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新冠肺炎合并严重肝功能不全患者中VV116的剂量确定:一例报告

Dose determination of VV116 in COVID-19 patients with severe liver dysfunction: a case report.

作者信息

Yang Jing, Jiang Wenwen, Deng Jianqing, Liu Min, Xue Ya, Bao Jizhang, Jia Tingting, Hu Qi, Zhang Lichao

机构信息

Department of Pharmacy, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Department of Hematology, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

出版信息

Front Med (Lausanne). 2025 Feb 25;12:1541235. doi: 10.3389/fmed.2025.1541235. eCollection 2025.

DOI:10.3389/fmed.2025.1541235
PMID:40070649
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11893389/
Abstract

VV116 is an oral antiviral drug against SARS-CoV-2, known for its favorable efficacy and safety profile. But its application in patients with severe liver dysfunction has not been evaluated. Here, we report a case in which a patient with aplastic anemia and liver impairment (recovery phase of acute liver failure) was infected with SARS-CoV-2. Based on clinical trials and pharmacokinetic analysis about VV116, we initiated a reduced dose of 300 mg every 12 h on day 1, 200 mg every 12 h on days 2-5 for antiviral therapy. Finally, the patient's viral load rapidly dropped to an undetected level, and no drug-related adverse effects were observed.

摘要

VV116是一种针对新型冠状病毒的口服抗病毒药物,以其良好的疗效和安全性而闻名。但其在严重肝功能不全患者中的应用尚未得到评估。在此,我们报告一例再生障碍性贫血合并肝损伤(急性肝衰竭恢复期)患者感染新型冠状病毒的病例。基于关于VV116的临床试验和药代动力学分析,我们在第1天开始每12小时给予300毫克的减量剂量,在第2至5天每12小时给予200毫克进行抗病毒治疗。最终,患者的病毒载量迅速降至检测不到的水平,且未观察到与药物相关的不良反应。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fb6b/11893389/209c0a3b4f93/fmed-12-1541235-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fb6b/11893389/f5e627dc7d00/fmed-12-1541235-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fb6b/11893389/d942d77d886a/fmed-12-1541235-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fb6b/11893389/209c0a3b4f93/fmed-12-1541235-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fb6b/11893389/f5e627dc7d00/fmed-12-1541235-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fb6b/11893389/d942d77d886a/fmed-12-1541235-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fb6b/11893389/209c0a3b4f93/fmed-12-1541235-g003.jpg

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Dose determination of VV116 in COVID-19 patients with severe liver dysfunction: a case report.新冠肺炎合并严重肝功能不全患者中VV116的剂量确定:一例报告
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本文引用的文献

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Severe metabolic accumulation of VV116 in kidney transplant patients with impaired renal function: a case series report.肾功能受损的肾移植患者中VV116的严重代谢蓄积:病例系列报告
Front Immunol. 2025 Jan 17;15:1501813. doi: 10.3389/fimmu.2024.1501813. eCollection 2024.
2
Pharmacovigilance of Drug-Drug Interactions with Nirmatrelvir/Ritonavir.奈玛特韦/利托那韦药物相互作用的药物警戒
Infect Dis Ther. 2024 Dec;13(12):2545-2561. doi: 10.1007/s40121-024-01050-w. Epub 2024 Oct 26.
3
Pharmacological innovation and clinical value of VV116.
VV116的药理创新与临床价值
Lancet Infect Dis. 2024 Apr;24(4):e212. doi: 10.1016/S1473-3099(24)00009-4. Epub 2024 Feb 7.
4
Small-molecule anti-COVID-19 drugs and a focus on China's homegrown mindeudesivir (VV116).小分子抗新冠病毒药物及对中国本土的民得维(VV116)的关注
Front Med. 2023 Dec;17(6):1068-1079. doi: 10.1007/s11684-023-1037-3. Epub 2024 Jan 2.
5
Oral VV116 versus placebo in patients with mild-to-moderate COVID-19 in China: a multicentre, double-blind, phase 3, randomised controlled study.中国轻至中度 COVID-19 患者中口服 VV116 与安慰剂对照的多中心、双盲、3 期、随机对照研究。
Lancet Infect Dis. 2024 Feb;24(2):129-139. doi: 10.1016/S1473-3099(23)00577-7. Epub 2023 Nov 22.
6
Evaluation of oral small molecule drugs for the treatment of COVID-19 patients: a systematic review and network meta-analysis.评价治疗 COVID-19 患者的口服小分子药物:系统评价和网络荟萃分析。
Ann Med. 2023;55(2):2274511. doi: 10.1080/07853890.2023.2274511. Epub 2023 Nov 15.
7
Alarming antibody evasion properties of rising SARS-CoV-2 BQ and XBB subvariants.令人担忧的 SARS-CoV-2 BQ 和 XBB 亚型不断出现的抗体逃逸特性。
Cell. 2023 Jan 19;186(2):279-286.e8. doi: 10.1016/j.cell.2022.12.018. Epub 2022 Dec 14.
8
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N Engl J Med. 2023 Feb 2;388(5):406-417. doi: 10.1056/NEJMoa2208822. Epub 2022 Dec 28.
9
Efficacy and safety of nirmatrelvir/ritonavir (Paxlovid) for COVID-19: A rapid review and meta-analysis.奈玛特韦/利托那韦(Paxlovid)治疗 COVID-19 的疗效和安全性:快速评价和荟萃分析。
J Med Virol. 2023 Feb;95(2):e28441. doi: 10.1002/jmv.28441.
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Front Immunol. 2022 Dec 6;13:1015355. doi: 10.3389/fimmu.2022.1015355. eCollection 2022.