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Heard it before? Drug company shake-up
Gastroenterology News continued
Lamivudine Shows Promise in Treatment of Chronic Hepatitis B esearchers at Queen Mary Hospital in Hong Kong, China, have published promising results from a year-long, double-blind trial of the agent lamivudine for the treatment of chronic hepatitis B (HBV). Following up on preliminary studies, which relied on 3- and 6-month treatment data, Lai et al. (with support from Glaxo Wellcome in the United Kingdom) reported in the July 9 New England Journal of Medicine that continued use of the agent reduces, though does not clear, the viral infection and appears to lower the risk of inflammatory liver disease and the development of cirrhosis. The trial, which took place in a country that has more than threefourths of the world’s HBV cases, randomly divided 358 patients into three groups: two receiving lamivudine daily for a year (100 or 25 mg) and one placebo. The lamivudine patients were much more likely to
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Heard it Before? Drug Company Shake-up n the latest of a string of shake-ups involving pharmaceutical companies, Swedish-based Astra AB combined Astra USA with Astra Merck to form Astra Pharmaceuticals, effective July 1. The combined company, headquartered in Wayne, PA, will eventually manufacture and market all Astra prescription products in the United States, including gastrointestinal medicines Prilosec and perprazole.
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show improved necroinflammatory activity than the placebos, with the larger-dose patients faring best. The 100-mg dose was also associated with reduced fibrosis progression, the highest rate of hepatitis B e antigen seroconversion (16%), the greatest suppression of HBV DNA (a 98% reduction by study’s end), and the highest rate of sustained normalization of alanine aminotransferase levels (72%). Moreover, the incidence of negative events was similar across the patient groups. ‘‘Given that this agent apparently has few side effects, it would seem worthwhile to continue it for a long time, even beyond a year,’’ observes David Shafritz of the Albert Einstein College of Medicine. ‘‘If it is arresting or retarding the development of chronic liver disease, that’s good for the patient from all perspectives.’’ Shafritz notes that the therapy has downsides, as mentioned by the authors in the article. In 14% of the patients in both lamivudine groups, genotypic mutations developed that
are known to reduce effectiveness of the treatment. ‘‘That’s something that has to be watched,’’ Shafritz says. ‘‘The concern is what will then happen to the viremia in the long run— will it return, and will it then be an aggressive disease?’’ Another question worth examining, Shafritz says, is what effect lamivudine would have in combination with interferon alfa, the more common worldwide treatment. ‘‘These agents work differently, so combination therapy immediately comes to mind as another approach to rid the viral infection,’’ Shafritz says. Less clear is the therapy’s effect on the development of liver cancer. Obtaining objective data will be difficult, Shafritz notes, requiring study of many patients and many years of follow-up. ‘‘My own view is that reducing the inflammatory liver disease will lower the risk for integration of the viral DNA into the cellular genome, and thus, possibly, reduce oncogenesis.’’
Astra’s public relations director, Cathy Kernen, said gastroenterologists will not see any immediate changes resulting from the restructuring. Astra anticipates no reduction in its sales force, and the reps will remain unchanged, Kernen said. Astra Merck, which had 1997 sales of $2.3 billion, has marketed certain Astra products in the United States, including Prilosec, the best-selling prescription medication in the world. Astra USA, which had 1997 sales of $400 million, has been a leading
marketer of hospital products in the United States, including Xylocaine, a leading local anesthetic. The parent company, which develops gastrointestinal, cardiovascular, respiratory, and pain-control products, posted 1997 revenues of $5.9 billion.
Stories by Dan Gordon The section editor can be sent suggestions for articles at [email protected]
Lamivudine Shows Promise in Treatment of Chronic Hepatitis B esearchers at Queen Mary Hospital in Hong Kong, China, have published promising results from a year-long, double-blind trial of the agent lamivudine for the treatment of chronic hepatitis B (HBV). Following up on preliminary studies, which relied on 3- and 6-month treatment data, Lai et al. (with support from Glaxo Wellcome in the United Kingdom) reported in the July 9 New England Journal of Medicine that continued use of the agent reduces, though does not clear, the viral infection and appears to lower the risk of inflammatory liver disease and the development of cirrhosis. The trial, which took place in a country that has more than threefourths of the world’s HBV cases, randomly divided 358 patients into three groups: two receiving lamivudine daily for a year (100 or 25 mg) and one placebo. The lamivudine patients were much more likely to
R
Heard it Before? Drug Company Shake-up n the latest of a string of shake-ups involving pharmaceutical companies, Swedish-based Astra AB combined Astra USA with Astra Merck to form Astra Pharmaceuticals, effective July 1. The combined company, headquartered in Wayne, PA, will eventually manufacture and market all Astra prescription products in the United States, including gastrointestinal medicines Prilosec and perprazole.
I
522
show improved necroinflammatory activity than the placebos, with the larger-dose patients faring best. The 100-mg dose was also associated with reduced fibrosis progression, the highest rate of hepatitis B e antigen seroconversion (16%), the greatest suppression of HBV DNA (a 98% reduction by study’s end), and the highest rate of sustained normalization of alanine aminotransferase levels (72%). Moreover, the incidence of negative events was similar across the patient groups. ‘‘Given that this agent apparently has few side effects, it would seem worthwhile to continue it for a long time, even beyond a year,’’ observes David Shafritz of the Albert Einstein College of Medicine. ‘‘If it is arresting or retarding the development of chronic liver disease, that’s good for the patient from all perspectives.’’ Shafritz notes that the therapy has downsides, as mentioned by the authors in the article. In 14% of the patients in both lamivudine groups, genotypic mutations developed that
are known to reduce effectiveness of the treatment. ‘‘That’s something that has to be watched,’’ Shafritz says. ‘‘The concern is what will then happen to the viremia in the long run— will it return, and will it then be an aggressive disease?’’ Another question worth examining, Shafritz says, is what effect lamivudine would have in combination with interferon alfa, the more common worldwide treatment. ‘‘These agents work differently, so combination therapy immediately comes to mind as another approach to rid the viral infection,’’ Shafritz says. Less clear is the therapy’s effect on the development of liver cancer. Obtaining objective data will be difficult, Shafritz notes, requiring study of many patients and many years of follow-up. ‘‘My own view is that reducing the inflammatory liver disease will lower the risk for integration of the viral DNA into the cellular genome, and thus, possibly, reduce oncogenesis.’’
Astra’s public relations director, Cathy Kernen, said gastroenterologists will not see any immediate changes resulting from the restructuring. Astra anticipates no reduction in its sales force, and the reps will remain unchanged, Kernen said. Astra Merck, which had 1997 sales of $2.3 billion, has marketed certain Astra products in the United States, including Prilosec, the best-selling prescription medication in the world. Astra USA, which had 1997 sales of $400 million, has been a leading
marketer of hospital products in the United States, including Xylocaine, a leading local anesthetic. The parent company, which develops gastrointestinal, cardiovascular, respiratory, and pain-control products, posted 1997 revenues of $5.9 billion.
Stories by Dan Gordon The section editor can be sent suggestions for articles at [email protected]