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Clin Gastroenterol Hepatol. 2017 Jun;15(6):945-949.e1. doi: 10.1016/j.cgh.2017.02.020. Epub 2017 Feb 24.

Real-World Effectiveness and Safety of Oral Combination Antiviral Therapy for Hepatitis C Virus Genotype 4 Infection.

Author information

1
Gastroenterology and Hepatology Unit, Hospital Universitario Marqués de Valdecilla, Santander, IDIVAL, Universidad de Cantabria, Santander, Spain. Electronic address: javiercrespo1991@gmail.com.
2
Department of Gastroenterology, Hospital Universitario Puerta de Hierro, Universidad Autonoma de Madrid and CIBERehd, Madrid, Spain.
3
Department of Gastroenterology, Hospital Universitario 12 de Octubre, Madrid, Spain.
4
Department of Gastroenterology, Hospital San Pedro, Logroño, Spain.
5
Department of Clinical Pharmacology, Hospital Universitario Puerta de Hierro, Madrid, Spain.
6
Department of Gastroenterology, Hospital Universitario Virgen del Rocío, IBIS and CIBERehd, Sevilla, Spain.
7
Liver Unit, Hospital Universitario La Paz, CIBERehd, IdiPAZ, Madrid, Spain.
8
Department of Gastroenterology, Hospital Universitario Ramon y Cajal and CIBERehd, Madrid, Spain.
9
Liver Unit, Hospital Universitario Vall D'Hebrón and CIBERehd, Barcelona, Spain.
10
Gastroenterology and Hepatology Unit, Hospital Universitario Marqués de Valdecilla, Santander, IDIVAL, Universidad de Cantabria, Santander, Spain.
11
Liver Unit, Hospital Cliníc de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.
12
Hospital Germans Trias i Pujol and CIBERehd, Badalona, Spain.
13
Department of Gastroenterology, Hospital Comarcal Laredo, Laredo, Spain.
14
Department of Gastroenterology, Hospital Universitario Virgen del Rocio, Sevilla, Spain.
15
Department of Gastroenterology, Complejo Hospitalario Universitario de Pontevedra and IISGS, Pontevedra, Spain.
16
Department of Gastroenterology, Hospital Universitario de Burgos, Burgos, Spain.
17
Department of Gastroenterology, Hospital Universitario Donostia, San Sebastian, Spain.
18
Department of Gastroenterology, Hospital General Universitario Gregorio Marañón and CIBERehd, Madrid, Spain.
19
Servicio de Medicina Digestiva, Unidad de Hepatología, Hospital Universitari i Politècnic La Fe and CIBERehd, Valencia, Spain.
20
Department of Gastroenterology, Complejo Asistencial Universitario León, León, Spain.
21
Department of Gastroenterology, Hospital Universitario de Toledo, Toledo, Spain.
22
Department of Gastroenterology, Hospital Universitario Central de Asturias, Oviedo, Spain.
23
Department of Gastroenterology, Hospital Clínico Universitario Santiago, Santiago de Compostela, Spain.
24
Department of Gastroenterology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
25
Department of Gastroenterology, Complejo Hospitalario Universitario de Albacete, Albacete, Spain.

Abstract

Patients with hepatitis C virus (HCV) genotype 4 infection are poorly represented in clinical trials of second-generation direct-acting antiviral agents (DAAs). More data are needed to help guide treatment decisions. We investigated the effectiveness and safety of DAAs in patients with genotype 4 infection in routine practice. In this cohort study, HCV genotype 4-infected patients treated with ombitasvir/paritaprevir/ritonavir (OMV/PTVr) + ribavirin (RBV) (n=122) or ledipasvir/sofosbuvir (LDV/SOF) ± RBV (n=130) included in a national database were identified and prospectively followed up. Demographic, clinical and virologic data and serious adverse events (SAEs) were analyzed. Differences between treatment groups mean that data cannot be compared directly. Overall sustained virologic response at Week 12 post treatment (SVR12) was 96.2% with OMV/PTVr+RBV and 95.4% with LDV/SOF±RBV. In cirrhotic patients, SVR12 was 91.2% with OMV/PTVr+RBV and 93.2% with LDV/SOF±RBV. There was no significant difference in SVR12 according to degree of fibrosis in either treatment group (P = .243 and P = .244, respectively). On multivariate analysis, baseline albumin <3.5 g/dL (OMV/PTVr) and bilirubin >2 mg/dL (both cohorts) were significantly associated with failure to achieve SVR (P < .05). Rates of SAEs and SAE-associated discontinuation were 5.7% and 2.5%, respectively, in the OMV/PTVr subcohort and 4.6% and 0.8%, respectively, in the LDV/SOF subcohort. DAA-based regimens returned high rates of SVR12, comparable to limited data from clinical trials, in cirrhotic and non-cirrhotic HCV genotype 4 patients managed in a realworld setting. Safety profiles of both regimens were good and comparable to those reported for other HCV genotypes.

KEYWORDS:

Cirrhosis; Direct-Acting Antiviral Agents; Genotype 4; Routine Clinical Practice

PMID:
28238958
DOI:
10.1016/j.cgh.2017.02.020
[Indexed for MEDLINE]

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