Report from the press conference from July 15th, 2014 in Vienna
From Prof. Dr. Peter Ferenci / Austria
Treatment of chronic hepatitis C is a success story of modern medicine. For the first time a chronic viral disease became curable, with a well tolerated oral treatment over just 12 weeks.
The great problem is the very high costs for the new drugs far exceeding the cost to produce them limiting their availability. Only 5 member countries of the European Union provide funding currently, but only to patients with advanced liver disease. Access to this effective treatment for patients without cirrhosis is not available. Thus the majority of HCV infected patients have only the choice to wait or to start treatment with less effective and poorly tolerated regimes. The urgency for immediate treatment is not based just on medical reasons. If you are a patient and your information is derived from various websites telling you how serious this disease is, you like to get treated. Is it ethically acceptable to deny an effective treatment to a patient? Just because they are not suffering from far advanced disease or living in a country which cannot afford the costs.
We are living in the 21st century where the income of investors is considered the first priority ("share holder value"). Gilead purchased Pharmaset, the company which developed sofosbuvir, for 11.7 billion US$ in 2011. Is this high price ethically acceptable? In just 2 years the drug was approved in many countries. In the first four months of 2014 Gilead sold sofosbuvir for 2.4 billion US$ and hopes to earn the costs for this purchase within 2 years, from 2016 on they hope for gigantic profits. Is this ethically acceptable? Is it more important to make share holders happy or to cure patients? Pharmacoeconomic analysis tells us that the treatment is cost effective (for whom?) but is this approach reasonable? What is the price of life or of well being?
The high price of sofosbuvir initiated a worldwide resistance. Gilead reduced the price for some patients cohort in the USA by 44% and reached agreements with local companies in developing countries (India, Pakistan, Egypt) to market sofosbuvir for less than 1000 US$ . But for the rest of the world including the European Union the situation became unacceptable. For Europe a paneuropean solution is needed we all hope that an immediate action is taken by the politicians in Brussels to make the drug available for all European patients.
Fibroscan: Screening for chronic liver disease avoiding pain and a liver biopsy needle.
From Prof. Dr. Arnulf Ferlitsch, Austria
Chronic liver disease affects one out of eleven persons worldwide. Viral Hepatitis B and C, or fatty liver disease are emerging. However, only few patients know about their disease, because symptoms are rare in the early stages and elevated liver enzymes are not necessarily seen in chronic liver disease. Liver biopsy was used for many years to estimate the level of advanced liver disease (Fibrosis) up to end stage liver disease (cirrhosis). Within recent years, Fibroscan could prove its value for non-invasive determination of liver fibrosis and cirrhosis. Measuring liver stiffness using the Doppler effect with an ultrasound like probe, early stages of liver disease can be detected without pain and complications. As reproducible and investigator independent method, Fibroscan could therefore be an ideal screening tool for chronic liver disease of all kinds, as we want to find early stages to prevent people from developing cirrhosis and its complications. If elevated levels of liver stiffness are detected, consecutive screening for viral hepatitis can lead to therapy in early stages of the disease and further transmission of these infectious diseases.