Effect of rifaximin on infections, acute‐on‐chronic liver failure and mortality in alcoholic hepatitis: A pilot study (RIFA‐AH)
César Jiménez, Meritxell Ventura‐Cots, Margarita Sala, Margalida Calafat, Montserrat Garcı́a-Retortillo, Isabel Cirera, Núria Cañete, Germán Soriano, María Poca, Macarena Simón‐Talero, José Altamirano, Michael R. Lucey, Guadalupe García–Tsao, Robert S. Brown, Robert F. Schwabe, Elizabeth C. Verna, Bernd Schnabl, Francisco Bosques‐Padilla, Philippe Mathurin, Juan Caballería, Alexandre Louvet, Debbie L. Shawcross, Juan G. Abraldeṣ, Joan Genescà, Ramón Bataller, Vı́ctor Vargas
Abstract
BACKGROUND & AIMS: Alcoholic hepatitis (AH) is associated with a high incidence of infection and mortality. Rifaximin reduces bacterial overgrowth and translocation. We aimed to study whether the administration of rifaximin as an adjuvant treatment to corticosteroids decreases the number of bacterial infections at 90 days in patients with severe AH compared to a control cohort. METHODS: This was a multicentre, open, comparative pilot study of the addition of rifaximin (1200 mg/day/90 days) to the standard treatment for severe AH. The results were compared with a carefully matched historical cohort of patients treated with standard therapy and matching by age and model of end-stage liver disease (MELD). We evaluated bacterial infections, liver-related complications, mortality and liver function tests after 90 days. RESULTS: Twenty-one and 42 patients were included in the rifaximin and control groups respectively. No significant baseline differences were found between groups. The mean number of infections per patient was 0.29 and 0.62 in the rifaximin and control groups, respectively (p = .049), with a lower incidence of acute-on-chronic liver failure (ACLF) linked to infections within the treatment group. Liver-related complications were lower within the rifaximin group (0.43 vs. 1.26 complications/patient respectively) (p = .01). Mortality was lower in the treated versus the control groups (14.2% vs. 30.9, p = .15) without significant differences. No serious adverse events were associated with rifaximin treatment. CONCLUSIONS: Rifaximin is safe in severe AH with a significant reduction in clinical complications. A lower number of infections and a trend towards a lower ACLF and mortality favours its use in these patients.