Observational Study
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Pharmacol Ther. May 6, 2017; 8(2): 137-146
Published online May 6, 2017. doi: 10.4292/wjgpt.v8.i2.137
Interferon-free treatments in patients with hepatitis C genotype 1-4 infections in a real-world setting
Huascar Ramos, Pedro Linares, Ester Badia, Isabel Martín, Judith Gómez, Carolina Almohalla, Francisco Jorquera, Sara Calvo, Isidro García, Pilar Conde, Begoña Álvarez, Guillermo Karpman, Sara Lorenzo, Visitación Gozalo, Mónica Vásquez, Diana Joao, Marina de Benito, Lourdes Ruiz, Felipe Jiménez, Federico Sáez-Royuela, Asociación Castellano y Leonesa de Hepatología (ACyLHE)
Huascar Ramos, Ester Badia, Judith Gómez, Visitación Gozalo, Federico Sáez-Royuela, Department of Gastroenterology and Hepatology, Hospital Universitario de Burgos, 09006 Burgos, Spain
Pedro Linares, Francisco Jorquera, Begoña Álvarez, Diana Joao, Department of Gastroenterology and Hepatology, Complejo Asistencial Universitario de León, 24071 León, Spain
Isabel Martín, Felipe Jiménez, Department of Gastroenterology and Hepatology, Hospital Universitario de Salamanca, 37007 Salamanca, Spain
Carolina Almohalla, Marina de Benito, Department of Hepatology, Hospital Universitario Rio Hortega, 47012 Valladolid, Spain
Francisco Jorquera, CIBERehd, 28029 Madrid, Spain
Francisco Jorquera, IBIOMED, 24071 León, Spain
Sara Calvo, Fundación Burgos por la Investigación de la Salud, Hospital Universitario de Burgos, 09006 Burgos, Spain
Isidro García, Department of Gastroenterology and Hepatology, Complejo Asistencial de Palencia, 34005 Palencia, Spain
Pilar Conde, Department of Gastroenterology and Hepatology, Complejo Asistencial de Zamora, 49022 Zamora, Spain
Guillermo Karpman, Department of Gastroenterology and Hepatology, Hospital El Bierzo, 24411 Ponferrada, Spain
Sara Lorenzo, Lourdes Ruiz, Department of Gastroenterology and Hepatology, Hospital Clínico Universitario de Valladolid, 47005 Valladolid, Spain
Mónica Vásquez, Department of Gastroenterology and Hepatology, Hospital Santos Reyes, 09400 Aranda de Duero, Spain
Author contributions: Ramos H, Badia E and Sáez-Royuela F contributed equally to this work; Ramos H, Badia E, Calvo S and Sáez-Royuela F designe the research; Ramos H, Linares P, Martín I, Almohalla C, Jorquera F, García I, Conde P, Álvarez B, Karpman G, Lorenzo S, Gozalo V, Vásquez M, Joao D, de Benito M, Ruiz L and Jiménez F performed the research; Badia E, Gómez J, Calvo S and Sáez-Royuela F analyzed the data; Badia E, Martín I, Gómez J, Jorquera F and Sáez-Royuela F wrote the paper.
Supported by Fundación Burgos por la Investigación de la Salud and Gerencia Regional de Salud de Castilla y León, No. BUO/06/15.
Institutional review board statement: The study was reviewed and approved by the Comité Ético de Investigación Clínica de Burgos y Soria (Spain).
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: No potential conflicts of interest relevant to this article were reported.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Federico Sáez-Royuela, MD, PhD, Department of Gastroenterology and Hepatology, Hospital Universitario de Burgos, Avda, Islas Baleares 3, 09006 Burgos, Spain. fsroyuela@gmail.com
Telephone: +34-94-7281800 Fax: +34-94-7281829
Received: November 4, 2016
Peer-review started: November 5, 2016
First decision: December 13, 2016
Revised: January 14, 2017
Accepted: February 8, 2017
Article in press: February 9, 2017
Published online: May 6, 2017
Processing time: 180 Days and 11.8 Hours
Abstract
AIM

To investigated the real-world effectiveness and safety of various regimens of interferon-free treatments in patients infected with hepatitis C virus (HCV).

METHODS

We performed an observational study to analyze different antiviral treatments administered to 462 HCV-infected patients, of which 56.7% had liver cirrhosis. HCV RNA after 4 wk of treatment and at 12 wk after treatment sustained virologic response (SVR) as well as serious adverse events (SAEs) was analyzed first for the whole cohort and then separately in patients who met or did not meet the inclusion criteria of a clinical trial (CT-met and CT-unmet, respectively).

RESULTS

The most frequently prescribed treatment was simeprevir/sofosbuvir (36.4%), followed by sofosbuvir/ledipasvir (24.9%) and ombitasvir/paritaprevir/ritonavir (r)/dasabuvir (19.9%). Ribavirin (RBV) was administered in 198 patients (42.9%). SVRs occurred in 437/462 patients (94.6%). The SVRs ranged between 93.3% and 100% for genotypes 1-4. SVRs were achieved in 96.2% patients in the CT-met group vs 91.9% patients in the CT-unmet group (P = 0.049). Undetectable HCV RNA at week 4 occurred in 72.9% of the patients. In the univariate analysis, the factors associated with SVRs were lower liver stiffness, absence of cirrhosis, higher platelet count, higher albumin levels, no RBV dose reduction, undetectable HCV RNA at week 4 and CT-met group. In the multivariate analysis, only albumin was an independent predictor of treatment failure (P = 0.04). Eleven patients (2.4%) developed SAEs; 5.2% and 0.7% of the patients in the CT-unmet and CT-met groups, respectively (P = 0.003).

CONCLUSION

A high proportion of patients with HCV infection achieved SVRs. For patients who did not meet the CT criteria, treatment regimens must be optimized.

Keywords: Hepatitis C virus infection; Genotype 1-4; Real world treatment; Direct-acting antiviral agents

Core tip: Our study analyzes the hepatitis C virus (HCV) most common genotypes treatment and all the possible combinations with direct-acting antiviral agents which are nowadays available in our country. We have found sustained virological response rates up to 90%, even in genotypes 1 and 3. The current study analyzes HCV RNA after 4 wk of treatment and 12 and 24 wk after the end of the treatment, as well as the adverse events. We analyze, separately, the patients who meet or do not meet the inclusion criteria of a clinical trial, finding that in this last group the response is lower.