28.04.2006 – 12:20
96-Week Data Show Entecavir Demonstrates More Viral Suppression Compared to Lamivudine in Hepatitis B Infected E-Antigen Negative Patients
Bristol-Myers Squibb Company (NYSE: BMY) today announced 96-week clinical trial results demonstrating that entecavir maintains more viral load suppression compared to lamivudine in nucleoside-naive, chronic hepatitis B e-antigen-negative (HBeAg-) patients. Data were presented today at the 41st Annual Meeting of the European Association for the Study of the Liver.
Ninety-four percent of HBeAg-negative patients treated with entecavir for up to 96 weeks compared to 77 percent of patients treated with lamivudine achieved an undetectable viral load, defined as HBV DNA less than 300 copies per milliliter of blood (mL). This difference was statistically significant (p < 0.0001). In addition, no evidence of entecavir resistance was identified with up to 96 weeks of entecavir treatment in patients without lamivudine resistance substitutions at baseline.
"Chronic hepatitis B is a significant health challenge in Europe, the Middle East and Africa," said study author Daniel Shouval, M.D., Professor of Medicine and Director, Liver Unit, Hadassah-Hebrew University Hospital, Jerusalem. "The burden is increasing despite the availability of vaccination programs. It is important to consider results from studies such as this one to address this disease."
The 96-week, Phase III clinical trial data are an update to the 48-week results published in the March 9 issue of The New England Journal of Medicine.
About the Study
Study ETV-027 was a large-scale, multinational, Phase III clinical trial of 638 HBeAg-negative chronic hepatitis B patients who had not previously received nucleoside treatment. The clinical profile of HBeAg-negative chronic hepatitis B differs from that of HBeAg-positive disease in that patients are typically older, serum HBV DNA levels are usually lower, and liver disease may fluctuate. Patients with HBeAg-negative chronic hepatitis B may also have more advanced liver disease, and the likelihood of spontaneous remission is low.
In the study, patients received either entecavir 0.5 mg once daily (n=325) or lamivudine 100 mg once daily (n=313) for a minimum of 52 weeks. At week 52, patients were categorized into one of three groups based on evaluations at week 48: non-responders, who discontinued treatment; responders for both virology and liver function, who discontinued treatment and were followed for 24 weeks off-treatment; and virologic responders with persistent liver enzyme elevations who went on to receive blinded treatment up to week 96.
In an analysis of study results that assessed the cumulative probability of response through 96 weeks among all treatment-naive, HBeAg-negative chronic hepatitis B patients who initiated treatment with entecavir (n=325) versus lamivudine (n=313), 94 percent of patients in the entecavir treatment group achieved virologic suppression to undetectable levels, compared to 77 percent of patients given lamivudine (p < 0.0001). Additionally, the proportion of patients achieving ALT level normalization was 89 percent for patients treated with entecavir, compared to 84 percent of patients treated with lamivudine (p=0.05).
No evidence of entecavir resistance was identified with up to 96 weeks of entecavir treatment in patients without lamivudine resistance substitutions at baseline.
The safety profile of entecavir was comparable between the treatment groups, with similar incidence of serious adverse events (6 percent with entecavir, 8 percent with lamivudine) and total adverse events (76 percent with entecavir, 80 percent with lamivudine). Discontinuations due to adverse events were observed in 2 percent of patients treated with entecavir versus 3 percent of patients treated with lamivudine. The incidence of ALT flares in patients treated with entecavir on- and off-treatment were <1 percent and 8 percent, respectively, and in patients treated with lamivudine were 2 percent and 11 percent, respectively. ALT flares are increases in liver inflammation associated with substantial enzyme elevations.
About Chronic Hepatitis B
Chronic hepatitis B is a serious global public health issue, with 300-400 million people worldwide chronically infected despite the availability of a vaccine.(1) In Europe, an estimated one million people are infected with hepatitis B every year.(2) Hepatitis B is the 10th leading cause of death worldwide, causing 1.2 million deaths annually, and chronic hepatitis B infection is responsible for 80 percent of hepatocellular carcinoma (liver cancer) cases.
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.
1. World Health Organization. "Hepatitis B". Available at
http://www.who.int/mediacentre/factsheets/fs204/en/. Accessed 13
2. British Liver Trust. "Hepatitis B Overview."
Accessed 13 March, 2006.
ots Originaltext: Bristol-Myers Squibb
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