Methods: From December 2013 to April 2014, a total of 101 genotype 1b hepatitis C patients were treated by SMV 100mg QD with PR for 12 weeks and with PR for additional 12 weeks. Prior non-re-sponders (n=28) or patients with non-favorable IL28B (non-TT genotype in rs8099917) received a 1 week Hormones antagonist lead-in therapy with PR followed by SMV/PR. Pre-existing baseline polymorphisms at NS3 region were determined by direct sequencing. Early virological dynamics was monitored at week 1, 2, 3, and 4. Factors predictive of rapid virological response (RVR) (HCV RNA undetectable by Taqman PCR (LLOD 1.2 log IU/ mL) at week 4) were determined. Results: Median age was

61 years (range 20-78). The incidence of baseline polymorphisms at NS3 region was as follows: Q80L (15%), Q80K (1%), S122G (28%), and V170I (54%). Polymorphism in V36, T54, A156, and D168 was not detected. The rate of HCV RNA undetectable at week 1, 2, and 3 was 10%, 32% and 68%. The overall rate of RVR rate was 84%, with no apparent association with degree of fibrosis (F0-2 vs. F3-4: 84% vs. 67%, p=0.1), age (<65 vs. ≥65: 80% vs. 73%, p=0.45), and NS3 polymorphisms (Q80 wild vs. Q80L: 76% vs. 75%, p>0.99, S122 wild vs. S122G: 81% vs. 60%, p=0.07, and V170 wild vs. V170I: 76% vs. 76%, p>0.99).

The RVR rate was significantly higher in naïve/prior relapsers compared to prior non-responders (87% vs. 50%, p=0.006). Among prior non-re-sponders, RVR rate was higher in patients with lower baseline HCV RNA level (<6.5 vs. ≥6.5 Antiinfection Compound Library price log IU/mL: 83% vs. 40%, p=0.02). Among prior non-responders, 61% achieved HCV RNA decrease of ≥0.7 log IU/mL by lead-in PR and selleck chemical their RVR rate was 75%. There

were no serious adverse events leading to discontinuation of SMV. Conclusions: SMV/PR therapy was well tolerated and resulted in high RVR rates in real-life clinical practice regardless of age, fibrosis stage and baseline NS3 polymorphism. Factors predictive of RVR was prior response, baseline HCV RNA level and response to lead-in PR. Disclosures: Namiki Izumi – Speaking and Teaching: MSD Co., Chugai Co., Daiichi Sankyo Co., Bayer Co., Bristol Meyers Co. The following people have nothing to disclose: Shoko Suzuki, Masayuki Kuro-saki, Jun Itakura, Kaoru Tsuchiya, Hiroyuki Nakanishi, Takanori Hosokawa, Yutaka Yasui, Nobuharu Tamaki, Nobuhiro Hattori, Yu Asano, Shuya Matsuda, Natsuko Nakakuki, Hitomi Takada, Koichi Gondou Background and Aim: Serum bilirubin levels have been reported to increase in patients with chronic hepatitis C virus (HCV) infection treated with simeprevir, pegylated interferon (Peg-IFN) plus ribavirin. The bilirubin increase is associated with hemolytic anemia caused by ribavirin as bilirubin levels did not increase in the ribavirin-free regimen trial (COSMOS trial).