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Zeffix Improves Liver Disease, Suppresses Virus in Hepatitis B Patients LAVAL, QC. -- October 21, 199 -- According to new data published today (Oct. 21) in the New England Journal of Medicine, patients suffering from chronic hepatitis B in the US benefit from treatment with BioChem Pharma Inc.’s Zeffix (lamivudine). The research shows the drug offers benefits in terms of improvement of liver disease and suppression of the hepatitis B virus, with sustained post-treatment responses in some patients. In addition the authors suggest that Zeffix therapy should be continued until seroconversion occurs in order to arrest or delay long-term liver damage. The clinical trial, reported by Dr. Jules Dienstag (Massachusetts General Hospital/Harvard Medical School) and co-authors, involved 137 adult patients from 34 clinical centers. Patients had chronic hepatitis B and received either Zeffix (lamivudine) 100 mg daily or a matching placebo for one year. Significantly more patients taking Zeffix (52 percent) had improvement in liver inflammation compared with those receiving placebo (23 percent). Furthermore only 5 percent of patients on Zeffix showed worsening of fibrosis (scarring of the liver) compared with 20 percent on placebo. Sustained normalization of ALT (a key protein in the blood which indicates ongoing liver damage) was also seen during Zeffix therapy. In addition this trial showed suppression of viral load in the blood to undetectable levels in 98 percent of patients on Zeffix compared with 33 percent on placebo. Loss of hepatitis B "e antigen" (HBeAg; a blood marker of ongoing viral replication) coupled with appearance of the e-antibody (seroconversion) was observed in 17 percent of patients on Zeffix but only 6 percent on placebo. These observations are important since seroconversion often predicts long-term disease remission. Overall these results are similar to those reported last year in a trial in Asian patients, thus showing comparable efficacy in Asian and Western patients. The study also provides further evidence to support a sustained response after stopping Zeffix therapy. Treatment was discontinued after one year and patients were monitored for 16 weeks without treatment. It was found that virological responses achieved during the year of therapy with Zeffix were usually sustained among patients who had achieved loss of HBeAg or seroconversion by the end of therapy. In addition, severe post-treatment clinical events were rare and not different in frequency following either Zeffix or placebo. "These new results will increase prescribers’ confidence about the many benefits that Zeffix brings to patients with chronic hepatitis B," said Dr. Gervais Dionne, Executive Vice President, Research and Development, BioChem Pharma. Hepatitis B is a potentially fatal liver disease. Approximately 350 million people around the world are long-term carriers of the hepatitis B virus and nearly one third of these individuals are expected to develop progressive inflammation of the liver, leading to cirrhosis and/or liver cancer. Previously, licensed therapy for chronic hepatitis B was limited to interferons, which are administered by injection and are often associated with unpleasant side effects. Related Links: Zeffix (lamivudine) and BioChem Pharma Inc. E-mail this page to a friend or colleague! To print, use this version