Pharmasset Announces Initiation of Combination Study of Clevudine and Viread(R) for HBV by French National Agency for Research on AIDS and Viral Hepatitis (ANRS)
Tuesday July 8, 7:00 am ET
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 - News) and Gilead Sciences, Inc. (Nasdaq: GILD - News), has initiated the first head-to-head study of clevudine and Viread® (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.
"Clevudine's unique mechanism of action as a non-chain terminating nucleoside analog HBV polymerase inhibitor may demonstrate additive antiviral benefit in combination with tenofovir's recently demonstrated antiviral potency in HBV," stated Dr. Michelle Berrey, Pharmasset's Chief Medical Officer. "We also plan to reproduce the results from earlier studies demonstrating clevudine's ability to provide a sustained virologic response in patients with eAg negative chronic HBV infection, as either monotherapy or in combination, offering infected individuals and their physicians an important new treatment option."
Ongoing Registration Studies for New Drug Application (NDA)
The ongoing clevudine Phase 3 registration program includes two 48-week clinical trials designed to demonstrate the superiority of clevudine 30mg over Hepsera® (adefovir dipivoxil) 10mg, each administered once-daily as monotherapy. Pharmasset plans to submit the 48-week data from these studies to the FDA as the basis for the clevudine marketing approval. Please see www.clinicaltrials.gov or e-mail clinicaltrials@pharmasset.com for more information about the clevudine registration studies.
surf's up......crikey
