People with advanced liver cirrhosis saw better survival and spent less time in the hospital after treatment with human albumin for 18 months, a researcher reported here.
Participants who received long-term albumin therapy in the ANSWER study experienced fewer complications and required paracentesis for ascites less frequently, according to Mauro Bernardi, MD, of the University of Bologna in Italy.
“Long-term administration of albumin to patients with decompensated cirrhosis could be seen as a disease-modifying treatment,” Bernardi told reporters at the International Liver Congress, the annual meeting of the European Association for the Study of the Liver.
Over the years or decades, chronic hepatitis B or C, excessive alcohol consumption and other causes of liver damage can lead to cirrhosis, liver cancer, liver transplantation and liver related death. Decompensated liver disease occurs when the liver can no longer perform its normal functions due to the accumulation of scar tissue and blocked blood flow. Once decompensation occurs, cirrhosis becomes a systemic disease and the probability of death for a year is around 20%, according to Bernardi.
The most common complication of decompensation is ascites, which is treated with diuretics and paracentesis, but a liver transplant is the only cure.
Human albumin protein helps maintain fluid balance in the body. Although it has been used for a long time to control the complications of cirrhosis, it has not been rigorously evaluated.
“We know that albumin is good in many circumstances, but what we did not know so far is the role of giving albumin, which is unfortunately very expensive, over a long period of time,” said Frank Tacke, MD, University Hospital Aachen said in Germany at an EASL press conference.
The ANSWER study included 440 patients with advanced cirrhosis at more than 30 centers in Italy. The majority were men and the average age was 60 years. The mean score for Child-Pugh was 8.1 and the mean score for the final stage of liver disease (MELD) was just over 13.
Participants had been treated for ascites with diuretics – at least 25 mg / day furosemide (Lasix) and 200 mg / day anti-mineralocorticoids. However, patients with refractory ascites who required paracentesis twice or more in the last month were excluded, as were those with liver cancer and several other complications.
Participants were randomly assigned to receive standard medical treatment using diuretics or standard treatment plus human albumin. Those in the albumin arm started with 40 g twice a week for 2 weeks, then went down once a week. They were followed for up to 18 months.
The primary endpoint of the study was overall survival, with secondary measures including the need for paracentesis, other complications of cirrhosis, hospital admissions, and quality of life.
Less than half of the participants completed follow-up, Bernardi said. Reasons for early termination included liver transplantation and underwent an intrahepatic portosystemic shunt (TIPS) transjugular procedure. But the most common reason was the need for paracentesis more than three times a month, which was the case of 18 people in the albumin arm and 42 in the standard care arm.
The researchers found that patients receiving human albumin had a higher survival rate. At 18 months, 78% of people receiving albumin were still alive, compared to 66% of those treated with standard care alone, for a 38% reduction in mortality, Bernardi said.
Patients who received albumin were also less likely to require paracentesis. Those who needed it later and the liquid was removed. At 18 months, 38% of patients receiving albumin underwent paracentesis at least once during follow-up, versus 66% in the standard care group, with a 54% reduction.
In addition, patients in the albumin arm were less likely to develop complications of cirrhosis including bacterial infections, hepatic encephalopathy and hepatorenal syndrome. They also spent 25% fewer days at the hospital, according to Bernardi.
Finally, people who received albumin along with standard therapy were more likely to report a better quality of life, while those in the standard care group were more likely to say that their quality of life was the same or worse.
“Overall, an improvement in quality of life was observed in patients receiving albumin,” Bernardi said, although complete statistical significance was not achieved.
Albumin was generally safe. Two people had mild allergic reactions and two developed severe and potentially fatal sepsis; The four recovered.
“Administration of albumin to patients with cirrhosis and ascites improves survival and improves quality of life, reduces the incidence of serious complications of cirrhosis and is generally well tolerated,” concluded Bernardi.
“Based on these data, weekly administration of albumin should be considered in patients with cirrhosis and ascites to prevent potentially fatal complications,” said Annalisa Berzigotti, MD, of the University of Bern in Switzerland in an EASL statement.