6/28/23, 10:55 PM GALA-RIF Pathway Feedback Search Clinical Topics Home Studies GALA RIF GALA RIF Disease Disease Alcohol-related liver disease Alcoholic hepatitis 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 N = 136 84.0% male 136 patients (22 female, 114 male) Inclusion criteria: adults, 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 28.0 % 28 26 21 0 % https://web.pathway.md/studies/rec4QzOKopZmwjVZx 1/2 6/28/23, 10:55 PM 21.0 % GALA-RIF Pathway 14.0 % 7.0 % No significant difference 0.0 % Rifaximin-alpha Placebo 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 adults, 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, Bj rn St hr Madsen, Nikolaj Torp et al. Rifaximin- 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. Open reference URL https://web.pathway.md/studies/rec4QzOKopZmwjVZx 2/2