Cirrhosis of the liver is a very frequent chronic disease that constitutes one of the main causes of death in Europe. Furthermore, it has a strong impact on the quality of life of patients and represents a major burden for the health system.
In the last 20 years there have been no significant advances made in the treatment of cirrhosis, which is still based on tackling the symptoms associated with complications of the disease, but not its cause. In order to respond to this therapeutic need, the goal of the project LiverHope, funded with a European Horizon 2020 grant, is to evaluate the efficacy of a combination of simvastatin, a frequently-used statin, and rifaximin, an antibiotic that regulates the intestinal microbiota, in patients with cirrhosis of the liver.
Pere Ginés, head pf the IDIBAPS Chronic liver diseases: molecular mechanisms and clinical consequences group and of the Hepatology Service at the Hospital Clínic, is coordinating the project, which involves a total of 16 participating institutions, including clinical centres, universities and European companies.
The first of the clinical trials conducted by the consortium concluded that the safe dose of simvastatin for cirrhosis patients, to be administered in combination with the rifaximin, is 20 mg per day. The results were published in the journal The Lancet Gastroenterology & Hepatology. The second clinical trial, which will analyse the efficiency of the combined treatment in halting progression from chronic to acute hepatic insufficiency, reducing the complications of the disease and hospital admissions, as well as increasing the quality of life and survival of patients with decompensated cirrhosis, commenced in November 2021 and will run until the end of 2022. A total of 250 patients are participating at 14 hospitals in 7 European countries. At the current time, the inclusion of patients into the study has been completed. It is planned to be able to communicate the conclusions of the trial in early 2023.
Within the framework of the LiverHope project, a guide for the design of clinical trials in cirrhosis has also been produced. The document, published in the Journal of Hepatology, contains recommendations both for trials aimed at modifying the natural history of decompensated cirrhosis and trials aimed at individual complications of cirrhosis. There has also been a study published recently in the journal Hepatology Communications, which analysed the changes caused by the combination of simvastatin and rifaximin to the set of metabolites, or metabolome, of patients with cirrhosis.