title: Comparison of tacrolimus and cyclosporin A in CYP3A5 expressing Chinese de novo kidney transplant recipients: a 2-year prospective study.
abstract: OBJECTIVE
  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.
authors.affiliation: Organ Transplant Center, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
authors.forename: L-S
authors.initials: LS
authors.lastname: Liu
authors.affiliation: Organ Transplant Center, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
authors.forename: J
authors.initials: J
authors.lastname: Li
authors.affiliation: Organ Transplant Center, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
authors.forename: X-T
authors.initials: XT
authors.lastname: Chen
authors.affiliation: Organ Transplant Center, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
authors.forename: H-X
authors.initials: HX
authors.lastname: Zhang
authors.affiliation: Organ Transplant Center, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
authors.forename: Q
authors.initials: Q
authors.lastname: Fu
authors.affiliation: Organ Transplant Center, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
authors.forename: H-Y
authors.initials: HY
authors.lastname: Wang
authors.affiliation: Organ Transplant Center, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
authors.forename: Y-Y
authors.initials: YY
authors.lastname: Xiong
authors.affiliation: Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China.
authors.forename: S
authors.initials: S
authors.lastname: Liu
authors.affiliation: Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China.
authors.forename: X-M
authors.initials: XM
authors.lastname: Liu
authors.affiliation: Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China.
authors.forename: J-L
authors.initials: JL
authors.lastname: Li
authors.affiliation: Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China.
authors.forename: M
authors.initials: M
authors.lastname: Huang
authors.affiliation: Organ Transplant Center, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
authors.forename: C-X
authors.initials: CX
authors.lastname: Wang
mesh_terms: D002681:China / Q000453:epidemiology; D016572:Cyclosporine / Q000008:administration & dosage*; D051544:Cytochrome P-450 CYP3A / Q000096:biosynthesis / Q000235:genetics*; D004247:DNA / Q000235:genetics; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005786:Gene Expression Regulation; D005838:Genotype; D006084:Graft Rejection / Q000188:drug therapy* / Q000453:epidemiology / Q000235:genetics; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D015994:Incidence; D016030:Kidney Transplantation / Q000009:adverse effects*; D008297:Male; D011446:Prospective Studies; D016559:Tacrolimus / Q000008:administration & dosage*; D066027:Transplant Recipients; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D016572:Cyclosporine; D004247:DNA; C510164:CYP3A5 protein, human; D051544:Cytochrome P-450 CYP3A; D016559:Tacrolimus