Liver Diseases

Following closely on the heels of the approval of telbivudine (Tyzeka, Novartis/Idenix) on October 25, 2006, for the treatment of chronic hepatitis B, presentations at the meeting featured the agent’s benefits of two-year results from the international GLOBE trial. Telbivudine, a once-daily oral agent, suppresses hepatitis B virus (HBV) in adults with evidence of viral replication and evidence of either persistently elevated liver enzymes aspartate and alanine transaminases (ALT and AST) or histologically active disease.

Lai et al.

Telbivudine and medication lamivudine (Epivir-HBV drug, GlaxoSmithKline) were compared in chronic hepatitis B early antigen (HBeAg)-positive patients and HBeAg-negative patients. Ching-Lung Lai, MD, Professor of Medicine at the University of Hong Kong and lead investigator of the GLOBE study, confirmed that superior responses reported for telbivudine at one year were sustained during a longer follow-up period.

The GLOBE trial included 1,367 patients with chronic HBV infection. These patients were randomly assigned, in a 1:1 ratio, to receive telbivudine or lamivudine tablet. Among the patients, 921 were HBeAg-positive (mean age, 32.5 years) and 446 were HBeAg-negative (mean age, 43 years). Approximately 75% of the patients were male.

Table 1 Efficacy of Telbivudine and Lamivudine at Year Two in HBeAg-Positive Patients

Telbivudine Lamivudine


Therapeutic response (%)


HBV DNA levels reduced
(mean logw)


HBV DNA levels
undetectable by PCR (%)


Normalization of ALT (%)


All values: P < .05 versus lamivudine.ALT = alanine transaminase; HBeAG = hepatitis B early antigen; HBV = hepatitis B virus; PCR = polymerase chain reaction.

At one year, significant advantages (P < .05) were reported in therapeutic responses (75% for telbivudine vs. 67% for lamivudine) in reducing HBV DNA (mean log10 6.5 vs. 5.5 copies) and in the percentage of patients with undetectable HBV DNA (60 vs. 40).

Table 2 Efficacy of Telbivudine and Lamivudine at Year Two in HBeAg-Negative Patients

Telbivudine Canadian Lamivudine



Therapeutic response (%)



HBV DNA levels reduced
(mean logw)



HBV DNA levels
undetectable by PCR (%)



Normalization of ALT (%) 78


Dr. Lai’s report of two-year results showed a continuing benefit for telbivudine in both HBeAg-positive and HBeAg-negative patients (Tables 1 and 2). The results also revealed that the advantage of telbivudine in normalizing ALT levels gained statistical significance (P < .05) in HBeAg-positive patients between the first and second years of the trial.

Category: Diseases / Tags: American Association, Liver Diseases

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