The treatment with the Bristol-Myers Squibb Company investigational chronic hepatitis B antiviral agent entecavir made significant improvements in liver histology (primary study endpoint), and reductions of hepatitis B virus (HBV) DNA levels as well as normalization of alanine aminotransferase (ALT) levels (secondary study endpoint) compared to lamivudine in nucleoside-naïve, chronic hepatitis B e-antigen (HBeAg) positive patients, according to the data presented at the 55th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).

Hepatitis B e-antigen (HBeAg) positive hepatitis B virus is a wild type strain of HBV and is responsible for deterioration of liver function, cirrhosis and liver cancer in 25 to 40 percent of patients who are chronically infected.

The study evaluated 709 nucleoside-naïve HBeAg positive chronic hepatitis B patients randomized to receive 0.5 mg of entecavir once daily (n=354) or lamivudine 100 mg once daily (n=355) for at least 52 weeks. At Week 48, histologic improvement was observed in 72 per cent of patients taking entecavir compared to 62 per cent of patients receiving lamivudine using the Knodell necroinflammatory score analysis. The 48-week results were statistically significant (p=0.0085); however, there was no significant difference between the two treatment arms in the secondary endpoint measure of liver histology using the Ishak Fibrosis Score analysis, a BMS release says.

"Preventing the progression of liver disease is the primary objective when treating chronic hepatitis B patients," said Dr. Robert Gish, an AI463-022 study investigator and medical director of the California Pacific Medical Centre's liver transplant programme in San Francisco. He added, "Phase III data for entecavir have demonstrated that hepatitis B e-antigen positive patients receiving entecavir experienced statistically significant improvements in liver histology and viral suppression compared to lamivudine."

Entecavir, currently in Phase III clinical development and discovered at Bristol-Myers Squibb, is an investigational oral nucleoside analogue which is a selective inhibitor of the hepatitis B virus. Bristol-Myers Squibb recently submitted a new drug application (NDA) for entecavir to the US FDA and a marketing authorization application (MAA) for entecavir with the European Medicines Evaluation Agency (EMEA). The applications include data from phase III clinical trials investigating the use of entecavir in more than 1,600 patients on five continents.

More than 2 billion people worldwide have been infected with hepatitis B virus and approximately 350-400 million of these people are chronically infected. According to the World Health Organization, more than half a million people worldwide die each year from primary liver cancer, and up to 80 percent of liver cancers are due to hepatitis B.