Bristol Hepatitis B Drug Beats Glaxo’s in Study

An experimental Bristol-Myers Squibb Co. pill for the liver disease hepatitis B proved better than a commonly-used anti-viral medicine made by GlaxoSmithKline in late-stage clinical studies, researchers said.

Bristol-Myers, which has already applied to U.S. regulators for approval of its hepatitis B drug entecavir, will present the pivotal clinical data next week at the American Association for the Study of Liver Diseases annual meeting in Boston.The Bristol drug demonstrated statistically significantly better suppression of the virus and improved control of inflammation and liver damage in the trials than Glaxo’s lamivudine, researchers said.Once approved, “we will have a powerful new medication that will be a very serious option to manage patients in need of new therapy,” said Dr. Robert Gish, medical director of the liver transplant program at California Pacific Medical Center, and the lead investigator of one of the trials. “The current options are not great.”Some 1.5 million Americans are chronic hepatitis B carriers — a highly infectious blood-borne disease which can be transmitted through unsterile needles, sexual contact or transfusions. Up to a third of them will die of chronic liver disease or cancer or need a transplant, according to government estimates.In one study of 709 patients with a common form of the disease, known as e-antigen positive, 72 percent of those taking 0.5 milligrams of entecavir once daily showed improvement of liver health, or histology, after 48 weeks, compared with 62 percent of those taking 100 mg of the Glaxo’s lamivudine, which is used to treat both HIV and hepatitis B.”Histologic improvement translates directly to decreased likelihood of one of these fatal outcomes,” Gish said.Patients taking the Bristol drug also experienced significant reduction of hepatitis B virus compared with the lamivudine group. Some 70 percent had so little of the virus present that it was undetectable, compared with 40 percent in the lamivudine group, researchers said.They cited a direct link between the level of the virus in the blood and the chance of transmitting the disease.Another head-to-head trial tested 638 patients with e-antigen negative chronic hepatitis B, a form of the disease linked to higher incidence of severe liver damage that often leads to cirrhosis and liver cancer.The e-negative form is found in relatively older people and more common in Mediterranean countries, Africa, Eastern Europe and some areas of East Asia.In that study, 70 percent of the entecavir patients showed significant liver improvement at 48 weeks, compared with 61 percent of those treated with lamivudine.In addition, 91 percent of those treated with the Bristol-Myers drug had an unmeasurable amount of the virus at 48 weeks compared with 73 percent of those taking the Glaxo medicine.”This is a degree never reported with an oral treatment,” said Dr. Daniel Shouval, director of the liver unit at Hadassah University Hospital in Jerusalem and lead investigator of the second study.Shouval said he believes entecavir will be approved as a first-line treatment for the disease.”Based on these results I think entecavir is an excellent opportunity to improve treatment and reduce the rate of progression of the disease and also bring down the number of patients who will need liver transplants,” Shouval said.(Source: Reuters, Oct 2004)