PHILADELPHIA — Treatment with rifaximin significantly reduced the risk for overt hepatic encephalopathy among patients with cirrhosis regardless of Child-Pugh class and was overall safe and well-tolerated, according to a presentation at the American College of Gastroenterology Annual Meeting.
According to Steven L. Flamm, MD, from the Northwestern Feinberg School of Medicine in Chicago, this study was a post hoc analysis designed to determine rifaximin’s safety and efficacy by Child-Pugh subclass, as a previous phase 3 study confirmed its overall superiority to placebo in the prevention of overt hepatic encephalopathy (HE).
In the initial trial, the researchers enrolled patients with cirrhosis and a history of two or more overt HE episodes within the previous 6 months and were currently in HE remission. During the post hoc analysis, Flamm and colleagues analyzed patient outcomes by subgroups of baseline Child-Pugh class A, B or C.
Regarding time to first overt HE episode, more patients in the placebo group had an overt HE episode during the 6-month treatment period compared with treated patients with Child-Pugh class A (46.4% vs. 17.4%; HR = 0.34; 95% CI, 0.15-0.75), Child-Pugh class B (44.4% vs. 23.1%; HR = 0.44; 95% CI, 0.24-0.82) or Child-Pugh class C (64.3% vs. 29.4%; HR = 0.34; 95% CI, 0.12-1.04).
While the rates did not meet significant differences, patients who received rifaximin did have longer times to first HE-related hospitalization compared with placebo for Child-Pugh class A (10.9% vs. 23.2%), Child-Pugh class B (12.3% vs. 20.8%) and Child-Pugh class C (23.5% vs. 35.7%).
The incidence of serious adverse events was similar in treated patients and those who received placebo across all three classes. The researchers also found no apparent trends in the types or frequencies of serious adverse events in each class.
“Regardless of Child-Pugh class of hepatic impairment, treatment with rifaximin ... for up to 6 months significantly reduced the risk of overt hepatic encephalopathy recurrence by up to 66% vs. placebo,” Flamm said. “Even with the majority of patients taking concomitant lactulose in the study, rifaximin ... provided further benefit in the prevention of overt hepatic encephalopathy recurrence.” – by Talitha Bennett
Reference: Flamm SL, et al. Abstract 58. Presented at: American College of Gastroenterology Annual Scientific Meeting; Oct. 5-10, 2018; Philadelphia.
Disclosure: Flamm reports financial interests with AbbVie, Bristol-Myers Squibb, Gilead Sciences, Intercept Pharmaceuticals, Merck and Salix Pharmaceuticals.