EARLY VIRAL RESPONSE TO CPG 10101, IN COMBINATION WITH PEGYLATED INTERFERON AND/

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EARLY VIRAL RESPONSE TO CPG 10101, IN COMBINATION WITH PEGYLATED

INTERFERON AND/OR RIBAVIRIN, IN CHRONIC HCV GENOTYPE 1 INFECTED

PATIENTS WITH PRIOR RELAPSE RESPONSE

(JH McHutchison, abstract 730) CPG 10101 (CPG) is an investigational

Toll-like receptor 9 (TLR9) agonist with antiviral activity. CPG

activates plasmacytoid dendritic cells and B cells directly and NK/NKT

cells indirectly, initiating and enhancing antiviral mechanisms

mediated by both innate (antiviral cytokines including IFN-_) and

adaptive immunity. This study investigates CPG's potential to exploit

immune-mediated HCV infection control mechanisms when used with

standard therapy in the relapsed subset of treatment-experienced

patients. Seventy-four HCV genotype 1-infected adults who previously

received ≥24 weeks PEG+RVN treatment resulting in undetectable HCV

RNA levels and then relapsed with subsequent detection of HCV RNA

within 6 months after cessation of treatment, were randomized and

treated initially for 12 weeks in one of five arms: PEG+RVN,

CPG+PEG+RVN, CPG+PEG, CPG+RVN, or CPG (CPG=0.2 mg/kg SC-weekly; PEG=1.5

_g/kg SC-weekly; RVN=800-1400 mg PO-daily).