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, Ruiz P, Fernández J R, Macías M, Pascasio J M, Moreno J M, Serra M Á, Arenas J, Real Y, Jorquera F, Calleja J L
Hospital Universitario Puerta de Hierro Majadahonda, IDIPHIM, Madrid, Spain.
CIBERehd, Madrid, Spain.
J Viral Hepat. 2017 Mar;24(3):226-237. doi: 10.1111/jvh.12637. Epub 2016 Dec 15.
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.
在过去5年中，丙型肝炎病毒（HCV）感染的治疗方法有了显著改善，在HCV基因1型患者的临床试验中，持续病毒学应答（SVR）率高达100%。我们在一项早期获取项目中研究了奥比他韦/帕利哌韦/利托那韦±达沙布韦的有效性和安全性。这是一项回顾性、多中心、全国性研究，纳入了291例初治和经治的基因1型或4型HCV感染患者。大多数患者（65.3%）为男性，平均年龄为57.5岁。平均基线病毒载量为6.1 log，69.8%为HCV 1b基因型，72.9%有肝硬化，34.7%为初治患者。治疗后12周的SVR为96.2%。4例患者出现病毒学失败（1.4%），1例导致停药。根据基因型或肝纤维化情况，病毒学应答无统计学差异。30例患者发生严重不良事件（SAE）（10.3%），6例导致停药。5例患者出现肝失代偿。4例患者在治疗或随访期间死亡，其中3例与肝衰竭直接相关。多变量分析显示，实现SVR的概率降低与基线白蛋白、胆红素和Child-Pugh评分B相关，发生SAE的概率增加与年龄和白蛋白相关。这种联合疗法在临床实践中非常有效，安全性可接受，治疗停药率低。
