Comparative Analysis of the Efficacy of Different Regimens of 12 Months Rifaximin-Alfa Therapy in Patients with Liver Cirrhosis and Minimal Hepatic Encephalopathy

Igor G Bakulin; Kristina N Ivanova; Elena Y Eremina; Natalya V Marchenko; NORMIND study team

doi:10.3390/diagnostics13203239

Comparative Analysis of the Efficacy of Different Regimens of 12 Months Rifaximin-Alfa Therapy in Patients with Liver Cirrhosis and Minimal Hepatic Encephalopathy

Diagnostics (Basel). 2023 Oct 17;13(20):3239. doi: 10.3390/diagnostics13203239.

Authors

Igor G Bakulin¹, Kristina N Ivanova¹, Elena Y Eremina², Natalya V Marchenko³; NORMIND study team

Affiliations

¹ Department of Propaedeutics of Internal Medicine, Gastroenterology and Dietetics Named after S.M. Ryss «Mechnikov North-Western State Medical University» of the Ministry of Health of Russia, 191015 St. Petersburg, Russia.
² Department of Propaedeutics of Internal Diseases, Federal State Budgetary Educational Institution of Higher Education «National Research Mordovian State University Named after. N.P. Ogarev», 430005 Saransk, Russia.
³ Clinical and Educational Center, Gastroenterology and Hepatology, St. Petersburg State University, 199034 St. Petersburg, Russia.

Abstract

It is a matter of current interest which rifaximin-α regimens in patients with liver cirrhosis and minimal hepatic encephalopathy are the most efficient.

Study objective: to evaluate the effect of various rifaximin-α regimens for 12 months on clinical and laboratory parameters and quality of life in patients with liver cirrhosis and minimal hepatic encephalopathy.

Methods: It was a multicenter, prospective, open-label, observational study that included 288 patients with liver cirrhosis and minimal hepatic encephalopathy of both sexes over the age of 18 years, who were prescribed a 12-month course of treatment with rifaximin-α in accordance with the product label. Statistical analysis was performed in the population of patients who completed all visits according to the protocol (n = 258). Retrospectively, the patients were divided into two subgroups: subgroup 1 (continuous course)-patients who received the study drug for a year and the number of days of administration was 360 days (n = 41); subgroup 2 (cyclic course)-patients who received the study drug during the year for less than 360 days (n = 217). At each of the 4 visits, the quality of life was assessed using the CLDQ questionnaire, the time to perform the number connection test, the severity of symptoms associated with hepatic encephalopathy, and laboratory parameters.

Results: During the 12-month observation period, an increase in the total score on the CLDQ quality of life questionnaire in patients with chronic liver diseases was revealed, which indicates an improvement in the quality of life of patients receiving rifaximin-α therapy. When patients were divided into subgroups depending on the duration of therapy, some benefits of continuous rifaximin-α therapy were noted in the more pronounced dynamics of decrease in the time to perform the number connection test, and in decreased severity of the following symptoms associated with hepatic encephalopathy: impaired concentration and memory, cognitive impairment, and decreased performance. Laboratory findings showed positive dynamics in both subgroups.

Conclusion: A continuous rifaximin-α regimen in patients with liver cirrhosis and minimal hepatic encephalopathy for 12 months was superior to cyclic use with a more pronounced effect on the quality of life of patients and on the symptoms associated with hepatic encephalopathy.

Keywords: hepatic encephalopathy; liver cirrhosis; minimal hepatic encephalopathy; rifaximin-α.

Grants and funding

Funding for the study was provided by Alfasigma Rus. I.G.B. was National Coordinator of the study. I.G.B. was received speaker’s fees from Alfasigma Rus. K.N.I., E.Y.E. and N.V.M. received emoluments from Alfasigma Rus in recognition of their participation in the study.