Nirmatrelvir/Ritonavir for hemodialysis patients with COVID-19.
Nirmatrelvir/Ritonavir for hemodialysis patients with COVID-19.
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DOI：
10.3389/fphar.2023.1161897
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发表时间：
2023
影响因子：
5.6
通讯作者：
中科院分区：
文献类型：
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作者：
背景：血液透析患者患重症/危重型COVID-19的风险高，相关死亡率高，但由于缺乏安全性证据，不推荐尼马特利韦/利托那韦用于感染COVID-19的血液透析患者。目的：本研究旨在评价不同剂量尼马特利韦/利托那韦治疗轻度COVID-19血液透析患者尼马特利韦的最低血药浓度（Cmin）及其安全性。方法：这是一项前瞻性、两步、非随机、开放标签的研究。参与者分别接受每日一次150毫克或300毫克的尼马特利韦（血液透析后再提供75毫克或150毫克）和每日两次100毫克的利托那韦治疗，持续5天。主要终点是尼马特利韦/利托那韦的安全性，包括尼马特利韦的Cmin和不良事件（AE）的数量。次要观察指标为血液透析患者的病毒消除时间。结果：步骤1组不良事件发生3例，步骤2组不良事件发生7例（p = 0.025）。其中药物相关不良事件分别为2例和6例（p = 0.054）。未发生SAE或肝功能损伤。步骤1和步骤2组的Cmin分别为5294.65±2,370.59 ng/mL和7,675.67±2,745.22 ng/mL （p = 0.125）。对照组的Cmin为2,274.10±1,347.25 ng/mL（与步骤2相比p = 0.001，与步骤1相比p = 0.059）。与不使用尼马特利韦/利托那韦的血液透析患者相比，总病毒消除时间无统计学差异（p = 0.232）。结论：在我们的研究中，两剂量的尼马特利韦/利托那韦对血液透析患者似乎是过量的。虽然所有患者耐受5天给药，但近一半患者出现药物相关不良事件。此外，药物组在病毒消除时间上没有明显的优势。
Background: Hemodialysis patients have a high risk of severe/critical COVID-19 and related high mortality, but nirmatrelvir/ritonavir is not recommended for hemodialysis patients with COVID-19 infection because of lack of evidence of safety. Objectives: Our study aims to evaluate the minimum plasma concentration (Cmin) of nirmatrelvir and its safety of different doses of nirmatrelvir/ritonavir in hemodialysis patients with mild COVID-19. Method: This was a prospective, two step, nonrandomized, open-label study. Participants were treated with nirmatrelvir 150 mg or 300 mg once a day (another 75 mg or 150 mg supplied after hemodialysis) and ritonavir 100 mg twice daily for 5 days, respectively. The primary outcome was the safety of nirmatrelvir/ritonavir, including the Cmin of nirmatrelvir and the number of adverse events (AE). The secondary outcome was the time of viral elimination in hemodialysis patients. Results: Adverse events were happened in 3 and 7 participants in the step 1 and step 2 group, respectively (p = 0.025). Among them, 2 and 6 participants were identified as drug-related adverse events (p = 0.054). No SAE or liver function damage happened. The Cmin of nirmatrelvir in step 1 and step 2 group were 5,294.65 ± 2,370.59 ng/mL and 7,675.67 ± 2,745.22 ng/mL (p = 0.125). The Cmin of the control group was 2,274.10 ± 1,347.25 ng/mL (p = 0.001 compared to step 2 and p = 0.059 compared to step 1). Compared to hemodialysis patients without nirmatrelvir/ritonavir, there were no statistical differences in overall viral elimination time (p = 0.232). Conclusion: In our study, two doses of nirmatrelvir/ritonavir appeared to be excessive for hemodialysis patients. Although all of the patients tolerated 5-day administration, nearly half of the patients experienced drug-related adverse events. In addition, the medication group did not show a significant advantage in the time of viral elimination.
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影响因子：
6.7
作者：
Singh, Ravi Shankar P.;Toussi, Sima S.;Hackman, Frances;Chan, Phylinda L.;Rao, Rohit;Allen, Richard;Van Eyck, Lien;Pawlak, Sylvester;Kadar, Eugene P.;Clark, Frances;Shi, Haihong;Anderson, Annaliesa S.;Binks, Michael;Menon, Sandeep;Nucci, Gianluca;Bergman, Arthur
通讯作者：
Bergman, Arthur
中国武汉 221 名 COVID-19 患者的临床特征和短期结果
影响因子：
8.8
作者：
Zhang, Guqin;Hu, Chang;Pan, Huaqin
通讯作者：
Pan, Huaqin
DOI：
10.1056/nejmoa2118542
发表时间：
2022-04-14
期刊：
The New England journal of medicine
影响因子：
--
作者：
Hammond J;Leister-Tebbe H;Gardner A;Abreu P;Bao W;Wisemandle W;Baniecki M;Hendrick VM;Damle B;Simón-Campos A;Pypstra R;Rusnak JM;EPIC-HR Investigators
通讯作者：
EPIC-HR Investigators
影响因子：
56.9
作者：
Owen, Dafydd R.;Allerton, Charlotte M. N.;Zhu, Yuao
通讯作者：
Zhu, Yuao
影响因子：
2.9
作者：
Terada M;Ohtsu H;Saito S;Hayakawa K;Tsuzuki S;Asai Y;Matsunaga N;Kutsuna S;Sugiura W;Ohmagari N
通讯作者：
Ohmagari N