• Jose Luis Calleja, Javier Crespo, Diego Rincón, Belén Ruiz-Antorán, Inmaculada Fernandez, Christie Perelló, Francisco Gea, Sabela Lens, Javier García-Samaniego, Begoña Sacristán, María García-Eliz, Susana Llerena, Juan Manuel Pascasio, Juan Turnes, Xavier Torras, Rosa Maria Morillas, Jordi Llaneras, Miguel A Serra, Moises Diago, Conrado Fernández Rodriguez, Javier Ampuero, Francisco Jorquera, Miguel A Simon, Juan Arenas, Carmen Alvarez Navascues, Rafael Bañares, Raquel Muñoz, Agustin Albillos, Zoe Mariño, and Spanish Group for the Study of the Use of Direct-acting Drugs Hepatitis C Collaborating Group.
• Hospital Universitario Puerta de Hierro, Universidad Autonoma de Madrid and CIBERehd, Madrid, Spain. Electronic address: joseluis.calleja@uam.es.
• J. Hepatol. 2017 Jun 1; 66 (6): 1138-1148.

Background & AimsClinical trials evaluating second-generation direct-acting antiviral agents (DAAs) have shown excellent rates of sustained virologic response (SVR) and good safety profiles in patients with chronic hepatitis C virus (HCV) genotype 1 infection. We aimed to investigate the effectiveness and safety of two oral DAA combination regimens, ombitasvir/paritaprevir/ritonavir plus dasabuvir (OMV/PTV/r+DSV) and ledipasvir/sofosbuvir (LDV/SOF), in a real-world clinical practice.MethodsData from HCV genotype 1 patients treated with either OMV/PTV/r+DSV±ribavirin (RBV) (n=1567) or LDV/SOF±RBV (n=1758) in 35 centers across Spain between April 1, 2015 and February 28, 2016 were recorded in a large national database. Demographic, clinical and virological data were analyzed. Details of serious adverse events (SAEs) were recorded.ResultsThe two cohorts were not matched with respect to baseline characteristics and could not be compared directly. The SVR12 rate was 96.8% with OMV/PTVr/DSV±RBV and 95.8% with LDV/SOF±RBV. No significant differences were observed in SVR according to HCV subgenotype (p=0.321 [OMV/PTV/r+DSV±RBV] and p=0.174 [LDV/SOF]) or degree of fibrosis (c0.548 [OMV/PTV/r/DSV±RBV] and p=0.085 [LDV/SOF]). Only baseline albumin level was significantly associated with failure to achieve SVR (p<0.05) on multivariate analysis. Rates of SAEs and SAE-associated treatment discontinuation were 5.4% and 1.7%, in the OMV/PTV/r+DSV subcohort and 5.5% and 1.5% in the LDV/SOF subcohort, respectively. Hepatocellular carcinoma (HCC) recurred in 30% of patients with a complete response to therapy for previous HCC. Incident HCC was reported in 0.93%.ConclusionsIn this large cohort of patients managed in the real-world setting in Spain, OMV/PTV/r+DSV and LDV/SOF achieved high rates of SVR12, comparable to those observed in randomized controlled trials, with similarly good safety profiles.Lay SummaryIn clinical trials, second-generation direct-acting antiviral agents (DAAs) have been shown to cure over 90% of patients chronically infected with the genotype 1 hepatitis C virus and have been better tolerated than previous treatment regimens. However, patients enrolled in clinical trials do not reflect the real patient population encountered in routine practice. The current study, which includes almost 4,000 patients, demonstrates comparable rates of cure with two increasingly used DAA combinations as those observed in the clinical trial environment, confirming that clinical trial findings with DAAs translate into the real-world setting, where patient populations are more diverse and complex.Copyright © 2017 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

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