PMID- 35769244 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220716 IS - 2671-8790 (Print) IS - 2671-8804 (Electronic) IS - 2671-8790 (Linking) VI - 35 IP - 3 DP - 2021 Sep 30 TI - Efficacy and safety of a switch from twice-daily tacrolimus to once-daily generic tacrolimus in stable liver transplant patients. PG - 168-176 LID - 10.4285/kjt.21.0012 [doi] AB - 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 endpoint was the incidence of biopsy-proven acute rejection (BPAR) for 24 weeks after conversion. 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 differences 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 increased due to low tacrolimus trough level. Ninety-two adverse events occurred in 54 patients. 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 generic once-daily tacrolimus is effective and safe in stable LT patients. CI - Copyright (c) 2021 The Korean Society for Transplantation. FAU - Kim, Jong Man AU - Kim JM AUID- ORCID: 0000-0002-1903-8354 AD - Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. FAU - Park, Pyoung-Jae AU - Park PJ AUID- ORCID: 0000-0001-6624-7522 AD - Department of Surgery, Korea University College of Medicine, Seoul, Korea. AD - Department of Surgery, Korea University Guro Hospital, Seoul, Korea. FAU - Hong, Geun AU - Hong G AUID- ORCID: 0000-0003-2597-1068 AD - Department of Surgery, Ewha Woman's University School of Medicine, Seoul, Korea. FAU - Joo, Dong Jin AU - Joo DJ AUID- ORCID: 0000-0001-8405-1531 AD - Department of Surgery, Yonsei University College of Medicine, Seoul, Korea. FAU - Kim, Kwan Woo AU - Kim KW AUID- ORCID: 0000-0002-7432-6949 AD - Department of Surgery, Dong-A University Hospital, Dong-A University College of Medicine, Busan, Korea. FAU - Ryu, Je Ho AU - Ryu JH AUID- ORCID: 0000-0002-9377-3074 AD - Department of Surgery, Pusan National University College of Medicine, Busan, Korea. FAU - Han, Young Seok AU - Han YS AUID- ORCID: 0000-0003-4075-730X AD - Department of Surgery, Kyungpook National University Hospital, School of Medicine, Kyungpook National University, Daegu, Korea. FAU - Cho, Jai Young AU - Cho JY AUID- ORCID: 0000-0002-1376-956X AD - Department of Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea. FAU - Song, Gi-Won AU - Song GW AUID- ORCID: 0000-0002-1581-7051 AD - Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. FAU - Kim, Bong-Wan AU - Kim BW AUID- ORCID: 0000-0001-9059-0451 AD - Division of Hepatobiliary Surgery and Liver Transplantation, Department of Surgery, Ajou University School of Medicine, Suwon, Korea. FAU - Kim, Dong-Sik AU - Kim DS AUID- ORCID: 0000-0002-0608-1580 AD - Department of Surgery, Korea University College of Medicine, Seoul, Korea. FAU - Kim, Seong Hoon AU - Kim SH AUID- ORCID: 0000-0001-7921-1801 AD - Center for Liver Cancer, National Cancer Center, Goyang, Korea. FAU - Choi, Sang Tae AU - Choi ST AUID- ORCID: 0000-0001-5164-6889 AD - Department of Surgery, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, Korea. FAU - You, Young Kyoung AU - You YK AUID- ORCID: 0000-0002-7363-8131 AD - Department of Surgery, College of Medicine, The Catholic University of Korea, Seoul, Korea. FAU - Suh, Kyung-Suk AU - Suh KS AUID- ORCID: 0000-0002-9535-7349 AD - Department of Surgery, Seoul National University College of Medicine, Seoul, Korea. FAU - Na, Yang-Won AU - Na YW AUID- ORCID: 0000-0001-8161-9849 AD - Department of Surgery, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea. FAU - Kang, Koo Jeong AU - Kang KJ AUID- ORCID: 0000-0003-1385-8308 AD - Department of Surgery, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, Korea. FAU - Joh, Jae-Won AU - Joh JW AUID- ORCID: 0000-0003-1732-6210 AD - Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. LA - eng PT - Journal Article PL - Korea (South) TA - Korean J Transplant JT - Korean journal of transplantation JID - 101775609 PMC - PMC9235448 OTO - NOTNLM OT - Immunosuppression OT - Liver transplantation OT - Tacrolimus OT - Therapeutic equivalence EDAT- 2022/07/01 06:00 MHDA- 2022/07/01 06:01 PMCR- 2021/09/30 CRDT- 2022/06/30 02:29 PHST- 2021/05/24 00:00 [received] PHST- 2021/08/27 00:00 [revised] PHST- 2021/09/09 00:00 [accepted] PHST- 2022/06/30 02:29 [entrez] PHST- 2022/07/01 06:00 [pubmed] PHST- 2022/07/01 06:01 [medline] PHST- 2021/09/30 00:00 [pmc-release] AID - kjt-35-3-168 [pii] AID - 10.4285/kjt.21.0012 [doi] PST - ppublish SO - Korean J Transplant. 2021 Sep 30;35(3):168-176. doi: 10.4285/kjt.21.0012.