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16/04/2014

A combination of two oral drugs heals the 97% of patients with hepatitis C

2014_0095_2014_0095_IMATGE

16/04/2014

Dr. Maria Buti is the co-author of the study published in The New Journal of Medicine.

A phase III clinical trial made in more than one hundred hospitals in the United States and Europe, including the Vall d’Hebron University Hospital, has shown that the combination of two antiviral drugs administered orally for 12 weeks heals patients with hepatitis C. Specifically, of the 865 patients who participated in the study, 97% were healed without suffering any major side effects. Dr. Mari Buti, researcher of the Liver Diseases Group at the Vall d’Hebron Insitute of Research (VHIR) and head of the Hepatology Section at Vall d’Hebron University Hospital, is the co-author of the research published by the online edition of the prestigious journal " "http://www.nejm.org/doi/full/10.1056/NEJMoa1402454#t=article" The New England Journal of Medicine.The traditional drugs to treat hepatitis C are interferon, which is administrated by subcutaneous injection and involves a large number of side effects such as flu symptoms and depression, and ribavirin, administrated orally and has also significant side effects such as anemia, fatigue and itching. Both drugs heal approximately for 70% of patients, but show a poor response in those patients previously treated with interferon and suffering liver cirrhosis. In this research, patients who had not been subjected to any of these treatments and had some degree of hepatitis C or had even developed cirrhosis, tested the effect during 12 and 14 weeks of two antiviral drugs, sofosbuvir and ledipasvir, combined in some cases with ribavirin. The trial results conclude that the most effective treating group is the combination of sofosbuvir whit ledipasvir during 12 weeks. According to Dr. Buti, this is a radical change in the treatment of hepatitis C, as "the new treatment is very well tolerated, has no significant side effects and can be used in a very wide range of patients, including those with decompensate liver cirrhosis". Thus, she adds, "the use of these drugs will reduce clearly the name of liver transplants caused by cirrhosis". Sofosbuvir is already approved in Europe and pending price in Spain, but ledispavir has not yet been filed in the registry of regulatory agencies. Both drugs will be approved as a combining form in a pill that will have to be administered daily for 12 weeks. According to the Spanish Association for the Study of the Liver (AEEH), "http://aeeh.es/2013/10/campana-de-concienciacion-para-la-prevencion-y-diagnostico-de-la-hepatitis/" in Spain around 900.000 people have hepatitis C, but more than half don’t know it, because it is a viral disease that presents no symptoms. Causes about 10.000 deaths annually and is the leading cause of cirrhosis and liver cancer. Therefore, according to the association, it is responsible for half of the nearly one thousand liver transplants performed each year throughout Spain. Along with this trial, "http://www.nejm.org/doi/full/10.1056/NEJMoa1402454#t=article" The New England Journal of Medicine includes in its online edition some clinical trials which support the effectiveness of various combinations of drugs to cure hepatitis C without resorting to interferon.

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