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Pharmasset Reports Preliminary Results of a 4-week Proof-of-Concept Combination Study of R7128 for the Treatment of Chronic Hepatitis C in Genotype 2 or 3 Non-Responders
Date:9/8/2008

are consistent with the in vitro data demonstrating equal potency by R7128 against HCV genotypes 1, 2, 3 and 4.

The preliminary safety and tolerability of R7128 1500mg BID with SOC was comparable to placebo with SOC in Cohort 4.

Dr. Michelle Berrey, Pharmasset's Chief Medical Officer stated, "In this study, R7128, in combination with SOC, has demonstrated significant antiviral activity in genotype 2 or 3 patients who had failed prior interferon-based therapy. R7128, an HCV nucleoside polymerase inhibitor, may provide better antiviral activity in these patients where the protease inhibitors and non-nucleoside polymerase inhibitors have not yet shown success. Longer-term studies of R7128 with SOC are needed to provide additional information about its potential to improve SVR rates and possibly shorten the treatment duration for genotype 2 or 3 HCV patients."

"Patients with genotype 2 or 3 represent 20-30% of the worldwide chronically infected HCV population. Up to 40% of these patients, using SOC in first line therapy for 24 weeks, do not achieve an SVR, which represents an unmet medical need that R7128 has the potential to address," stated Patrick Higgins, Pharmasset's Executive Vice President of Sales and Marketing. "R7128 is the first small molecule to demonstrate significant antiviral activity in humans against a broad spectrum of HCV genotypes. If this early evidence of competitive advantage is sustained in future development, this potentially means that R7128 could become the preferred direct-acting antiviral to be added to the SOC because it is equally active across all of the most common genotypes and has a high barrier to drug resistance."

R7128 4-week Combination Study Overview

The 4-week Phase 1 combination clinical trial was a multiple center, observer-blinded, randomized and placebo-controlled study that was conducted in 81 treatment-naive patients chronically infected with HCV genotype 1 and 25 prior treatment non-resp
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SOURCE Pharmasset, Inc.
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