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Potent Antiviral Activity With A Nucleoside Polymerase (R7128) And Protease (R7227/ITMN-191) Inhibitor Combination in HCV Genotype 1: Initial Safety, Pharmacokinetics, And Virologic Results From INFORM-1
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Reported by Jules Levin
EASL Copenhagen April 23-26 2009
I just returned to my computer to report the final oral session at EASL that included new orally administered HCV drugs. The major story coming out of this meeting was the presentation in this session of the first data from the first study to examine the combination of two oral HCV drugs, which is a milestone in new HCV drug development. The INFORM Study looks at these 2 orally administered drugs - protease ITMN-191 (R7227) NNRTI polymerase R7128 in treatment-naive patients. Both the potency is and safety profile are good, after 14 days treatment median viral load reduction was about 5 logs or greater, see the graphs and tables below. They are planning the next study to look at higher doses of the protease, the dosing regimens planned are in the attached report. telaprevir PROVE3 data for patients who are prior nonresponders and I will report that to you next.
EJ Gane1, SK Roberts2, C Stedman3, PW Angus4, B Ritchie5, R Elston6, D Ipe6, L Baher6, P Morcos6, I Najera6, M Mannino6, B Brennan6, M Berrey7, W Bradford8, E Yetzer6, NS Shulman6, and PF Smith6
1Auckland Clinical Studies, Auckland, New Zealand; 2The Alfred, Melbourne, Australia, 3Christchurch Clinical Studies, Christchurch, New Zealand, 4Austin Hospital, Heidelberg, Australia, 5Royal Adelaide Hospital, Adelaide, Australia, 6Roche Palo Alto LLC, Palo Alto, CA 7Pharmasset, Inc., Princeton, NJ, 8Intermune, Inc., Brisbane, CA, USA
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