2026-06-08T03:24:29Zhttps://docta.ucm.es/rest/oai/requestoai:docta.ucm.es:20.500.14352/1141342025-01-15T01:08:07Zcom_20.500.14352_14col_20.500.14352_15
Docta Complutense
author
Crespo, Javier
author
Fernández Vázquez, María Inmaculada
author
Rincón Rodríguez, Diego
author
Sánchez Antolín, Gloria
2025-01-14T08:56:58Z
2025-01-14T08:56:58Z
2017-06
Crespo J, Calleja JL, Fernández I, Sacristan B, Ruiz-Antorán B, Ampuero J, Hernández-Conde M, García-Samaniego J, Gea F, Buti M, Cabezas J, Lens S, Morillas RM, Salcines JR, Pascasio JM, Turnes J, Sáez-Royuela F, Arenas J, Rincón D, Prieto M, Jorquera F, Sanchez Ruano JJ, Navascués CA, Molina E, Moya AG, Moreno-Planas JM; Spanish Group for the Study of the Use of Direct-acting Drugs Hepatitis C Collaborating Group. Real-World Effectiveness and Safety of Oral Combination Antiviral Therapy for Hepatitis C Virus Genotype 4 Infection. Clin Gastroenterol Hepatol. 2017 Jun;15(6):945-949.e1. doi: 10.1016/j.cgh.2017.02.020.
1542-3565
10.1016/j.cgh.2017.02.020
https://hdl.handle.net/20.500.14352/114134
https://doi.org/10.1016/j.cgh.2017.02.020
28238958
https://www.sciencedirect.com/science/article/abs/pii/S1542356517302008?via%3Dihubhttps://pubmed.ncbi.nlm.nih.gov/28238958/
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.
eng
Real-World Effectiveness and Safety of Oral Combination Antiviral Therapy for Hepatitis C Virus Genotype 4 Infection
journal article
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Clin Gastro AND Hepatol 2017.pdf