22 - Terlipressin Treatment of Patients With Hepatorenal Syndrome Type 1 Decreased the Need for Renal Replacement Therapy in Transplant Recipients: A 12-Month Follow-Up of the CONFIRM Study

Tuesday, October 25, 2022

9:00 AM – 9:10 AM ET

Location: Hall C2

Presenting Author(s)

KR

K. Rajender Reddy, MD, FACG

Ruimy Family President's Distinguished Professor, University of Pennsylvania; Director of Hepatology; Medical Director of Liver Transplantation
University of Pennsylvania
Philadelphia, PA

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Khurram Jamil, MD¹, Ethan Weinberg, MD², Rajender Reddy, MD, FACG²
¹Mallinckrodt, Hampton, NJ; ²University of Pennsylvania, Philadelphia, PA

Introduction: Hepatorenal syndrome type 1 (HRS) is a rapid-onset renal failure in the setting of end-stage liver disease. While liver transplant (LT) is the definitive treatment, posttransplant renal failure requiring renal replacement therapy (RRT) is common and contributes to low patient survival rates. A randomized, placebo (PBO)-controlled study (CONFIRM; NCT02770716) demonstrated that terlipressin (TERLI) reversed HRS and reduced the need for RRT. This subgroup analysis of LT recipients from CONFIRM assessed whether TERLI treatment reduced the incidence of RRT and improved overall survival (OS) through 12-months posttransplant.

Methods: Patients with HRS were treated with TERLI plus albumin (n=199) or PBO plus albumin (n=101) for up to 14 days. RRT was defined as any procedure that replaced nonendocrine kidney function including continuous hemofiltration and hemodialysis, intermittent hemodialysis, peritoneal dialysis, ultrafiltration, or other dialysis and filtration techniques. The incidence of verified HRS reversal (primary endpoint in CONFIRM), HRS reversal, the need for RRT (pretransplant; at Day 180 and Day 365 posttransplant), and OS at 12-months were compared between groups. Verified HRS reversal was defined as the percentage of patients with 2 consecutive qualified serum creatinine (SCr) values of ≤1.5 mg/dL at least 2 hours apart. HRS reversal was defined as the percentage of patients with a SCr value of ≤1.5 mg/dL while receiving treatment by Day 14 or day of discharge.

Results: In total, 46 (23%) patients in the TERLI group and 29 (28%) patients in the PBO group received an LT (P=.290). Five of these patients (TERLI n=3; PBO n=2) received a simultaneous liver–kidney transplant. Verified HRS reversal was comparable between the TERLI group (30%, n=14) and the PBO group (17%, n=5; P=.168). HRS reversal was significantly higher in the TERLI group (37%, n=17) vs the PBO group (14%, n=4; P=.021). The pretransplant need for RRT was significantly lower in the TERLI group compared with PBO (P=.007; Figure). The posttransplant need for RRT was significantly lower in the TERLI vs PBO group at Day 180 (P=.017; Figure) and Day 365 (P=.009; Figure). Posttransplant 12-month OS in the TERLI group was 94% (n=43) compared with 83% (n=24) in the PBO group (P=.093).

Discussion: Patients with HRS who received TERLI treatment and an LT had a decreased need for RRT for up to 12-months posttransplant. These findings have implications for morbidity and mortality in patients with advanced cirrhosis.

Figure: Figure: Incidence of RRT by Treatment Group in Transplant Recipients in the CONFIRM Study, ITT population.

Values at the bottom of each bar represent n/N.
ITT, intent-to-treat; n, number of patients requiring RRT; N, number of patients who were alive at each timepoint; RRT, renal replacement therapy.

Disclosures:

Khurram Jamil: Mallinckrodt – Employee.

Ethan Weinberg: BioVie – Consultant. Mallinckrodt – Advisory Committee/Board Member. PharmaIN – Consultant.

Rajender Reddy: Abbvie – Grant/Research Support, Personal Fees. BMS – Grant/Research Support, Personal Fees. Dova – Personal Fees. Exact Sciences – Grant/Research Support. Gilead – Grant/Research Support, Personal Fees. Grifols – Grant/Research Support. HCC-TARGET – Grant/Research Support. HCV-TARGET – Grant/Research Support. Intercept – Grant/Research Support. Mallinckrodt Pharmaceuticals – Grant/Research Support. Merck – Grant/Research Support, Personal Fees. NASH-TARGET – Grant/Research Support. Spark Therapeutics – Personal Fees.

Khurram Jamil, MD¹, Ethan Weinberg, MD², Rajender Reddy, MD, FACG², 22, Terlipressin Treatment of Patients With Hepatorenal Syndrome Type 1 Decreased the Need for Renal Replacement Therapy in Transplant Recipients: A 12-Month Follow-Up of the CONFIRM Study, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.