Lessons from Epivir/HBV data

Information from Glaxo Wellcome's trials of BioChem Pharma Inc.'s Epivir/HBV for hepatitis B virus could change the way clinicians think about analyzing the condition of patients and the way clinical trials in the disease are designed.

At last week's FDA Antiviral Drugs Advisory Committee review of Epivir/HBV, panel members decided to place a greater emphasis on the interpretation of liver biopsies than on changes in the immune response as indicated by seroconversion to hepatitis B virus negative (see BioCentury Extra, Oct. 7). Although they heard testimony that there is a significant degree of variability in the interpretation of liver biopsies, the committee said hepatic histology should be retained as the key end point in studies of HBV therapies...