative to HBV DNA assays, healthcare providers in resource-poor settings can still assess the eligibility of pregnant women for antiviral prophylaxis. This can help improve access to appropriate interventions and reduce the risk of MTCT of HBV infection. The recommendation is particularly relevant in areas where HBV DNA assays are not readily available.
AI Innovations Methodology
Based on the provided description, the study focuses on the accuracy of hepatitis B e antigen (HBeAg) testing in identifying pregnant women at risk of transmitting hepatitis B virus (HBV) to their neonates. The goal is to improve access to maternal health by determining the HBV DNA threshold for mother-to-child transmission (MTCT) and evaluating the sensitivity and specificity of HBeAg testing.

To simulate the impact of recommendations on improving access to maternal health, a methodology could include the following steps:

1. Identify the target population: Determine the specific group of pregnant women who would benefit from improved access to maternal health, such as those in resource-poor settings or areas with inadequate HBV DNA assays.

2. Define the recommendations: Based on the study findings, develop clear and actionable recommendations to improve access to maternal health. For example, one recommendation could be to use HBeAg testing as an alternative to assess eligibility for antiviral prophylaxis in areas where HBV DNA assays are unavailable.

3. Assess the current situation: Collect data on the current state of access to maternal health in the target population. This could involve gathering information on the availability of HBV DNA assays, the use of HBeAg testing, and the implementation of preventive measures for MTCT.

4. Simulate the impact: Use modeling techniques to simulate the potential impact of implementing the recommendations on improving access to maternal health. This could involve creating a mathematical model that takes into account factors such as the number of pregnant women affected, the effectiveness of HBeAg testing, and the potential reduction in MTCT cases.

5. Analyze the results: Evaluate the simulated outcomes to determine the potential benefits and limitations of implementing the recommendations. This could include assessing the reduction in MTCT cases, the cost-effectiveness of using HBeAg testing, and any potential challenges or barriers to implementation.

6. Refine and iterate: Based on the analysis, refine the recommendations and simulation methodology as needed. Consider additional factors or variables that may impact access to maternal health, and repeat the simulation to further assess the potential impact.

By following this methodology, policymakers and healthcare providers can gain insights into the potential benefits of implementing recommendations to improve access to maternal health, specifically in relation to HBV transmission. This can inform decision-making and resource allocation to address the identified gaps and improve maternal health outcomes.

Statistics:
Citations: 58
Authors: 12
Identifiers:
DOI: 10.1016/S1473-3099(20)30593-4
ISSN: 14733099
Research Areas:
Community Interventions, Genetics and Genomics, Health System and Policy, Infectious Diseases, Maternal and Child Health, Sexual and Reproductive Health
Study Approach:
Systematic Review
Participants Gender:
Female
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