索磷布韦为基础的直接作用抗病毒药物治疗基因型 3/6 丙型肝炎病毒感染患者的疗效和安全性。
Efficacy and Safety of Sofosbuvir-Based Direct-Acting Antiviral Agents Treatment for Patients with Genotype 3/6 Hepatitis C Virus Infection.
机构信息
Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510630, Guangdong, China.
Guangdong Key Laboratory of Liver Disease Research, Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510630, Guangdong, China.
出版信息
Can J Gastroenterol Hepatol. 2020 Oct 31;2020:8872120. doi: 10.1155/2020/8872120. eCollection 2020.
AIMS
The aim is to evaluate the efficacy and safety of Sofosbuvir- (SOF-) based direct-acting antiviral agents (DAAs) treatment for patients with genotype (GT) 3/6 hepatitis C virus (HCV) infection.
METHODS
Patients infected with GT 3/6 HCV and treated with SOF-based DAAs were enrolled in this prospective, open, single-center, and real-world study. Drugs included Sofosbuvir (SOF), Velpatasvir (VEL), Daclatasvir (DCV), and Ribavirin (RBV). The treatment regimens included SOF + RBV for 24 weeks, SOF + DCV ± RBV for 12/24 weeks, and SOF/VEL ± RBV for 12 weeks.
RESULTS
A total of 54 patients were included. Age was 42.5 ± 10.4 years. Baseline HCV RNA was 6.29 ± 0.89log10 IU/mL. The numbers of GT 3a, 3b, and 6a patients were 10, 12, and 32, respectively. The numbers of chronic hepatitis, compensated cirrhosis, and decompensated cirrhosis patients were 39, 9, and 6, respectively. In patients with chronic hepatitis C and liver cirrhosis, sustained virological response 12 weeks after the end of treatment (SVR12) was 97.4% and 96.7%, respectively, and rapid virological response (RVR) was 75.0% and 57.1%, respectively. SVR12 of GT3a, GT3b, and GT6a was 100%, 83.3%, and 97%, respectively. ALT normality rate in chronic hepatitis group is higher than that in cirrhosis group at 4 weeks of treatment (89.7% versus 60.0%, = 0.033) and at 12 weeks after EOT (94.9% versus 66.7%, = 0.021). The overall incidence rate of adverse events was 44.4%, with fatigue being the most common (13.0%).
CONCLUSION
SOF-based DAAs regimen can achieve ideal SVR12 for Chinese patients with both GT3a and GT6a HCV infection. The tolerance and safety of SOF-based DAAs regimen are good.
目的
评估索非布韦（SOF）为基础的直接作用抗病毒药物（DAAs）治疗基因型（GT）3/6 丙型肝炎病毒（HCV）感染患者的疗效和安全性。
方法
本前瞻性、开放、单中心、真实世界研究纳入了 GT 3/6 HCV 感染并接受 SOF 为基础的 DAA 治疗的患者。药物包括索非布韦（SOF）、维帕他韦（VEL）、达拉他韦（DCV）和利巴韦林（RBV）。治疗方案包括 SOF+RBV 治疗 24 周，SOF+DCV±RBV 治疗 12/24 周，SOF/VEL±RBV 治疗 12 周。
结果
共纳入 54 例患者。年龄为 42.5±10.4 岁。基线 HCV RNA 为 6.29±0.89log10IU/mL。GT 3a、3b 和 6a 患者分别为 10、12 和 32 例。慢性肝炎、代偿性肝硬化和失代偿性肝硬化患者分别为 39、9 和 6 例。在慢性丙型肝炎和肝硬化患者中，治疗结束后 12 周持续病毒学应答（SVR12）分别为 97.4%和 96.7%，快速病毒学应答（RVR）分别为 75.0%和 57.1%。GT3a、GT3b 和 GT6a 的 SVR12 分别为 100%、83.3%和 97%。治疗 4 周时，慢性肝炎组的 ALT 正常率高于肝硬化组（89.7%比 60.0%，=0.033），EOT 后 12 周时，慢性肝炎组的 ALT 正常率仍高于肝硬化组（94.9%比 66.7%，=0.021）。不良反应总发生率为 44.4%，以疲劳最常见（13.0%）。
结论
SOF 为基础的 DAA 方案可使中国 GT3a 和 GT6a HCV 感染患者达到理想的 SVR12。SOF 为基础的 DAA 方案的耐受性和安全性良好。
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