151. 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.
- Author
-
Perelló C, Carrión JA, Ruiz-Antorán B, Crespo J, Turnes J, Llaneras J, Lens S, Delgado M, García-Samaniego J, García-Paredes F, Fernández I, Morillas RM, Rincón D, Porres JC, Prieto M, Lázaro Ríos M, Fernández-Rodríguez C, Hermo JA, Rodríguez M, Herrero JI, Ruiz P, Fernández JR, Macías M, Pascasio JM, Moreno JM, Serra MÁ, Arenas J, Real Y, Jorquera F, and Calleja JL
- Subjects
- Adult, Aged, Aged, 80 and over, Drug Therapy, Combination adverse effects, Drug-Related Side Effects and Adverse Reactions epidemiology, Drug-Related Side Effects and Adverse Reactions pathology, Female, Hepacivirus genetics, Hepacivirus isolation & purification, Hepatitis C, Chronic virology, Humans, Male, Middle Aged, Retrospective Studies, Spain, Sustained Virologic Response, Treatment Outcome, Antiviral Agents therapeutic use, Genotype, Hepacivirus classification, Hepatitis C, Chronic drug therapy
- 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., (© 2016 John Wiley & Sons Ltd.)
- Published
- 2017
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