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Pharmasset Commences Dosing R7128 Cohorts 3 and 4 for the Treatment of Chronic Hepatitis C
Date:5/14/2008

ard of care regimen for each genotype. Preliminary safety and antiviral activity data from the 4-week combination treatment period are anticipated during the third quarter of 2008.

"Based on our pharmacokinetic modeling, we believe that the R7128 1000mg BID combination dosing regimen in Cohort 3 may be able to achieve similar antiviral responses as were demonstrated with R7128 1500mg BID in Cohort 2," stated Dr. Michelle Berrey, Pharmasset's Chief Medical Officer. "Cohort 4 will be the first administration of R7128 in patients with HCV genotypes 2 or 3, and thus will serve as proof-of-concept for this population who we believe represent an area of great unmet medical need. If R7128 shows activity in HCV genotype 2 or 3 patients, this would demonstrate a distinct clinical attribute of nucleoside polymerase inhibitors."

Please see http://www.clinicaltrials.gov or e-mail clinicaltrials@pharmasset.com for more information.

About R7128

R7128 is being developed for the treatment of chronic HCV infection. R7128 is a prodrug of PSI-6130, a cytidine nucleoside analog inhibitor of HCV RNA polymerase. A prodrug is a chemically modified form of a molecule designed to enhance the absorption, distribution and metabolic properties of that molecule. Results from a Phase 1 oral single ascending dose study of R7128 in 46 healthy male volunteers showed that R7128 was generally well tolerated with no serious adverse events in doses up to 9000 mg.

In a Phase 1 study, R7128 demonstrated potent, dose-dependent antiviral activity across four genotype 1 prior treatment-failure patient cohorts (n=40) receiving 750 mg or 1500 mg administered either once-daily or twice-daily for 14 days as monotherapy. The greatest mean decrease in HCV RNA from baseline was demonstrated in the patient cohort that received 1500 mg twice-daily, the highest dose of R7128 administered in the study. These patients demonstra
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SOURCE Pharmasset, Inc.
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