Hepatic cirrhosis, regardless of its origin - hepatitis B or C infection, non-alcoholic fatty liver disease or alcohol consumption - is one of the leading causes of death in Europe. It is responsible for about 170,000 deaths each year and it is estimated that in the same time period of time, it causes one million hospitalizations. Only 3% of patients are candidates for liver transplantation because of the low number of organs available, and in most cases the disease progresses.
There is no effective treatment to curb the progression of cirrhosis, although in recent years there have been several studies indicating that certain antibiotics and statins have beneficial effects on the disease. Antibiotics, especially rifaximin, modulate the intestinal microbiome and reduce the passage of bacteria and bacterial products into the systemic circulation, an important mechanism of progression of cirrhosis. On the other hand, statins improve circulation within the liver, reduce fibrogenesis and inflammation, both intrahepatic and systemic, and decrease portal hypertension. However, clinical validation of the beneficial effects of this combination therapy has not yet been made.
The LIVERHOPE project aims to solve this problem and researchers will conduct two clinical trials to test the safety and efficacy of combination therapy with rifaximin and simvastatin. In the first one, two doses of simvastatin versus placebo will be used to determine both the safety and the tolerability of the drug. In the second trial, the effect of the treatment in the prevention of disease progression in patients with decompensated cirrhosis will be evaluated. "This new therapy we propose is innovative because it is directed against several of the factors responsible for the progression of this pathology," explains Dr. Pere Ginès, who is also Professor of Medicine of the University of Barcelona. "We hope this treatment can reduce the number of hospitalizations due to complications of the disease by 30%," he adds.
On the other hand, the project will analyze the plasma and urine samples of the patients taken at different times of the study to identify biomarkers of progression of cirrhosis, since there are no biomarkers currently available. "The goal is to develop a kit that will be used for the staging and clinical management of patients with cirrhosis, which will allow the carefully selection of candidates for a liver transplant and make the follow up," concludes Dr. Ginès.