The phase III GLOBE trial for Telbivudine successfully reached its primary, composite efficacy endpoint of therapeutic response at one year in chronic hepatitis B patients.
This endpoint, which was designed to assess if Telbivudine was at least as effective as Lamivudine ( Epivir ), evaluated the combination of viral suppression ( serum HBV DNA suppression below 100,000 copies/mL ) coupled with either improved liver function ( ALT normalization ) or loss of detectable hepatitis B e-antigen ( HbeAg ).

The GLOBE trial enrolled more than 1,350 patients in over 130 centers worldwide.
The ongoing trial is evaluating the safety and efficacy of Telbivudine compared to Lamivudine in patients with HBeAg-positive and HBeAg-negative compensated chronic hepatitis B for two years of treatment in two daily treatment regimens: Telbivudine 600 mg or Lamivudine 100 mg.

The World Health Organization ( WHO ) has estimated that approximately 350 million people, or 5% of the world's population, are chronically infected with hepatitis B virus or HBV.
Current treatment options are often associated with limited efficacy, poor tolerability or resistance concerns, and new therapeutic options are needed to respond to the significant unmet need in treating chronic HBV.

Telbivudine is a specific and selective, oral, once-daily nucleoside that is unique in its preferential inhibition of 2nd strand HBV DNA synthesis.
This distinct mechanism of action may be responsible for the rapid and profound viral suppression associated with Telbivudine treatment.

The GLOBE study results continue to support a favorable overall safety profile for Telbivudine with no substantial safety issues being identified to date through the combined two years of treatment in the phase IIb clinical trial and in the phase III clinical program to date.

An additional phase III trial ( NV-02B-011 ) is evaluating the safety and efficacy of Telbivudine compared to Lamivudine in HBeAg-positive and HBeAg-negative patients with decompensated chronic hepatitis B. This ongoing trial has enrolled 87 patients to date.

Source: Novartis, 2005


XagenaMedicine2005