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Abstract: PO0052

Treatment of Hepatorenal Syndrome Type 1 with Terlipressin Reduces Need for Renal Replacement Therapy After Liver Transplantation

Session Information

Category: Acute Kidney Injury

  • 102 AKI: Clinical, Outcomes, and Trials

Authors

  • Velez, Juan Carlos Q., Ochsner Health System, New Orleans, Louisiana, United States
  • Sclair, Seth, University Hospitals Cleveland Medical Center Department of Orthopaedics, Cleveland, Ohio, United States
  • Sanchez, Antonio J., University of Iowa Hospitals & Clinics, Iowa City, Iowa, United States
  • Caldwell, Stephen, University of Virginia, Charlottesville, Virginia, United States
  • Sigal, Samuel, Montefiore Medical Center, Bronx, New York, United States
  • Thuluvath, Paul J., Mercy Medical Center & University of Maryland School of Medicine, Baltimore, Maryland, United States
  • Satoskar, Rohit, MedStar Georgetown University Hospital, Washington, District of Columbia, United States
  • Pappas, S. Chris, Orphan Therapeutics, Lebanon, New Jersey, United States
  • Jamil, Khurram, Mallinckrodt Pharmaceuticals Specialty Brands Principal Office, Bedminster, New Jersey, United States
Background

Hepatorenal syndrome type 1 (HRS-1) is a severe but reversible acute kidney injury in patients with cirrhosis. The need for renal replacement therapy (RRT) posttransplant is associated with prolonged intensive care unit stays and decreased survival. Recently, a randomized placebo (PBO)-controlled trial (CONFIRM, NCT02770716) demonstrated the efficacy of terlipressin (TERLI) for inducing reversal of HRS-1 and reducing the cumulative need for RRT. This study assessed whether TERLI reduces the rate of RRT following liver transplantation (LT).

Methods

CONFIRM was a North American trial (N=300) that compared HRS-1 reversal rates between patients treated 2:1 with albumin plus TERLI (n=199) or albumin plus PBO (n=101). In a post hoc analysis, we assessed the rate of RRT post-LT by intention-to-treat analysis through 90 days of follow-up. We also conducted a pooled analysis of the 3 TERLI RCTs in HRS-1 (OT-0401 [NCT00089570], REVERSE [NCT01143246], and CONFIRM) to examine 90-day overall and RRT-free survival rates in patients who received LT.

Results

In CONFIRM, 23.1% (46/199) of patients in the TERLI group and 28.7% (29/101) of patients in the PBO group underwent LT. Following LT, the rate of post-LT RRT in patients who received TERLI was significantly lower than that in those who received PBO (19.6% [9/46] vs 44.8% [13/29], respectively; P=0.036). The overall 90-day survival rate for those transplanted in the TERLI group was 100% (46/46) compared with 93.1% (27/29) in the PBO group (P=not significant). Further, in the pooled analysis of the 3 phase 3 studies, the 90-day survival rates were 98.9% (93/94) and 91.0% (71/78), respectively (P=0.014). In the pooled analysis of REVERSE and CONFIRM, for transplant-listed patients, 50.0% (46/92) of patients in the TERLI group were alive without RRT at Day 90 compared with 32.2% (19/59) in the PBO group (P=0.032).

Conclusion

Treatment with TERLI added to albumin for patients with HRS-1 significantly decreases the need for RRT following LT.