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Interim Results Presented at EASL from PROVE 1 Clinical Trial of,Investigational Drug Telaprevir in Patients with Genotype 1,Hepatitis C

of of of treatment dosing dosing dosing, value DC=F carried (a) forward) ---------------------------------------- -------- -------- ---------- TVR + peg-IFN + RBV (arms B, C 153 of 138 of 123 of 149 of 175 and D) 175 175 175 (85%) (88%) (79%) (70%) ---------------------------------------- -------- -------- ---------- Placebo + peg-IFN + RBV (arm A) 12 of 75 8 of 75 29 of 75 32 of 75 (16%) (11%) (39%) (43%) ---------------------------------------- -------- -------- ---------- (a) Intent-to-treat, discontinuation=failure analysis. Patients who had HCV RNA (less than)10 IU/mL at the time of discontinuation are counted as "failures", however these patients will be followed post- discontinuation to determine if they achieve a sustained viral response (SVR). ---------------------------------------------------------------------

In PROVE 1, a low rate of viral breakthrough was observed. Viral breakthrough occurred in 12 patients receiving telaprevir (7%), all but one of which occurred in the first 4 weeks of treatment.

Analysis of PROVE 1 Patients who Finished All Treatment at 12 Weeks

Seventeen of 175 patients received at least one dose of telaprevir in "Arm D" of the PROVE 1 study (telaprevir + peg-IFN + RBV). According to the study protocol, patients in Arm D were eligible to stop all treatment at week 12 if they met on-treatment criteria, including the achievement of RVR ((less than)10 IU/mL at week 4) and maintenance of this viral response ((less than)10 IU/mL) at week 10 of treatment. Nine of 17 patients met these criteria and stopped therapy at 12 weeks, and 6 of these patients continued to have undetectable HCV RN
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