Telbivudine for chronic hepatitis B: The GLOBE trial

Abstract

Telbivudine is the latest nucleoside/nucleotide analog approved for the treatment of chronic hepatitis B. It has been extensively studied in Phase I, II and III trials. The Phase III trial (the GLOBE study) recruited more than 1300 chronic hepatitis B patients. It demonstrated that telbivudine was superior to lamivudine with a greater reduction of HBV DNA levels in hepatitis B e antigen (HBeAg)-positive and -negative disease after 1 year of treatment. The resistance rate at year 1 was also lower in patients receiving telbivudine. This antiviral superiority is maintained up to 2 years of treatment. There were no serious adverse effects in patients receiving telbivudine treatment. To further minimize the chance of emergence of drug resistance, careful patient selection according to the baseline HBV DNA levels, alanine aminotransferase levels and HBV DNA levels at week 24 of treatment should be carried out. Continuation of telbivudine monotherapy is associated with a low chance of resistance patients receiving telbivudine who have undetectable HBV DNA levels at week 24. © 2008 Future Medicine Ltd.