GALA-RIF
Trial question
What is the role of rifaximin-alpha in patients with ALD?
Study design
Single center
Double blinded
RCT
Population
Characteristics of study participants
16.0% female
84.0% male
N = 136
136 patients (22 female, 114 male).
Inclusion criteria: adult patients aged 18-75 years who had current or previous alcohol overuse, biopsy-proven ALD, and no previous hepatic decompensation.
Key exclusion criteria: known allergy to rifaximin; antibiotic treatment in the previous 4 weeks; contraindications for liver biopsy; cancer or other debilitating disease with a life expectancy < 1 year.
Interventions
N=68 rifaximin-alpha (an oral dose of 550 mg BID for 18 months).
N=68 placebo (matching placebo for 18 months).
Primary outcome
Regression of liver fibrosis per-protocol analysis
26%
28%
28.0 %
21.0 %
14.0 %
7.0 %
0.0 %
Rifaximin-alpha
Placebo
No significant
difference ↔
No significant difference in regression of liver fibrosis the per-protocol analysis (26% vs. 28%; OR 1.1, 95% CI 0.45 to 2.68).
Secondary outcomes
Significant decrease in progression of liver fibrosis in the per-protocol analysis (24% vs. 43%; OR 0.42, 95% CI 0.18 to 0.98).
No significant difference in regression of hepatic lobular inflammation (50% vs. 33%; OR 0.5, 95% CI 0.22 to 1.11).
No significant difference in progression of hepatic steatosis (26% vs. 35%; OR 0.64, 95% CI 0.28 to 1.47).
Safety outcomes
No significant difference in adverse and serious adverse events.
Conclusion
In adult patients aged 18-75 years who had current or previous alcohol overuse, biopsy-proven ALD, and no previous hepatic decompensation, rifaximin-alpha was not superior to placebo with respect to regression of liver fibrosis the per-protocol analysis.
Reference
Mads Israelsen, Bjørn Stæhr Madsen, Nikolaj Torp et al. Rifaximin-α for liver fibrosis in patients with alcohol-related liver disease (GALA-RIF): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Gastroenterol Hepatol. 2023 Jun;8(6):523-532.
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