Long-term therapy with intravenous human albumin increase survival in patients with decompensated cirrhosis and refractory ascites

Background Refractory ascites in cirrhosis is associated with 50% survival at six months. The benefit of long-term human albumin therapy (HAT) was proven by ANSWER study in decompensated cirrhosis and have become best practice in Italian Liver Units. Methods We reported data of an observational study including 134 patients with cirrhosis and refractory ascites undergoing large-volume paracenteses (LVP) in the Day Hospital of our Liver Unit. The group I included 90 patients, observed from January 2019 and April 2022, who received HAT only during LVP. The group II of 44 patients, observed from May 2022 and November 2023, received HAT during LVP and long-term (40 grams/week). Results The mean age of patients was 68 years and 70% were male, the mean of MELD-score was 14, of serum albumin 32 g/L and sodium 136 mmol/L. The etiology was MASH in 38 patients, alcohol in 26, HCV in 3, HBV in 12, autoimmune in 2, while 10 patients had a cryptogenic cirrhosis and 15 had a mixed etiology. Twenty-nine patients had HCC and 17 had portal thrombosis. There were no significant clinical differences between the 2 groups at baseline. During the first year of follow-up, 10 patients received liver transplant and in 17 patients was placed a TIPS; 74 patients (82%) of group I and 19 patients (45%) of group II needed at least one hospitalization for complications (p< 0.001). In group I all patients undergoing LVP, while in group II 12 patients (27%) no longer performed LVP (p< 0.001). Finally, 65 patients (71%) of group I and 11 patients (26%) of group II died (p<0.001 by log rank test) (figure 1) Conclusions Long-term human albumin therapy treatment can significantly improve prognosis and reduce mortality in patients with refractory ascites. It is a well-tolerated treatment with no complications or contraindications. Refractory ascites in cirrhosis is associated with 50% survival at six months. The benefit of long-term human albumin therapy (HAT) was proven by ANSWER study in decompensated cirrhosis and have become best practice in Italian Liver Units. We reported data of an observational study including 134 patients with cirrhosis and refractory ascites undergoing large-volume paracenteses (LVP) in the Day Hospital of our Liver Unit. The group I included 90 patients, observed from January 2019 and April 2022, who received HAT only during LVP. The group II of 44 patients, observed from May 2022 and November 2023, received HAT during LVP and long-term (40 grams/week). The mean age of patients was 68 years and 70% were male, the mean of MELD-score was 14, of serum albumin 32 g/L and sodium 136 mmol/L. The etiology was MASH in 38 patients, alcohol in 26, HCV in 3, HBV in 12, autoimmune in 2, while 10 patients had a cryptogenic cirrhosis and 15 had a mixed etiology. Twenty-nine patients had HCC and 17 had portal thrombosis. There were no significant clinical differences between the 2 groups at baseline. During the first year of follow-up, 10 patients received liver transplant and in 17 patients was placed a TIPS; 74 patients (82%) of group I and 19 patients (45%) of group II needed at least one hospitalization for complications (p< 0.001). In group I all patients undergoing LVP, while in group II 12 patients (27%) no longer performed LVP (p< 0.001). Finally, 65 patients (71%) of group I and 11 patients (26%) of group II died (p<0.001 by log rank test) (figure 1) Long-term human albumin therapy treatment can significantly improve prognosis and reduce mortality in patients with refractory ascites. It is a well-tolerated treatment with no complications or contraindications.