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| |  Lamivudine Reduces Liver Damage Due to Chronic Hepatitis B -- Study LONDON and LAVAL, Quebec -- April 10, 1997 -- The results from a Phase III clinical study of lamivudine in hepatitis B show the investigational drug to be significantly effective in reducing the damaging effects of chronic hepatitis B on the liver. These results will be presented today in London, U.K., at the annual meeting of the European Association for the Study of the Liver. The study involved 358 Asian patients with chronic hepatitis B across centres in Hong Kong, Singapore and Taiwan. Lamivudine is a nucleoside analogue antiviral drug for the treatment of hepatitis B, which is under development by Glaxo Wellcome. The company intends to file for regulatory approval of lamivudine worldwide beginning with filings in Asia later this year. This study was designed primarily to assess the long-term effect of lamivudine on improving liver histology, an important indicator of severity and stage of liver disease caused by the body's immune response against liver cells infected with hepatitis B. These results indicate that over a one year period, improvements in liver histology were demonstrated in a significantly higher percentage of lamivudine patients compared to placebo (67% of patients receiving lamivudine 100 mg orally once daily and 59% of patients receiving lamivudine 25 mg orally once daily, compared to 30% of patients receiving placebo). In addition, fewer lamivudine patients (7% of patients on 100 mg and 10% of patients on 25 mg) had deterioration of liver histology compared to placebo (32%). Chronic hepatitis B can cause deteriorating liver histology, leading to cirrhosis (severe liver scarring) and liver cancer. Such clinical conditions are due to progressive liver damage. The most important goal of hepatitis B therapy is to reduce liver damage caused by the immune system. An antiviral, such as lamivudine, which reduces viral replication, can reduce the level of immunological activity against infected liver cells and may prevent long-term complications associated with this disease. The presence of hepatitis B e antigen (HBeAg) in patients with hepatitis B is associated with active viral replication. The study results indicate that 16% of patients on lamivudine 100 mg compared to 4% of patients on placebo converted from being HBeAg positive to HBeAg negative with undetectable hepatitis B virus (HBV) DNA. This response, known as seroconversion, is indicative of the body's immune system mounting an effective response to this viral protein. Sustained reductions in the levels of HBV DNA in the lamivudine treatment arms mirrored the significant data obtained in the Phase II studies. HBV DNA is an important marker of viral replication and viraemia (the level of virus in the blood). Lamivudine was discovered by BioChem Pharma of Laval, Quebec, Canada and licensed to Glaxo (now Glaxo Wellcome) in 1990. Glaxo Wellcome is a research-based pharmaceutical company. BioChem Pharma is an international biopharmaceutical company involved in the research, development and commercialization of innovative products for the prevention, detection and treatment of human diseases.
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