Patients with cirrhosis who undergo placement of a transjugular intrahepatic portosystemic shunt (TIPS) may benefit from treatment with rifaximin before and after the procedure, according to a recent randomized controlled trial.
Researchers in France randomly assigned patients with cirrhosis who were undergoing TIPS for intractable ascites or prevention of variceal rebleeding to receive rifaximin, 600 mg twice daily, or placebo beginning 14 days before the procedure and continuing 168 days afterward. The trial's primary efficacy end point was incidence of overt hepatic encephalopathy within 168 days after the TIPS procedure. Secondary end points were incidence of other complications related to liver disease (GI bleeding, acute kidney injury, and hepatocellular carcinoma), transplant-free survival at 168 days, and duration and severity of the first overt episode of hepatic encephalopathy. Results of the trial were published Feb. 2 by Annals of Internal Medicine.
Between October 2013 and June 2016, 197 patients were randomly assigned to receive a study drug. Of these, 194 received at least one dose of rifaximin or placebo and 186 patients, 93 in each study group, had TIPS placement. Among the TIPS patients, 34% (95% CI, 25% to 44%) in the rifaximin group versus 53% (95% CI, 43% to 63%) in the placebo group had an overt episode of hepatic encephalopathy after the procedure (odds ratio, 0.48 [95% CI, 0.27 to 0.87]). Rates of adverse events and transplant-free survival did not differ between the two groups.
The authors noted that most of the patients in their trial had alcoholic cirrhosis and that the effects of longer antibiotic prophylaxis are not known. They concluded that their results support the use of rifaximin to prevent hepatic encephalopathy after TIPS in patients with cirrhosis but also raise questions, including how long therapy should continue for optimal results, how to select patients for TIPS, and whether rifaximin could be used to prevent overt hepatic encephalopathy in other high-risk situations.