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| |  Liver Damage Improved With Zeffix (Lamivudine) Treatment In Hepatitis B Patients LAVAL, QC -- November 1, 2000 -- BioChem Pharma Inc. announced that the liver damage suffered by hepatitis B patients, previously thought to be irreparable, has, for the first time, been shown to be improved by antiviral treatment, according to new research. A study presented this week at the American Association for the Study of Liver Diseases (AASLD) Congress in Texas, USA, demonstrates a regression in cirrhosis (severe liver scarring) in 64 percent (14/22) of patients with pre-existing cirrhosis, following two or more years of treatment with Zeffix (lamivudine). Over the same period of treatment, 51 percent (26/51) of patients also experienced resolution or improvement in bridging fibrosis (a precursor to cirrhosis). The study's findings suggest that extended treatment with Zeffix may not only stop further damage caused by the hepatitis B virus, but also allow the body to regenerate healthy liver tissue and repair pre-existing damage. Reduction in liver inflammation and improvements in liver scarring were observed in 52 percent (39/75) of patients with a variant form of the hepatitis B virus (YMDD variant hepatitis B virus), which have reduced susceptibility to Zeffix in laboratory assays. Professor Eugene Schiff, from the University of Miami, who was the lead investigator of the study, commented, "The results are particularly exciting because, until now, advanced fibrosis and cirrhosis were considered to be irreversible and we had limited options to interrupt the progression of liver disease, with many patients ultimately developing liver failure and requiring liver transplantation. The fact that extended treatment with Zeffix can improve these conditions in many cases signals a significant breakthrough in our management of chronic hepatitis B. Early intervention with Zeffix treatment may offset the need for liver transplantation in the future, and ultimately improve chances for survival. The fact that such improvements are seen even in patients with YMDD variant hepatitis B virus is particularly reassuring." The two-year interim results presented this week are derived from a large international multicenter five-year follow-up study which involved 236 chronic hepatitis B patients with evidence of active viral replication, who completed 2 years of treatment. The results were based on 128 patients from whom liver biopsies were available, both before and after treatment. All patients in the study received at least two years of Zeffix treatment. Professor Schiff explained, "Many of the 350 million people chronically infected with hepatitis B worldwide will gradually develop liver fibrosis and then cirrhosis, as the immune response to the virus slowly destroys liver cells. These results offer them new hope." Hepatitis B is one of the most common viruses and causes severe disease or premature death. Over 75 percent of the world's 350 million hepatitis B carriers reside in the Asia-Pacific region.(1) Worldwide, at least one million people die each year from hepatitis B virus infection,(2) making it the ninth leading cause of death globally.(3) The majority of these deaths are due to liver failure from end-stage cirrhosis. Zeffix is currently available in more than 30 countries including China (as Heptodin), South Korea, the USA (as Epivir-HBV), Canada (as Heptovir) and the EU, and approved in over 60 countries worldwide. Under agreement, BioChem Pharma receives royalties from Glaxo Wellcome on sales of its discovery lamivudine for use in treatment of both HIV/AIDS 3TC/Epivir/Combivir/Trizivir) and HBV (Zeffix/Zefix/Epivir-HBV/Heptovir/Heptodin). Glaxo Wellcome has the right to develop, manufacture and sell lamivudine worldwide, except in Canada, where BioChem Pharma and Glaxo Wellcome have formed a commercialization partnership. Heptodin, Zeffix, Zefix, Epivir-HBV, Heptovir, 3TC, Epivir, Combivir, and Trizivir are trademarks of the Glaxo Wellcome group of companies. References: Related Links: Zeffix (lamivudine), BioChem Pharma and Glaxo Wellcome.
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