Gilead announces presentation of data from trials

Gilead has today announced the presentation of two-year data from a pair of phase III pivotal clinical trials.

The studies were to evaluate the safety and efficacy of once-daily Vireaed (tenofovir disoproxil fumarate) among adult patients with chronic hepatitis B virus (HBV) infection.

Along with oral sessions, the date will be presented at the annual meeting of the American Association for the Study of Liver Diseases, being held in San Francisco, US.

Named Study 102 and 103, the trials are also set to evaluate treatment with Viread for up to eight years among patients who suffer from HBeAg-positive and HBeAg-negative chronic hepatitis B, respectively – and also have compensated liver disease.

Patrick Marcellin of Hopital Beaujon in Clichy, France and principal investigator of Study 102, said: “In this study, Viread produced a significant and sustained effect over two years of treatment with no evidence of resistance, which is a substantial clinical finding.”

The trials follow the US Food and Drug Administration (FDA)’s August 2008 approval of Viread for chronic HBV in adults, based upon earlier results from these studies.

Based in Foster City, California, Gilead Sciences has annual revenues exceeding $4 billion (2.5 billion pounds), with a workforce of over 3,400 employees at its operations across North America, Europe and Australia.