THE IMPACT OF TERLIPRESSIN TREATMENT ON LIVER TRANSPLANTATION RATES IN PATIENTS WITH HEPATORENAL SYNDROME-ACUTE KIDNEY INJURY (HRS-AKI) IN THE CONTEXT OF THE CHANGING MELD SCORE DEFINITIONS ?

Document Type

Conference Proceeding

Publication Date

10-9-2024

Publication Title

Hepatology

Abstract

Background: HRS-AKI is a lethal complication of cirrhosis. Liver transplantation (LT) is the only curative option for patients (pts) with HRS-AKI. In the US, organ priority allocation is based on the Model for End-Stage Liver Disease (MELD) score. MELD-sodium (MELD-Na) score has been used since 2016; and in 2023, MELD 3.0 (which also includes albumin and sex) replaced MELD-Na. Terlipressin (terli) is the only US FDA-approved drug for the treatment of HRS-AKI. However, the reduction in MELD score, secondary to an improvement in serum creatinine (sCr) due to HRS reversal, may negatively affect pt prioritization for LT. To assess outcomes in pts who would be eligible for treatment per the terli FDA label (ie, MELD score <35 if transplant listed, sCr <5 mg/dL, and acute-on-chronic liver failure [ACLF] grade 0-2, henceforth referred to as the mitigated population), we evaluated the LT rate and changes in the 3 MELD score variants in this population. Methods: The rate of LT up to the end of the study observation period (ie, 90 days) and change from baseline to the end of treatment in MELD, MELD-Na, and MELD 3.0 scores were retrospectively assessed in the mitigated population from the Phase III pbo-controlled CONFIRM study (NCT02770716). Results: LT rate by Day 90 was 22.7% (30/132) and 21.1% (15/71) in the terli and pbo arms, respectively (P =.793); 2.3% (3/132) and 1.4% (1/ 71) of pts, respectively, received a simultaneous liverkidney transplant (SLKT) (P = 1.0) (Figure). The median time to transplantation was 22 days (terli arm) vs 11.5 days (pbo arm; P= .147). Data to calculate changes in MELD scores were available for 107/132 pts in the terli arm and for 55/71 pts in the pbo arm. All 3 MELD scores decreased from baseline to the end of treatment in the terli arm (all P< .001), but not in the pbo arm. Median score changes were -3.0 in MELD, -4.0 in MELD-Na, and -6.0 in MELD 3.0 in the terli arm, while changes for all 3 MELD scores in the pbo arm were 0. The difference in changes between the terli and pbo arms was significant in all cases (all P < .01). Conclusion: Improvement in MELD due to terli treatment did not lead to a decrease in transplantation rate, despite a decrease in all 3 MELD score variants for terli vs pbo in the mitigated population. The rates of LT and SLKT in this population were similar in both treatment arms.

Volume

80

First Page

S1633

Last Page

S1634

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