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Albumin treatment for cirrhosis improves overall survival

AMSTERDAM — Patients with cirrhosis who were treated with human albumin experienced improvement in a number of outcomes, including overall survival, compared to standard therapy, according to data presented at the International Liver Congress.

“Long-term albumin administration to patients with decompensated cirrhosis could be seen as a disease-modifying treatment,” Mauro Bernardi, MD, of the University of Bologna, in Italy, said in a press conference. “At the moment, the only curative approach is transplant. Treatment to influence the survival of these patients is most needed.”

In the current study, all participants received anti-mineralocorticoid at 200 mg per day plus furosemide at 25 mg per day. Those in the treatment group were given human albumin at 40 g twice a week for 2 weeks, then 40 g per week. Patients were followed monthly for 18 months unless they underwent transplantation or transjugular intrahepatic portosystemic shunt (TIPS).

The primary endpoint was OS. Parameters including cumulative number of paracentesis, ascites incidence, bacterial infections, renal dysfunction, HRS type 1, hepatic encephalopathy, portal hypertensive gastrointestinal bleeding, hospital admission and QOL comprised the secondary outcomes.

OS rates were 78% for the albumin group and 66% for the standard therapy group (HR = 0.62; 95% CI, 0.40-0.95). “Mortality was reduced by 38% in the human albumin group,” Bernardi said.

Paracentesis rates were 38% in the albumin arm and 66% in the standard therapy arm (IR = 3.50; 95% CI, 0.40-0.53), representing a reduction of 54% (P < .0001).

Other findings indicated that albumin reduced hospital stay duration by 19.4 days per year, representing a 45% reduction compared with standard therapy (P < .0001).

Regarding quality of life, patients in the albumin group improved at 3 months (P = .059) and 6 months (P = .004) before a slight drop-off at 12 months (P = .127).

Refractory ascites also improved in the albumin group (0.54, P < .0001), as did spontaneous bacterial peritonitis (SBP; IRR = 032; P < .0001), non-SBP bacterial infections (IRR = 0.70; P = .0045), episodes of renal dysfunction (IRR = 0.50; P < .0001), hepatorenal syndrome type 1 (IRR = 0.38; P = .0039), and grade 3 or 4 hepatic encephalopathy (IRR = 0.48; P < .0001), according to Bernardi.

Variceal bleeding rates did not differ between the two study arms.

Four patients developed adverse reactions to albumin. Two were mild allergic reactions, while there was one case of life-threatening severe sepsis and one case of life-threatening septic shock plus disseminated intravascular coagulation.

He concluded that this approach aids in managing ascites and improves both survival and QOL. “It reduces the incidence of severe complications of cirrhosis and reduces the number of hospitalizations,” he said. “It is generally well tolerated.” – by Rob Volansky

Reference: Caraceni P, et al. LBO-08. Presented at: International Liver Congress; April 19-24, 2017; Amsterdam.

Disclosure: Bernardi reports consulting for Baxter Healthcare SA and CSL Behring GmbH and delivering sponsored lectures for Abbvie Italia, Baxter Healthcare SA, CSL Behring GmbH, Gilead Sciences, Grifols SA, and PPTA Europe.