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Inicio Annals of Hepatology P-5 APACHE STUDY DESIGN TO EVALUATE THE EFFICACY AND SAFETY OF PLASMA EXCHANGE W...
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Vol. 29. Issue S1.
Abstracts of the 2023 Annual Meeting of the ALEH
(February 2024)
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Vol. 29. Issue S1.
Abstracts of the 2023 Annual Meeting of the ALEH
(February 2024)
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P-5 APACHE STUDY DESIGN TO EVALUATE THE EFFICACY AND SAFETY OF PLASMA EXCHANGE WITH HUMAN SERUM ALBUMIN 5% ON SHORT-TERM SURVIVAL IN PATIENTS WITH ACUTE-ON-CHRONIC LIVER FAILURE AT HIGH RISK OF HOSPITAL MORTALITY.
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Nikolaos Pyrsopoulos1, Giovanni Perricone2, Jasmohan S. Bajaj3, Thierry Gustot4, Thomas Reiberger5, Mireia Torres6, Peter Nelson6, Javier Fernandez7, Apache Study Investigators 8
1 Division of Gastroenterology and Hepatology, Rutgers-New Jersey Medical School, New Jersey, Estados Unidos (EEUU)
2 Hepatology and Gastroenterology Unit, ASST GOM Niguarda, Milan, Italia
3 Division of Gastroenterology, Hepatology, and Nutrition, Richmond VA Medical Center and Virginia Commonwealth University, Richmond, Virginia, Estados Unidos (EEUU)
4 Department of Gastroenterology, Hepato-Pancreatology, HUB Erasme Hospital, Université Libre de Bruxelles, Brussels, Bélgica
5 Division of Gastroenterology and Hepatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria
6 Clinical Operations, Scientific Innovation Office, Grifols, Barcelona, España
7 Liver Unit, EF Clif, EASL-CLIF Consortium and Grifols Chair, Hospital Clínic, IDIBAPS and CIBERehd, Barcelona, España
8 Apache Study Investigators, Barcelona, España
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Vol. 29. Issue S1

Abstracts of the 2023 Annual Meeting of the ALEH

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Introduction and Objectives

Acute-on-chronic liver failure (ACLF) in cirrhotic patients is characterized by acute deterioration of liver function and severe organ injury with high short-term mortality. Liver transplantation is the only treatment to improve survival. A pilot study suggested that plasma exchange with human serum albumin 5% (PEA5%) as a replacement fluid is feasible and safe in ACLF patients and may improve organ function and survival. This study aimed to assess PE-A5% as a treatment for patients with ACLF in a pivotal study.

Materials and Methods

A phase 3, multicenter, randomized (1:1), controlled, parallel-group, open-label study (APACHE) compares standard medical treatment (SMT) + PE-A5% (treatment arm) to SMT alone (control arm). PE-A5% is performed using Albutein 5% (Grifols). Treatment schedule consists of two initial PE-A5% sessions on consecutive days followed by every other day PE-A5% (min-max 4-9 PE-A5%). Patients receive IVIG (200mg/kg) after every 2 PE-A5% to prevent hypogammaglobulinemia-associated infections, and FFP after each PE-A5% to prevent coagulopathy. Eligible patients are adult (18-79 years old), with ACLF-1b, ACLF-2, or ACLF-3a at admission or during hospitalization. Main exclusion criteria are patients with ACLF-1a or ACLF-3b, ACLF >10 days before randomization, septic shock requiring norepinephrine (>0.3µg/kg/min) or a second vasopressor, active infection, and severe respiratory failure.

Results

Target enrollment is 380 ACLF patients at high risk of hospital mortality. The primary efficacy endpoint is the 90-day overall survival. Secondary efficacy endpoints include 90-day transplant-free survival and 28-day overall survival. Main exploratory endpoints include overall and transplant-free survival at days 28 and 90, in-patient hospital and ICU stay, incidence of organ failures and ACLF course. Safety analyses include adverse events, vital signs, physical assessments, and laboratory tests.

Conclusions

APACHE will provide pivotal results on the efficacy and safety of PE-A5% as a treatment to improve survival in ACLF (NCT03702920;EudraCT:2016-001787-10).

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