LIVERHOPE
Trial question
What is the role of simvastatin plus rifaximin in patients with decompensated liver cirrhosis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
28.0% female
72.0% male
N = 237
237 patients (67 female, 170 male).
Inclusion criteria: patients with decompensated liver cirrhosis.
Key exclusion criteria: severe liver impairment; HCC; severe extrahepatic comorbidities; COPD; serum creatinine ≥ 2 mg/dL; receipt of RRT; receipt rifaximin or statins; adverse events related to study medications.
Interventions
N=117 simvastatin plus rifaximin (simvastatin 20 mg PO daily and rifaximin 400 mg PO TID for 12 months).
N=120 placebo (matching placebo for 12 months).
Primary outcome
Incidence of acute-on-chronic liver failure
17.9%
14.2%
17.9 %
13.4 %
8.9 %
4.5 %
0.0 %
Simvastatin plus
rifaximin
Placebo
No significant
difference ↔
No significant difference in incidence of acute-on-chronic liver failure (17.9% vs. 14.2%; HR 1.23, 95% CI 0.65 to 2.34).
Secondary outcomes
No significant difference in transplant or death (18.8% vs. 24.2%; HR 0.75, 95% CI 0.43 to 1.32).
No significant difference in complications of cirrhosis (42.7% vs. 45.8%; HR 0.93, 95% CI 0.63 to 1.36).
No significant difference in AKI (15.4% vs. 18.3%; HR 0.75, 95% CI 0.4 to 1.41).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with decompensated liver cirrhosis, simvastatin plus rifaximin was not superior to placebo with respect to incidence of acute-on-chronic liver failure.
Reference
Elisa Pose, César Jiménez, Giacomo Zaccherini et al. Simvastatin and Rifaximin in Decompensated Cirrhosis: A Randomized Clinical Trial. JAMA. 2025 Mar 11;333(10):864-874.
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