Childs-Kean Lindsey M, Brumwell Natalie A, Lodl Emma F
Department of Pharmacotherapy and Translational Research, University of Florida College of Pharmacy, Gainesville, FL, USA.
Infect Drug Resist. 2019 Jul 23;12:2259-2268. doi: 10.2147/IDR.S171338. eCollection 2019.
The treatment of chronic hepatitis C has been revolutionized with the introduction of direct-acting antivirals (DAAs). However, some patients are not cured with first-line treatment. Sofosbuvir/velpatasvir/voxilaprevir is a fixed-dose combination of a polymerase inhibitor, an NS5A inhibitor, and a protease inhibitor with activity against strains of the hepatitis C virus that show resistance to other first-line antiviral regimens. Sofosbuvir/velpatasvir/voxilaprevir has been studied in four Phase III randomized trials: POLARIS-1, -2, -3, and -4, which enrolled both treatment naïve and experienced patients with and without compensated cirrhosis. In these trials, at least 95% of patients treated with sofosbuvir/velpatasvir/voxilaprevir achieved sustained virological response (SVR). This includes favorable treatment outcomes in patients who had previously failed a regimen containing sofosbuvir or an NS5A inhibitor. Patient-reported outcomes also improved during and after treatment with sofosbuvir/velpatasvir/voxilaprevir. Treatment with sofosbuvir/velpatasvir/voxilaprevir is well tolerated, with the most commonly reported adverse events being headache, fatigue, diarrhea, and nausea. The approval of sofosbuvir/velpatasvir/voxilaprevir allows a treatment option for patients who have failed treatment with certain DAA regimens.
直接作用抗病毒药物(DAAs)的引入彻底改变了慢性丙型肝炎的治疗方法。然而,一些患者一线治疗未能治愈。索磷布韦/维帕他韦/伏西瑞韦是一种固定剂量组合药物,包含一种聚合酶抑制剂、一种NS5A抑制剂和一种蛋白酶抑制剂,对丙型肝炎病毒中对其他一线抗病毒方案耐药的毒株具有活性。索磷布韦/维帕他韦/伏西瑞韦已在四项III期随机试验中进行了研究:POLARIS-1、-2、-3和-4,这些试验纳入了初治和经治的有或无代偿性肝硬化的患者。在这些试验中,至少95%接受索磷布韦/维帕他韦/伏西瑞韦治疗的患者实现了持续病毒学应答(SVR)。这包括之前使用含索磷布韦或NS5A抑制剂的方案治疗失败的患者取得了良好的治疗效果。患者报告的治疗期间及治疗后的结果也有所改善。索磷布韦/维帕他韦/伏西瑞韦治疗耐受性良好,最常报告的不良事件为头痛、疲劳、腹泻和恶心。索磷布韦/维帕他韦/伏西瑞韦的获批为某些DAA方案治疗失败的患者提供了一种治疗选择。