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Zeffix May Reduce Incidence Of Post-Liver Transplant Hepatitis B Re-infection LAVAL, QC -- November 8, 1999 -- BioChem Pharma Inc. announced that new research on its discovery Zeffix (lamivudine), presented at a major liver specialists’ congress, may offer some new options for hepatitis B patients undergoing or awaiting liver transplant. A liver transplant is often the only option left for patients with life-threatening liver damage induced by hepatitis B. However, because the virus is present in tissues outside the liver and in the blood at the time of the transplant procedure, patients undergoing transplant surgery run the risk of often fatal hepatitis B virus (HBV) renfection occurring in the grafted organ. In light of this, many liver transplant centers will not offer liver transplantation to end-stage hepatitis B patients unless adequate suppression of HBV infection can be achieved. The data, presented at the annual meeting of the American Association for the Study of Liver Diseases (AASLD), in Dallas, Texas, show that treatment with Zeffix (lamivudine) can reduce the post-transplant recurrence of HBV infection, delaying or potentially removing the need for liver transplantation in some patients. It also may alleviate the clinical signs of liver failure-endpoints which could all be viewed as positive signals for improved survival. The North American multi-center study looked at the effects of Zeffix (100 mg daily) treatment on patients who were accepted as candidates for a liver transplant. It then divided into two arms, one looking at the incidence of re-infection post-transplant, the other evaluating the disease outcomes for those patients who did not progress to transplantation. Within the study, 47 patients who were being treated with Zeffix 100 mg daily received a liver transplant and continued treatment following surgery. Of the patients with available data following one year of treatment post-transplant with Zeffix, there was no evidence of recurrent HBV re-infection post-transplant in 71 percent (24/34). This figure is higher than historical expectations(1) for post-transplant re-infection. Lead investigator Dr. Robert Perrillo, Director of Gastroenterology and Hepatology, Ochsner Clinic, New Orleans explained: "We set out to evaluate the extent to which lamivudine prevented re-infection with HBV following transplant surgery. We’ve seen that lamivudine therapy reduces the proportion of patients with HBV re-infection post-transplant and that most patients were clinically stable one year following liver transplantation." Additionally, there were 27 patients with advanced hepatitis B who were accepted as candidates for a liver transplant, but who did not undergo the procedure for a number of reasons. Results from these patients were presented by Dr. Perrillo in a separate report at the Dallas meeting. Data from the evaluable patients in this group demonstrated that 63 percent (12/19) were HBV DNA negative (a marker of viral replication) at last study visit (weeks 6 to 136). These data demonstrate that Zeffix treatment may result in prolonged periods of disease improvement or stabilization and extended pre-transplant survival for patients with advanced hepatitis B. Approximately 350 million people are long-term carriers of the hepatitis B virus(2) and up to 40 percent of those who become infected will die as a consequence of cirrhosis (severe liver scarring) and liver cancer(3). Lamivudine for hepatitis B is already available in 17 countries including China, South Korea, the US, Canada, UK, Germany and France. While in most markets the trade name Zeffix is used, it is known as Epivir-HBV in the US it is, in Canada as Heptovir and in China as Heptodin. References: 1. Samuel et al. N Engl J Med 1993; 329:1842-1847. 2. The World Health Report. WHO 1998. 3. Mast EE, Alter MJ. Epidemiology of viral hepatitis: an overview. Sem Virol 1993; 4:273-283. Related Links: Zeffix (lamivudine) and BioChem Pharma Inc. E-mail this page to a friend or colleague! To print, use this version