The EC H2020 Funded LIVERHOPE Project has achieved its primary objective of completing TWO randomized double-blind trials (SAFETY and EFFICACY Trials) to investigate the efficacy of the combination of simvastatin plus rifaximin in patients with decompensated cirrhosis to halt progression to acute-on-chronic liver failure (ACLF), decrease complications of the disease, reduce hospital readmissions, improve cost-effectiveness, improve patients quality-of-life, and increase survival. The Efficacy Trial has been performed in 14 hospitals in 7 European countries.
The administration of the combined treatment with simvastatin and rifaximin is a very innovative approach to therapy of cirrhosis that targets both the systemic inflammation and the alteration in gut microbiome and gut-liver axis that characterize advanced chronic liver diseases. The recruitment of patients with decompensated cirrhosis in the LiverHope Efficacy trial was completed on the 30th November 2022 with a sample size of 254 patients.
The results of the trial will be presented at the International EASL Meeting June 2023. Furthermore the secondary objectives of the project, assessment of biomarkers in decompensated cirrhosis and evaluation of the changes in plasma metabolome during cirrhosis progression are currently being studied with the preliminary results due later 2023.
STIGMA in Liver Diseases has been an important objective of the project and the role of the Patients Association and the Expert Nurses team have been essential in achieving results. The qualitative results have been presented at international congresses and published PLoS One 2022 and an extensive review in Journal of Hepatology 2023.