Objective: This study investigated the efficacy and safety of pharmacologic interventions to prevent vertical transmission of the hepatitis B virus.
Data Sources: Medline, Cochrane, and Scopus databases were searched up to October 28, 2020.
Study Eligibility Criteria: All randomized controlled trials reporting vertical hepatitis B virus transmission with pharmacologic intervention were included.
Methods: Risk of bias was assessed using the Cochrane Risk-of-Bias tool, version 2. Treatment efficacy was estimated using stratified network meta-analysis on the basis of maternal hepatitis B envelope antigen status.
Results: Nineteen studies were included for mothers positive for hepatitis B surface and envelope antigens. Pooling indicated that a combination of hepatitis B vaccination and hepatitis B immunoglobulin in infants significantly reduced transmission risk compared with vaccination alone, with a risk ratio of 0.52 (95% confidence interval; 0.30–0.91). Only the addition of maternal tenofovir disoproxil fumarate, but not telbivudine, lamivudine, or maternal hepatitis B immunoglobulin further reduced transmission risk compared with a combination of hepatitis B vaccination and hepatitis B immunoglobulin in infants, with a pooled risk ratio of 0.10 (0.03–0.35). Twelve studies conducted in mothers with hepatitis B surface antigen positivity and mixed, unknown, or negative hepatitis B envelope antigen status provided limited evidence to suggest that maternal hepatitis B immunoglobulin combined with hepatitis B vaccination and immunoglobulin in infants was the likely best treatment, but this failed to reach statistical significance compared with a combination of hepatitis B vaccination and immunoglobulin in infants. Similarly, infant hepatitis B immunoglobulin, added to vaccination, likely provides additional benefit but failed to reach statistical significance.
Conclusion: A combination of hepatitis B vaccination and immunoglobulin in infants is the cornerstone for prevention of vertical transmission for mothers positive for both hepatitis B surface and envelope antigens. The addition of maternal tenofovir to this infant combination regimen was considered the likely most effective treatment. For infants of mothers with hepatitis B surface antigen positivity and mixed, unknown, or negative hepatitis B envelop antigen status, no additional agents provided further benefit beyond hepatitis B vaccination alone.
Bibliographical noteFunding Information:
This work was conducted as part of the Mahidol University Health Technology Assessment program through a scholarship provided by Mahidol University and the International Decision Support Initiative (iDSI). This work was produced as part of the iDSI ( www.idsihealth.org ) to support countries in obtaining optimal value for money from health spending. iDSI receives funding support from the Bill & Melinda Gates Foundation , the UK Department for International Development , and the Rockefeller Foundation . The findings, interpretations, and conclusions expressed in this article do not necessarily reflect the views of the aforementioned funding agencies.
© 2022 The Authors
- hepatitis B immune globulin
- hepatitis B virus
- vertical transmission
ASJC Scopus subject areas
- Obstetrics and Gynaecology