Study (year)Representative-ness of the exposed cohortSelection of the non-exposed cohortAscertainment of exposureDemonstration that outcome of interest was not present at baselineComparability of cohorts on the basis of the design or analysisAssessment of outcomesWas follow up long enough for outcomes to occurAdequacy of follow up of cohortsTotal number of stars (risk of bias)a
Chen QR (2018)☆ At least somewhat representative of the average HBV-infected pregnant woman☆ Drawn from the same community (same inclusion and exclusion criteria also)No description☆ Always the case☆☆Same HBeAg serostatus and comparable HBV DNA levels at baseline. Same regimen for infant immunoprophylaxis at birthNo description☆ YesNo statement on LFU6 (high)
Li JH (2017)☆ At least somewhat representative of the average HBV-infected pregnant woman☆ Drawn from the same community (same inclusion and exclusion criteria also)☆Valid method was used to ascertain adherence to the antiviral therapy (decrease in viral load levels subsequent to the treatment)☆ Always the case☆ Comparable for HBV DNA levels at baseline but HBeAg serostatus not described. Same regimen for infant immunoprophylaxis☆ Indication of record linkage (results viewed retrospectively in medical records)☆ Yes (always the case)None reported (retrospective)7 (low)
Ren CJ (2016)☆ At least somewhat representative of the average HBV-infected pregnant woman☆ Drawn from the same community (same inclusion and exclusion criteria also)☆Valid method was used to ascertain adherence to the antiviral therapy (decrease in viral load levels subsequent to the treatment)☆ Always the case☆☆Same HBeAg serostatus and same thresholds for HBV DNA level. Same regimen for infant immunoprophylaxis at birth☆ Laboratory methods described in detail (which assay used), indicating use of a central laboratory and/or record linkage☆ YesNo statement on LFU8 (low)
Shen ML (2016)☆ At least somewhat representative of the average HBV-infected pregnant woman☆ Drawn from the same community (same inclusion and exclusion criteria also)☆Valid method was used to ascertain adherence to the antiviral therapy (decrease in viral load levels subsequent to the treatment)☆ Always the caseSame thresholds for HBV DNA level but HBeAg serostatus not described. Regimen for infant immunoprophylaxis at birth not clearly described☆ Laboratory methods described in detail (which assay used), indicating use of a central laboratory and/or record linkage☆ YesNo statement on LFU6 (high)
Wang DM (2016)☆ At least somewhat representative of the average HBV-infected pregnant woman☆ Drawn from the same community (same inclusion and exclusion criteria also)☆Valid method was used to ascertain adherence to the antiviral therapy (decrease in viral load levels subsequent to the treatment)☆ Always the case☆☆Same HBeAg serostatus and same thresholds for HBV DNA level. Same regimen for infant immunoprophylaxis at birth☆ Laboratory methods described in detail (which assay used), indicating use of a central laboratory and/or record linkage☆ YesNo statement on LFU8 (low)
Ge YL (2015)☆ At least somewhat representative of the average HBV-infected pregnant woman☆ Drawn from the same community (same inclusion and exclusion criteria also)☆Valid method was used to ascertain adherence to the antiviral therapy (decrease in viral load levels subsequent to the treatment)☆ Always the case☆☆Same HBeAg serostatus and same thresholds for HBV DNA level. Same regimen for infant immunoprophylaxis at birthNo description☆ YesNo statement on LFU7 (low)
Han YP (2014)☆ At least somewhat representative of the average HBV-infected pregnant woman☆ Drawn from the same community (same inclusion and exclusion criteria also)☆Valid method was used to ascertain adherence to the antiviral therapy (decrease in viral load levels subsequent to the treatment)☆ Always the case☆☆Same HBeAg serostatus and same thresholds for HBV DNA level. Same regimen for infant immunoprophylaxis at birthNo description☆ YesNo statement on LFU7 (low)
Wang W (2014)☆ At least somewhat representative of the average HBV-infected pregnant woman☆ Drawn from the same community (same inclusion and exclusion criteria also)☆Valid method was used to ascertain adherence to the antiviral therapy (decrease in viral load levels subsequent to the treatment)☆ Always the case☆Comparable for HBV DNA levels but HBeAg serostatus not described. Same regimen for infant immunoprophylaxis at birth☆ Laboratory methods described in detail (which assay used), indicating use of a central laboratory and/or record linkage☆ YesNo statement on LFU7 (low)
