Microbial Resistance of Rifaximin in Hepatic Encephalopathy

Summary

Aims and Objectives: To determine the safety and efficacy of rifaximin plus lactulose as secondary prophylaxis of HE compared to lactulose alone. To evaluate the effect of long-term administration of rifaximin on development of resistant mutants and investigating its correlation with its efficacy. Methods: An open label parallel, prospective interventional study was conducted. One hundred patients experienced at least one attack of hepatic encephalopathy were included in the study. Patients were randomly allocated either to receive rifaximin plus lactulose or lactulose alone for 6 months. Conn score, Model of End stage Liver Disease (MELD) score, asterixis grade, complete blood count (CBC), liver function tests, kidney function tests, urine and stool analysis and abdominal ultrasonography were compared in both groups. The primary efficacy endpoint was the time to the first breakthrough. The secondary efficacy endpoint was the time to the first hospitalization involving HE. Safety assessment was done by reporting any adverse events, serious adverse events and by repeating biochemical evaluation every 2 weeks. Determination of the minimum inhibitory concentration (MIC) of rifaximin for lactose fermenter isolates was done for the entire patients before starting treatment and at the end of treatment.

Timeline

Start

2015-01

Primary completion

2018-12

Completion

2019-06

Publications

• Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.
• Abdel Moneim M, Abdelaziz DH, Ibrahim Nagy Y, Abdel Baki A, Attia AS, Sabry N. Rifaximin microbial resistance and its efficacy and safety as a secondary prophylaxis of hepatic encephalopathy in patients with hepatitis C virus-related cirrhosis. Int J Clin Pract. 2021 Nov;75(11):e14807. doi: 10.1111/ijcp.14807. Epub 2021 Sep 17.

Drugs

Indications