Peak mean induction was observed by Day 3 (48 hours) with return to baseline values by Day 8. No increase in serum IFNα was observed. No clinically significant changes in HBsAg levels or HBV DNA were observed. Conclusions: Oral administration of GS-9620 stimulates a pre-systemic immune response without clinical significant systemic Fluorouracil mouse adverse events associated with IFNα in chronic hepatitis B patients. Baseline characteristics Treatment naϊve N=25 SAD 0.3 mg (N=6) 1 mg
(N=6), 2 mg (N=6) MAD 0.3 (N=6), 1 mg (N=1) Virologically suppressed N=22 SAD 0.3 (N=6), 1 (N=6), 2 mg (N=4) MAD 0.3 (N=6) Age, mean years 40 44 Male, % 68 96 HBeAg positive, % 16 36 IL28B genotype, CC % 44 59 HBsAg, mean IU/mL 7169 5768 HBV DNA, mean log10 IU/mL 4.15 <1.46 ISGl5an d CCL8 mRNA inductioi
> 2 fold change from baseline n of patients ISG15 INK 128 nmr CCL8 ISG15 CCL8 SAD 0.3 mg [min, max induction] 3/5 [2-12] 5/5 [2-10] 2/5 [3-18] 3/5 [2-610] SAD 1 mg [min, ma, Inc,Mont 3/5 [3-36] 4/5 [3-9] 3/5 [2-9] 4/5 [2-17] SAD 2 mg [min, max induction] 2/5 [2-16] 5/5 [2-164] 1/3 [3-13] 1/3 [3-186] Placebo [min, max induction] 0/3 1/3 [2] 0/3 1/3 [2] Disclosures: Edward J. Gane – Advisory Committees or Review Panels: Roche, AbbVie, Novar-tis, Tibotec, Gilead Sciences, Janssen Cilag, Vertex, Achillion; Speaking and Teaching: Novartis, Gilead Sciences, Roche Stuart C. Gordon – Advisory Committees or Review Panels: Tibotec; Consulting: Merck, CVS Caremark, Gilead Sciences, BMS; Grant/Research Histone demethylase Support: Roche/Genentech, Merck, Vertex Pharmaceuticals, Gilead Sciences, BMS, Abbott, Intercept
Pharmaceuticals, Exalenz Sciences, Inc. Stuart K. Roberts – Board Membership: Jannsen, Roche, Gilead, BMS Carla S. Coffin – Grant/Research Support: BMS, Gilead Sciences, Roche Paul Y. Kwo – Advisory Committees or Review Panels: Abbott, Anadys, Novartis, Merck, Gilead, BMS, Janssen; Consulting: Vertex; Grant/Research Support: Roche, Vertex, GlaxoSmithKline, Merck, BMS, Abbott, Idenix, Vital Therapeutics, Gilead, Vertex, Merck, Idenix; Speaking and Teaching: Merck, Merck Barbara A. Leggett – Advisory Committees or Review Panels: MSD, MSD, MSD, MSD; Speaking and Teaching: Roche, Roche, Roche, Roche, Gilead Daryl Lau – Advisory Committees or Review Panels: Gilead, BMS; Consulting: Roche; Grant/Research Support: Gilead, Merck Stefan Pflanz- Employment: Gileadn Sciences Benedetta Massetto – Employment: Gilead Sciences, Inc.; Stock Shareholder: Gilead Sciences, Inc Mani Subramanian – Employment: Gilead Sciences John G.