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Potential Safety Issue Identified in Ongoing Phase 2 Clinical Study of HCV-796
Date:8/19/2007

nders

Peg-Intron + ribavirin HCV-796 + Peg-Intron + HCV-796 +

(control therapy) ribavirin Peg-Intron +

ribavirin

Percent of

patients with 7% 45% 4%

undetectable HCV (5 of 75) (34 of 75) (3 of 78)

levels (<10 IU/ml)

For Patients On-therapy at Week 12:

Treatment Naive Patients Null Responders

Peg-Intron + ribavirin HCV-796 + Peg-Intron + HCV-796 +

(control therapy) ribavirin Peg-Intron +

ribavirin

Percent of

patients with 39% 73% 23%

undetectable HCV (15 of 38) (27 of 37) (17 of 73)

levels (<10 IU/ml)

The above data are based on a randomized, open-label study of the safety, tolerability, antiviral activity, and pharmacokinetics of HCV-796 administered in combination with pegylated interferon plus ribavirin versus pegylated interferon plus ribavirin (standard of care) in HCV genotype 1-infected subjects who are naive to treatment. The combination of HCV-796, pegylated interferon and ribavirin was also assessed in a group of HCV genotype 1 patients who had previously failed treatment (null-responders). The number of subjects enrolled and dosed in each of the three treatment groups ranged from 78 to 84.

Individual subjects in all dose cohorts will continue to be eligible for treatment for up to 48 weeks with standard of care, provided that, sufficient antiviral responses are observed at interim time points (12 and 24 weeks of treatment). Subjects will continue to be followed for an additional 24-week period to assess sustained virological response (SVR).

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SOURCE ViroPharma Incorporated

Copyright©2007 PR Newswire.

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