Zhu M (2014)☆ At least somewhat representative of the average HBV-infected pregnant woman☆ Drawn from the same community☆Valid method was used to ascertain adherence to the antiviral therapy (decrease in viral load levels subsequent to the treatment)☆ Always the case☆ Comparable for HBeAg serostatus but HBV DNA levels not described. Same regimen for infant immunoprophylaxis☆ Laboratory assays described☆ Yes (always the case)No statement on LFU6 (high)
Zeng YM (2013)☆ At least somewhat representative of the average HBV-infected pregnant woman☆ Drawn from the same community (same inclusion and exclusion criteria also)☆Valid method was used to ascertain adherence to the antiviral therapy (decrease in viral load levels subsequent to the treatment)☆ Always the case☆Same HBeAg serostatus and same thresholds for HBV DNA level. Regimen for infant immunoprophylaxis at birth not described clearly☆ Laboratory methods described in detail (which assay used), indicating use of a central laboratory and/or record linkage☆ YesNo statement on LFU7 (low)
Zhou DS (2013)☆ At least somewhat representative of the average HBV-infected pregnant woman☆ Drawn from the same community (same inclusion and exclusion criteria also)No description☆ Always the case☆Same thresholds for HBV DNA level but HBeAg serostatus not described. Same regimen for infant immunoprophylaxis at birth☆ Laboratory methods described in detail (which assay used), indicating use of a central laboratory and/or record linkage☆ YesNo statement on LFU6 (high)
Jiang HX (2012)☆ At least somewhat representative of the average HBV-infected pregnant woman☆ Drawn from the same community (same inclusion and exclusion criteria also)☆Valid method was used to ascertain adherence to the antiviral therapy (decrease in viral load levels subsequent to the treatment)☆ Always the case☆☆Same HBeAg serostatus and same thresholds for HBV DNA level. Same regimen for infant immunoprophylaxis at birth☆ Laboratory methods described in detail (which assay used), indicating use of a central laboratory and/or record linkage☆ YesNo statement on LFU8 (low)
Wang EJ (2012)☆ At least somewhat representative of the average HBV-infected pregnant woman☆ Drawn from the same community (same inclusion and exclusion criteria also)☆Valid method was used to ascertain adherence to the antiviral therapy (decrease in viral load levels subsequent to the treatment)☆ Always the case☆☆Same HBeAg serostatus and same thresholds for HBV DNA level. Same regimen for infant immunoprophylaxis at birth☆ Laboratory methods described in detail (which assay used), indicating use of a central laboratory and/or record linkage☆ YesNo statement on LFU8 (low)
Yuan QF (2012)☆ At least somewhat representative of the average HBV-infected pregnant woman☆ Drawn from the same community (same inclusion and exclusion criteria also)Adherence/compliance not mentioned and no data presented on decrease in HBV DNA levels☆ Always the case☆ Comparable for HBeAg serostatus but HBV DNA level not described. Same regimen for infant immunoprophylaxis☆ Indication of record linkage☆ Yes (always the case)No statement on LFU6 (high)
Cheng YC (2011)☆ At least somewhat representative of the average HBV-infected pregnant woman☆ Drawn from the same community (same inclusion and exclusion criteria also)☆Valid method was used to ascertain adherence to the antiviral therapy (decrease in viral load levels subsequent to the treatment)☆ Always the case☆☆Same HBeAg serostatus and same thresholds for HBV DNA level. Same regimen for infant immunoprophylaxis at birth☆ Laboratory methods described in detail (which assay used), indicating use of a central laboratory and/or record linkage☆ YesNo statement on LFU8 (low)
Ren YJ (2011)☆ At least somewhat representative of the average HBV-infected pregnant woman☆ Drawn from the same community☆Valid method was used to ascertain adherence to the antiviral therapy (decrease in viral load levels subsequent to the treatment)☆ Always the case☆ Comparable for HBeAg serostatus but not for HBV DNA level. Same regimen for infant immunoprophylaxis☆ Laboratory assays described☆ Yes (always the case)No statement on LFU7 (low)
Zhang YF (2010)☆ At least somewhat representative of the average HBV-infected pregnant woman☆ Drawn from the same community (same inclusion and exclusion criteria also)☆Valid method was used to ascertain adherence to the antiviral therapy (decrease in viral load levels subsequent to the treatment)☆ Always the case☆☆Same HBeAg serostatus and same thresholds for HBV DNA level. Same regimen for infant immunoprophylaxis at birthNo description☆ YesNo statement on LFU7 (low)
