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RESEARCH TRIANGLE PARK, N.C. -- The results of a large, controlled, multi-centered study were published today in the New England Journal of Medicine indicating that long-term treatment with EPIVIR- HBV(R) (lamivudine) delayed disease progression in chronic hepatitis B patients with advanced fibrosis or cirrhosis by significantly reducing the rate of liver complications including the development of liver cancer. Treatment with lamivudine was associated with an approximate 50 percent reduction in disease progression during the treatment period. The study results are significant because in many geographic areas and ethnic populations, chronic hepatitis B is a major health problem.
The study reports results of a 651 patient, double-blind, placebo-controlled clinical trial that was conducted at multiple centers in Asia- Pacific countries.
* Patients received treatment for a median of 32 months. During this time only eight percent of lamivudine-treated patients had defined events indicating disease progression in advanced chronic hepatitis B as compared with 18 percent of patients receiving placebo.
* Among the individual disease endpoints, three percent of the lamivudine group saw an increase in the Child-Pugh score (a scoring system to assess liver function), compared with nine percent of those patients on placebo.
* Hepatocellular carcinoma (liver cancer) occurred in four percent of lamivudine treated patients and in seven percent of placebo recipients
"These results are clinically very important and signal hope for many patients," stated Professor Y.F. Liaw of Chang Gung Memorial Hospital and University, Taipei, Taiwan. "They show that lamivudine is not only an effective treatment for chronic hepatitis B, but that it can also delay development of serious life-threatening complications associated with disease progression. These results underscore the importance of lamivudine treatment in delaying the progression of this serious disease."
EPIVIR-HBV is approved in the United States for the treatment of chronic hepatitis B associated with viral replication and active liver inflammation in adults and children ages two to 17 years. The recommended oral dose of EPIVIR-HBV for treatment of chronic hepatitis B in adults is 100 mg once daily. The safety and effectiveness of treatment beyond one year and long-term treatment benefits have not been established. The optimal duration of treatment has not been established. EPIVIR-HBV is not a cure for hepatitis B and has not been shown to reduce the risk of transmission of HBV to others.
Cirrhosis due to chronic hepatitis B is a common cause of liver failure, liver cancer and a major cause of morbidity and mortality in the Asia-Pacific region. One in 10 Asian-Americans is also infected with hepatitis B and 5,000 people in the United States will die from hepatitis B-associated complications annually.
Treatment with lamivudine was generally well-tolerated. Adverse events were reported by 77 percent of patients who received lamivudine and 83 percent of those who received placebo. The three most frequently reported adverse events in the study were ear, nose and throat infections (22 percent on lamivudine and 20 percent on placebo), abdominal discomfort and pain (18 percent and 20 percent, respectively) and malaise and fatigue (15 percent and 20 percent, respectively). Events meeting the criteria that defined them as serious adverse events occurred in 12 percent of patients receiving lamivudine and 18 percent receiving placebo. Elevations in serum ALT (an enzyme that is elevated if there is liver inflammation) occurred about twice as often in patients receiving placebo compared with those receiving lamivudine.
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases have been reported with the use of nucleoside analogues alone or in combination, including lamivudine and other antiretrovirals.
Human immunodeficiency virus (HIV) counseling and testing should be offered to all patients before beginning EPIVIR-HBV and periodically during treatment, because EPIVIR-HBV Tablets and Oral Solution contain a lower dose of the same active ingredient (lamivudine) as EPIVIR Tablets and Oral Solution used to treat HIV infection. If treatment with EPIVIR-HBV is prescribed for chronic hepatitis B for a patient with unrecognized or untreated HIV infection, rapid emergence of HIV resistance is likely because of subtherapeutic dose and inappropriate monotherapy.
Severe acute exacerbations of hepatitis have been reported in patients who have discontinued anti-hepatitis B therapy (including EPIVIR-HBV). Hepatic function should be monitored closely with both clinical and laboratory follow- up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis therapy may be warranted.