Real-world experience with long-term albumin in patients with cirrhosis and ascites☆

Abstract

Background and AimsLong-term albumin (LTA) is currently standard of care for patients with decompensated cirrhosis in many Italian hepatological centres. This real-life study aimed to describe patient, logistical and treatment-related characteristics in daily clinical practice and to identify predictors of response. MethodsMulticentre, retrospective, observational study in patients with cirrhosis and ascites receiving LTA between 01/2016 and 02/2022 and followed until death, TIPS, transplantation or 02/2023. Results312 patients, the majority with alcohol-related cirrhosis, were included. At baseline, median Child-Pugh was 8, MELD 15, and MELD-Na 18. Ascites was grade 2 in 55% of patients, grade 3 in 35% and refractory in 27%, while 47% had paracentesis in the previous 6 months. Median LTA was 10 months with a median dose of 40 g/week.Ascites resolved to grade 0-1 in 34% of patients within the first 3 months and 56% at the end of treatment. Predictors of ascites resolution were age (p=0.007), baseline grade of ascites (p=0.007), no paracentesis in the previous 6 months (p=0.001), etiological treatment in the past 12 months or during LTA (p=0.005), weekly albumin dose (p=0.014) and serum albumin concentration of 40 g/L after one month of treatment (p=0.017). Of the 83 patients with refractory ascites at inclusion, 26% had grade 0/1 ascites at the last observation. No severe albumin-related side-effects were reported and only 1% discontinued due to logistic reasons. ConclusionsLTA is feasible as an outpatient treatment for the management of ascites. In the current study, more than half of patients receiving LTA on top of diuretics resolved their ascites, including some with refractory ascites. Predictors of response to LTA provide useful information for tailoring treatment. IMPACT AND IMPLICATIONSThe ANSWER randomized clinical trial has shown that long-term albumin treatment (LTA) is an effective approach for the management of patients with cirrhosis and ascites. This observational study provides novel information on target patients, modalities and length of treatment, predictors of ascites resolution, stopping criteria, and clinical trajectories of patients on treatment.LTA is a feasible option in the daily clinical practice for the management of ascites when given on top of diuretics. Rather than an alternative therapy, LTA should be integrated with the other treatments options already available for patients with difficult-to-treat ascites. The predictive factors of response identified in the present study can help physicians to individualize LTA and optimize the decision-making process.