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Three-Day, Dose-Ranging Study of the HCV NS5A Inhibitor GS-5885
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Reported by Jules Levin
EASL 2011 Berlin March 31-Apr 2
· GS-5885 is a novel HCV NS5A inhibitor with potent in vitro activity
- EC50 of 34 pM in GT1a replicon assay
- EC50 of 4 pM in GT1b replicon assay
· Safety and pharmacokinetic data from healthy volunteers were supportive of continued investigation of GS-5885 with once daily dosing
· OBJECTIVE: Evaluate the safety, pharmacokinetics and antiviral activity of GS-5885 when administered to patients infected with HCV GT 1 treatment-naives 1a & 1b
· Cohorts were randomized to GS-5885 or placebo (10:2) administered once daily with various doses for 3 days under fasted conditions
· After 3 days of dosing median maximum change in HCV RNA with GS-5885 NS5A inhibitor was 3.1 to 3.3 log, with some patients achieving 3.5 to 4 logs reduction.
E Lawitz,1 D Gruener,2 J Hill,3 T Marbury,4 S Komjathy,5 M DeMicco,6 A Murillo,7 F Jenkin,8 K Kim,9 J Simpson,10 M Aycock,10 A Mathias,10 C Yang,10
E Dowdy,10 M Liles,10 G Cheng,10 E Mondou,10 J Link,10 C Ohmstede,10 R Bannister,10 J McHutchison,10 and D Brainard10
1Alamo Medical Research, San Antonio, TX, USA; 2CRI Worldwide, Philadelphia, PA , USA; 3Avail Clinical Research, Deland, FL , USA; 4Orlando Clinical Research Center, Orlando, FL , USA; 5Charles River Clinical Services, Tacoma, WA , USA; 6Advanced Clinical Research Institute, Anaheim, CA , USA; 7Elite Research Institute, Miami, FL , USA; 8Synergy, National City, CA , USA; 9West Coast Clinical Trials, Cypress, CA , USA; 10Gilead Sciences, Foster City, CA , USA
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