AASLD: Hepatitis B Yields More to Telbivudine than Epivir

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AASLD: Hepatitis B Yields More to Telbivudine than Epivir

By Neil Osterweil, Senior Associate Editor, MedPage Today

Reviewed by Zalman S. Agus, MD; Emeritus Professor at the University of

Pennsylvania School of Medicine.

November 15, 2005

Also covered by: Forbes, News

MedPage Today Action Points

Inform interested patients that in this preliminary study the

investigational agent telbivudine appears to be more effective than

lamivudine against hepatitis B viral infections. Telbivudine is not FDA

approved however.

Review

SAN FRANCISCO, Nov. 15 - In patients with chronic hepatitis B infection,

investigational telbivudine (LdT), a newer nucleoside analog, showed

significantly better antiviral activity than the old standby Epivir

(lamivudine).

That's the conclusion of researchers based on early data from the

international GLOBE trial, a phase 3 study comparing the two HBV antivirals

in both HBV e-antigen positive and negative patients.

One-year results of the international study of the nucleosides were

presented by Ching-Lung Lai, M.D., of the University of Hong Kong on behalf

of GLOBE investigators at the annual meeting of the American Association for

the Study of Liver Diseases here.

Telbivudine, Dr. Lai said, " has the potential to reduce the serious

complications associated with chronic hepatitis B, and telbivudine's

favorable safety and convenience profile in trials to date also may make it

a promising treatment option for patients, including those requiring

long-term therapy. "

The GLOBE study is a randomized, double-blind trial comparing oral

telbivudine at 600 mg/day with oral Epivir at 100 mg/day in 1,367 adults

with chronic hepatitis B from 112 clinical centers in Asia, Europe, and

North America.

At the time of entry into the two-year study, patients had to be HB

e-antigen positive (HBeAg+), indicating a high viral load and high risk of

infectivity, have HBV DNA levels > 6 log10 copies mL, have alanine

aminotransferase levels (ALT) 1.3-10 times the upper limit of normal, and

have compensated liver disease.

The primary endpoint is therapeutic response, a composite endpoint

comprising viral suppression (serum HBV DNA suppression below 100,000

copies/mL) with either improved liver disease markers (ALT normalization) or

loss of detectable HBeAg.

The investigators found that HBeAg+ patients taking telbivudine had a mean

reduction in HBV DNA of -6.5 log10 vs. -5.5 log10 among patients on

lamivudine. (P<0.01).

Among HBeAg- patients, those taking telbivudine had a -5.2 log10 HBV DNA

reduction, vs. -4.4 log10 with Epivir (P<0.01).

Among HBeAg+ patients, 60% of those on telbivudine had an e-antigen loss,

compared with 40% of those on Epivir (p<0.01).

Among those who were HBeAg-, telbivudine treatment reduced HBV DNA to below

detectable levels in 88%s, compared with 71% of those on Epivir.

Looking at the composite endpoint of therapeutic response in

antigen-positive patients, the authors found that 75% of this group achieved

a response, compared with 67% of those on Epivir (P<0.05).

Among e-antigen negative patients, slightly more patients on lamivudine had

a therapeutic response 77%, vs. 75% for telbivudine (P value not given).

Adverse events were similar between the groups, and included upper

respiratory infections and headache in about 12% in each group, and fatigue

and nasopharyngitis in about 11% in each group.

More patients on lamivudine than telbivudine had serum ALT elevations (8%

vs, 4%, respectively), but more patients on telbivudine had transient

creatine kinase elevations not requiring treatment modification (9% vs 3%

for Epivir).

Dr. Lai is a consultant for Idenix Pharmaceuticals of Cambridge, Mass.,

maker of telbivudine.

Primary source: AASLD

Source reference:

Lai C et al. Telbivudine (LdT) vs. Lamivudine for Chronic Hepatits B:

First-Year Results from the International Phase III GLOBE Trial.

Late-breaking abstract 1, presented Nov. 14.

