Early Post-Transplant Immunosuppression (IS) Withdrawal – Final Outcomes of the ITN030ST AWISH Study.

A. Shaked,¹ S. Feng,² J. Punch,³ J. Reyes,⁴ J. Levitsky,⁵ G. Klintmalm,⁶ H. Kopetskie,⁷ M. DesMarais,² A. Priore,⁸ N. Bridges,⁸ P. Sayre.²

¹UPenn, Philadelphia
²UCSF, San Francisco
³U Michigan, Ann Arbor
⁴U Washington, Seattle
⁵Northwestern, Chicago
⁶Baylor, Dallas
⁷RhoFed, Chapel Hill
⁸NIAID, Bethesda.

Meeting: 2016 American Transplant Congress

Abstract number: 185

Keywords: Immunosuppression, Liver transplantation, Tolerance

Session Information

Session Name: Concurrent Session: Clinical Science: Tolerance: Clinical Studies

Session Type: Concurrent Session

Date: Monday, June 13, 2016

Session Time: 2:30pm-4:00pm

Presentation Time: 2:30pm-2:42pm

Location: Room 304

ITN030ST is a prospective randomized trial designed to determine the clinical benefit of early IS withdrawal in adult liver transplant (LT) recipients. Recipients did not receive induction therapy and were maintained on standard CNI IS.

275 participants were enrolled at LT across 7 US sites; 145 had non immune non-viral (NINV) causes and 130 had hepatitis C virus (HCV) as indication for LT. Subject disposition is shown in Figure 1: 199 (72%) achieved IS monotherapy early after LT (median 218[IQR 124-326]days). Subjects achieving stable monotherapy, acceptable liver function, and biopsy without rejection or fibrosis (n=95) were randomized to withdrawal (n=77) or maintenance (n=18) at a mean of 17±4.5 months post-LT. Major reasons disqualifying randomization were voluntary withdrawal (n=41), HCV activity (n=40), and protocol deviation (n=19).

Response to IS withdrawal was similar for HCV or NINV subjects. 52/77 (68%) achieved ≤50% of baseline dose. 10/77 (13%) were off IS ≥ 1 year: 9 remained IS free until study completion (24 months of follow-up) and 1 until retransplantation for HCV recurrence. Of 67 who failed withdrawal, 30 had biopsy-proven rejection and 37 had abnormal liver tests; all resolved with CNI therapy with or without antimetabolites. Only 13 (19%) subjects required corticosteroids.

The primary composite endpoint, evaluated 24 months after randomization, was comprised of death or graft loss; grade 4 malignancy or opportunistic infection; stage ≥3 fibrosis; or 25% decrease in GFR. The endpoint occurred in 4 of 13 (31%) and 12 of 66 (18%) evaluable subjects in the maintenance and withdrawal groups respectively.

Conclusion: IS minimization starting 12-24 months after LT was tolerated by the majority of recipients. Complete IS withdrawal was achieved in 13% of those qualified for the minimization protocol.

Figure 1. Participant Disposition

CITATION INFORMATION: Shaked A, Feng S, Punch J, Reyes J, Levitsky J, Klintmalm G, Kopetskie H, DesMarais M, Priore A, Bridges N, Sayre P. Early Post-Transplant Immunosuppression (IS) Withdrawal – Final Outcomes of the ITN030ST AWISH Study. Am J Transplant. 2016;16 (suppl 3).

To cite this abstract in AMA style:

Shaked A, Feng S, Punch J, Reyes J, Levitsky J, Klintmalm G, Kopetskie H, DesMarais M, Priore A, Bridges N, Sayre P. Early Post-Transplant Immunosuppression (IS) Withdrawal – Final Outcomes of the ITN030ST AWISH Study. [abstract]. Am J Transplant. 2016; 16 (suppl 3). https://atcmeetingabstracts.com/abstract/early-post-transplant-immunosuppression-is-withdrawal-final-outcomes-of-the-itn030st-awish-study/. Accessed May 17, 2025.

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