United States Experience With Terlipressin in Hepatorenal Syndrome: Response, Mortality, and Transplant Outcomes - Results From the HRS Harmony Consortium

Document Type

Article

Publication Date

5-8-2026

Publication Title

Clinical Gastroenterology and Hepatology

Abstract

BACKGROUND & AIMS: Terlipressin became the first United States Food and Drug Administration-approved therapy for hepatorenal syndrome-acute kidney injury in 2022. We present its initial experience at 16 United States academic medical centers.

METHODS: Consecutive patients with hepatorenal syndrome-acute kidney injury treated with terlipressin were followed for 90 days. Patients met standard criteria (conforming to United States Food and Drug Administration labeling guidance) or extended criteria (presence of ≥ 1 United States Food and Drug Administration warning/limitation: acute-on-chronic liver failure grade 3, serum creatinine >5 mg/dL, or hypoxia at initiation). Primary outcomes were overall response (complete or partial response per guidelines) and hepatorenal syndrome reversal (terminal serum creatinine < 1.5 mg/dL plus ≥0.3 mg/dL reduction). Fine and Gray models with liver transplant as a competing risk were used to assess 90-day mortality.

RESULTS: A total of 243 patients were analyzed. 40.5% died and 28.4% received liver transplant by 90 days. Overall response occurred in 55.1% and hepatorenal syndrome reversal in 30.9%. Forty-nine percent met extended criteria, most commonly due to acute-on-chronic liver failure grade 3 (45%). Standard criteria was associated with higher overall response (62.9% vs 47.1%; P = .019) and fewer adverse events leading to terlipressin discontinuation (12.1% vs 22.7%; P = .044). In adjusted analysis, hepatorenal syndrome reversal was not associated with reduced mortality, but overall response was (subdistribution hazard ratio, 0.57; 95% confidence interval, 0.38-0.86; P = .01).

CONCLUSIONS: This United States multicenter study provides insights into real-world use of terlipressin for hepatorenal syndrome-acute kidney injury. Terlipressin was frequently used in patients with acute-on-chronic liver failure grade 3. Adherence to United States Food and Drug Administration labeling criteria was associated with superior efficacy and safety. The significant association between overall response and reduced mortality underscores its potential as a clinically relevant endpoint for future studies.

PubMed ID

42107856

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© 2026 American Gastroenterological Association Institute.

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