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Telbivudine Continues to Show Superior Efficacy over Lamivudine in Chronic HBV in Continuing GLOBE trial, 18 Mos: Presented at HEP DART
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By Bonnie Darves
KOHALA COAST, HAWAII -- December 29, 2005 -- The investigational polymerase inhibitor telbivudine continues to show strong antiviral activity in chronic hepatitis B (HBV) when compared with standard treatment with lamivudine, with the efficacy gap between the two drugs widening as treatment duration continues.
Eighteen months into treatment, 84% of patients on telbivudine had undetectable HBV DNA, compared to 67% of lamivudine patients. At that time point, alanine aminotransferase normalization had occurred in 76% of participants taking telbivudine versus 64% of subjects on lamivudine.
In an oral session here on December 15th at the Frontiers in Drug Development for Viral Hepatitis HEP DART 2005 meeting, lead investigator Ching-Lung Lai, MD, Professor, Department of Medicine, University of Hong Kong, presented 76-week data of the international, 2-year, randomized, blinded, phase 3 GLOBE trial.
"In all patient subgroups, telbivudine was looking better than lamivudine at week 76, and viral breakthrough was seen in only 3% of telbivudine patients, compared to 10% in the lamivudine [group]," Dr. Lai said.
The study is comparing oral telbivudine at a daily dose of 600 mg with oral lamivudine at 100 mg daily. Subjects are adults living being in 112 centres in Asia, Europe and North America.
To date, adverse events have been similar between the two treatment groups. Upper respiratory infections and headache have occurred in roughly 12% of patients in each group, and fatigue and nasopharyngitis have been reported by nearly 11% of all trial participants.
Dr. Lai noted that slightly more patients on telbivudine than on lamivudine (9% versus 3%) experienced transient creatinine elevations, but he added that no adverse events have been severe enough to require dose modification or treatment discontinuation.
One-year results of the trial, which includes 1367 patients randomised 1:1 to receive telbivudine or lamivudine, were presented at the American Association for the Study of Liver Diseases meeting in San Francisco in November 2005.
[Presentation title: A Phase III Comparative Trial of Telbivudine (LdT) vs. Lamivudine for Chronic Hepatitis B: First-year Results from the Large International GLOBE Trial. Abstract 95]
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