Idenix, Novartis say telbivudine suppresses hepatitis B virus better than lamivudine

By Angela McDaniels

Seattle, March 27 - Idenix Pharmaceuticals Inc. and Novartis Pharmaceuticals Corp. said new data shows that their drug candidate telbivudine provided significantly greater antiviral and clinical efficacy in patients with chronic hepatitis B after one year of treatment than lamivudine, a current standard of care.

The data is from an ongoing, randomized, double-blind phase 3 trial being conducted in China that compares two years of treatment with telbivudine to treatment with lamivudine in 332 adults with chronic hepatitis B.

After one year of treatment, telbivudine significantly reduced virus levels by 6.22 log10, or more than 1 million-fold, compared with 5.4 log10 for lamivudine, and undetectable virus levels were achieved in 70% of telbivudine-treated patients, compared with 43% of lamivudine-treated patients, according to the companies' new release.

Therapeutic response, defined as a reduction of hepatitis B viral load to below 5 log 10 copies per mL with HBeAg loss or liver enzyme normalization, was found in 87% of telbivudine-treated patients, compared with 64% of lamivudine-treated patients.

Finally, 89% of telbivudine-treated patients achieved normalization of liver enzymes, compared with 76% of lamivudine-treated patients.

The companies said the rate of clinical adverse events was similar between the telbivudine and lamivudine treatment groups, with colds (25% and 21%, respectively), upper respiratory tract infection (3% and 4.8%, respectively) and fatigue (3.6% for both) occurring most commonly.

The one-year results were presented on Monday at the biennial meeting of the International Liver Congress in Shanghai.

This data, together with one-year data from the companies' international phase 3 Globe study, were included in a recent regulatory submission to Chinese health authorities for marketing approval of telbivudine.

Chronic hepatitis B is the 10th leading cause of death worldwide, according to the release. An estimated 350 million people are chronically infected worldwide, and China has the largest population affected by the hepatitis B virus of any nation with 120 million infected, or nearly one out of every 10 people, and 30 million chronic sufferers.

Idenix Pharmaceuticals is a biopharmaceutical company based in Cambridge, Mass., that discovers and develops drugs for the treatment of viral and other infectious diseases.

Novartis Pharmaceuticals is an East Hanover, N.J., subsidiary of Novartis AG.

Idenix is developing its hepatitis B clinical product candidates, telbivudine and valtorcitabine, in collaboration with Novartis under a development and commercialization arrangement established in May 2003.

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