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Pharmasset Receives Notice of Allowance
Date:6/26/2008

o 3000 mg.

R7128 demonstrated potent, dose-dependent antiviral activity across four 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 demonstrated a mean 2.7 log10 IU/mL (>99%) decrease in HCV RNA. There was no evidence of the development of viral resistance in any dose cohort after 14 days of dosing.

In a 4-week Phase 1 combination study that was conducted in 50 treatment-naive patients chronically infected with HCV genotype 1, R7128 demonstrated potent short-term antiviral activity and was generally safe and well tolerated. Eighty-five percent (85%) of patients receiving R7128 1500mg twice-daily (BID) with Pegasys plus Copegus for 4 weeks achieved undetectable HCV RNA levels with safety and tolerability comparable to placebo with Pegasys plus Copegus.

We have commenced dosing two additional cohorts of this 4-week Phase 1 study. Cohort 3 will continue dose-exploration with administration of R7128 1000mg twice-daily (BID) with Pegasys plus Copegus in treatment-naive patients with HCV genotype 1. Cohort 4 will evaluate R7128 1500mg BID with Pegasys plus Copegus in treatment-experienced patients with genotypes 2 or 3 who did not achieve a sustained virologic response (SVR) with previous interferon-based therapy.

About Hepatitis C

Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost four million people in the United States have been infected with HCV, of whom 2.7 million are chronically inf
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SOURCE Pharmasset, Inc.
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Related medicine technology :

1. Pharmasset Presents R7128 Phase 1 Single Ascending Dose Study in Healthy Volunteers
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3. Pharmasset Commences Dosing in 28-Day Combination Study of R7128 with Pegasys(R) plus Copegus(R) for Hepatitis C
4. Pharmasset Announces Clevudine and R7128 Presentations at HEP-DART
5. Pharmasset Announces R7128 Achieves 85% Rapid Virologic Response in a 4-week Combination Study for the Treatment of Chronic Hepatitis C
6. Roche and Pharmasset To Present the R7128 Monotherapy Resistance Profile
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