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| |  EASL MEETING: Zeffix May Offer Long-Term Benefits For Chronic Hepatitis B Patients LAVAL, QC -- April 12, 1999 -- Millions of chronic hepatitis B sufferers, at risk of their liver disease progressing to cirrhosis (severe liver scarring), could have a powerful new therapeutic ally in Glaxo Wellcome’s and BioChem Pharma’s Zeffix (lamivudine), according to new data presented today at the annual meeting of the European Association for the Study of the Liver (EASL). Data from three large clinical studies demonstrated that a smaller proportion of chronic hepatitis B patients treated with Zeffix progressed to cirrhosis compared to those treated with placebo or interferon-alpha. These results were supported by other data presented at the meeting showing additional benefits with Zeffix therapy. Data were presented from three studies involving 578 patients with chronic hepatitis B: two comparing Zeffix (100 mg once daily) with placebo and one comparing Zeffix (100 mg once daily) with interferon-alpha. The studies were designed to assess changes in liver inflammation over one year. An analysis of the integrated data from all three studies was performed to assess patients' progression to cirrhosis during the study periods. The results showed that a smaller proportion of Zeffix-treated patients progressed to cirrhosis (1.8 percent, 4/219), when compared to placebo-treated patients (7.1 percent, 7/99), or patients treated with interferon-alpha (9.5 percent, 4/42). Data from an additional study which support these findings were presented by professor Nancy Leung from the Prince of Wales Hospital in Hong Kong and were part of a large Asian multicentre study of patients with chronic hepatitis B. Of the 285 patients who completed the study, 58 patients received 100 mg Zeffix, once daily, continuously for three years. The results demonstrate that the efficacy of Zeffix is cumulative with duration of treatment and showed: -- Continued increase in the incidence of e-antigen seroconversion (an immune response to the virus that is thought to predict long lasting remission of the disease); and -- Continued reduction in levels of viral replication. Hepatitis B is a potentially fatal liver disease -- the ninth most common cause of death world-wide. Approximately 350 million people around the world are long-term carriers of the hepatitis B virus (HBV) and nearly one third of these individuals are expected to develop progressive inflammation of the liver, leading to cirrhosis and liver cancer. Previously, licensed therapy for chronic hepatitis B was limited to interferons, which are administered by injection and can be associated with unpleasant side effects. The findings in the cirrhosis study extend results reported over the past year from three international studies, which demonstrated that Zeffix reduced the progression of fibrosis (growth of fibrous liver tissue) in chronic hepatitis B patients.
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