Journal article

The oral toll-like receptor-7 agonist GS-9620 in patients with chronic hepatitis B virus infection

Edward J Gane, Young-Suk Lim, Stuart C Gordon, Kumar Visvanathan, Eric Sicard, Richard N Fedorak, Stuart Roberts, Benedetta Massetto, Zhishen Ye, Stefan Pflanz, Kimberly L Garrison, Anuj Gaggar, G Mani Subramanian, John G McHutchison, Shyamasundaran Kottilil, Bradley Freilich, Carla S Coffin, Wendy Cheng, Yoon Jun Kim

JOURNAL OF HEPATOLOGY | ELSEVIER SCIENCE BV | Published : 2015

Abstract

BACKGROUND & AIMS: GS-9620 is an oral agonist of toll-like receptor 7, a pattern-recognition receptor whose activation results in innate and adaptive immune stimulation. We evaluated the safety, pharmacokinetics, and pharmacodynamics of GS-9620 in patients with chronic hepatitis B. METHODS: In two double-blind, phase 1b trials of identical design, 49 treatment-naïve and 51 virologically suppressed patients were randomized 5:1 to receive GS-9620 (at doses of 0.3mg, 1mg, 2mg, 4mg) or placebo as a single dose or as two doses seven days apart. Pharmacodynamic assessment included evaluation of peripheral mRNA expression of interferon-stimulated gene 15 (ISG15), serum interferon gamma-induced prot..

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