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 hepatitis B virus (HBV)-infected patients for 96 weeks. At that time, all therapy will be discontinued, and patients will be monitored for sustained virologic response 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 III studies are currently being conducted in approximately 140 global clinical sites to support the registration of clevudine in the Americas and Europe.
Michelle Berrey, Pharmasset’s chief medical officer, said: “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.”