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

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CDC HIV/STD/TB Prevention News Update

Wednesday, December 17, 2003

CHINA:

" Hepatitis B: Study Suggests Telbivudine More Effective than

Current Standard of Care "

Hepatitis Weekly (11.17.03)

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. "