Abstract

Background: Alcohol-related liver disease is a major cause of liver cirrhosis and has recently emerged as the most common indication for liver transplantation. Hepatorenal syndrome (HRS)—a rapidly progressive renal failure—is a fatal complication of decompensated cirrhosis with ascites. The FDA-approved vasopressin analogue, terlipressin (terli)—in combination with albumin—is recommended to treat patients (pts) with HRS-acute kidney injury (AKI). Terli also demonstrated efficacy in the subpopulation of pts with alcohol-related hepatitis. Based on the Premier Healthcare Database, the annualized estimate of HRS cases in 2021 was over 60,000 pts; approximately 60% of HRS cases were alcohol-related. In the pooled population of 3 Phase III North American, randomized, placebo (pbo)-controlled trials (NA RCTs) of terli in pts with HRS, cirrhosis had an alcohol-related etiology in 59.5% of pts. This study estimated the benefits of terli in adult pts with HRS and alcohol-related cirrhosis (AC) in real-world practice.

Methods: A decision-analytic approach was used to create a model based on the US annual projection for HRS and AKI using data from the Premier Healthcare Database on the prevalence of an alcohol-related HRS diagnosis among hospitalized pts and the efficacy of terli vs pbo—including HRS reversal—reported in the 3 NA RCTs (OT-0401, REVERSE, and CONFIRM). Under the assumption that 80% of pts with HRS and AC would meet the FDA label criteria for terli (ie, pts with serum creatinine <5 mg/dL, acute-on-chronic liver failure grade 0–2), the model projected additional responses (ie, HRS reversal), reduction in intensive care unit (ICU) stay duration, reduction in the need for renal replacement therapy (RRT), and an increase in transplant-free survival.

Results: Using the estimate of 50,000 cases of HRS-AKI per year in the US, 60% of HRS-AKI cases with AC, and 80% of those pts meeting the label criteria, the model resulted in 24,000 pts with HRS-AKI and AC who would be eligible for terli treatment. The estimated outcomes are summarized in Table.

Conclusion: Model estimates using terli (vs pbo) in pts with HRS and AC projected a substantial annual improvement in HRS reversal and remaining alive and transplant-free, and a reduction in RRT and duration of ICU stay. These projected benefits may result in improved outcomes and decreased cost of care among pts with HRS and AC who are treated with terli.