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ViroPharma Announces Presentation of Additional HCV-796 Data at,Meeting of The European Association for the Study of the Liver

on with peg-IFN has been completed. Combination therapy including HCV-796 was found to be generally well tolerated. The observed safety profile supports the evaluation of HCV-796 in studies of longer duration.

-- Adverse events across all dose cohorts were generally mild to moderate in severity and were characteristic of the known side effects of interferons.

-- Adverse events that occurred at a frequency of greater than 15 percent across all dose cohorts of HCV-796 plus peg-IFN and peg-IFN alone included headache, chills, myalgias, fever, pain, arthralgia and rash.

-- There were two reports of serious adverse events: one in the placebo arm (pneumonia), and one in the 1000 mg combination cohort (seizure and rhabdomyolysis in a subject receiving high dose methadone chronically).

-- The rate of discontinuation due to adverse events was low across the study. No patient discontinued due to adverse events in the 100, 250, or 500 mg dose cohorts. In the peg-IFN alone group, one patient discontinued due to hypertension; of those that received 1000 mg HCV-796 plus peg-IFN, three patients discontinued due to either vasovagal syncope after a blood draw, rash, or seizure and rhabdomyolysis (in a subject receiving high dose methadone chronically).

-- No dose-limiting toxicities were identified across the range of study doses.

Genetic Sequencing

NS5B sequencing was performed on 36 subjects (11 on peg-IFN alone; 25 HCV- 796 and peg-IFN). Consistent with data from the Phase 1b study of HCV-796 as monotherapy, the only variant of importance detected in patients receiving HCV-796 was a C316Y variant known to have reduced susceptibility to HCV-796. Baseline sequencing did not find any variation from wild type at this position. The C316Y variant was observed in 7 (28 percent) of patients on HCV- 796 plus peg-IFN, occurring less frequently than previously seen in patients receiving HCV-796 as monotherapy, and was not clearly associated w
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