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CONTINUED HIGH VIROLOGIC RESPONSE RATES WITH ACH-1625 DAILY DOSING PLUS PEGIFN-ALPHA 2A IN A 28-DAY AND 12-WEEK PHASE 2A TRIAL
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Reported by Jules Levin
EASL 2012 Apr 18-22 Barcelona Spain
Authors: F. Poordad1*, J. Lalezari2, E. Lawitz3, H. Van Vlierberghe4, M. Shiffman5, I. Jacobson6, M. Kankam7, V. Araya8, R. Ghalib9, M. Ryan10, B. Bacon11, S. Flamm12, E. Godofsky13, L. Hazan14, F. Hinestrosa15, P. Michielsen16, P. Deltenre17, H. Robison18, L. Robarge18, E. Olek18
Affiliations: 1Cedar Sinai, Los Angeles, CA, 2Quest Clinical Research, San Francisco, CA, 3Alamo Medical Research, San Antonio, TX, 4Ghent University Hospital, Ghent, Belgium, 5Liver Institute of Virginia, Bon Secours Health System, Richmond, VA, 6Weill Cornell Medical College, New York, NY, 7Vince and Associates Clinical Research, Overland Park, KS, 8Albert Einstein Medical Center, Philadelphia, PA, 9The North Texas Research Institute, Arlington, TX, 10Digestive and Liver Disease Specialists, Norfolk, VA, 11Saint Louis University School of Medicine, Saint Louis, MO, 12Northwestern University, Chicago, IL, 13Bach and Godofsky Infectious Diseases, Bradenton, FL, 14Axis Clinical trials, Los Angeles, CA, 15Orlando Immunology Center, Orlando, FL, 16Antwerp University Hospital, Antwerp, Belgium, 17Centre Hospitalier de Jolimont-Lobbes, Hainaut, Belgium, 18Achillion Pharmaceuticals, Inc., New Haven, CT
CONCLUSIONS
- QD dosing with ACH-1625 at 200, 400, and 800 mg in combination with PegIFN/RBV for up to 12 weeks is safe and tolerable in naïve chronic GT-1 HCV infected patients
- Treatment with the novel NS3 protease inhibitor ACH-1625 demonstrates high viral response rates
- From 94% up to 100% of study subjects receiving ACH-1625 plus PegIFN / RBV for 12 weeks achieved cEVR regardless of dose level and IL28B status
- Full SVR4 and SVR12 results will guide dose selection for upcoming interferon-free combination therapy studies
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