#98-041
Mari Mansfield, (919) 483-8582
Bill Chapman, (919) 483-2839
NEW CLINICAL DATA PRESENTED AT DDW MEETING: LAMIVUDINE OFFERS HOPE FOR HEPATITIS B SUFFERERS
NEW ORLEANS, May 17, 1998 -- Two major clinical studies presented today at the Digestive Disease Week meeting add important new information about the anti-viral drug, lamivudine, in the treatment of patients with chronic hepatitis B. The studies with lamivudine, an oral anti-viral treatment under development by Glaxo Wellcome Inc., show that the drug offers benefits that can be sustained for as long as two years in patients with chronic hepatitis B.
Hepatitis B is a potentially fatal liver disease -- the ninth most common cause of death worldwide. An estimated 350 million people are long-term carriers of the hepatitis B virus (HBV), and approximately one-third of these individuals are expected to develop serious progressive liver disease. Chronic hepatitis B can cause progressive inflammation and scarring in the liver, leading to liver failure or liver cancer. Currently, established treatments for hepatitis B are designed to boost the immune system. The goal of anti-viral treatment with drugs such as lamivudine is to inhibit HBV replication, thus leading to reduced inflammatory attack by the immune system on HBV-infected cells in the liver, and potentially stopping or delaying the progressive liver damage.
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The first study, which was presented by Y.F. Liaw, M.D., professor at Chang Gung Memorial Hospital in Taiwan, is a continuation of treatment for patients previously treated in a one-year treatment study reported last year. The continuation study was designed to assess longer term efficacy of lamivudine measured by sustained reductions in HBV virus levels in the blood. Of the 358 patients who participated in the earlier one-year treatment study, 334 enrolled in the continuation study. At the start of the continuation study, patients who were receiving lamivudine in the preceding study (at either of two dose levels) were randomized to continued treatment at their previous dose-level, or to placebo treatment; patients who received placebo in the preceding study were all assigned to receive lamivudine treatment 100mg daily in the continuation study.
The present report concerns interim treatment comparisons after the first year of additional treatment in the continuation study -- i.e., after two years of total treatment in the two sequential clinical studies. This ongoing study will continue for an additional two years. The analyses showed that patients receiving 100mg lamivudine daily for two years had the best results, with regard to reduced viral levels and improvements in seroconversion (seroconversion usually denotes long-term disease remissions). In the earlier study, the seroconversion rate was 17 percent at one year for lamivudine vs. 4 percent for placebo. The seroconversion rate for continuous lamivudine treatment increased to 27 percent after two years. In addition, many patients achieved persistently normal levels of serum liver enzymes, which are typically elevated in patients with hepatitis.
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Lamivudine was well tolerated by the patients in the study with 90 percent of patients completing the two-year study. The adverse events observed in lamivudine-treated patients were similar to those observed in the placebo group. The most common adverse events by patients taking lamivudine 100mg were cough (33 percent), respiratory infection (25 percent), malaise/fatigue (19 percent) and abdominal pain/discomfort (19 percent).
ìThese results add evidence that lamivudine therapy provides continuing and increasing improvements in patients with chronic hepatitis B,î said Dr. Y.F. Liaw. ìTreatment with lamivudine 100mg daily for two years resulted in a higher proportion of patients achieving sustained HBV DNA suppression, HBeAg seroconversion and ALT normalization.î
A second major study presented at the conference today by Jules Dienstag, M.D., from the Harvard University Medical School, Boston, focused on the benefits of lamivudine in previously untreated U.S. patients with chronic hepatitis B.
Patients in this study were randomized to double-blinded treatment with lamivudine 100mg daily or placebo for a period of one year, and then participated in post-treatment follow-up for 16 weeks. The primary efficacy measure in the trial was improvement in liver biopsies (reduction in liver inflammation and scarring). Liver biopsies were performed prior to treatment and after one year of treatment (week 52 on study).
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The study showed that the proportion of patients exhibiting substantial improvement in the follow-up liver biopsies was significantly greater in patients treated with lamivudine compared to patients treated with placebo (52 percent vs. 23 percent, p<0.001). In addition, after one year of treatment, patients treated with lamivudine were more likely to experience seroconversion than patients taking placebo (17 percent vs. 6 percent, p<0.04). In this study lamivudine was generally well-tolerated with a similar safety profile to placebo. The most common adverse events reported by patients taking lamivudine 100mg vs. placebo were: malaise/fatigue (37 percent vs. 31 percent), headache (27 percent vs. 23 percent), nausea/vomiting (21 percent vs. 27 percent), and abdominal pain/discomfort (17 percent vs. 23 percent).
ìThese two important studies show that we get similar results across diverse patient groups with lamivudine,î said Nancy Leung, M.D., chief of hepatology and honorable associated professor at the Prince of Wales Hospital in Hong Kong, ìand efficacy continues to improve with two years of therapy in Chinese patients.î
Lamivudine was discovered by BioChem Pharma of Laval, Quebec and licensed to Glaxo (now Glaxo Wellcome) in 1990.
Glaxo Wellcome Inc., based in Research Triangle Park, N.C., is one of the nationÃs leading research-based pharmaceutical firms. A subsidiary of London-based Glaxo Wellcome plc, the company is committed to fighting disease by bringing innovative medicines and services to patients and to the healthcare providers who serve them.
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