Telbivudine More Effective than Epivir for Hepatitis B
November 22, 2005
Investigational drug telbivudine has shown significantly better antiviral activity against hepatitis B than Epivir (lamivudine) in the international GLOBE trial. This phase III trial compared telbivudine and Epivir in hepatitis B virus (HBV) e-antigen-positive and-negative patients.
One-year study results were presented at the annual meeting of the American Association for the Study of Liver Diseases in San Francisco by Ching-Lung Lai, MD, of the University of Hong Kong on behalf of GLOBE researchers. A summary of results was published by MedPage Today on 15 November 2005.
Telbivudine, a nucleoside analog, "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," said Dr Lai.
Study Plan
This randomized, double-blind trial included 1,367 adults with chronic hepatitis B from 112 clinical centers in Asia, Europe and North America. Participants received either oral telbivudine (600 mg/day) or oral Epivir (100 mg/day).
Upon entering the two-year study, patients met the following inclusion criteria: They were HB e-antigen positive (HBeAg+), which indicates a high viral-load and high risk of infectivity; they had HBV DNA levels > 6 log10 copies mL; they had alanine aminotransferase levels (ALT) 1.3-10-fold higher than the upper limit of normal; and they had compensated liver disease.
The study's primary endpoint is therapeutic response. A composite endpoint, this comprised viral suppression (serum HBV DNA suppression < 100,000 copies/mL) with either (1) improved liver-disease markers (ALT normalization) or (2) loss of detectable HBeAg.
Results
HBeAg+ patients receiving telbivudine had a mean reduction in HBV DNA of -6.5 log10, compared with a mean reduction of -5.5 log10 in patients receiving lamivudine. (P<0.01).
Among HBeAg- patients, those receiving telbivudine had a -5.2 log10 HBV DNA reduction, compared with -4.4 log10 with Epivir (P<0.01).
A total of 60% of HBeAg+ patients receiving telbivudine had an e-antigen loss, compared with 40% of patients receiving Epivir (p<0.01). Among 88% of HBeAg- patients receiving telbivudine, HBV DNA levels decreased to below detectable levels, compared with 71% of patients receiving Epivir.
Overall, an examination of the composite endpoint of therapeutic response in HBeAg+ patients revealed that 75% of this group achieved a response, compared with 67% of patients reciving Epivir (P<0.05). Among HBeAg- patients, 77% of patients receiving lamivudine showed a therapeutic response, compared with 75% of patients receiving telbivudine.
The incidence of adverse events was similar between the groups. These included upper respiratory infections and headache in about 12% of patients in each group, and fatigue and nasopharyngitis in about 11% in each group.
Serum ALT elevations occurred more often in patients receiving lamivudine than in patients receiving telbivudine (8% versus 4%, respectively). However, more patients receiving telbivudine than Epivir had transient creatine kinase elevations that required no treatment modification (9% versus 3%, respectively).
Dr Lai is a consultant for Idenix Pharmaceuticals of Cambridge, Massachusetts, who manufacture telbivudine.
Sources:
AASLD:
Hepatitis B Yields More to Telbivudine than Epivir, MedPage
Today, 15 November 2005.
Lai C et al. Telbivudine (LdT)
vs. Lamivudine for Chronic Hepatits B: First-Year Results from the
International Phase III GLOBE Trial. American Association For
The Study of Liver Diseases annual meeting, 11-15 November 2005,
San Francisco. Late-breaking abstract 1, presented 14 November
2005
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