Valeant: Viser 2 fails efficacy endpoint in hepatitis C study

By Elaine Rigoli

Tampa, Fla., Sept. 12 - Valeant Pharmaceuticals International reported summary results of Viser 2, the second of two phase 3 pivotal trials for Viramidine, and said the study did not meet the non-inferiority efficacy endpoint on an intent-to-treat basis, with overall sustained viral response rates of 40% versus 55% for the Viramidine and ribavirin arms, respectively.

However, consistent with the results seen in Viser 1, sustained viral response rates in Viser 2 trended higher among patients receiving increased exposure on a mg/kg basis in the Viramidine arm without a substantial increase in the anemia rate, according to a news release.

The Costa Mesa, Calif., specialty pharmaceutical company said Viser 2 confirmed the safety advantages of Viramidine for the treatment of chronic hepatitis C in treatment-naive patients.

Anemia rates (Hgb less than 10g/dL) during the treatment period were significantly lower in patients treated with Viramidine than those treated with ribavirin (6% versus 22%), the company noted.

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