• The Journal of infection · Feb 2015

    Multicenter Study

    Exploratory trial of ombitasvir and ABT-450/r with or without ribavirin for HCV genotype 1, 2, and 3 infection.

    • Eric Lawitz, Greg Sullivan, Maribel Rodriguez-Torres, Michael Bennett, Fred Poordad, Mudra Kapoor, Prajakta Badri, Andrew Campbell, Lino Rodrigues, Yiran Hu, Tami Pilot-Matias, and Regis A Vilchez.
    • The Texas Liver Institute, University of Texas Health Science Center, 607 Camden, San Antonio, TX 78215, USA. Electronic address: lawitz@txliver.com.
    • J. Infect. 2015 Feb 1; 70 (2): 197-205.

    ObjectivesTo examine the safety and efficacy of ombitasvir and ABT-450 with ritonavir (ABT-450/r) ± ribavirin (RBV) in treatment-naïve, non-cirrhotic adults with chronic HCV genotype 1-3 infection.MethodsPatients in this open-label, exploratory, phase 2, multicenter study received ombitasvir (25 mg QD) and ABT-450/r (200/100 mg QD) ± RBV for 12 weeks. Primary efficacy endpoint was HCV RNA < lower limit of quantitation (LLOQ) from week 4 through 12. Sustained virologic response 12 weeks post-treatment (SVR12) was a secondary endpoint.ResultsSixty-one patients were enrolled. Among genotype 1-, 2-, and 3-infected patients, respectively, HCV RNA wasConclusionsIn this study, ombitasvir and ABT-450/r ± RBV regimens were generally well-tolerated. Sustained virologic response was achieved in most patients with HCV genotype 1 or 2 infection, but low SVR rates were observed in HCV genotype 3-infected patients.Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

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