Systematic Review on Immunoglobulins for Preventing Hepatitis A

Objective To assess the efficacy and safety of the pre-exposure and post-exposure prophylaxis with immunoglobulins for preventing hepatitis A. Methods We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials in The Cochrane Library, Medical Literature Analysis and Retrieval System Online, Excerpta Medica Database, Chinese Biomedical Database, and Science Citation Index Expanded for randomized trials, and hand searched three Chinese journals. Randomized clinical trials on immunoglobulin prophylaxis for preventing hepatitis A were collected, the primary outcome was incidence of hepatitis A, and the results were presented as relative risks （RR） with 95% confidence intervals. Results Thirteen trials with 567 476 participants were included, and two thirds of the 13 trials had high risk of bias. For pre-exposure prophylaxis, immunoglobulin significantly reduced the number of adults or children patients with hepatitis A at 6 to 12 months compared with no intervention or inactive control （P<0.05）. There was no significant difference between immunoglobulin and inactivated hepatitis A vaccine in seroconversion to hepatitis A vaccine antibodies at four weeks （P>0.05）, but immunoglobulin was significantly less effective than vaccine regarding antibody levels at 8, 12, or 24 weeks （P<0.05）. Higher dosage was generally more effective than lower dosage in preventing hepatitis A （P<0.01）. For post-exposure prophylaxis, immunoglobulin was more effective than placebo （P<0.01）. No significant systemic adverse events were reported. Conclusions Immunoglobulins seem to be effective for pre-exposure and post-exposure prophylaxis of hepatitis A. However, caution is warranted for the positive findings due to the limited number of trials, old publication, and risk of bias. Further well-designed randomized controlled trials are expected for rigorous evidence.