Efficacy and safety of ombitasvir/paritaprevir/r and dasabuvir compared to IFN-containing regimens in genotype 1 HCV patients: The MALACHITE-I/II trials

• DOI: 10.1016/j.jhep.2015.08.015
• Publication Date: 2015-08-29T13:26:17Z
• Authors: Gregory J. Dore; Brian Conway; Yan Luo; Ewa Janczewska; Brygida Knysz; Yan Liu; Adrian Streinu-Ce...; Florin Alexandru ...; Manuela Curescu; Richard Skoien; Wayne Ghesquiere; Włodzimierz Mazur; Alejandro Soza; Francisco Fuster; Susan Greenbloom; Adriana Motoc; Victoria Arama; David Shaw; Istvan Tornai; Joseph Sasadeusz; Olav Dalgard; Danielle Sullivan; Xuan Liu; Mudra Kapoor; Andrew Campbell; Thomas Podsadecki
• Keywords: Ombitasvir; Paritaprevir; Ritonavir; Dasabuvir

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 dasabuvir±ribavirin (OBV/PTV/r+DSV±RBV) TPV+PegIFN/RBV.Treatment-naïve (MALACHITE-I) or PegIFN/RBV-experienced (MALACHITE-II) non-cirrhotic, HCV GT1-infected patients were randomized to OBV/PTV/r+DSV+weight-based RBV, OBV/PTV/r+DSV (treatment-naïve, GT1b-infected only), 12weeks TPV+PegIFN+weight-based RBV 12-36 additional weeks PegIFN/RBV. The primary endpoint was sustained virologic response post-treatment (SVR12). Patient-reported outcome questionnaires evaluated mental physical health during the studies.Three hundred eleven treatment-naïve 148 treatment-experienced dosed. Among patients, SVR12 rates 97% (67/69) 82% (28/34), respectively, OBV/PTV/r+DSV+RBV TPV+PegIFN/RBV-treated GT1a-infected patients; 99% (83/84), 98% (81/83), 78% (32/41) OBV/PTV/r+DSV+RBV, OBV/PTV/r+DSV, patients. (100/101) 66% (31/47) with TPV+PegIFN/RBV. Mental generally better OBV/PTV/r+DSV±RBV than Rates discontinuation due adverse events (0-1% 8-11%, p<0.05) hemoglobin decline <10g/dl (0-4% 34-47%, lower TPV+PegIFN/RBV.Among 97-99% 12week, multi-targeted regimens 66-82% 24-48 total associated health, more favorable tolerability, treatment events.