Study designs of evaluations included in the review
Inclusion criteria for the study designs were not specified. All of the included studies were prospective cohort studies.
Specific interventions included in the review
Studies of primary lamivudine therapy were eligible for inclusion. In the included studies, the dose of lamivudine ranged from 50 to 150 mg/day and the duration of lamivudine therapy from 4 to 35 months.
Participants included in the review
Eligible participants were renal transplant recipients with hepatitis B. Studies that included patients on maintenance haemodialysis or peritoneal dialysis were excluded, as were studies that included patients infected with the human immunodeficiency virus, haemophilia or liver diseases other than hepatitis B. The mean age of participants in the included studies ranged from 30 to 52 years and 54 to 100% were men. The mean time from transplantation to the start of treatment, where reported, ranged from 8 to 156 months.
Outcomes assessed in the review
The primary efficacy outcomes eligible for inclusion were hepatitis B e antigen (HBeAg) and/or hepatitis B virus DNA (HBV-DNA) clearance after lamivudine therapy. The secondary outcomes included drop-out rate and lamivudine resistance as measures of tolerability, and biochemical response (normalisation of alanine aminotransferase (ALT) levels at the end of treatment).
How were decisions on the relevance of primary studies made?
The authors did not state how the papers were selected for the review, or how many reviewers performed the selection. There was 100% agreement between reviewers with respect to the final inclusion or exclusion of studies.