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Efficacy and Safety of Once-Daily Everolimus With Minimized Once-Daily Tacrolimus After Liver Transplantation

P. De Simone,1 P. Carrai,1 L. Coletti,1 A. Precisi,2 D. Campani,3 F. Filipponi.1

1Hepatobiliary Surgery and Liver Transplantation, University of Pisa Medical School Hospital, Pisa, Italy
2Laboratory, University of Pisa Medical School Hospital, Pisa, Italy
3Pathology, University of Pisa Medical School Hospital, Pisa, Italy.

Meeting: 2015 American Transplant Congress

Abstract number: A199

Keywords: Efficacy, Immunosuppression, Liver transplantation, Outcome

Session Information

Session Name: Poster Session A: Liver: Immunosuppression and Rejection

Session Type: Poster Session

Date: Saturday, May 2, 2015

Session Time: 5:30pm-7:30pm

 Presentation Time: 5:30pm-7:30pm

Location: Exhibit Hall E

Background: The everolimus (EVR) pharmacokinetic profile allows for its once daily (OD) administration. We tested the efficacy and safety of a combination schedule of OD-EVR and reduced-exposure OD tacrolimus (rOD-TAC) with a pilot, prospective study in adult, maintenance (≥6 months) liver transplant (LT) recipients.

Materials and methods: Primary, deceased donor LT recipients on TAC-based immunosuppression were enrolled. Patients on OD-TAC were randomized to receive either OD-EVR (Group A; OD-EVR+rOD-TAC) or TD-EVR (Group B; TD-EVR+rOD-TAC). Patients on twice-daily TAC (TD-TAC) received TD-EVR only (Group C; TD-EVR+rTD-TAC) and were used as the referent case population. After EVR was in the target range (3-8 ng/mL), TAC exposure was minimized (3-5 ng/mL) for the entire duration of the study (12 months (M)). The primary endpoint was the 12-M efficacy failure rate, as the composite of treated biopsy proven acute rejection (tBPAR), graft loss, patient's death, and loss to follow-up. The secondary endpoint was the safety profile of the 3 combination regimens in the intent-to-treat (ITT) population.

Results: Fifty-four patients were allocated to the 3 treatment arms on a 1:1:1 basis (18 patients in each group). The 12-M composite efficacy rate was similar across groups (94.5% (A); 100% (B); and 100% (C), respectively; p=ns). One case of mild BPAR (RAI=6) was observed in Group A and C each, and there was only 1 death in Group C due to recurrent hepatocellular carcinoma. The most frequent adverse event was hyperlipidemia, with a 22.2%, 16.6%, and 16.6% incidence in Group A, B, and C, respectively (p=ns). Proteinuria ≥0.5/g was observed in 1 case in each Group (0.5%; p=ns). The endpoint (12M) renal function (4-MDRD eGFR) improved by 4.5 ± 7.6, 5.1 ± 6.2, and 5.7 ± 6.8 mL/min in Group A, B, and C, respectively (p=ns).

Conclusions: A full once-daily combination schedule of EVR and TAC allows for TAC minimization and shows comparable efficacy and safety vs. the twice-daily regimen.

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To cite this abstract in AMA style:

Simone PDe, Carrai P, Coletti L, Precisi A, Campani D, Filipponi F. Efficacy and Safety of Once-Daily Everolimus With Minimized Once-Daily Tacrolimus After Liver Transplantation [abstract]. Am J Transplant. 2015; 15 (suppl 3). https://atcmeetingabstracts.com/abstract/efficacy-and-safety-of-once-daily-everolimus-with-minimized-once-daily-tacrolimus-after-liver-transplantation/. Accessed May 9, 2025.

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