Hepatitis B immunoglobulin injection in pregnancy to interrupt hepatitis B virus mother-to-child transmission—a meta-analysis

Summary Objectives To evaluate the efficacy and safety of using hepatitis B immunoglobulin (HBIG) during pregnancy to prevent hepatitis B virus (HBV) mother-to-child transmission (MTCT). Methods We systematically reviewed the effect of HBIG in decreasing HBV MTCT from randomized controlled trials (RCTs) carried out between January 1990 and December 2008, in English and Chinese languages. Multiple databases were searched, and experts in this field were contacted. The methodological quality of each RCT was assessed by the Jadad score. We abstracted data on HBV intrauterine infection, MTCT, treatment methods, newborn immune prophylaxis methods, and adverse effects. A Mantel–Haenszel random-effects model was employed for all analyses using odds ratios (OR) and 95% confidence intervals (95% CI). Results Five thousand nine hundred newborns of asymptomatic hepatitis B surface antigen (HBsAg)-seropositive mothers from 37 qualified RCTs were included. Compared with the control group, newborns in the HBIG group had a lower intrauterine infection rate (indicated by HBsAg as OR 0.22, 95% CI [0.17, 0.29], from 32 RCTs; indicated by HBV DNA as OR 0.15, 95% CI [0.07, 0.30], from 13 RCTs; p < 0.01 for both) and a higher protection rate (indicated by hepatitis B surface antibody (HBsAb) as OR 11.79, 95% CI [4.69, 29.61], from 15 RCTs; p < 0.01). The same trend was found in MTCT by the time of 9–12 months after birth, indicated by HBsAg (OR 0.33, 95% CI [0.21, 0.51], from nine RCTs; p < 0.01) and HBsAb (OR 2.49, 95% CI [1.55, 4.01], from 11 RCTs; p < 0.01). HBIG appears to be safe, but a few RCTs have reported adverse events. Conclusion Multiple injections of HBIG in HBV carrier mothers with a high degree of infectiousness in late pregnancy, effectively and safely prevent HBV intrauterine transmission.