_________________________________________________________________

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[Guest guest]

AASLD: Hepatitis B Yields More to Telbivudine than Epivir

By Neil Osterweil, Senior Associate Editor, MedPage Today

Reviewed by Zalman S. Agus, MD; Emeritus Professor at the University of

Pennsylvania School of Medicine.

November 15, 2005

Also covered by: Forbes, News

MedPage Today Action Points

Inform interested patients that in this preliminary study the

investigational agent telbivudine appears to be more effective than

lamivudine against hepatitis B viral infections. Telbivudine is not FDA

approved however.

Review

SAN FRANCISCO, Nov. 15 - In patients with chronic hepatitis B infection,

investigational telbivudine (LdT), a newer nucleoside analog, showed

significantly better antiviral activity than the old standby Epivir

(lamivudine).

That's the conclusion of researchers based on early data from the

international GLOBE trial, a phase 3 study comparing the two HBV antivirals

in both HBV e-antigen positive and negative patients.

One-year results of the international study of the nucleosides were

presented by Ching-Lung Lai, M.D., of the University of Hong Kong on behalf

of GLOBE investigators at the annual meeting of the American Association for

the Study of Liver Diseases here.

Telbivudine, Dr. Lai said, " has the potential to reduce the serious

complications associated with chronic hepatitis B, and telbivudine's

favorable safety and convenience profile in trials to date also may make it

a promising treatment option for patients, including those requiring

long-term therapy. "

The GLOBE study is a randomized, double-blind trial comparing oral

telbivudine at 600 mg/day with oral Epivir at 100 mg/day in 1,367 adults

with chronic hepatitis B from 112 clinical centers in Asia, Europe, and

North America.

At the time of entry into the two-year study, patients had to be HB

e-antigen positive (HBeAg+), indicating a high viral load and high risk of

infectivity, have HBV DNA levels > 6 log10 copies mL, have alanine

aminotransferase levels (ALT) 1.3-10 times the upper limit of normal, and

have compensated liver disease.

The primary endpoint is therapeutic response, a composite endpoint

comprising viral suppression (serum HBV DNA suppression below 100,000

copies/mL) with either improved liver disease markers (ALT normalization) or

loss of detectable HBeAg.

The investigators found that HBeAg+ patients taking telbivudine had a mean

reduction in HBV DNA of -6.5 log10 vs. -5.5 log10 among patients on

lamivudine. (P<0.01).

Among HBeAg- patients, those taking telbivudine had a -5.2 log10 HBV DNA

reduction, vs. -4.4 log10 with Epivir (P<0.01).

Among HBeAg+ patients, 60% of those on telbivudine had an e-antigen loss,

compared with 40% of those on Epivir (p<0.01).

Among those who were HBeAg-, telbivudine treatment reduced HBV DNA to below

detectable levels in 88%s, compared with 71% of those on Epivir.

Looking at the composite endpoint of therapeutic response in

antigen-positive patients, the authors found that 75% of this group achieved

a response, compared with 67% of those on Epivir (P<0.05).

Among e-antigen negative patients, slightly more patients on lamivudine had

a therapeutic response 77%, vs. 75% for telbivudine (P value not given).

Adverse events were similar between the groups, and included upper

respiratory infections and headache in about 12% in each group, and fatigue

and nasopharyngitis in about 11% in each group.

More patients on lamivudine than telbivudine had serum ALT elevations (8%

vs, 4%, respectively), but more patients on telbivudine had transient

creatine kinase elevations not requiring treatment modification (9% vs 3%

for Epivir).

Dr. Lai is a consultant for Idenix Pharmaceuticals of Cambridge, Mass.,

maker of telbivudine.

Primary source: AASLD

Source reference:

Lai C et al. Telbivudine (LdT) vs. Lamivudine for Chronic Hepatits B:

First-Year Results from the International Phase III GLOBE Trial.

Late-breaking abstract 1, presented Nov. 14.

_________________________________________________________________

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http://messenger.msn.click-url.com/go/onm00200471ave/direct/01/