China: Hepatitis B Study Suggests Telbivudine More Effective Than Current Standard of Care

At the 54th Annual Meeting of the American Association for the Study of Liver Diseases, Lai Ching-Lung, professor of medicine at the University of Hong Kong, presented data showing an investigational drug -- telbivudine (L-deoxythymidine or LdT) -- achieved significantly better suppression of hepatitis B virus and normalization of ALT (a measure of liver disease) than lamivudine monotherapy, the current standard of care.

A randomized, double-blind international Phase IIb clinical trial compared the safety and antiviral effectiveness of telbivudine alone or in combination with lamivudine versus lamivudine monotherapy in patients with chronic HBV. Patients on telbivudine showed rapid, marked reduction in HBV blood-serum levels after one year of treatment.

Lai's data showed that after one year of treatment, antiviral activity and ALT normalization were significantly greater for telbivudine monotherapy than lamivudine monotherapy. Patients on telbivudine achieved an average reduction in viral load (serum HBV DNA) of 1 million-fold (6 log10). Average reductions from baseline for the three types of treatment were 6.01 log10 for telbivudine monotherapy; 5.99 log10 for the telbivudine/lambivudine combination and 4.57 for lamivudine alone.

Most of the telbivudine-treated patients achieved early, sustained normalization of serum ALT levels, reflecting reductions in underlying HBV-related liver inflammation. Of patients on telbivudine monotherapy, 86 percent achieved normalized ALT levels, compared to 63 percent on lamivudine monotherapy. In 61 percent of patients on telbivudine, the level of virus in their blood serum became undetectable by highly sensitive PCR assays, compared to 49 percent of patients on combination therapy and 32 percent of patients on lamivudine monotherapy.

Overall, the patients who achieved the greatest reductions in viral load at an early stage in the course of treatment had the most significant improvement in markers of clinical efficacy after one year of treatment. The researchers found no safety issues through the first year of treatment and encountered no drug-attributed serious adverse events and no pattern of dose-related or treatment-related clinical side effects or laboratory abnormalities.

"We are all very excited with these results," said Lai. "Our patients are responding extremely well to telbivudine, with no safety issues identified to date. Hepatitis B represents a large unmet medical need given current treatment options and the very high prevalence rates throughout Asia, and telbivudine offers renewed hope to these patients."

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