Prophylactic antibiotics do not reduce mortality in severe alcohol-related hepatitis
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Key takeaways:
- Amoxicillin-clavulanate with prednisolone did not improve survival in patients with severe alcohol-related hepatitis.
- Researchers do not support the use of prophylactic antibiotics in these patients.
The use of amoxicillin-clavulanate with prednisolone did not improve 2-month survival compared with prednisolone alone in patients hospitalized with severe alcohol-related hepatitis, according to data in JAMA.
“Patients with severe alcohol-related hepatitis are at increased risk for bacterial and fungal infection,” Alexandre Louvet, MD, of the University of Lille in France, and colleagues wrote. “Approximately 25% to 30% of patients with severe alcohol-related hepatitis develop infection during corticosteroid treatment. Patients who develop infection while receiving corticosteroid therapy have higher rates of adverse outcomes, such as hepatorenal syndrome and worsening of liver insufficiency.”
To determine whether prophylactic antibiotics combined with prednisolone improved mortality in hospitalized patients with severe alcohol-related hepatitis, Louvet and colleagues enrolled 292 adults (mean age, 52.8 years; 27.4% women) from 25 centers in France and Belgium in the AntibioCor trial.
All participants received 40 mg per day oral prednisolone for 30 days and were then randomized to receive amoxicillin-clavulanate (1 g/125 mg) three times daily with prednisolone (n = 145) or placebo with prednisolone (n = 147). Patients were monitored for 180 days.
The primary outcome was all-cause mortality at 60 days; secondary outcomes included all-cause mortality at 90 and 180 days, incidence of infection or hepatorenal syndrome and proportion of patients with MELD score less than 17 at 60 days, and proportion of patients with a Lille score less than 0.45 at 7 days.
Of 284 patients included in analysis, there was “no significant difference” in all-cause mortality at 60 days in the antibiotic group vs. placebo group (17.3% vs. 21.9%; absolute difference = –4.7%; 95% CI, –14 to 4.7; HR = 0.77; 95% CI, 0.45-1.31). However, incidence of infection was significantly higher in patients who received placebo (41.5%) compared with those who received antibiotics (29.7%).
There were 230 serious adverse events reported in 68 patients in the antibiotic group and 77 patients in the placebo group at 60 days, the most common of which were liver failure, infections and gastrointestinal disorders.
Researchers observed no significant differences between patients given antibiotics vs. placebo in 90-day (21% vs. 26.3%) and 180-day (31.3% vs. 34.4%) mortality, incidence of hepatorenal syndrome (7.7% vs. 8.5%) and MELD score less than 17 (48% vs. 55%) at day 60, or Lille score less than 0.45 (56.7% vs. 55.1%) at the 7-day follow-up.
“In patients hospitalized with severe alcohol-related hepatitis, amoxicillin-clavulanate combined with prednisolone did not improve 2-month survival compared with prednisolone alone,” Louvet and colleagues concluded. “These results do not support prophylactic antibiotics to improve survival in patients hospitalized with severe alcohol-related hepatitis.”
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