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Valeant Pharmaceuticals Highlights Taribavirin Phase IIb 60-Week Data Presentation at European Association for the Study of Liver (EASL) Annual Meeting
Date:4/23/2009

e IIb TBV TBV TBV RBV 20 mg/kg 25 mg/kg 30 mg/kg 800-1400mg n=67 n=70 n=68 n=70 TW4 Undetectable(1) 11 (16.4%) 10 (14.3%) 11 (16.2%) 8 (11.4%) TW12 Undetectable(1) 28 (41.8%) 29 (41.4%) 17 (25.0%) 22 (31.4%) TW48 Undetectable(1) 29 (43.4%) 21 (30%) 20 (29.4%) 23 (32.9%) SVR12 Undetectable(1) 19 (28.4%) 17 (24.3%) 14 (20.6%) 15 (21.4%) Anemia SVR12(2) 10 (14.9%)* 11 (15.7%)* 19 (27.9%) 23 (32.9%) (1) HCV RNA < 39 IU/mL (2) Anemia: hemoglobin < 10g/dL *P<0.05 vs. RBV

The most common adverse events during treatment were fatigue, nausea, flu-like symptoms, headache and diarrhea. The incidence rates for these adverse events among treatment arms were generally comparable except with respect to diarrhea, where incidence of diarrhea was approximately twice as common in patients receiving taribavirin compared to patients receiving ribavirin. However, the diarrhea was generally mild and not treatment limiting for taribavirin or ribavirin patients.

The Phase IIb trial is a U.S. multi-center, randomized, parallel, open-label study in 278 treatment-naive, genotype 1 patients evaluating taribavirin at weight-based doses of 20 mg/kg, 25 mg/kg, and 30 mg/kg per day in combination with pegylated interferon alfa-2b. The control group was administered weight-based dose ribavirin (800/1000/1200/1400mg daily) and pegylated interferon alfa-2b. Overall treatment duration is 48 weeks with a post-treatment follow-up period of 24 weeks.

About Taribavirin

Taribavirin is an investigational compound that has not been found by the Food and Drug Administration (FDA) or any other regulatory agency to be safe or effective in the diagnosis, mitigatio
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SOURCE Valeant Pharmaceuticals International
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