Long-term administration of human albumin was
associated with fewer serious complications, less hospitalisation, better
quality of life and longer survival for people with decompensated liver
cirrhosis, according to a report at the International Liver Congress last month
in Amsterdam. The congress is the annual meeting of the European Association
for the Study of the Liver (EASL).
Over years or decades, chronic hepatitis B or C, excessive alcohol
consumption and other causes of liver damage can lead to advanced cirrhosis,
liver cancer, and ultimately liver failure, transplantation or death.
Decompensated liver disease occurs when the liver can no longer carry out
its vital functions due to the accumulation of scar tissue
and blockage of blood flow. Complications
include ascites (fluid build-up in the abdominal cavity), bleeding veins in the
oesophagus and hepatic encephalopathy. Ascites is generally treated with
diuretics and paracentesis – a procedure that involves draining fluid with a
needle – but a liver transplant is the only curative therapy.
A protein made in the liver, needed to maintain a balance of the fluids in the body. In a blood test, lower than normal levels of albumin and total protein may indicate liver damage or disease. If there is not enough albumin, fluid may accumulate in the abdomen (ascites).
An accumulation of fluid in the abdomen; may be caused by liver damage, especially cirrhosis.
- decompensated cirrhosis
The later stage of
cirrhosis, during which the liver cannot perform some vital functions and
complications occur. See also ‘cirrhosis’ and ‘compensated cirrhosis’.
A disease or infection affecting the brain.
The presence of pus-forming bacteria in the body.
Stretched veins which may burst and cause severe bleeding; a complication of cirrhosis.
Mauro Bernardi of the University
of Bologna and colleagues conducted a
randomised clinical trial to assess whether long-term administration of human albumin
– a protein that helps maintain fluid balance in the body – had advantages over the standard of care.
The ANSWER study enrolled 440 people with advanced
cirrhosis and uncomplicated ascites at more than 30 centres in Italy. A
majority were men, with an average age of 60 years.
The mean Child-Pugh score was 8.1 (Class
B) and the mean MELD score – used to prioritise patients for liver
transplantation – was approximately 13. Participants had been treated for
ascites using diuretics (at least 25mg/day furosemide and 200mg/day
anti-mineralocorticoid drugs), but those with refractory ascites who needed
paracentesis twice or more in the past month were excluded, as were those with
gastrointestinal bleeding, hepatocellular carcinoma and several other
Participants were randomly assigned to
receive either standard medical treatment using diuretics or standard treatment
plus human albumin. Those in the albumin arm started with 40 grams twice weekly
for two weeks, then reduced their dose to once weekly.
The primary study endpoint was overall
survival, with secondary measures including need for paracentesis, other
complications of cirrhosis, hospital admissions and quality of life. Study
participants were followed for up to 18 months.
Fewer than half the participants completed follow-up. Major
reasons for discontinuation included liver transplantation, having a transjugular
intrahepatic portosystemic shunt (TIPS) procedure and, most often, needing
paracentesis more than three times a month. This was the case for 18 people in
the albumin arm and 42 in the standard-of-care arm.
People who received albumin had a higher
survival rate than those who did not. At 18 months, 78% of people who used
albumin were still alive, compared to 66% of those treated with standard therapy
alone – a 38% reduction.
in the albumin arm of the study were less likely to require paracentesis, and
those who did needed it later and had less fluid removed. By 18 months, 38% of people
in the albumin arm underwent paracentesis at least once, compared to 66% in the
standard-of-care arm – a 54% reduction. Refractory ascites was seen in 25% and
48%, respectively, a 46% reduction. Both differences were highly significant.
People in the albumin arm were less likely
to develop a variety of cirrhosis complications including bacterial infections,
hepatic encephalopathy, bleeding varices, kidney dysfunction and hepatorenal
In addition, people receiving albumin
were hospitalised significantly less that those in the standard-of-care arm, both
in terms of number of hospitalisations (35% less) and cumulative number of days
in hospital (45% less).
Finally, people who received albumin
reported that their quality of life improved, while those in the
standard-of-care arm were more likely to say their quality of life was the same
or worse at 3, 6 and 12 months.
Albumin was generally safe and well tolerated. Two participants
had mild allergic reactions and two developed severe sepsis, but all four
“There has been a lack of scientific evidence
proving that long-term human albumin can treat cirrhosis with ascites," Dr
Bernardi said in an EASL press release. "The ANSWER study has now
clarified this issue, showing that human albumin extends survival and helps
better manage ascites, as well as reducing the incidence of severe
complications of this very serious disease."
"Based on this data, weekly administration of
albumin should be considered in patients with cirrhosis and ascites to prevent
life-threatening complications," added Annalisa Berzigotti from the
University of Berne.