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Efficacy and safety of antiviral prophylaxis during pregnancy to prevent mother-to-child transmission of hepatitis B virus: a systematic review and meta-analysis - 24/12/20

Doi : 10.1016/S1473-3099(20)30586-7 
Anna L Funk, PhD a, b, Ying Lu, PhD c, Kyoko Yoshida d, Tianshuo Zhao, MSc e, Pauline Boucheron, MD a, Judith van Holten, PhD c, Roger Chou, ProfMD f, Marc Bulterys, MD c, g, Yusuke Shimakawa, MD a,
a Unité d’Épidémiologie des Maladies Émergentes, Institut Pasteur, Paris, France 
b Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada 
c Global Hepatitis Programme, World Health Organization, Geneva, Switzerland 
d Faculty of Medicine, Tokyo Medical and Dental University, Tokyo, Japan 
e School of Public Health, Peking University, Beijing, China 
f Department of Medicine and Department of Medical Informatics and Clinical Epidemiology, Oregon Health and Science University, Portland, OR, USA 
g US Centers for Disease Control and Prevention, Nairobi, Kenya 

* Correspondence to: Dr Yusuke Shimakawa, Unité d’Épidémiologie des Maladies Émergentes, Institut Pasteur, Paris 75015, France Unité d’Épidémiologie des Maladies Émergentes Institut Pasteur Paris 75015 France

Summary

Background

To eliminate mother-to-child transmission (MTCT) of hepatitis B virus (HBV), peripartum antiviral prophylaxis might be required for pregnant women infected with HBV who have a high risk of MTCT despite infant immunoprophylaxis. We aimed to determine the efficacy and safety of peripartum antiviral prophylaxis to inform the 2020 WHO guidelines.

Methods

In this systematic review and meta-analysis, we searched PubMed, Embase, Scopus, CENTRAL, CNKI, and Wanfang for randomised controlled trials and non-randomised studies of peripartum antiviral prophylaxis versus placebo or no prophylaxis, with no language restriction, published from database inception until March 28, 2019. We used search terms covering HBV, antiviral therapy, and pregnancy. We included studies that enrolled pregnant women with chronic infection with HBV who received antiviral prophylaxis anytime during pregnancy; that included any of the following antivirals: adefovir, emtricitabine, entecavir, lamivudine, telbivudine, tenofovir alafenamide fumarate, and tenofovir disoproxil fumarate; and that reported the following outcomes: MTCT, indicated by infant HBsAg positivity or HBV DNA positivity, or both, at age 6–12 months, and any infant or maternal adverse events. Two reviewers independently extracted data. Our primary endpoint was MTCT based on infant HBsAg positivity. We assessed pooled odds ratios (ORs) of the efficacy of peripartum antiviral prophylaxis to reduce the risk of MTCT. We assessed safety of prophylaxis by pooling risk differences. The protocol for the systematic review was pre-registered in PROSPERO, CRD42019134614.

Findings

Of 7463 articles identified, 595 articles were eligible for full-text review and 129 studies (in 157 articles) were included. The following antivirals were assessed in the meta-analysis: tenofovir disoproxil fumarate 300 mg (19 studies, with 1092 mothers and 1072 infants), lamivudine 100–150 mg (40 studies, with 2080 mothers and 2007 infants), and telbivudine 600 mg (83 studies, with 6036 mothers and 5971 infants). The pooled ORs for randomised controlled trials were similar, at 0·10 (95% CI 0·03–0·35) for tenofovir disoproxil fumarate, 0·16 (0·10–0·26) for lamivudine, and 0·14 (0·09–0·21) for telbivudine. The pooled ORs in non-randomised studies were 0·17 (0·10–0·29) for tenofovir disoproxil fumarate, 0·17 (0·12–0·24) for lamivudine, and 0·09 (0·06–0·12) for telbivudine. We found no increased risk of any infant or maternal safety outcomes after peripartum antiviral prophylaxis.

Interpretation

Peripartum antiviral prophylaxis is highly effective at reducing the risk of HBV MTCT. Our findings support the 2020 WHO recommendation of administering antivirals during pregnancy, specifically tenofovir disoproxil fumarate, for the prevention of HBV MTCT.

Funding

World Health Organization.

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Vol 21 - N° 1

P. 70-84 - janvier 2021 Retour au numéro
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  • Accuracy of HBeAg to identify pregnant women at risk of transmitting hepatitis B virus to their neonates: a systematic review and meta-analysis
  • Pauline Boucheron, Ying Lu, Kyoko Yoshida, Tianshuo Zhao, Anna L Funk, Françoise Lunel-Fabiani, Alice Guingané, Edouard Tuaillon, Judith van Holten, Roger Chou, Marc Bulterys, Yusuke Shimakawa

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