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While patients with cirrhosis and no prior COVID-19 infection appeared to have less of an immune response to the Pfizer or Moderna COVID mRNA vaccines, certain factors predicted a poorer response than others, a researcher said.

Both active hepatocellular carcinoma (HCC) and immuno-depression predicted a lower response after two doses of vaccine in COVID-naive patients with cirrhosis, while higher anti-spike protein titers after a single dose and receiving the Moderna vaccine predicted more of an immune response, reported Massimo Iavarone, MD, PhD, of Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan.

In a late-breaking presentation at the virtual American Association for the Study of Liver Diseases (AASLD) annual meeting, he noted that while the phase III clinical trials for Pfizer and Moderna vaccines included over 100,000 people, the number of patients with chronic liver disease, specifically cirrhosis, was "limited."

Given the fact that patients with cirrhosis often have an impaired immune response to other vaccines, such as those for influenza or hepatitis B, Iavarone's team conducted a prospective study of patients with cirrhosis at their hospital. Patients received the COVID-19 vaccine there, followed by subsequent data collection and sampling.

Immunogenicity data were assessed at various time points:

• Baseline
• 21 days after the first dose
• 21 days after the second dose
• Median 133 days after the second dose

Because Italy changed their vaccine policy to allow medically vulnerable people to get boosters, the range for receiving a booster was 70 to 182 days after the second dose, Iavarone noted.

Vaccine effectiveness and safety were secondary outcomes, as was T-cell response 10 days after the first dose and 60 days after the second dose.

Overall, Iavarone and colleagues examined data from 182 patients with cirrhosis and 38 unmatched healthy controls from the same hospital setting.

Patients with cirrhosis were a mean age of 61, three-quarters were men, and nearly all (92%) were Caucasian. The most common etiology of liver disease was viral (45%). Three-quarters had Child-Pugh score A, or well-compensated cirrhosis. Notably, 56% of patients had esophagogastric varices, and 31% had HCC.

Of the patients, 121 received the Pfizer vaccine and 61 received the Moderna vaccine.

Iavarone also noted that 28 patients with cirrhosis and 12 controls had a previous history of COVID infection.

Not surprisingly, patients with past COVID infection had higher titers of anti-spike protein, he said.

He noted that anti-spike titers did not increase significantly in COVID-naive patients with cirrhosis until after the second dose, and they had a lower response compared with controls. These patients also had a significant decrease in titers a median of 133 days after the second dose.

Examining other clinical factors, patients with Child-Pugh B or C scores had lower responses verus those with well-compensated disease, as did patients with active HCC versus those without. There was no significant difference in humoral response when looking at MELD (Model for End-Stage Liver Disease) score.

T-cell data were only available for 14 COVID-naive patients with cirrhosis, which Iavarone said confirmed the "heterogeneity of response."

When asked by session moderator Thomas Berg, MD, of the University of Leipzig Medical Center in Germany, if there was a correlation between T-cell response and antibody response, Iavarone said that there was a correlation, "however, it is too early to have a generalization in these terms," given the low number of patients with T-cell data.

Among patients with available data, four of 133 COVID-naive patients with cirrhosis tested positive for COVID at a median of 133 days after the second dose. All were asymptomatic, and none required hospitalization. Nearly all side effects after the first and second doses were grade 1, and none were grade 3/4. Of the grade 2 side effects, the most common was fever in five patients after the second dose.

In the U.S., the CDC recommends that patients with chronic liver disease of COVID vaccine.

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