The addition of amoxicillin/clavulanate to prednisolone does not extend survival among patients with severe alcoholic hepatitis, though it may reduce infection risk, according to a French study presented at ILC 2021.
Participants in the Antibiocor study were 284 patients aged 18–75 years with biopsy-proven alcoholic hepatitis, Maddrey’s discriminate function ≥32, and Model For End-Stage Liver Disease (MELD) score ≥21. They were randomized 1:1 to receive prednisolone (40 mg/day) in addition to oral amoxicillin (1 g)/clavulanate (125 mg) or placebo three times/day for 1 month. Prednisolone was not discontinued at 7 days if there was no response.
Baseline characteristics were similar in the amoxicillin/clavulanate and placebo arms including age (median 53.5 vs 52.5 years), male sex (71.8 percent vs 73.2 percent), bilirubin level (median 27.1 vs 31.1 mg/dL), international normalized ratio (median 2 in both groups), creatinine level (median 0.7 vs 0.8 mg/dL), Maddrey function (median 63.7 vs 69.9), and MELD score (median 24 vs 25).
Survival at 2 months in the intention-to-treat analysis did not significantly differ between patients in the amoxicillin/clavulanate and placebo groups (82.7 percent vs 78.1 percent; hazard ratio [HR], 0.769, 95 percent confidence interval [CI], 0.451–1.310; p=0.331), with 24 and 31 deaths occurring in the respective groups. [ILC 2021, abstract LBO-2631]
Survival outcomes between groups were also similar at 3 and 6 months (HR, 0.776; p=0.304 and HR, 0.874; p=0.519, respectively).
