Six trials were included in the review (n=551 patients); one was prospective and five were retrospective. Sample sizes ranged from 29 to 165 patients. All trials randomised patients to treatment groups, but only one reported methods for randomisation. All trials had complete follow-up, but none were double blind. Follow-up ranged between 60 and 104 months.
Patients receiving lamivudine plus hepatitis B immunoglobulin showed a significant reduction in the rate of hepatitis B recurrence (RR 0.38, 95% CI 0.25 to 0.58; six trials), and YMDD mutants (RR 0.40, 95% CI 0.23 to 0.72; five trials) compared with patients receiving lamivudine monotherapy. Lamivudine plus hepatitis B immunoglobulin also had a significant reduction in hepatitis B recurrence in hepatitis B virus DNA positive patients before liver transplantation (RR 0.31, 95% CI 0.21 to 0.45; five trials).
No significant differences in patient and graft survival or disease related death were observed between the two treatment groups. There was no evidence of significant statistical heterogeneity for any comparisons, and no evidence of publication bias using a funnel plot.