What is the efficacy of rifaximin (Xifaxan) in the treatment of hepatic encephalopathy (HE)?

Updated: Apr 04, 2019
  • Author: David C Wolf, MD, FACP, FACG, AGAF, FAASLD; Chief Editor: BS Anand, MD  more...
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Answer

Rifaximin (Xifaxan), a nonabsorbable derivative of rifampin, has been used in Europe for more than 20 years for a wide variety of gastrointestinal indications. Multiple clinical trials have demonstrated that rifaximin at a dose of 400 mg taken orally 3 times a day was as effective as lactulose or lactitol at improving hepatic encephalopathy symptoms. [45, 52, 53] Similarly, rifaximin was as effective as neomycin and paromomycin. Rifaximin had a tolerability profile comparable to placebo. It was better tolerated than both the cathartics and the other nonabsorbable antibiotics. A potential mechanism for rifaximin's clinical activity is its effects on the metabolic function of the gut microbiota, rather than a change in the relative bacterial abundance. [54]

In 2004, rifaximin received approval by the FDA in the United States for the treatment of travelers' diarrhea. In 2005, it received orphan drug status as a treatment for hepatic encephalopathy. In March 2010, rifaximin was approved by the FDA to reduce recurrence of hepatic encephalopathy. The approval was based on a phase 3 clinical trial conducted by Bass et al. [55]


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