Journal article
Efficacy and safety of ombitasvir/paritaprevir/r and dasabuvir compared to IFN-containing regimens in genotype 1 HCV patients: The MALACHITE-I/II trials
GJ Dore, B Conway, Y Luo, E Janczewska, B Knysz, Y Liu, A Streinu-Cercel, FA Caruntu, M Curescu, R Skoien, W Ghesquiere, W Mazur, A Soza, F Fuster, S Greenbloom, A Motoc, V Arama, D Shaw, I Tornai, J Sasadeusz Show all
Journal of Hepatology | ELSEVIER SCIENCE BV | Published : 2016
Abstract
Background & Aims Telaprevir plus pegylated interferon/ribavirin (TPV + PegIFN/RBV) remains a therapeutic option for chronic hepatitis C virus (HCV) genotype (GT) 1 infection in many regions. We conducted two open-label, phase IIIb trials comparing safety and efficacy of all-oral ombitasvir/paritaprevir/ritonavir and dasabuvir ± ribavirin (OBV/PTV/r + DSV ± RBV) and TPV + PegIFN/RBV. Methods Treatment-naïve (MALACHITE-I) or PegIFN/RBV-experienced (MALACHITE-II) non-cirrhotic, chronic HCV GT1-infected patients were randomized to OBV/PTV/r + DSV + weight-based RBV, OBV/PTV/r + DSV (treatment-naïve, GT1b-infected patients only), or 12 weeks of TPV + PegIFN + weight-based RBV and 12-36 additiona..
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Funding Acknowledgements
The authors would like to express their gratitude to the trial participants, investigators, and coordinators who made this study possible as well as Barbara McGovern, Nancy Shulman, Regis Vilchez, Melissa Cook, Christi Kosogof, Antonis Panagopoulos, Sara Lari, Antigoni Tsoutsou, Barbara Cristofanelli, Travis Yanke, Danielle Grant, Melannie Co, Rajeev Menon, Prajakta Badri, Christine Collins, Tami Pilot-Matias, Rakesh Tripathi, Gretja Schnell, Preethi Krishnan, Thomas Reisch, Jill Beyer, Michelle Irvin, Martin King, Hsiao-Ming Sun, Yan Xie, Jun Sun, Andrea Craze, Kathryn Joiner, and Victoria Mullally of AbbVie for their contributions. This study was funded by AbbVie Inc. Medical writing support was provided by Christine Ratajczak (AbbVie).