Xia Huan, Lu Chengzhen, Wang Yin, Zaongo Silvere D, Hu Yue, Wu Yue, Yan Zhongfang, Ma Ping
Department of Infectious Disease, Tianjin Second People's Hospital, Tianjin, China.
Department of Hepatology, Tianjin Second People's Hospital, Tianjin, China.
Front Pharmacol. 2020 May 19;11:710. doi: 10.3389/fphar.2020.00710. eCollection 2020.
Toward the limited real-world data concerning the treatment response to brand direct-acting antiviral agents (DAAs) therapy, we proposed to evaluate the efficacy and safety of DAAs for the treatment of chronic hepatitis C virus (HCV) in mainland China.
In this retrospective, single-center, cohort study, all HCV-infected adult patients treated with brand DAA drugs covered by Tianjin local health insurance (Apr 2018-Sept 2019) and responding to other specific inclusion criteria were recruited. The five available DAA regimens included sofosbuvir + ribavirin (SOF + RBV), elbasvir/grazoprevir (EBR/GZR), ombitasvir/paritaprevir/ritonavir/dasabuvir (OBV/PTV/r/DSV) ± RBV, daclatasvir + asunaprevir (DCV + ASV), and SOF + DCV ± RBV. Demographic, virologic, clinical, and adverse effects data obtained during and after DAAs treatment were collected. We evaluated the rate of sustained virological response at 12 weeks post-treatment (SVR12), the incidence of adverse effects, and assessed the factors associated with SVR12.
Four hundred ninety-four patients finished the treatment and completed the 12-week post-treatment follow-up. The overall SVR12 rate was estimated at 96.96%. SVR rates greater than 95% were achieved in most of the HCV genotypes with the exception of GT1a (0%), GT3a (93.33%), and GT3b (88.24%). SVR12 for patients treated with DCV + ASV, EBR/GZR, OBV/PTV/r/DSV ± RBV, SOF + DCV ± RBV, and SOF + RBV for 12 or 24 weeks was 86.67%, 100%, 98.11%, 97.56%, and 95.06%, respectively. Subjects with compensated cirrhosis (92.73%) and prior treatment experience (77.78%) had significantly lower SVR rates when compared to chronic hepatitis C (98.15%) and treatment-naive (97.69%) groups. In Tianjin, the available DAA regimens were generally well-tolerated, and not a single serious adverse event was reported.
In this large real-life single-center HCV cohort from China, oral DAAs were highly effective and well-tolerated. Further and larger-scale studies are needed to evaluate their clinical safety and efficacy.
鉴于关于品牌直接抗病毒药物（DAA）治疗反应的真实世界数据有限，我们旨在评估DAA在中国内地治疗慢性丙型肝炎病毒（HCV）的疗效和安全性。
在这项回顾性、单中心队列研究中，招募了所有接受天津地方医疗保险覆盖的品牌DAA药物治疗（2018年4月至2019年9月）且符合其他特定纳入标准的HCV感染成年患者。五种可用的DAA方案包括索磷布韦+利巴韦林（SOF+RBV）、艾尔巴韦/格拉瑞韦（EBR/GZR）、奥比他韦/帕利哌韦/利托那韦/达沙布韦（OBV/PTV/r/DSV）±RBV、达拉他韦+阿舒瑞韦（DCV+ASV）以及SOF+DCV±RBV。收集DAA治疗期间及之后获得的人口统计学、病毒学、临床和不良反应数据。我们评估了治疗后12周的持续病毒学应答率（SVR12）、不良反应发生率，并评估了与SVR12相关的因素。
494例患者完成治疗并完成了治疗后12周的随访。总体SVR12率估计为96.96%。除GT1a（0%）、GT3a（93.33%）和GT3b（88.24%）外，大多数HCV基因型的SVR率均大于95%。接受DCV+ASV、EBR/GZR、OBV/PTV/r/DSV±RBV、SOF+DCV±RBV以及SOF+RBV治疗12周或24周的患者的SVR12分别为86.67%、100%、98.11%、97.56%和95.06%。与慢性丙型肝炎（98.15%）和初治（97.69%）组相比，代偿期肝硬化患者（92.73%）和有既往治疗史患者（77.78%）的SVR率显著较低。在天津，可用的DAA方案总体耐受性良好，未报告任何严重不良事件。
在这个来自中国的大型单中心HCV真实世界队列中，口服DAA高效且耐受性良好。需要进一步开展更大规模的研究来评估其临床安全性和疗效。
