학술논문
Effectiveness and safety of ombitasvir, paritaprevir, ritonavir ± dasabuvir ± ribavirin: An early access programme for Spanish patients with genotype 1/4 chronic hepatitis C virus infection.
Document Type
Article
Author
Perelló, C.; Carrión, J. A.; Ruiz‐Antorán, B.; Crespo, J.; Turnes, J.; Llaneras, J.; Lens, S.; Delgado, M.; García‐Samaniego, J.; García‐Paredes, F.; Fernández, I.; Morillas, R. M.; Rincón, D.; Porres, J. C.; Prieto, M.; Lázaro Ríos, M.; Fernández‐Rodríguez, C.; Hermo, J. A.; Rodríguez, M.; Herrero, J. I.
Source
Subject
*CHRONIC hepatitis C
*COMBINATION drug therapy
*DRUG efficacy
*MEDICATION safety
*RITONAVIR
*RIBAVIRIN
*GENOTYPES
*THERAPEUTICS
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Language
ISSN
1352-0504
Abstract
Over the last 5 years, therapies for hepatitis C virus ( HCV) infection have improved significantly, achieving sustained virologic response ( SVR) rates of up to 100% in clinical trials in patients with HCV genotype 1. We investigated the effectiveness and safety of ombitasvir/paritaprevir/ritonavir±dasabuvir in an early access programme. This was a retrospective, multicentre, national study that included 291 treatment-naïve and treatment-experienced patients with genotype 1 or 4 HCV infection. Most patients (65.3%) were male, and the mean age was 57.5 years. The mean baseline viral load was 6.1 log, 69.8% had HCV 1b genotype, 72.9% had cirrhosis and 34.7% were treatment-naïve. SVR at 12 weeks posttreatment was 96.2%. Four patients had virological failure (1.4%), one leading to discontinuation. There were no statistical differences in virological response according to genotype or liver fibrosis. Thirty patients experienced serious adverse events ( SAEs) (10.3%), leading to discontinuation in six cases. Hepatic decompensation was observed in five patients. Four patients died during treatment or follow-up, three of them directly related to liver failure. Multivariate analyses showed a decreased probability of achieving SVR associated with baseline albumin, bilirubin and Child-Pugh score B, and a greater probability of developing SAEs related to age and albumin. This combined therapy was highly effective in clinical practice with an acceptable safety profile and low rates of treatment discontinuation. [ABSTRACT FROM AUTHOR]