AMERICAN LIVER FOUNDATION NEWSLETTER

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The Monday Update American Liver Foundation Newsletter Dear JEANNE,This newsletter aims to

keep you up to date with the latest developments in the areas of liver medicine and science. Here are the top liver news stories for the past week. Dynavax, Merck: FDA puts clinical hold on investigational hepatitis B vaccine Dynavax Technologies Corp. and Merck & Co. said the Food and Drug Administration has placed a clinical hold on the two investigational new drug applications for Heplisav, an investigational hepatitis B vaccine being jointly developed the companies. The FDA's order comes after one subject who received Heplisav in a Phase III study was preliminarily diagnosed as having Wegener's granulomatosis, an uncommon disease in which the blood vessels are inflamed. All of the subjects in this study have received all doses according to the protocol and will continue to be monitored, the companies said. CNNMoney.com New Method Disrupts Hepatitis C Virion Production In the March issue of the journal PLoS Pathogens, Tellinghuisen, an assistant professor in the Department of Infectology at Scripps Florida, and his colleagues describe how they used mutations of the viral NS5A phosphoprotein to disrupt virus particle production at an early stage of assembly. "Though this discovery isn't a cure for HCV, it is an important research tool that stops the assembly pathway," says Tellinghuisen. Total disruption of the replication process would be a cure for the disease, he adds, and that's the team's long-term goal.

Science Daily FDA issues alert about HIV drug Prezista The U.S. Food and Drug Administration has issued an alert concerning reports of liver injury in patients taking Prezista. The FDA said

Prezista (darunavir), an anti-retroviral drug used to treat for the human immunodeficiency virus HIV, is suspected of contributing to several hepatic events, including liver failure, destruction of liver tissue, cirrhosis, hepatitis and jaundice. United Press International Nevada completes inspections in hepatitis C case State health officials on Thursday completed inspections of all but two of 50 Nevada clinics checked following an outbreak of hepatitis C in six patients who went to a Las Vegas endoscopy center. Seven of the inspected clinics had "major infection control problems, such as the reuse of single-dose vials," according to a release from Gov. Jim Gibbons' office. Two others had "medium-level" issues such as sterilization problems, 17 had minor problems and the rest had no deficiencies. The Mercury News email: asu@... phone: web: http://www.liverfoundation.org Thank you for your continued support of the American Liver Foundation. For more information on liver disease or our work as an organization, please visit our Web site or contact your local ALF chapter. Give to ALF today. Jeanne