P0995 - The Effect of Race on Treatment Response to Terlipressin in Patients with Hepatorenal Syndrome: A Pooled Analysis of 3 Phase III Clinical Studies

Paul J. Thuluvath, MD¹, Nikolaos T.. Pyrsopoulos, MD, PhD, MBA², Kalyan Ram. Bhamidimarri, MD, MPH, FACG³, Nicholas Lim, MBBCh⁴, Khurram Jamil, MD^5
1Mercy Medical Center, Baltimore, MD; ²Rutgers New Jersey Medical School, Newark, NJ; ³University of Miami School of Medicine, Miami, FL; ⁴University of Minnesota Medical School, Minneapolis, MN; ⁵Mallinckrodt Pharmaceuticals, Bridgewater, NJ

Introduction: Owing to its ability to reverse hepatorenal syndrome (HRS)—a form of acute kidney injury—terlipressin is recommended (in combination with albumin) as a first-line therapy for adult patients with HRS. The efficacy and safety of terlipressin treatment for patients with HRS has been examined in 3 placebo-controlled North American Phase III clinical studies. Notably, across these clinical studies, most patients were White. Therefore, this study used a pooled dataset of patients with HRS to examine whether there is any impact of race (White vs non-White) on treatment response to terlipressin.

Methods: The pooled intent-to-treat dataset included data from 3 clinical studies (ie, OT-0401, REVERSE, and CONFIRM) that examined terlipressin treatment in adult patients with HRS, defined as a rapidly progressive worsening of kidney function to a serum creatine (SCr) ≥ 2.25 mg/dL (CONFIRM) or ≥ 2.5 mg/dL (OT-0401 and REVERSE). HRS reversal, defined as the proportion of patients achieving a SCr level of ≤ 1.5 mg/dL while on treatment, including up to 24 hours after the last dose of study drug, was examined by race (ie, White vs non-White). Race was assessed for the potential to predict treatment response (ie, HRS reversal) by univariate logistic regression analysis.

Results: These 3 clinical studies were conducted at large tertiary centers in the US and Canada and enrolled 608 patients in total. Most patients evaluable for the race group (n = 603) were White (terlipressin, 313/348 [89.9%]; placebo, 235/255 [92.2%]). Among White patients (n = 548), more patients achieved HRS reversal with terlipressin than with placebo (34.5% vs 17.0%; P < .001). Similarly, among non-White patients (n = 55), more patients achieved HRS reversal with terlipressin (22.9%) than with placebo (10.0%); however, statistical significance was not reached (P = .297) (Table). Race (White vs non-White) was not significantly associated with HRS reversal (odds ratio [95% CI]: terlipressin, 1.778 [0.781 – 4.048], P = .170; placebo, 1.846 [0.412 – 8.273], P = .423).

Discussion: Race was not significantly associated with the odds of achieving HRS reversal for patients in the terlipressin group. Therefore, race is unlikely to influence the clinical response to terlipressin treatment among patients with HRS.


Disclosures:


Paul J. Thuluvath, MD¹, Nikolaos T.. Pyrsopoulos, MD, PhD, MBA², Kalyan Ram. Bhamidimarri, MD, MPH, FACG³, Nicholas Lim, MBBCh⁴, Khurram Jamil, MD⁵. P0995 - The Effect of Race on Treatment Response to Terlipressin in Patients with Hepatorenal Syndrome: A Pooled Analysis of 3 Phase III Clinical Studies, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.