Li Juan, Wu Dong-Bo, Jiang Wei, Chen Xue-Bin, Xiao Gui-Bao, Wang Yong-Hong, Wang Meng-Lan, Tao Ya-Chao, Chen En-Qiang
Department of Infectious Diseases, Pidu District People's Hospital.
Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu.
Medicine (Baltimore). 2020 Oct 23;99(43):e22726. doi: 10.1097/MD.0000000000022726.
Several new, pangenotypic direct-acting antiviral agents (DAAs) have been approved, may reduce the need for genotyping to guide therapy decisions for patients with chronic hepatitis C (CHC).This study aimed to investigate the efficacy and safety of Sofosbuvir (SOF)-based pangenotypic DAAs therapy for CHC patients without genotype (GT determination in the real-world practice.This retrospective cohort study included treatment-naïve CHC patients without GT determination, who received SOF-based DAAs therapy, including 400 mg SOF plus 60 mg daclatasvir (DCV) daily or 400 mg SOF plus 100 mg velpatasvir (VEL) daily for 12 or 24 weeks. Clinical and laboratory data, including sustained virologic response (SVR), were obtained at baseline, end of treatment (EOT), 12 weeks after EOT, and 48 weeks after EOT.A total of 95 CHC patients, including 30 (31.58%) had liver cirrhosis were enrolled. SVR rates after 12 weeks of treatment (SVR12) was 96.84% (92/95), including 96.20% (76/79) of patients receiving SOF plus DCV and 100% (16/16) of patients receiving SOF plus VEL. For 92 patients achieving an SVR12, no virological relapse was observed at 48 weeks after EOT. Furthermore, serum evaluation of liver fibrosis aspartate aminotransferase-to-platelet ratio index and Fibrosis-4 score were decreased significantly at EOT and 12 weeks after EOT, compared to pre-treatment values (both P < .05). Treatment was well-tolerated by our patients.SOF-based pangenotypic DAAs including SOF plus DCV and SOF plus VEL, were effective and safe for CHC patients without GT determination in this study. This may provide a potential simple strategy for CHC treatment without GT determination.
几种新型的泛基因型直接抗病毒药物（DAA）已获批准，可能减少对慢性丙型肝炎（CHC）患者进行基因分型以指导治疗决策的需求。本研究旨在调查在现实世界实践中，基于索磷布韦（SOF）的泛基因型DAA疗法对未进行基因型（GT）测定的CHC患者的疗效和安全性。这项回顾性队列研究纳入了未进行GT测定、接受基于SOF的DAA疗法的初治CHC患者，包括每日400mg SOF加60mg达拉他韦（DCV）或每日400mg SOF加100mg维帕他韦（VEL），疗程为12或24周。在基线、治疗结束时（EOT）、EOT后12周和EOT后48周获取临床和实验室数据，包括持续病毒学应答（SVR）。共纳入95例CHC患者，其中30例（31.58%）有肝硬化。治疗12周后的SVR率（SVR12）为96.84%（92/95），包括接受SOF加DCV治疗的患者中的96.20%（76/79）和接受SOF加VEL治疗的患者中的100%（16/16）。对于92例实现SVR12的患者，在EOT后48周未观察到病毒学复发。此外，与治疗前值相比，EOT时和EOT后12周时肝纤维化血清评估指标天冬氨酸氨基转移酶与血小板比值指数和纤维化-4评分显著降低（均P<0.05）。我们的患者对治疗耐受性良好。在本研究中，基于SOF的泛基因型DAA，包括SOF加DCV和SOF加VEL，对未进行GT测定的CHC患者有效且安全。这可能为无需GT测定的CHC治疗提供一种潜在的简单策略。
