BACKGROUND This is a real-world evidence study that aims to analyze the efficacy, tolerability and safety profile of paritaprevir/ombitasvir/ritonavir and dasabuvir, in patients with renal impairment. METHODS We conducted an observational prospective study, on 232 patients with chronic kidney disease, undergoing treatment with paritaprevir/ombitasvir/ritonavir and dasabuvir, for chronic hepatitis C infection - genotype 1b. Renal and liver function were assessed at the beginning of therapy, monthly during treatment and three months after therapy completion. RESULTS All patients achieved sustained virologic response. Common side effects were nausea, fatigue and headache. Close monitoring of tacrolimus blood levels and dose reduction was required in kidney transplant recipients. CONCLUSIONS HCV therapy in the setting of renal dysfunction has always been a challenging topic. Direct-acting antivirals have shown promising effects, demonstrating good tolerance and efficacy in patients with HCV infection and renal impairment. Sustained virologic response within our study population was 100%.

中文翻译：

---

直接作用抗病毒药对慢性肾脏病患者的慢性丙型肝炎的安全性和有效性。

背景技术这是一项现实世界的证据研究，旨在分析paritaprevir / ombitasvir / ritonavir和dasabuvir在肾功能不全患者中的疗效，耐受性和安全性。方法我们对232例慢性肾脏病患者进行了一项观察性前瞻性研究，他们接受了paritaprevir / ombitasvir / ritonavir和dasabuvir治疗慢性C型肝炎感染-基因型1b。在治疗开始时，治疗期间每月和治疗结束后三个月评估肾和肝功能。结果所有患者均获得了持续的病毒学应答。常见的副作用是恶心，疲劳和头痛。肾移植接受者需要密切监测他克莫司的血药浓度并降低剂量。结论HCV治疗肾功能不全一直是一个具有挑战性的话题。直接作用的抗病毒药物已显示出令人鼓舞的效果，证明对HCV感染和肾功能不全的患者具有良好的耐受性和疗效。在我们的研究人群中，持续的病毒学应答率为100％。