Objective: To assess the effectiveness and safety of immune globulins in preventing infectious hepatitis and hepatitis A.
Study design: Systematic review with meta-analysis.
Data sources: We searched the Cochrane Library, MEDLINE, EMBASE, Biological Abstracts and Science Citation Index to December 2002. Vaccine manufacturers were contacted for additional data.
Review methods: We included randomised controlled trials comparing effectiveness of hepatitis A immune globulins with no intervention or placebo, and carried out a meta-analysis.
Results: We included six studies (two in Russian). Tested immune globulins show higher effectiveness than placebo or do-nothing against infectious hepatitis both in primary prevention and in prevention after exposure (effectiveness 83%; RR: 0.17; 95% CI: 0.15-0.19; and effectiveness 69%; RR: 0.31; 95% CI: 0.20-0.47, respectively). We found considerable heterogeneity among studies, possibly due to different methodology, background rates of disease and immune globulins dosage and concentrations. No safety data were reported in the studies.
Conclusions: Immune globulins are efficacious in preventing infectious hepatitis and hepatitis A, but included studies do not report data about their safety. Average length of passive protection was three months. Given the notable heterogeneity of performance of immune globulins, short protection conferred and absence of trial safety data, the only indications for the use of immune globulins may be in situations in which inadequate supplies of vaccine are available or when the eight-day window of opportunity for vaccine use is past.