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R7128 Demonstrates Safety and Potent Antiviral Activity in HCV-Infected Patients
Date:9/10/2007

d on the results of this study, Pharmasset and Roche plan to initiate a 28-day study of R7128 in combination with Pegasys (pegylated interferon) plus Copegus (ribavirin) in treatment-naive patients chronically infected with HCV genotype 1. Patient recruitment for this combination study is expected to begin in late September 2007. The purpose of this study is a preliminary evaluation of the safety, tolerability, pharmacokinetics and antiviral activity of R7128 in the clinically-relevant setting of combination therapy with the current standard of care consisting of Pegasys plus Copegus. Please see http://www.clinicaltrials.gov or e-mail clinicaltrials@pharmasset.com for more information.

In addition, a late breaker abstract for the Phase 1 multiple ascending dose study has been accepted as a presentation at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) being held in Boston, MA from November 2-6, 2007. In accordance with the conference press embargo guidelines, no additional data will be available for this study until the scientific abstracts are published by AASLD on October 1, 2007.

Dr. Rajender Reddy, Professor of Medicine and Surgery in the Division of Gastroenterology at the University of Pennsylvania and a clinical investigator in the R7128 multiple ascending dose study, stated "The R7128 results are exciting based on the combination of potency, safety and tolerability. There were no major organ or other acute toxicities observed during the 14-day dosing period, which is encouraging for future studies with longer exposures to R7128 in combination with the standard of care. Leading clinicians believe that HCV therapy will evolve to include direct-acting antiviral drug combinations, and nucleoside polymerase inhibitors such as R7128 could improve sustained virologic response (SVR) rates for the treatment of chronic HCV."

"R7128 has demonstrated
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SOURCE Pharmasset, Inc.
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