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使用雷迪帕韦/索磷布韦使伴有或不伴有代偿性肝硬化的慢性丙型肝炎患者实现最佳病毒载量抑制所需的时间。

Time required to achieve optimum viral load suppression with Ravidasvir/sofosbuvir in chronic hepatitis C patients with or without compensated cirrhosis.

作者信息

Muhamad Nor Asiah, Rosli Izzah Athirah, Maamor Nur Hasnah, Mohd Zain Rozainanee, Leman Fatin Norhasny, Chan Huan-Keat, Hassan Muhammad Radzi Abu, Murad Shahnaz

机构信息

Sector for Evidence-Based Healthcare, National Institutes of Health, Ministry of Health, Selangor, Malaysia.

Institute for Medical Research, National Institutes of Health, Ministry of Health, Selangor, Malaysia.

出版信息

Sci Rep. 2025 Apr 25;15(1):14550. doi: 10.1038/s41598-025-99665-7.

Abstract

A study indicated that ravidasvir (RDV) has excellent safety and tolerability when used with sofosbuvir (SOF) to treat chronic HCV infection. The aim of this study was to determine the time taken by RDV/SOF to achieve optimum viral load suppression in chronic hepatitis C patients with or without compensated cirrhosis. Data from the open-label, multicentre, single-arm, phase II/III clinical trial (STORM-C-1) were utilized. Time‒to-event analysis via Kaplan-Meier curves was performed to determine the time required to achieve optimum viral load suppression in both the cirrhotic and noncirrhotic groups. Multivariate logistic regression analyses were performed to identify potential predictors of achieving suppression within four and eight weeks. The time to achieve optimum viral load suppression ranged from six to 85 days and from five to 148 days among noncirrhotic and cirrhotic patients, respectively. Among noncirrhotic patients, 80.6% achieved optimum viral load suppression within 4 weeks, and 92.6% achieved this within 8 weeks. Among cirrhotic patients, 76.1% and 90.4% achieved optimum viral load suppression within 4 and 8 weeks, respectively. Notably, optimum viral load suppression differs from sustained virological response (SVR12), which is defined as undetectable HCV RNA 12 weeks after treatment completion. While the study demonstrates promising early viral suppression, it does not evaluate the efficacy of a shortened regimen. Further research is needed to assess whether shorter treatment durations maintain high SVR12 rates without compromising treatment success.

摘要

一项研究表明,雷迪帕韦(RDV)与索磷布韦(SOF)联合使用治疗慢性丙型肝炎病毒(HCV)感染时具有出色的安全性和耐受性。本研究的目的是确定RDV/SOF在伴有或不伴有代偿期肝硬化的慢性丙型肝炎患者中实现最佳病毒载量抑制所需的时间。利用了开放标签、多中心、单臂、II/III期临床试验(STORM-C-1)的数据。通过Kaplan-Meier曲线进行事件发生时间分析,以确定肝硬化组和非肝硬化组实现最佳病毒载量抑制所需的时间。进行多变量逻辑回归分析以确定在4周和8周内实现病毒载量抑制的潜在预测因素。非肝硬化患者实现最佳病毒载量抑制的时间为6至85天,肝硬化患者为5至148天。在非肝硬化患者中,80.6%在4周内实现了最佳病毒载量抑制,92.6%在8周内实现了这一目标。在肝硬化患者中,分别有76.1%和90.4%在4周和8周内实现了最佳病毒载量抑制。值得注意的是,最佳病毒载量抑制不同于持续病毒学应答(SVR12),后者定义为治疗完成后12周HCV RNA检测不到。虽然该研究显示了有前景的早期病毒抑制效果,但并未评估缩短疗程的疗效。需要进一步研究以评估更短的治疗疗程在不影响治疗成功率的情况下是否能维持高SVR12率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bdcc/12032149/9980f225c8b4/41598_2025_99665_Fig1_HTML.jpg

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