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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• 作者：C. Perelló ; J. A. Carrió ; n ; B. Ruiz-Antorá ; n ; J. Crespo ; J. Turnes ; J. Llaneras ; S. Lens ; M. Delgado ; J. Garc&iacute ; a-Samaniego ; F. Garc&iacute ; a-Paredes ; I. Ferná ; ndez ; R. M. Morillas ; D. Rincó ; n ; J. C. Porres ; M. Prieto ; M. Lá ; zaro R&iacute ; os ; C. Ferná ; ndez-Rodr&iacute ; guez ; J. A. Hermo ; M. Rodr&iacute ; guez ; J. I. Herrero ; P. Ruiz ; J. R. Ferná ; ndez ; M. Mac&iacute ; as ; J. M. Pascasio ; J. M. Moreno ; M. Á ; . Serra ; J. Arenas ; Y. Real ; F. Jorquera ; J. L. Calleja and for the Spanish Collaborative Group for the Study of the Use of Hepatitis C Direct-Acting Drugs
• 刊名：Journal of Viral Hepatitis
• 出版年：2017
• 出版时间：March 2017
• 年：2017
• 卷：24
• 期：3
• 页码：226-237
• 全文大小：471K
• ISSN：1365-2893

文摘

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.