Kidney Week

Abstract: SA-PO038

Hepatorenal Syndrome-AKI Reversal and Liver Transplant Rates in Patients Treated with Terlipressin

Session Information

• AKI: Clinical, Outcomes, and Trials - Management
  October 26, 2024 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Acute Kidney Injury

• 102 AKI: Clinical, Outcomes, and Trials

Authors

• Belcher, Justin Miles, Yale University School of Medicine, New Haven, Connecticut, United States

Justin Miles Belcher, MD, PhD, FASN

• Regner, Kevin R., Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Kevin R. Regner, MD, MS, FASN

• Subramanian, Ram, Emory University, Atlanta, Georgia, United States

Ram Subramanian, MD, MBA

• Mujtaba, Muhammad Ahmad, The University of Texas Medical Branch at Galveston, Galveston, Texas, United States

Muhammad Ahmad Mujtaba, MD, FASN

• Allegretti, Andrew S., Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, United States

Andrew S. Allegretti, MD, MS

• Cardoza, Sanaz, Mallinckrodt LLC, Bridgewater, New Jersey, United States

Sanaz Cardoza

• Wadei, Hani, Mayo Clinic in Florida, Jacksonville, Florida, United States

Hani Wadei, MD, FASN

Background

Hepatorenal syndrome-acute kidney injury (HRS-AKI) occurs in patients (pts) with advanced cirrhosis and ascites. Liver transplantation (LT) is the definitive treatment for the underlying disease, while pre-LT renal replacement therapy (RRT) is associated with poorer post-LT outcomes. Terlipressin (terli) reverses HRS-AKI, which is associated with a reduced need for RRT and improved LT outcomes. However, there are concerns that HRS-AKI reversal and the consequent decrease in serum creatinine (SCr) may reduce the MELD score and thereby negatively affect LT prioritization. The FDA recommends using terli in pts with SCr <5 mg/dL, ACLF grade 0–2, and MELD score <35 (if transplant listed).

Methods

Pts LT-listed at baseline who met the FDA criteria from 2 Phase III, randomized, placebo (pbo)-controlled studies of terli in pts with HRS-AKI (CONFIRM and REVERSE) were pooled for analysis.

Results

In LT-listed pts (terli: n=53; pbo: n=35), the rate of HRS-AKI reversal was significantly higher in the terli group vs pbo (terli: 43% vs pbo: 20%, P=.023) (Figure). The RRT rate in the terli group vs pbo was 28% vs 46% (P=.094) by Day 30; 32% vs 54% (P=.038) by Day 60; and 36% vs 54% (P=.087) by Day 90. However, the LT rate was similar in the terli and pbo groups: 53% vs 51% (P=.90) by Day 30; 66% vs 57% (P=.40) by Day 60; and 66% vs 63% (P=.76) by Day 90 (Figure).

Conclusion

Terli increased the rate of HRS-AKI reversal and reduced the need for RRT vs pbo. Importantly, the increase in HRS-AKI reversal in the terli group (vs pbo) did not negatively impact the LT rate in pts listed for LT at baseline in the population meeting the FDA criteria for terli treatment.

Funding

• Commercial Support – Mallinckrodt Pharmaceuticals