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748A AASLD ABSTRACTS HEPATOLOGY, October, 2015 Christine Jacomet - Advisory Committees or Review Panels: ANSM; Consulting: CONVERGENCE; Grant/Research Support: JANSSEN, ROCHE, MSD; Speaking and Teaching: ABBOTT, BMS, MSD, JANSSEN, VIIV, GILEAD Claudine C. Duvivier - Grant/Research Support: Gilead Sciences Laurent Cotte - Grant/Research Support: MSD, ViiV The following authors have nothing to disclose: Isabelle Poizot-Martin, Alissa Naqvi, Véronique Obry-Roguet, Eric Billaud, Antoine Chéret, David Rey, Pascal Pugliese, Pierre Pradat 1094 Sofosbuvir Plus Ribavirin Without Interferon For Treatment of Acute Hepatitis C Virus Infection in HIV-1 infected Individuals (SWIFT-C) Susanna Naggie 1 , Kristen M. Marks 2 , Michael Hughes 3 , Daniel S. Fierer 4 , Arthur Y. Kim 5 , Kimberly Hollabaugh 3 , Jennifer Kiser 6 , Jhoanna Roa 3 , Bill Symonds 7 , Diana M. Brainard 8 , John G. McHutchison 8 , Marion G. Peters 9 , Raymond T. Chung 5 ; 1 Duke University Medical Center, Durham, NC; 2 Weill Cornell, New York, NY; 3 Harvard, Cambridge, MA; 4 Mount Sinai School of Medicine, New York, NY; 5 Massachusetts General Hospital, Boston, MA; 6 University of Colorado, Denver, CO; 7 Roivant, New York, NY; 8 Gilead Sciences, Inc, Foster City, CA; 9 University of California, San Francisco, San Francisco, CA Background: The role of interferon-free, oral direct acting antivirals (DAA) for the treatment of acute hepatitis C virus (HCV) infection in HIV-infected persons has not been explored. Methods: SWIFT-C is a multicenter, single arm trial of the AIDS Clinical Trials Group (ACTG) investigating the safety and efficacy of 12 weeks of sofosbuvir (400mg/day) and weight based ribavirin (1000mg
HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 749A dL (IQR: 0.5 – 0.9 mg/dL). Of the patients with data available 12-weeks after the end-of-treatment, 43/48 (90%) achieved SVR12. Of the 5 patients who failed, 4 relapsed within the first 4 weeks after the end-of-treatment. One patient was sent to hospice after a hospitalization for acute cholangitis with elevated total bilirubin, rectal bleeding, and worsening renal function. The average cost of pharmaceuticals per patient was $90,234. The average cost-per-SVR was $100,727. Compared to treatment with SMV/SOF, the cost-per-SVR with LDV/SOF was on average $68,337 lower. Conclusions: We observed high SVR rates (90%) with LDV/SOF in standard clinical practice. The cost-per-SVR was $100,000 and was approximately $68,000 less than previous treatments. Future investigations of real-world SVR rates are needed. Disclosures: Kian Bichoupan - Consulting: Janssen, Gilead Alyson Harty - Advisory Committees or Review Panels: Gilead; Consulting: Gilead, Jannsen, Acaria Pharmacy, Abbvie David B. Motamed - Advisory Committees or Review Panels: Gilead Pharmaceuticals Viktoriya Khaitova - Advisory Committees or Review Panels: Gilead, Johnson and Johnson Charissa Y. Chang - Consulting: Gilead, Vertex, Onyx Jennifer Leong - Advisory Committees or Review Panels: Gilead; Consulting: Bayer Scott L. Friedman - Advisory Committees or Review Panels: Pfizer Pharmaceutical; Consulting: Conatus Pharm, Exalenz, Genfit, Exalenz Biosciences, Eli Lilly PHarmaceuticals, Fibrogen, Boehringer Ingelheim, Nitto Corp., Immune Therapeutics, Synageva, Roche/Genentech Pharmaceuticals, DeuteRx, Abbvie, Novartis, RuiYi, Kinemed, Sanofi Aventis, Takeda Pharmaceuticals, Nimbus Therapeutics, Bristol Myers Squibb, Astra Zeneca, Sandhill Medical Devices, Galmed, Northern Biologics, Enanta Pharmaceuticals, Regado Bioscience, Raptor Pharmaceuticals, Teva Pharmaceuticals, Zafgen Pharmaceuticals, Merck Pharmaceuticals, Debio Pharmaceuticals; Grant/Research Support: Galectin Therapeutics, Tobira Pharm; Stock Shareholder: Angion Biomedica, Intercept Pharma Albert Min - Consulting: Bristol Myers Squibb, Gilead, Janssen, Merck; Grant/ Research Support: Bristol Myers Squibb, Gilead; Speaking and Teaching: Bristol Myers Squibb, Gilead Douglas Dieterich - Advisory Committees or Review Panels: Gilead, BMS, Abbvie, Janssen, Merck, Achillion Andrea D. Branch - Grant/Research Support: Gilead, Janssen The following authors have nothing to disclose: Daniel J. Waintraub, Neal M. Patel, Sweta Chekuri, Joshua Hartman, Alicia Stivala, Angela Woody, Meena B. Bansal, Priya Grewal, Ritu Agarwal, Gene Y. Im, Lawrence Liu, Joseph A. Odin, Nancy Bach, Thomas D. Schiano, Ponni V. Perumalswami, Lan S. Wang, Jahnavi Naik 1096 IFN-λ inhibits miR-122 transcription through a Stat3- HNF4a inflammatory feedback loop in an IFN-α resistant HCV cell culture system Fatma Aboulnasr 1 , Sidhartha Hazari 1 , Partha K. Chandra 1 , Pauline Ferraris 1 , Rajesh Panigrahi 1 , Srinivas Chava 1 , Ramazan Kurt 1 , Kyoungsub Song 1 , Asha Dash 1 , Luis A. Balart 2 , Tong Wu 1 , Srikanta Dash 