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Observational Study
. 2022 May;42(5):1109-1120.
doi: 10.1111/liv.15207. Epub 2022 Mar 7.

Effect of rifaximin on infections, acute-on-chronic liver failure and mortality in alcoholic hepatitis: A pilot study (RIFA-AH)

César Jiménez  1 , Meritxell Ventura-Cots  1   2   3 , Margarita Sala  2   4 , Margalida Calafat  2   4 , Montserrat Garcia-Retortillo  5 , Isabel Cirera  5 , Nuria Cañete  5 , Germán Soriano  2   6 , María Poca  2   6 , Macarena Simón-Talero  1   2 , José Altamirano  7 , Michael Lucey  8 , Guadalupe Garcia-Tsao  9 , Robert S Brown Jr  10 , Robert F Schwabe  11 , Elizabeth C Verna  12 , Bernd Schnabl  13 , Francisco Bosques-Padilla  14 , Philippe Mathurin  15 , Juan Caballería  2   16 , Alexandre Louvet  15 , Debbie L Shawcross  17 , Juan G Abraldes  18 , Joan Genescà  1   2 , Ramon Bataller  3 , Víctor Vargas  1   2
Affiliations
Observational Study

Effect of rifaximin on infections, acute-on-chronic liver failure and mortality in alcoholic hepatitis: A pilot study (RIFA-AH)

César Jiménez et al. Liver Int. 2022 May.

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.

Keywords: acute-on-chronic liver failure; alcohol-related liver disease; bacterial infection; cirrhosis; rifaximin; severe alcoholic hepatitis.

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Conflict of interest statement

BS has been consulting for the Ferring Research Institute, Gelesis, HOST Therabiomics, Intercept Pharmaceuticals, Mabwell Therapeutics, Patara Pharmaceuticals and Takeda. BS’s institution UC San Diego has received research support from Axial Biotherapeutics, BiomX, CymaBay Therapeutics, NGM Biopharmaceuticals, Prodigy Biotech and Synlogic Operating Company. BS is a founder of Nterica Bio. UC San Diego has registered several patents with BS as an inventor related to this work. DS has performed consultancy, delivered paid lectures and is taking part in two investigator‐initiated studies (REEFSYS and EMITTIC) funded by Alfasigma/Norgine, who manufacture rifaximin.

Figures

FIGURE 1
FIGURE 1
Flowchart for the inclusion and exclusion of subjects and their allocation to the rifaximin and control groups. ACLF, acute‐on‐chronic liver failure; OLT, orthotopic liver transplantation; ALT, alanine aminotransferase; AST, aspartate aminotransferase; HCC, hepatocellular carcinoma; INTEAM consortium (Integrated Approaches for Identifying Molecular Targets in Alcoholic Hepatitis); MELD, model for end‐stage liver disease
FIGURE 2
FIGURE 2
Infection‐free survival in the rifaximin and control groups (p = .12)
FIGURE 3
FIGURE 3
Bilirubin levels and MELD scores during the follow‐up (baseline, 7, 30, 60 and 90 days). (A) Differences in the levels of bilirubin in the rifaximin and control groups at 60 days were observed. (B) No differences in MELD score during the follow‐up; MELD, model for end‐stage liver disease
FIGURE 4
FIGURE 4
Actuarial survival in the rifaximin and control groups (p = .15)
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Comment in

References

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