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Gilead announces publication of trials’ data
Gilead has announced the publication of 48-week data from two phase III pivotal clinical trials.
The tests, to evaluate the efficacy and safety of once-daily Viread (tenofovir disoproxil fumarate), found the drug is more effective in treating the virus that causes chronic hepatitis B (HBV), in comparison to Hepsera.
Results of both the studies – 102 and 103 – were published in the December 4th issue of The New England Journal of Medicine.
Patrick Marcellin, managing director of Hopital Beaujon in Clichy, Francy, was the principal investigator of Study 102 and one of the lead authors of the resulting paper.
He said: “Chronic hepatitis B is a long-term, life-threatening disease that may result in tremendous complications.”
“Hepsera represented an important advance in the treatment of chronic HBV, but these findings demonstrate that Viread can result in an even greater antiviral response.”
Last month, Gilead was told Teva Pharmaceutical Industries is seeking approval to sell a generic version of Truvada.
As a result, the company said it has 45 days following receipt of the notification in order to begin a patent infringement lawsuit against Teva.
Formed in 1987, Gilead is headquartered in Foster City, US and has annual revenues of $4 billion (2.7 billion pounds).
The company employs more than 3,400 people.
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