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Background & Aims: Chlorcyclizine HCl (CCZ) is a piperazine-class antihistamine with antihepatitis C virus (HCV) activity in vitro and in vivo. In a first-in-humans study for HCV, we evaluated the antiviral effects and safety of CCZ±ribavirin (RBV), characterized pharmacokinetic (PK) and viral kinetic (VK) patterns, and provide insights into CCZs mode of action against HCV. Methods: Chronic HCV patients were randomized to CCZ (75mg twice daily) or CCZ+weightbased RBV (1000/1200mg daily) for 28 days. Therapy started with a loading dose of CCZ 150mg ±RBV. Serial assessments of safety, liver tests, PK and VK markers were obtained.

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