Su TB (2009)☆ At least somewhat representative of the average HBV-infected pregnant woman☆ Drawn from the same community (same inclusion and exclusion criteria also)Does not provide any details on adherence☆ Always the case☆ Both HBeAg serostatus and HBV DNA not described. Same regimen for infant immunoprophylaxis☆ Testing done centrally in the hospital that study staff worked in☆ Yes (always the case)No statement on LFU6 (high)
Tang X (2009)☆ At least somewhat representative of the average HBV-infected pregnant woman☆ Drawn from the same community (same inclusion and exclusion criteria also)☆Valid method was used to ascertain adherence to the antiviral therapy (decrease in viral load levels subsequent to the treatment)☆ Always the case☆☆Same HBeAg serostatus and same thresholds for HBV DNA level. Same regimen for infant immunoprophylaxis at birth☆ Laboratory methods described in detail (which assay used), indicating use of a central laboratory and/or record linkage☆ YesNo statement on LFU8 (low)
Feng HF (2007)☆ At least somewhat representative of the average HBV-infected pregnant woman☆ Drawn from the same community (same inclusion and exclusion criteria also)☆Valid method was used to ascertain adherence to the antiviral therapy (decrease in viral load levels subsequent to the treatment)☆ Always the case☆☆Same HBeAg serostatus and same thresholds for HBV DNA level. Same regimen for infant immunoprophylaxis at birth☆ Laboratory methods described in detail (which assay used), indicating use of a central laboratory and/or record linkage☆ YesNo statement on LFU8 (low)
Li G (2006)☆ At least somewhat representative of the average HBV-infected pregnant woman☆ Drawn from the same community (same inclusion and exclusion criteria also)☆Valid method was used to ascertain adherence to the antiviral therapy (decrease in viral load levels subsequent to the treatment)☆ Always the case☆ Comparable HBeAg serostatus but HBV DNA levels not described. Same regimen for infant immunoprophylaxis☆ Laboratory assays described☆ Yes (always the case)☆ LFU reported and <20% LFU in both treatment group and control group8 (low)
Li WF (2006)☆ At least somewhat representative of the average HBV-infected pregnant woman☆ Drawn from the same community (same inclusion and exclusion criteria also)☆Valid method was used to ascertain adherence to the antiviral therapy (decrease in viral load levels subsequent to the treatment)☆ Always the case☆☆Same HBeAg serostatus and same thresholds for HBV DNA level. Same regimen for infant immunoprophylaxis at birth☆ Laboratory methods described in detail (which assay used), indicating use of a central laboratory and/or record linkage☆ YesNo statement on LFU8 (low)
Ma J (2006)☆ At least somewhat representative of the average HBV-infected pregnant woman☆ Drawn from the same community (same inclusion and exclusion criteria also)☆Valid method was used to ascertain adherence to the antiviral therapy (decrease in viral load levels subsequent to the treatment)☆ Always the caseComparable HBeAg serostatus but HBV DNA levels not described. Regimen for infant immunoprophylaxis not described☆ Laboratory assays described☆ Yes (always the case)No statement on LFU6 (high)
Han ZH (2005)☆ At least somewhat representative of the average HBV-infected pregnant woman☆ Drawn from the same community (same inclusion and exclusion criteria also)☆Valid method was used to ascertain adherence to the antiviral therapy (decrease in viral load levels subsequent to the treatment)☆ Always the case☆☆Same HBeAg serostatus and same thresholds for HBV DNA level. Same regimen for infant immunoprophylaxis at birth☆ Laboratory methods described in detail (which assay used), indicating use of a central laboratory and/or record linkage☆ YesNo statement on LFU8 (low)
Wang TM (2005)☆ At least somewhat representative of the average HBV-infected pregnant woman☆ Drawn from the same community (same inclusion and exclusion criteria also)☆Valid method was used to ascertain adherence to the antiviral therapy (decrease in viral load levels subsequent to the treatment)☆ Always the case☆Same HBeAg serostatus but HBV DNA level not described. Same regimen for infant immunoprophylaxis at birthNo description☆ YesNo statement on LFU6 (high)
a

Risk of bias assessments should be classified as being either low (≥7) or high (<7) by the Newcastle–Ottawa scale

From: Web Annex A, Systematic review of the efficacy and safety of antiviral therapy during pregnancy

Cover of Prevention of Mother-to-Child Transmission of Hepatitis B Virus: Guidelines on Antiviral Prophylaxis in Pregnancy
Prevention of Mother-to-Child Transmission of Hepatitis B Virus: Guidelines on Antiviral Prophylaxis in Pregnancy.
Geneva: World Health Organization; 2020 Jul.
© World Health Organization 2020.

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