Antibiotics plus prednisolone do not improve survival in alcoholic hepatitis
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Amoxicillin/clavulanate plus prednisolone in severe alcoholic hepatitis do not improve survival at 2 months, according to a presentation at the International Liver Congress.
“A 30-day course of antibiotics associated to prednisolone does not improve 2-month survival in patients with severe alcoholic hepatitis and a [model for end-stage liver disease score (MELD)] score greater than 21,” Alexandre Louvet, PhD, professor of hepatology in the gastroenterology department of the University Hospital of Lille, France, said during his presentation. “The incidence of hepatorenal syndrome, survival at 3 and 6 months, probability of treatment response and having a MELD score lower than 17 are not affected by antibiotics. The use of antibiotics was safe.”
For the Antibiocor trial, Louvet and colleagues identified 284 patients with biopsy-proven alcoholic hepatitis and randomly assigned 142 to receive prednisolone plus antibiotics (group A) and 142 to prednisolone plus placebo (group B). Two-month survival served as the primary endpoint. Other endpoints included development of infections and of hepatorenal syndrome, response to therapy using the Lille model and evaluation of liver function at 2 months.
Investigators noted antibiotics and placebo were given orally three times a day during the 28-day course of prednisolone. A daily dose of prednisolone was 40 mg with 1 g three times a day of amoxicillin/clavulanate. Both groups had a similar number of patients who experienced severe adverse events, with 93 in group A and 102 in group B.
According to results from the intention-to-treat analysis, the 2-month survival was not different between the treatment groups, with 24 deaths in group A and 31 in group B (82.7% vs. 78.1%; HR 0.769; 95% CI, 0.451–1.31). Investigators noted the antibiotic group had a lower cumulative incidence of infection (42 vs. 59 events; P = .015, HR = .616). Both groups had a similar rate of hepatorenal syndrome at 2 months (9.9% vs. 9.2%,). In addition, the groups had similar percentage of patients with a MELD score less than 17 at 2 months (48% vs. 50%).
Louvet and colleagues said the Lille model was not significantly different between the groups at day 7 (0.37 vs. 0.39).
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Louvet A, et al. Abstract: LBO-2631. Presented at: The International Liver Congress; June 23-26 (virtual meeting).
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