RT Journal Article
T1 Real-World Effectiveness and Safety of Oral Combination Antiviral Therapy for Hepatitis C Virus Genotype 4 Infection
A1 Crespo, Javier
A1 Fernández Vázquez, María Inmaculada
A1 Rincón Rodríguez, Diego
A1 Sánchez Antolín, Gloria
AB 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.
PB Elsevier
SN 1542-3565
YR 2017
FD 2017-06
LK https://hdl.handle.net/20.500.14352/114134
UL https://hdl.handle.net/20.500.14352/114134
LA eng
NO 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.
NO Ministerio de Sanidad (España)
DS Docta Complutense
RD 27 abr 2025