Scotto Riccardo, Buonomo Antonio Riccardo, Moriello Nicola Schiano, Maraolo Alberto Enrico, Zappulo Emanuela, Pinchera Biagio, Gentile Ivan, Borgia Guglielmo
Department of Clinical Medicine and Surgery, Section of Infectious Diseases, University of Naples Federico II, Naples, Italy.
Rev Recent Clin Trials. 2019;14(3):173-182. doi: 10.2174/1574887114666190306154650.
Advances in the development of Direct-Acting Antivirals (DAAs), particularly pangenotypic drugs, have led to a high rate of hepatitis C virus (HCV) eradication. Notably, real- world studies have confirmed the efficacy and safety of pangenotypic DAA combinations reported in registration trials. The aim of this study was to review the treatment recommendations, and the efficacy and safety data of anti-HCV pangenotypic drugs reported in registration clinical trials and in recent real-life cohort studies.
We reviewed the efficacy and safety data of pangenotypic anti-HCV drug combinations reported in original articles and in online conference abstracts.
Current pangenotypic drug combinations resulted in very high rates of sustained virologic response and few adverse reactions in real-life settings. SVR12 rates in real-life studies ranged from 90-100% depending on the pangenotypic combination, the HCV genotype and the stage of liver disease. Most adverse reactions reported in real-life settings were mild in intensity and rarely led to treatment discontinuation. These results are in accordance with those of clinical trials.
Pangenotypic DAAs result in very high rates of sustained virologic responses and are well tolerated. However, they are contraindicated in patients with decompensated cirrhosis or advanced chronic kidney disease who failed previous DDA-based treatment. Further research is required to customize treatment to "unpackage" current DAA combinations and to develop generic drugs against HCV.
直接作用抗病毒药物(DAAs),尤其是泛基因型药物的研发进展,已使丙型肝炎病毒(HCV)根除率很高。值得注意的是,真实世界研究已证实注册试验中报告的泛基因型DAA组合的疗效和安全性。本研究的目的是回顾注册临床试验和近期真实队列研究中报告的抗HCV泛基因型药物的治疗推荐、疗效和安全性数据。
我们回顾了原始文章和在线会议摘要中报告的泛基因型抗HCV药物组合的疗效和安全性数据。
在真实环境中,当前的泛基因型药物组合导致持续病毒学应答率非常高且不良反应很少。真实世界研究中的SVR12率根据泛基因型组合、HCV基因型和肝病阶段在90%至100%之间。真实环境中报告的大多数不良反应强度较轻,很少导致治疗中断。这些结果与临床试验结果一致。
泛基因型DAA导致持续病毒学应答率非常高且耐受性良好。然而,它们在失代偿期肝硬化或晚期慢性肾病且既往基于DDA的治疗失败的患者中禁用。需要进一步研究以定制治疗,“拆解”当前的DAA组合并开发抗HCV的仿制药。