Leading international gastroenterologists and hepatologists at a round table during the 43rd Annual Meeting of the European Association for the Study of the LiverMilan, Italy, 25th April 2008 – No biopsy, unless necessary, but instead a blood test to measure selected markers for fibrogenesis/fibrolysis and have an evaluation of the stage of liver fibrosis. FibroTest/FibroMAX, the most validated tests, give a quantitative estimation that allows conversion to the METAVIR score, currently considered the “gold standard” for liver fibrosis staging. More than 7,400 medical doctors and liver experts gathered at the 43rd Annual Meeting of the EASL, held in Milan last April 23rd-27th, and a symposium on invasive and non-invasive assessment of liver fibrosis was held at the presence of the most representative members of clinical hepatology in the world, where they agreed that future diagnosis of liver fibrosis will be possible by the use of non-invasive tests.
Fibrosis is a progressive injury of the liver leading to irreversible damage (cirrhosis), and to cancer, hemorrhage or failure. Chronic liver disease is responsible for over 1.4 million deaths every year (WHO, World Health Report 2004). A painless alternative to liver biopsy for evaluating the stage of liver fibrosis is the FibroScan® technique. New non-invasive blood tests, which consist in detection and measure of biomarkers of fibrogenesis and fibrolysis (MP3, Fibrotest, Fibrometer, Hepascore, Forns’ score and APRI) have been recently compared in terms of diagnostic performance in alternative to liver biopsy [J Hepatol. 2007 May;46(5):775-82].
A round table, held in Milan on April 26th, on non-invasive tests FibroTest/FibroMAX has seen personalities in the field of liver diseases from different countries for an overview on the use of new diagnostic tests in France and Italy, Russia and Ukraine, USA, Egypt and Lybia.
“The urge for the inclusion of non-invasive tests for diagnosis of liver disease in the Italian guidelines is fundamental”, said Dr. Giada Sebastiani, from the Department of Gastroenterology and Hepatology, Ospedale Umberto I, Venice, Italy, in an interview. “And this has been the subject of discussion in a very important symposium today at the EASL [Editor’s note: Symposium 5 on “Clinical invasive and non-invasive assessment of liver fibrosis”]. The current international “gold standard” for diagnosis of fibrosis is biopsy, but non-invasive test alone or in combination [FibroTest/FibroMAX plus FibroScan] may effectively substitute it in the future with a great advantage to the patient”. Prevalence of viral hepatitis C [HCV] is approximately 3% in the Italian population, with an increasing gradient from the North to the South, and it reaches 10% in the elderly. But people arriving from Eastern Europe, Egypt and South-East Asia are yet mostly positive for viral hepatitis B [HBV], increasing the number of people presenting with liver fibrosis, although most Italian people are vaccinated.”
“A national survey revealed that 3% of the French population show stage 2-3 fibrosis [Editor’s note: F2-F3 METAVIR score], that means 7,500 people only in Paris. This is why we advise the screening in people over the age of 40 – stated Prof. Thierry Poynard, Head of the Gastro-Enterology department at La Pitié Salpêtrière Hospital in Paris, France. – Eighty percent of this population presents with steatosis, due to metabolic factors or alcohol, and 20% is affected by HBV and HCV, since in France only 30% of the infants are vaccinated for HBV”. Prof. Poynard worked on non-invasive markers, i.e. FibroTest, for the last 15 years. In 2001 published his first paper in the Lancet, and followed all test validation independent studies in different countries for HCV, HBV, alcoholic hepatitis and metabolic steatosis, which is the most frequent hepatic disease in the world. In France, FibroTest can be prescribed by GPs who may later refer the patient to the hepatologist. “We are at the point where GPs can make the difference, as mortality for liver diseases is increasing steeply, from 4,000 deaths for liver disease ten years ago to 7,700 deaths to-date”. Also mortality for cancer is increasing in France, as in the US, due to metabolic disease or viral infection, cause of liver fibrosis.
