Comparison of tacrolimus and cyclosporin A in CYP3A5 expressing Chinese de novo kidney transplant recipients: a 2-year prospective study.

AIMS: To assess the efficacy and safety of tacrolimus and cyclosporin A (CsA)-based immunosuppressive regimens in Chinese de novo kidney transplant recipients who are CYP3A5 expressers.

METHODS: The CYP3A5 (6986 A>G, rs776746) polymorphism of eligible patients was determined before transplantation. De novo kidney transplant recipients enrolled in this study were assigned to tacrolimus (Tac group) or CsA (CsA group) based therapy. The follow-up period was 2 years. The incidence of acute rejection, patient and graft survival rates, renal allograft function and post-transplant complications were compared. The intra-individual variability (IIV) of Tac and CsA blood concentrations was analysed. Medication costs were also compared. The analysis was conducted on the intention-to-treat principle.

RESULTS: A total of 72 CYP3A5 expressers were enrolled, with 36 patients in each group. AR incidence was higher in the Tac group (11.1% vs. 5.6%), but there was no significant difference (p > 0.05). The 2-year patient and graft survival was comparable, and renal function was comparable in the two groups. Notably, the Tac group presented a significantly higher incidence of BK viremia (22.2% vs. 5.6%, p < 0.05) and BK viruria (38.9% vs. 16.7%, p < 0.05) than the CsA group. The CsA IIV at 1 and 3 months post-transplant was significantly lower than the Tac IIV (p < 0.05). The medical costs of both immunosuppressive drugs and management of complications was significantly lower in the CsA group.

CONCLUSIONS: Cyclosporin A-based maintenance therapy is safe for Chinese de novo kidney transplant recipients who are CYP3A5 expressers. CsA significantly reduced medication costs and decreased BKV infection, suggesting that it is more beneficial for this specific population.