Introduction: Once daily formulation of tacrolimus (TAC-OD) has been proven to be comparable to twice daily formulation (TAC-BID) in terms of efficacy and safety for Kidney (K) and Liver (L) transplantation (Tx) and is progressively replacing TAC-BID. The impact of initiation of TAC-OD strategies on patient outcomes, treatment acceptability and compliance still remains to be assessed.

Purpose: To describe TAC-OD initiation practices after KTx and LTx either during post-Tx hospitalization (gr1) or throughout follow-up (gr2), and to evaluate patient acceptability and compliance.

Methods: Multicentre, longitudinal observational 6-month study including clinical data collection and patient self questionnaire at inclusion, 3 and 6 months. Interim analysis data at 3 months is presented.

Results: A total of 1,190 patients (75% K, 24%L, 1% K&L) were included by 78 physicians among 34 Tx centres. TAC-OD was initiated after surgery in 7% of patients at a mean of 14 days (12 d in KTx, 22 d in LTx) and during follow-up in 93% (n=1,097) at a mean of 4,8 years (range 1 to 25). 95% of gr2 patients were switched from TAC-BID, mg:mg associated with a mean decrease of C0 ∼10%. Only 10,5% of patients needed a dose change during the first month post initiation. 22% of LTx patients were taking TAC-OD monotherapy, 48% on bi-therapy and 60% of KTx patients were on triple immunosuppression therapy. Reducing the daily pill intake was the main reason for switching.

At 3 months after TAC-OD initiation, 98% of patients were still on TAC-OD with no modification of concomitant treatment for 97% of them. Systemic exposure remained stable (mean C0 6,33ng/mL) and only 4 acute rejections were reported between 46 and 84 days after TAC-OD initiation (3 KTx, 1 LTx) with no graft loss. Initiation of TAC-OD increased compliance in 20% of patients as self-assessed by patients questionnaires.

Conclusion: In this study, initiation of TAC-OD-based immunosuppression in a large cohort of KTx and LTx recipients was associated with a 20% improvement of treatment compliance without any safety concerns. Dosage and systemic exposure remained stable, less than 1% acute rejection and no graft loss were reported.

Cantarovich, D.: Grant/Research Support, Astellas. Rostaing, L.: Grant/Research Support, Astellas. Kamar, N.: Grant/Research Support, Astellas. Kessler, M.: Grant/Research Support, Astellas. Pageaux, G.: Grant/Research Support, Astellas.

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