96-Week Data Show Entecavir Demonstrates More Viral Suppression Compared to Lami

[Guest guest]

96-Week Data Show Entecavir Demonstrates More Viral Suppression Compared to

Lamivudine in Hepatitis B Infected E-Antigen Negative Patients

PR Newswire Europe (inc. UK Disclose) - Apr. 28, 2006

VIENNA, Austria, April 28 /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 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.

Bristol-Myers Squibb Company

Henry of Bristol-Myers Squibb, Office, +33-1-58-83-69-38, Mobile,

+33-6-75-09-08-99, brian.henry@...

http://www.therapeuticsdaily.com/news/article.cfm?contenttype=sentryarticle & cont\

entvalue=882220 & channelID=31

_________________________________________________________________

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[Guest guest]

96-Week Data Show Entecavir Demonstrates More Viral Suppression Compared to

Lamivudine in Hepatitis B Infected E-Antigen Negative Patients

PR Newswire Europe (inc. UK Disclose) - Apr. 28, 2006

VIENNA, Austria, April 28 /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 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.

Bristol-Myers Squibb Company

Henry of Bristol-Myers Squibb, Office, +33-1-58-83-69-38, Mobile,

+33-6-75-09-08-99, brian.henry@...

http://www.therapeuticsdaily.com/news/article.cfm?contenttype=sentryarticle & cont\

entvalue=882220 & channelID=31

_________________________________________________________________

FREE pop-up blocking with the new MSN Toolbar – get it now!

http://toolbar.msn.click-url.com/go/onm00200415ave/direct/01/

[Guest guest]

96-Week Data Show Entecavir Demonstrates More Viral Suppression Compared to

Lamivudine in Hepatitis B Infected E-Antigen Negative Patients

PR Newswire Europe (inc. UK Disclose) - Apr. 28, 2006

VIENNA, Austria, April 28 /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 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.

Bristol-Myers Squibb Company

Henry of Bristol-Myers Squibb, Office, +33-1-58-83-69-38, Mobile,

+33-6-75-09-08-99, brian.henry@...

http://www.therapeuticsdaily.com/news/article.cfm?contenttype=sentryarticle & cont\

entvalue=882220 & channelID=31

_________________________________________________________________

FREE pop-up blocking with the new MSN Toolbar – get it now!

http://toolbar.msn.click-url.com/go/onm00200415ave/direct/01/

[Guest guest]

96-Week Data Show Entecavir Demonstrates More Viral Suppression Compared to

Lamivudine in Hepatitis B Infected E-Antigen Negative Patients

PR Newswire Europe (inc. UK Disclose) - Apr. 28, 2006

VIENNA, Austria, April 28 /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 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.

Bristol-Myers Squibb Company

Henry of Bristol-Myers Squibb, Office, +33-1-58-83-69-38, Mobile,

+33-6-75-09-08-99, brian.henry@...

http://www.therapeuticsdaily.com/news/article.cfm?contenttype=sentryarticle & cont\

entvalue=882220 & channelID=31

_________________________________________________________________

FREE pop-up blocking with the new MSN Toolbar – get it now!

http://toolbar.msn.click-url.com/go/onm00200415ave/direct/01/