Efficacy and safety of a switch from twice-daily tacrolimus to once-daily generic tacrolimus in stable liver transplant patients
- Authors
- 김종만; 박평재; 홍근; 주동진; 김관우; 류제호; 한영석; 조재영; 송기원; 김봉완; 김동식; 김성훈; 최상태; 유영경; 서경석; 나양원; 강구정; 조재원
- Issue Date
- Sep-2021
- Publisher
- 대한이식학회
- Keywords
- Tacrolimus; Liver transplantation; Therapeutic equivalence; Immunosuppression
- Citation
- Korean Journal of Transplantation, v.35, no.3, pp.168 - 176
- Journal Title
- Korean Journal of Transplantation
- Volume
- 35
- Number
- 3
- Start Page
- 168
- End Page
- 176
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/82280
- DOI
- 10.4285/kjt.21.0012
- ISSN
- 2671-8790
- Abstract
- Background: Once-daily tacrolimus reduces non-compliance relative to twice-daily tacrolimus. However, little is known about the safety and efficacy of conversion from twice-daily tacrolimus to generic once-daily tacrolimus in liver transplantation (LT). Herein, we investigated the efficacy and safety of a switch from twice-daily tacrolimus to generic once-daily tacrolimus in patients with stable liver graft function.
Methods: This prospective, multicenter, open-label, single-arm study was conducted in 17 medical centers for 1 year from July 2019 to July 2020 (NCT04069065). Primary end- point was the incidence of biopsy-proven acute rejection (BPAR) for 24 weeks after con- version. Secondary endpoints were graft failure, patient death, and adverse events (AEs). Results: Of 151 screened LT patients, 144 patients were enrolled. BPAR, graft failure, and patient death did not occur in this patient population. There were no statistical dif- ferences in blood tests, liver function tests, or biochemical tests between visits in any of the patients. Median tacrolimus trough level decreased abruptly from 4.7 ng/mL to 3.2 ng/mL after generic once-daily tacrolimus conversion, but median tacrolimus dose in- creased due to low tacrolimus trough level. Ninety-two adverse events occurred in 54 pa- tients. Liver enzyme levels increased in seven patients (4.9%) after the switch to generic once-daily tacrolimus, but the liver function tests of these patients normalized thereafter. There were three cases of severe AEs not related to investigational drug.
Conclusions: Present study suggests that conversion from twice-daily tacrolimus to ge- neric once-daily tacrolimus is effective and safe in stable LT patients.
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