“Hepatitis is instead very spread in Russia. Five millions people are affected by HCV, and the same figure is observed for HBV, but also alcohol is a big problem”, noted Dr. Chedvar Pavlov, scientific collaborator in-chief at the I. M. Setchenov Moscow Medical Academy. “In our clinic, the percentage of people affected by liver fibrosis is 10%, diagnosed by biopsy.” Up-to-date, Dr. Pavlov has conducted approximately 2,000 biopsies within his centre, and up to 100 patients have been tested with FibroTest and FibroMAX. The results were published in Russia and news ones are presented at the EASL conference in Milan. Further data indicate that “approximately 8 millions people are affected by diabetes, 30% of whom may develop NASH (non-alcoholic steato-hepatitis)”, confirmed Dr. Sabir Mekhtiev, Military Medicine Academy, the second most important department in Russia for the improvement of gastro-hepatological techniques, in St. Petersburg. In the centre directed by Dr. Mekhtiev, “only 32 patients have been studied to-date (21 FibroMAX, 11 FibroTest), but morphological studies are carried out in the same patients, although no correlation can be made at moment until we reach the end of the study”.
“Within a population of 49 millions, the prevalence of hepatitis in Ukraine is about 25%, mainly of viral and alcoholic origin. FibroMAX and FibroTest are next to be used in various centres within the country, as well as at the Gastroenterology and Dietology department of Kiev Medical Academy”, directed by Natalia Khartchenko, Professor at the department of the National Academy for Medicine and Post-University Teaching. “Their availability in the future is of utmost importance since patients are concerned about the risks of biopsy”, Prof. Khartchenko confirmed.
“A prevalence of approximately 12%, within a population of 75 millions people in Egypt, is observed for HCV. This is higher than the figure observed for HBV – told Hesham ElKhayat, Professor of Gastroenterology and Hepatology and consultant for the Eastern Tobacco Company in Cairo, in an interview. – Alcohol problems still persist despite religion rules, but the concern is low in our country.” “Since 2005, when FibroTest and FibroMAX were introduced, we got to know that there were tests for liver steatosis and fibrosis and how useful they both were. Today almost 90-95% patients are given liver biopsy, but because of patients’ awareness of its contra-indications and severe side effects, such as bleeding, morbidity and mortality, they will be more willing to have these tests and avoid biopsy”, asserted Prof. ElKhayat.
“In Libya, we just have completed a two year-survey on hepatitis B and C and found a prevalence of 2.2% for HBV and 4% for HCV, when considering a total population of about 6 millions people. Alcoholic hepatitis is not very high because of religion, with no concern in Libya. But we do see autoimmune disease, and obviously steatosis, due to obesity for new dietetic habits, – declared Prof. Abdelnasser ElZouky, vice-president of the Lybian Society of Gastroenterology and Hepatology – which increases the number of patients for liver disease. In Bengasi, FibroTest has been introduced for suspected NASH, but we just started its application, whereas we already used 200 tests in Tripoli”.
“The prevalence of liver disease in the US is significant: 10 millions people deal with alcohol-related problems, most of them have liver problems”, stated Prof. Tarek Hassanein, Medical director of liver transplantation and Chief of clinical hepatology at the University College in San Diego, USA. “As for steatosis, 55% of the US population is overweight and people have different degrees of the disease. Among a population of 300 millions, approximately 15 millions people are affected by liver disease, and when also fibrosis is concerned that becomes a problem. Fibrosis is the indication that liver disease is progressing – continued Prof Hassanein. – At this point, one can only avoid getting all the way to liver cirrhosis since approximately 5% will end the process.” “FibroTest/FibroMAX evaluate several markers in the blood, and these tests are becoming more refined to make a difference among the phases of fibrosis, so that patients can be followed up during the treatment. We can hit the prognosis, either for HBV or HCV, and we can tell the patient when to do the biopsy only to verify that his/her liver is cleared of the virus.”