To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: EASL: Zeffix (Lamivudine) Induces Virologic Response In Children With Hepatitis B URL: http://www.pslgroup.com/dg/1F89A6.htm Doctor's Guide April 23, 2001
LAVAL, QC -- April 23, 2001 -- BioChem Pharma Inc. announced that new Zeffix (lamivudine) data were presented at the European Association for the Study of the Liver (EASL) Congress, in Prague, the Czech Republic. One in four of the many millions of children worldwide who become chronically infected with the hepatitis B virus (HBV) during early childhood, will go on to die from liver cancer or cirrhosis of the liver in adulthood as a result of the infection.(1) This statistic could soon become a thing of the past, according to exciting new research presented at the EASL Congress. The study's results show that a year's treatment with Zeffix, induces a complete virologic response* (CVR), a good indicator that the virus has been effectively suppressed, in almost a quarter (23 percent) of children suffering from the disease. These children were therefore able to stop treatment. This was significantly better than the placebo group, where only 13 percent achieved the same outcome. The result is similar to that observed after one year's treatment in adults suffering from chronic hepatitis B, where Zeffix is already an established treatment. Data in adults have shown that the number of patients who achieve complete virologic response on Zeffix treatment increases year-on-year, and at four years, three quarters of patients with active liver disease** are able to stop treatment.(2) These new data suggest that this pattern of improvement may be mirrored in children. Importantly, even the 18 percent of patients with a variant form of HBV (YMDD variant HBV), which have reduced susceptibility to Zeffix in laboratory assays, derived some clinical benefit from treatment. Professor Etienne Sokal, from the Université Catholique de Louvain, in Brussels, Belgium, who was the lead European investigator in this study, commented, "Despite the major advances made by hepatitis B vaccination programmes throughout the world, chronic hepatitis B infection in children remains a serious health problem. This is especially the case amongst people living in, or coming from, the Asia Pacific region, where many millions of children are chronic hepatitis B carriers and several million new-born infants are also thought to be infected with the virus. This study's results provide compelling evidence to show that Zeffix is effective at suppressing the virus. A quarter of all treated patients, and up to one third of patients with more active disease, heal from the active-replicative phase of hepatitis after only one year of treatment. This compares with 13 percent of controls in the total patient population and 16 percent of controls in those with more active disease. Zeffix is also a well tolerated oral treatment, and such a safety profile is of particular significance when treating young children." This large international multi-centre study involved 286 children between two and seventeen years of age with chronic hepatitis B. All the children at the start of the study were positive for HBeAg and HBV DNA (markers of active HBV replication) and the liver enzyme ALT was at least 1.3 times above normal levels (ALT is released in large amounts into the blood when liver cells are damaged). A third (95) of the children received placebo and the remaining two thirds (191), were treated with Zeffix (up to 100 mg once daily) for a year. In addition to a significantly higher CVR in Zeffix compared with placebo, the results also demonstrated that: - Significantly more children became HBeAg negative on Zeffix (26 percent) compared with placebo (15 percent); - Significantly higher numbers of children achieved sustained normalization of ALT with Zeffix (55 percent) compared with placebo (13 percent); and - HBV DNA was undetectable in 61 percent of children taking Zeffix compared with 16 percent in the placebo group. Chronic (long-term) hepatitis B is a potentially fatal liver disease, and there are more than 350 million carriers worldwide.(3) Children are particularly susceptible to developing chronic infection. It is estimated that nine out of ten infants contracting hepatitis B infection will go on to become chronically infected.(1) Chronic hepatitis B causes at least one million premature deaths every year from cirrhosis of the liver or liver cancer.(4) It is second only to tobacco as a leading cause of cancer in humans.(5) Zeffix is indicated for treatment of patients 16 years of age or over with chronic hepatitis B and evidence of HBV replication. A regulatory application to extend the indication for the treatment of chronic hepatitis B in patients two years and above was submitted to the FDA in March 2000. Zeffix is currently available in over 50 countries worldwide, including China (as Heptodin), the USA (as Epivir-HBV), Canada (as Heptovir) and the EU. More than 200,000 patients have been treated with Zeffix since its first launch in November 1998. References: (1) WHO website http://www.who.int/inf-fs/en/fact204.html (2) Chang TT, Lai CL, Liaw YF et al. Incremental increase in HBeAg seroconversion and continued ALT normalization in Asian chronic HBV patients treated with Lamivudine for four years. Antiviral Therapy 2000; (3) The World Health Report. WHO 2001. (4) Davey S. State of the World's Vaccines and Immunization. Geneva: World Health Organization, 1996:76-82. (5) WHO, Geneva 1999 Department of vaccines and other biological v&b annual report, 1998. * CVR defined as HBeAg-ve with undetectable hepatitis B virus DNA ** With greater than twice the upper limit of the normal level of a liver enzyme called ALT SOURCE: BioChem Pharma --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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