Study compares hepatitis B treatments.

2004 DEC 1 - (NewsRx.com & NewsRx.net) -- Bristol-Myers Squibb announced that data from two studies show its investigational chronic hepatitis B compound, entecavir, demonstrated significantly greater improvements in both liver histology and reductions of hepatitis B virus (HBV) DNA levels compared to another hepatitis B compound, lamivudine.

According to the announcement, the first study - AI463-027 - evaluated 638 nucleoside-naive patients with HBeAg negative chronic hepatitis B, who received entecavir .5 mg once daily or lamivudine 100 mg once daily (for at least 52 weeks.

HBeAg negative chronic hepatitis B is characterized by a progressive course of severe liver damage with a poor long-term prognosis and frequent progression to cirrhosis and liver cancer. After 48 weeks of treatment, 70% of patients treated with entecavir demonstrated histologic improvements compared to 61% of patients treated with lamivudine using the Knodell necroinflammatory score analysis. However, the announcement also noted that there was no significant difference between the two treatment arms in the secondary endpoint measure of liver histology using the Ishak Fibrosis Score analysis.

Patients taking entecavir experienced a significant mean reduction in HBV DNA from baseline compared to lamivudine. Additionally, at the 48th week, undetectable HBV DNA was achieved in 91% of people in the entecavir arm compared to 73% of people in the lamivudine arm. There was no significant difference in the proportion of patients with alanine aminotransferase (ALT) level normalization. Elevated ALT levels can indicate liver inflammation and liver disease progression.

Bristol-Myers said that safety was comparable between the treatment groups, with similar incidence of serious adverse events (6% with entecavir, 8% with lamivudine) and total adverse events (75% with entecavir, 79% with lamivudine).

"In this study, a higher proportion of hepatitis B e-antigen negative patients receiving entecavir experienced improvements in liver histology and viral suppression compared to lamivudine," said Dr. Daniel Shouval, a lead AI463-027 investigator and director of the Hadassah University Hospital's liver unit in Jerusalem, Israel.

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