a Department of Gastroenterology , Grigore T. Popa University of Medicine and Pharmacy , Iasi , Romania.
b Department of Gastroenterology , St. Spiridon, Emergency Clinical Hospital , Iasi , Romania.
Expert Opin Pharmacother. 2019 Mar;20(4):379-384. doi: 10.1080/14656566.2018.1560424. Epub 2018 Dec 21.
Alisporivir (ALV) (previously known as Debio 025) is a potent, pangenotypic host-targeting antiviral oral agent acting on cyclophilin A, which is necessary for HCV replication. Areas covered: This article reviews the therapeutic efficacy and safety of ALV for the treatment of HCV infection. Expert opinion: Direct-acting antivirals (DAAs) have revolutionized the HCV antiviral treatment paradigm with success rates well above 95% for all HCV genotypes. However, challenges still remain in certain patient populations such as those who have developed resistance and have experienced multi-DAA failure. To cure HCV infection, a treatment regimen must combine antiviral potency and a high barrier to resistance. ALV fulfills this need as shown by the studies evaluating its clinical efficacy. Nevertheless, ALV missed the chance to be included in the HCV treatment armamentarium after the FDA halted clinical studies following reports of serious side effects (three cases of pancreatitis, one lethal). However, it is possible that ALV could still be considered for HCV-infected non-cirrhotic patients that are infected with a multiresistant virus or with HCV genotype 3, although it must be said that the drug industry would be reluctant to invest in new antivirals if the current clinical need is effectively met.
阿利司波韦（ALV）（以前称为 Debio 025）是一种有效的、针对所有基因型 HCV 的泛基因型宿主靶向抗病毒口服药物，作用于 HCV 复制所必需的亲环素 A。
本文综述了 ALV 治疗 HCV 感染的疗效和安全性。
直接作用抗病毒药物（DAAs）彻底改变了 HCV 的抗病毒治疗模式，所有 HCV 基因型的治愈率均超过 95%。然而，在某些患者群体中仍然存在挑战，例如已经产生耐药性和经历过多种 DAA 失败的患者。为了治愈 HCV 感染，治疗方案必须结合抗病毒效力和高耐药屏障。ALV 满足了这一需求，其临床疗效的研究也证明了这一点。然而，在 FDA 报告严重副作用（三例胰腺炎，一例致命）后停止临床试验后，ALV 错失了成为 HCV 治疗武器库一部分的机会。然而，如果当前的临床需求得到有效满足，对于感染多耐药病毒或 HCV 基因型 3 的非肝硬化 HCV 感染患者，仍有可能考虑使用 ALV，但必须指出，如果当前的临床需求得到有效满足，制药行业可能不愿意投资新的抗病毒药物。
