Rifaximin reduces liver complications but does not improve survival in patients with severe cirrhosis

Treatment with rifaximin appears to provide no benefits in terms of 12-month survival or incidence of complications of cirrhosis in patients with severe cirrhosis and low ascitic fluid protein levels, a recent study has shown.

"However, improved adherence may help reduce liver-related complications,” the investigators said.

This study was conducted at 17 French centres and included patients with severe cirrhosis and grade 2/3 ascites and ascites protein level <15 g/L. Participants were randomly assigned to receive rifaximin 550 mg or placebo twice daily for 12 months as primary prophylaxis for spontaneous bacterial peritonitis (SBP).

A total of 1,957 patients with cirrhosis and ascites were screened between 2018 and 2022. Of these, 159 were randomized, and 152 (72 in the rifaximin arm and 80 in the placebo arm) were analysed in the modified intention-to-treat population.

Rifaximin fell short of significantly improving survival at 12 months (rifaximin vs placebo: 56.6 percent vs 68.1 percent; p=0.74), 6 months (76.4 percent vs 71.1 percent), or 3 months (82.6 percent vs 75.4 percent), or the incidence of liver complications (ie, SBP, encephalopathy, gastrointestinal bleeding, or hepatorenal syndrome).

In the per-protocol population (127 patients adherent to the study drug), the incidence of liver-related events was lower among those treated with rifaximin. Moreover, rifaximin was well tolerated.

“Our trial did not demonstrate an improvement in survival or liver complications at 12 months with rifaximin as primary prophylaxis for SBP vs placebo,” the investigators said. “However, in the subgroup of patients who adhered to rifaximin, liver complications decreased.”