基于索磷布韦的治疗方案对丙型肝炎病毒6型感染患者的疗效：一项来自中国东部的真实世界研究。
Effectiveness of sofosbuvir-based treatments for patients with hepatitis C virus genotype 6 infection: a real-world study from East China.
作者信息
Jiang Fan-Rong, Ye Xiao-Ting, Huang He-Qing, Hu Yu-Tao, Wang Dong-Hui, Jiang Su-Wen, Wang Jia-Lan, Hu Ai-Rong
机构信息
Department of Pharmacy, Ningbo No. 2 Hospital, Ningbo, China.
Department of Infectious Diseases, Ruian People's Hospital, Ruian, China.
出版信息
Front Med (Lausanne). 2024 Nov 26;11:1462706. doi: 10.3389/fmed.2024.1462706. eCollection 2024.
BACKGROUND
Over the past decade, the proportion of hepatitis C virus (HCV) genotypes (GT) 1 and 2 has decreased in almost all regions of China, while GT 3 and 6 have emerged as new challenges. GT 6 is unique in many respects, like high genetic variability and emerging resistant variants. This study aims to assess the efficacy of sofosbuvir (SOF)-based treatments in patients with GT 6 chronic hepatitis C (CHC).
METHODS
A retrospective analysis was conducted on patients with GT 6 HCV infection, who were diagnosed between July 2018 and May 2023. All patients received a 12-week course of SOF-based treatments. The primary efficacy endpoint was sustained virologic response (SVR), which is defined as having undetectable HCV RNA at 12 weeks after treatment completion (SVR12). The efficacy data for SVR12 were analyzed using both the evaluated population (EP) and per-protocol population (PP). For the PP populations, efficacy data were stratified using Forrester plots.
RESULTS
A total of 201 patients were included in the study. In PP population, the end of treatment virological response rate was 99.48% (190/191), the SVR12 rate was 99.31% (143/144), and the SVR24 rate was 100.00% (75/75). Only one patient with genotype 6a experienced a relapse 12 weeks after the completion of treatment, but her HCV RNA was undetectable both at the end of treatment and 24 weeks after the end of treatment. Additionally, the normalization rates of alanine transaminase (ALT) and aspartate aminotransferase (AST) were significantly higher at the end of treatment (EOT) compared to baseline (27.36% vs. 93.03%, 36.32% vs. 95.02%, < 0.001). Significant improvements were observed in the levels of total bilirubin, ALT, AST, albumin, globulin, albumin/globulin ratio, gamma-glutamyl transferase, alkaline phosphatase, platelet, fibrosis-4 (FIB-4), and aspartate transaminase to platelet ratio index (APRI) between baseline and EOT ( < 0.05).
CONCLUSION
SOF-based treatments achieved high virological and biochemical response rates in patients with HCV GT 6 infection.
背景
在过去十年中，中国几乎所有地区丙型肝炎病毒（HCV）1型和2型基因型（GT）的比例均有所下降，而GT 3型和6型已成为新的挑战。GT 6型在许多方面具有独特性，如高基因变异性和新出现的耐药变异体。本研究旨在评估基于索磷布韦（SOF）的治疗方案对GT 6型慢性丙型肝炎（CHC）患者的疗效。
方法
对2018年7月至2023年5月期间诊断为GT 6型HCV感染的患者进行回顾性分析。所有患者均接受了为期12周的基于SOF的治疗方案。主要疗效终点为持续病毒学应答（SVR），定义为治疗结束后12周时HCV RNA检测不到（SVR12）。使用全分析集（EP）和符合方案集（PP）对SVR12的疗效数据进行分析。对于PP人群，疗效数据使用福雷斯特图进行分层。
结果
本研究共纳入201例患者。在PP人群中，治疗结束时病毒学应答率为99.48%（190/191），SVR12率为99.31%（143/144），SVR24率为100.00%（75/75）。只有1例6a基因型患者在治疗结束后12周出现复发，但她在治疗结束时及治疗结束后24周时HCV RNA均检测不到。此外，与基线相比，治疗结束时丙氨酸转氨酶（ALT）和天冬氨酸转氨酶（AST）的正常化率显著更高（27.36%对93.03%，36.32%对95.02%，P<0.001）。在基线和治疗结束时，总胆红素、ALT、AST、白蛋白、球蛋白、白蛋白/球蛋白比值、γ-谷氨酰转移酶、碱性磷酸酶、血小板、纤维化-4（FIB-4）和天冬氨酸转氨酶与血小板比值指数（APRI）水平均有显著改善（P<0.05）。
结论
基于SOF的治疗方案在HCV GT 6型感染患者中实现了较高的病毒学和生化应答率。
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