Efficacy of XIFAXAN for overt hepatic encephalopathy

Dr. Fred Poordad

Professor at University of Texas Health Science Center

San Antonio (UTHSCSA) in San Antonio, Texas

Watch Dr. Poordad describe the Phase 3 clinical trial that assessed the efficacy of XIFAXAN in reducing the risk of recurrence for overt HE and HE-related hospitalizations.

Study design1,2
  • In a randomized, placebo-controlled, double-blind, multicenter, multinational, 6-month study, the efficacy of XIFAXAN 550 mg (taken orally twice a day) was evaluated in 299 adult subjects
  • Inclusion criteria: Currently in remission (Conn score of 0 or 1) from HE and ≥2 episodes of HE associated with chronic liver disease in the previous 6 months
  • Primary endpoint: Time to first breakthrough overt HE episode, defined as a marked deterioration in neurological function (an increase in Conn score to grade ≥2 or an increase in Conn score and asterixis grade of 1 each if subject entered study at grade 0)
  • Key secondary endpoint: HE-related hospitalization
91% of patients in the placebo and XIFAXAN groups were on lactulose1

References: 1. XIFAXAN [prescribing information]. Bridgewater, NJ: Salix Pharmaceuticals. 2. Bass NM, Mullen KD, Sanyal A, et al. Rifaximin treatment in hepatic encephalopathy. N Engl J Med. 2010;362(12):1071-1081.


XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

  • XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
  • Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.