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96-Week Data Show Entecavir Demonstrates More Viral Suppression Compared to Lamivudine in Hepatitis B Infected E-Antigen Negative Patients

Vienna, Austria (ots/PRNewswire)

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.
    References
    1. World Health Organization. "Hepatitis B". Available at
       http://www.who.int/mediacentre/factsheets/fs204/en/. Accessed 13
       March, 2006.
    2. British Liver Trust. "Hepatitis B Overview."
       http://www.britishlivertrust.org.uk/content/diseases/hepatitis_b.asp.
       Accessed 13 March, 2006.

Contact:

Brian Henry of Bristol-Myers Squibb, Office, +33-1-58-83-69-38,
Mobile, +33-6-75-09-08-99, brian.henry@bms.com

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