Hepatitis B immunoglobulin human 500units/10ml solution for infusion vials

Background: There isn’t consensus about the optimal dose of hepatitis B immunoglobulin (HBIG) in combination with hepatitis B vaccine to preventing mother-to-child transmission (MTCT) of hepatitis B virus(HBV). Methods: : We systematically searched MEDLINE, Embase, and Cochrane Library from database inception to Jan 16, 2019 for studies. The primary outcome was HBsAg and/or HBV DNA positive in infants at 6-12 months old. We performed a meta-analysis with a random-effects model to calculate a pooled estimate of MTCT. Results: : We included 31 studies, comprising of 12151 infants. There wasn't significant differences in the pooled MTCT rates between 100 IU HBIG group and 200 IU HBIG group (5% vs 5%, P = 0.757). When further stratified according to HBeAg status, in HBeAg(+) mothers, 7% (95%CI 4%-11%) infants became chronic HBV infection in 100 IU HBIG group compared to 7% (95%CI 5%-9%）in 200 IU group. The rates were 1% (95%CI 0%-2%) in 100IU group and 0% (95%CI 0%-1%) in 200IU group in infants born to HBeAg(-) mothers, respectively. When further comparing MTCT in infants from mothers with HBV DNA ≥ 1×10^6 IU/mL, the pooled MTCT rate was 12% (95%CI 7%-17%) in 100IU group and 8% (95%CI 5%-13%) in 200IU group, respectively. In addition, comparative analysis of four studies concerning two different dosages of HBIG further manifested the comparability. Conclusion: 100 IU HBIG is sufficient in preventing MTCT for infants from chronic hepatitis B infected mothers, regardless of maternal HBeAg status or viral load.

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