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Although lamivudine had shown promise in patients in Hong Kong with chronic hepatitis B, long-term data on patients from the United States had been lacking until they appeared in 1999 in The New England Journal of Medicine.
Lamivudine appears to keep hepatitis B under control without causing major side effects. The hepatitis B virus (HBV) is spread through sexual contact, by sharing needles for injecting drugs, and from mother-to-child during delivery. (The virus can also be transmitted through blood transfusions but screening of the blood supply in the United States has made such transmission ultra rare.) Infection with HBV can develop into a chronic infection that may go on for years.
Research had proved lamivudine's effectiveness in treating chronic HBV infection in Hong Kong. However, most Asian people contract HBV at delivery. There was concern that lamivudine might not work as well in Western countries where most people become infected with HBV as adults.
In the 1999 New England Journal study, the researchers randomly assigned 137 people with chronic HBV infection to receive lamivudine or a placebo (dummy pill) for a year. After the end of the year, the participants were followed for another 16 weeks to see how long the effect of the drug lasted. Of 66 people on lamivudine, 34 (52%) had significant whereas only 16 of 71 (23%) in the placebo group showed as much improvement. Liver tissue taken before and after treatment also revealed that inflammation decreased in 64% of people taking lamivudine, compared with 34% of those taking placebo. A year of lamivudine treatment appeared to be more effective in suppressing HBV than a shorter course of the drug. Once treatment stopped, levels of HBV did remain significantly suppressed in the lamivudine group. If lamivudine is used for only 3 and 6 months, the levels of HBV rebound within 2 months after stopping the treatment.
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The citation to the original 1999 article in The New England Journal of Medicine is as follows: Dienstag JL et al. Lamivudine as initial treatment for chronic hepatitis B in the United States. New Engl J Med 1999;341:1256-1263.
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