The efficacy and safety of rifaximin-α: a 2-year observational study of overt hepatic encephalopathy

Abstract

Background: After 5 years since the registration of rifaximin-α as a secondary prophylaxis for overt hepatic encephalopathy (HE) in the Netherlands, we aimed to evaluate the use of hospital resources and safety of rifaximin-α treatment in a real-world setting.

Methods: We carried out prospective identification of all patients using rifaximin-α for overt HE. We assessed hospital resource use, bacterial infections, and adverse events during 6-month episodes before and after rifaximin-α initiation.

Results: During 26 months we included 127 patients [71.7% male; median age 60.8 years (interquartile range: 56.2-66.1); median model for end-stage liver disease (MELD) score 15.0 (interquartile range: 12.1-20.4); 98% using lactulose treatment]. When comparing the first 6 months after rifaximin-α initiation with the prior 6 months, HE-related hospital admissions decreased (0.86 to 0.41 admissions/patient; p < 0.001), as well as the mean length of stay (8.85 to 3.79 bed days/admission; p < 0.001). No significant differences were found regarding HE-related intensive care unit admissions (0.09 to 0.06 admission/patient; p = 0.253), stay on the intensive care unit (0.43 to 0.57 bed days/admission; p = 0.661), emergency department visits (0.66 to 0.51 visits/patient; p = 0.220), outpatient clinic visits (2.49 to 3.30 bed visits/patient; p = 0.240), or bacterial infections (0.41 to 0.35 infections/patient; p = 0.523). Adverse events were recorded in 2.4% of patients.

Conclusions: The addition of rifaximin-α to lactulose treatment was associated with a significant reduction in the number and length of HE-related hospitalizations for overt HE. Rifaximin-α treatment was well tolerated.

Keywords: efficacy; end-stage liver disease; healthcare utilization; hepatic encephalopathy; rifaximin-α; safety.

Figure 1.

Flow chart of study inclusion.

Figure 2.

Differences in proportion of patients with at least one hospital visit or hospitalization during 6-month episodes before and after initiation of rifaximin-α treatment. A&E, accident and emergency; HE, hepatic encephalopathy.

Figure 3.

Kaplan–Meier curve showing the proportion (red line) of patients using rifaximin-α after initiation of treatment.