Pharmasset Announces Initiation of Combination Study of Clevudine and Viread(R) for HBV by French National Agency for Research on AIDS and Viral Hepati...( 96-week comparative study of C...),Health

96-week comparative study of Clevudine versus Viread(R) versus

Clevudine+Viread(R) in 150 patients with chronic hepatitis B

PRINCETON, N.J., July 8 /PRNewswire-FirstCall/ -- The French National Agency for Research on AIDS and Viral Hepatitis (ANRS), with the support of Pharmasset, Inc. (Nasdaq: VRUS) and Gilead Sciences, Inc. (Nasdaq: GILD), has initiated the first head-to-head study of clevudine and Viread(R) (tenofovir disoproxil fumarate) administered separately, versus their combination, for the treatment of chronic hepatitis B virus (HBV) infection in non-cirrhotic patients. The study treatments include clevudine 30mg/day, tenofovir 300mg/day or the combination of both drugs administered to 150 treatment-naive hepatitis B e-antigen negative HBV-infected patients for 96 weeks. At that time, all therapy will be discontinued, and patients will be monitored for sustained virologic response (SVR) after being off of therapy for 24 weeks, the primary endpoint of the study.

Clevudine is an oral, once-daily pyrimidine nucleoside analog that has been evaluated in 18 clinical trials in more than 800 individuals. Phase 3 studies are currently being conducted in approximately 140 global clinical sites to support the registration of clevudine in the Americas and Europe. Pharmasset licensed clevudine for these territories from Bukwang Pharm. Co., Ltd, who has received South Korean regulatory approval and is currently marketing clevudine in South Korea under the brand name Levovir.

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