1,2 ; 1 Pathology, Tulane University, New Orleans, LA; 2 Medicine, Division of Gasteroenterology and Hepatology, Tulane University, New Orleans, LA Background: HCV replication in persistently infected cell culture remains resistant to IFN-α /RBV combination treatment, whereas IFN-λ1 induces viral clearance. The antiviral mechanisms by which IFN-λ1 induces sustained HCV clearance have not been determined. Aim: To investigate the mechanisms by which IFN-λ clears HCV replication in an HCV cell culture model. Methods: IFN-α sensitive (S3-GFP) and resistant (R4-GFP) cells were treated with equivalent concentrations of either IFN-λ1 or IFN-α.The relative antiviral effects of IFN-α and IFN-λ1 were compared by measuring the HCV replication, quantification of HCV-GFP expression by flow cytometry, and viral RNA levels by real time RT-PCR. Activation of Jak-Stat signaling, interferon stimulated gene (ISG) expression, and miRNA-122 transcription in S3-GFP and R4-GFP cells were examined. Results: We have shown that IFN-λ1 induces HCV clearance in IFN-α resistant and sensitive replicon cell lines in a dose dependent manner through Jak-Stat signaling, and induces STAT1 and STAT2 activation, ISRE-luciferase promoter activation and ISG expression. Stat3 activation is also involved in IFN-λ1 induced antiviral activity in HCV cell culture. IFNλ1 induced Stat3 phosphorylation reduces the expression of hepatocyte nuclear factor 4 alpha (HNF4α) through miR-24 in R4-GFP cells. Reduced expression of HNF4α is associated with decreased expression of miR-122 resulting an anti-HCV effect. Northern blot analysis confirms that IFN-λ1 reduces miR-122 levels in R4-GFP cells. Our results indicate that IFN-λ1 activates the Stat3-HNF4a feedback inflammatory loop to inhibit miR- 122 transcription in HCV cell culture. Disclosures: Luis A. Balart - Advisory Committees or Review Panels: abbvie, Genentech; Grant/Research Support: Merck, Genentech, Bayer, conatus, Ocera, Hyperion, Gilead Sciences, Bristol Myers Squibb, abbvie, Vertex, Merck, Genentech, Bayer, Conatus, Ocera, Hyperion, Gilead Sciences, Bristol Myers Squibb, Mochida, Eisai, Vertex, takeda, GI Dynamics, tobira; Speaking and Teaching: Merck, Merck, Merck, Merck, Abbvie, janssen The following authors have nothing to disclose: Fatma Aboulnasr, Sidhartha Hazari, Partha K. Chandra, Pauline Ferraris, Rajesh Panigrahi, Srinivas Chava, Ramazan Kurt, Kyoungsub Song, Asha Dash, Tong Wu, Srikanta Dash 1097 Efficacy of Daclatasvir/Asunaprevir According to Resistance Associated Variants in Chronic Hepatitis C Genotype1b Etsuko Iio 1 , Noritomo Shimada 2 , Hiroshi Abe 3 , Masanori Atsukawa 4 , Kai Yoshiza 5 , Koichi Takaguchi 6 , Yuichiro Eguchi 7 , Hideyuki Nomura 8 , Tomoyuki Kuramitsu 9 , Jong-Hon Kang 10 , Takeshi Matsui 10 , Noboru Hirashima 11 , Atsunori Kusakabe 12 , Yasuhito Tanaka 1 ; 1 Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan; 2 Ootakanomori Hospital, Kashiwa, Japan; 3 Jikei University School of Medicine Katsushika Medical Center, Tokyo, Japan; 4 Nippon Medical School Chiba Hokusoh Hospital, Chiba, Japan; 5 Machida Municipal Hospital, Tokyo, Japan; 6 Kagawa Prefectural Central Hospital, Takamatsu, Japan; 7 Saga University Hospital, Saga, Japan; 8 Shin-Kokura Hospital, Kitakyushu, Japan; 9 Kuramitsu Clinic, Akita, Japan; 10 Teine Keijinkai Hospital, Sapporo, Japan; 11 National Hospital Organization Nagoya Medical Center, Nagoya, Japan; 12 Nagoya Red Cross Hospital, Nagoya, Japan [Background/Aims] Interferon (IFN)-free daclatasvir (DCV) and asunaprevir (ASV) therapy for 24 weeks improved efficacy and safety outcomes for patients with hepatitis C virus (HCV) infection. The aim of the present study is to assess the treatment outcome according to resistance associated variants (RAVs) in NS3/NS5A regions among patients with chronic HCV genotype 1b infection (HCV-1b). [Methods] 612 patients with HCV-1b were enrolled at multi centers in Japan. This study protocol was approved by the appropriate institutional ethics review committees and written informed consents were observed. Direct sequencing in NS5A region was performed for all 612 patients before DCV/ASV therapy. 393 chronic hepatitis (CH) and 219 liver cirrhosis (LC) patients. The median age was 71 (30-87) and male was 267 (43.6%). The median platelet count was 12.6×10 4 /μL and HCV-RNA was 6.1 log IU/mL. 36 patients had experience of Peg-IFN/RBV/Protease inhibitors (PI) combination therapy, and 27 with simeprevir (SMV). [Results] Direct sequencing analysis of 612 patients administered DCV/ASV therapy showed the existence of 31M (2.4%), 93H (4.1%), and 31M/93H (0.3%) variants in NS5A region. The 531 patients received over the 4 weeks of DCV/
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1312A AUTHOR INDEX HEPATOLOGY, Octo
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