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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.

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.
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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, Calleja JL, ,


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, Calleja JL, , (click to view)

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, Calleja JL, ,

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Journal of viral hepatitis 2016 12 15() doi 10.1111/jvh.12637

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.

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