– Findings from a retrospective analysis suggest that patients with baseline acute-on-chronic liver failure (ACLF) grade ≤2 treated with TERLIVAZ® plus albumin had a higher incidence of HRS reversal than those treated with placebo plus albumin1 –
TERLIVAZ is the first and only FDA-approved product indicated for the treatment of adults with HRS involving rapid reduction in kidney function,2 an acute and life-threatening condition requiring hospitalization.3 Terlipressin is recommended by the
Please see Limitation of Use and Important Safety Information, including Boxed Warning, below.
The retrospective analysis used pooled data from the OT-0401, REVERSE, and CONFIRM Phase III studies to compare the incidence of HRS reversal by baseline ACLF grade in patients treated with terlipressin plus albumin versus placebo plus albumin for up to 14 days. Severity of ACLF was graded according to the number of organ failures (ACLF grade 0-1, grade 2, and grade 3). The incidence of HRS reversal was defined as at least one serum creatinine value of ≤1.5 mg/dL while on treatment.1
"We're excited to share these data that not only provide valuable insight into the association between baseline patient ACLF grade and treatment response with TERLIVAZ, but also reinforce the importance of early treatment intervention to help improve outcomes for patients with HRS with rapid reduction in kidney function,1,2" said
In the pooled analysis population (n=607), 278 patients had ACLF grade 0-1 (terlipressin: n=164; placebo: n=114), 208 patients had ACLF grade 2 (terlipressin: n=116; placebo: n=92), and 121 patients had ACLF grade 3 (terlipressin: n=72; placebo: n=49). The incidence of HRS reversal in terlipressin-treated patients decreased with increasing ACLF grade (ACLF grade 0-1: 43% (n=71/164); ACLF grade 2: 28% (n=32/116); ACLF grade 3: 19% (n=14/72)), whereas HRS reversal was similar across ACLF grades in placebo-treated patients (ACLF grade 0-1: 18% (n=21/114); ACLF grade 2: 15% (n=14/92); ACLF grade 3: 14% (n=7/49)).1
Additionally, a higher percentage of terlipressin-treated patients with ACLF grade 0-1 or grade 2 achieved HRS reversal compared with those in the respective placebo-treated groups (ACLF grade 0-1: terlipressin 43% (n=71/164) vs placebo 18% (n=21/114); ACLF grade 2: terlipressin 28% (n=32/116) vs placebo 15% (n=14/92)) (p<0.0001 and p=0.02, respectively). No differences in the incidence of HRS reversal were observed between terlipressin- (19%; n=14/72) and placebo- (14%; n=7/49) treated patients with ACLF grade 3 (p=0.46).1
This study was sponsored by Mallinckrodt Pharmaceuticals:
Baseline ACLF Grade and Treatment Response to Terlipressin in Patients with Hepatorenal Syndrome1
Find more information on the
About Hepatorenal Syndrome (HRS)
Hepatorenal syndrome (HRS) involving rapid reduction in kidney function2 is an acute and life-threatening condition that occurs in people with advanced liver disease.3 HRS is classified into two distinct types – a rapidly progressive type that leads to acute renal failure where patients are typically hospitalized for their care and a more chronic type that progresses over weeks to months.3 HRS involving rapid reduction in kidney function2 is estimated to affect between 30,000 and 40,000 Americans annually.6,7 If left untreated, HRS with rapid reduction in kidney function has a median survival time of approximately two weeks and greater than 80 percent mortality within three months.8
INDICATION AND LIMITATION OF USE
TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE
TERLIVAZ is contraindicated:
Warnings and Precautions
Please click here to see full Prescribing Information, including Boxed Warning.
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CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements, including with regard to TERLIVAZ, its potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's Annual Report on Form 10-K for the fiscal year ended
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1 Subramanian R. Baseline ACLF Grade and Treatment Response to Terlipressin in Patients with Hepatorenal Syndrome. Abstract. Presented at the
2 TERLIVAZ® (terlipressin) for injection [Prescribing Information].
4 Biggins SW, Angeli P,
5 Bajaj JS, O'Leary JG, Lai JC, et al. Acute-on-chronic liver failure clinical guidelines. Am J Gastroenterol. 2022;1-28.
6 C Pant, B S Jani, M Desai, A Deshpande,
8 Flamm SL, Brown K, Wadei HM., et al. The Current Management of Hepatorenal Syndrome–Acute Kidney Injury in
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