Chronic Human Albumin Therapy Prolongs Survival in Patients with Decompensated Cirrhosis

Results from a large multicenter, randomized, parallel, open-label clinical trial conducted in 33 academic and nonacademic Italian hospitals have led a team of Italian investigators to conclude adding longterm administration of human albumin to conventional treatment in patients with decompensated cirrhosis appears to prolong survival.

From April 2011 to May 2015, 440 patients with cirrhosis and uncomplicated ascites who were treated with anti-aldosteronic drugs and furosemide were enrolled and randomly assigned to receive either standard medical treatment (SMT) or SMT plus 40 grams of human albumin twice weekly for two weeks, followed by 40 grams weekly for up to 18 months

Thirty-eight of 218 patients died in the SMT plus human albumin group (17.4%), compared to 46 of 213 patients in the SMT group (21.6%). Overall 18-month survival was significantly higher in the SMT plus human albumin group than in the SMT only group (Kaplan-Meier estimates 77% vs. 66%; p=0.028), as reflected in a 38 percent reduction in the mortality hazard ratio (0.62, 95 confidence interval, 0.40–0.95). The rate of grade three to four non-liver-related adverse events was identical (22%) in both treatment groups.

The investigators proposed that chronic administration of human albumin might prolong survival in decompensated cirrhosis patients by acting as a disease-modifying treatment.