PROPHYLACTIC use of amoxicillin-clavulanate with prednisolone does not improve survival in patients hospitalised with severe alcohol-related hepatitis, compared to prednisolone alone. Those with severe-related hepatitis are more likely to develop infection during corticosteroid treatment, leading to higher rates of adverse outcomes, including worsening of liver insufficiency and hepatorenal syndrome.
Alexandre Louvet, University of Lille, France, and colleagues, analysed data from 292 adults enrolled in the AntibioCor trial, aiming to determine whether mortality would improve when prophylactic antibiotics were combined with prednisolone. Participants were randomised to receive placebo with prednisolone (n=147) or amoxicillin-clavulnate (1 g/125 mg) and prednisolone (n=145) for 30 days, and were monitored for 180 days.
All-cause mortality at 60 days was the primary outcome, and secondary outcomes included incidence of infection or hepatorenal syndrome; all-cause mortality at 90 and 180 days; proportion of patients with a Lille score lower than 0.45 at 17 days; and proportion of patients with Model for End-Stage Liver Disease (MELD) score lower than 17 at 60 days.
The researchers noted no significant difference in all-cause mortality at 60 days in the placebo group compared to the antibiotic group. The incidence of infection, however, was significantly higher in the placebo group (41.5%) compared to those receiving antibiotics (29.7%).
In the placebo group, 77 serious adverse events were reported at 60 days, compared to 68 in the antibiotic group, including infections, liver failure, and gastrointestinal disorders. There was no significant difference in 90-day mortality, 180-day mortality, incidence of hepatorenal syndrome, Lille score lower than 0.45, and MELD score lower than 17 between the two groups.
The team concluded: “In patients hospitalised with severe alcohol-related hepatitis, amoxicillin-clavulanate combined with prednisolone did not improve 2-month survival compared with prednisolone alone.” These results do not support the use of prophylactic antibiotics in patients hospitalised with severe alcohol-related hepatitis to improve survival.