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Pharmasset Announces Clevudine and R7128 Presentations at HEP-DART
Date:12/11/2007

ine triphosphate was determined to be non-competitive. Since several active site mutations are known to confer resistance to clevudine in vitro, clevudine triphosphate may be binding at or near the active site of the HBV polymerase without being utilized as a substrate. To the best of our knowledge, this is the first example of a nucleoside analog triphosphate showing non-competitive inhibition.

Potent Antiviral Activity of the Nucleoside HCV Inhibitor, R7128, in Prior IFN Non-Responders. JG McHutchison, et al.

Abstract Summary: R7128 is a prodrug of PSI-6130, a cytidine nucleoside analog polymerase inhibitor, for treatment of HCV. A 14-day monotherapy study demonstrated that R7128, a direct antiviral, can deliver sufficient antiviral potency via monotherapy to suppress HCV below the level of detection (<15 IU/mL) in an interferon failure population. The mean reduction in HCV RNA with the 1500 mg BID dose was -2.7 log10 IU/mL and ranged from -1.2 to -4.2 log10 (below the limit of detection) at Day 15. Twice-daily (BID) administration was superior to once-daily (QD) administration for antiviral suppression. The pharmacokinetic profile following single and multiple doses indicated good exposure to PSI-6130 with no dose-related adverse events or laboratory abnormalities. The lack of virologic rebound also provides early evidence of high genetic barrier for nucleoside inhibitors of NS5B polymerase. The safety and efficacy of this monotherapy study support further development of R7128 in combination with pegylated interferon and ribavirin.

High Genetic Barrier to HCV Resistance Presented by PSI-6130. A Uzgiris, et al.

Abstract Summary: PSI-6130 is the parent molecule of the prodrug R7128, an orally active inhibitor of the hepatitis C virus NS5B polymerase currently in clinical development. Proprietary and public database containing HCV NS5B sequences representing six HCV genotypes were analyzed for the presence of the S282T substitution. S282T
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