从其他标准半衰期的凝血因子VIII浓缩物转换为科法曲（Kovaltry）后，A型血友病男孩的药代动力学得到改善，出血情况减少。
Enhanced pharmacokinetics and reduced bleeds in boys with hemophilia A after switching to Kovaltry from other standard half-life factor VIII concentrates.
作者信息
Huang Kun, Zhen Yingzi, Li Gang, Wu Xinyi, Chen Zhenping, Wu Runhui
机构信息
Hematology Center National Center for Children's Health Beijing Children's Hospital Capital Medical University Beijing China.
Hematologic Disease Laboratory Beijing Pediatric Research Institute National Center for Children's Health Beijing Children's Hospital Capital Medical University Beijing China.
出版信息
Res Pract Thromb Haemost. 2022 Mar 25;6(2):e12686. doi: 10.1002/rth2.12686. eCollection 2022 Feb.
BACKGROUND
BAY81-8973 (Kovaltry; Bayer, Berkeley, CA, USA) was reported with enhanced pharmacokinetic (PK) profiles compared with some other standard half-life (SHL) factor VIII (FVIII) concentrates. Limited head-to-head comparative studies were conducted in a real-world setting.
OBJECTIVE
To make head-to-head comparisons of PK and clinical outcomes between Kovaltry and three other SHL FVIII concentrates.
METHODS
Forty-seven boys with severe hemophilia A were enrolled and divided into three groups according to their previously used FVIII concentrates (Kogenate FS, N = 22; Advate, N = 14; GreenMono, N = 11). Two separate PK tests were conducted in each participant with a five-point assay during the study period from 6 months before switching to 6 months after switching. FVIII levels were detected by one-stage assay, and PK profiles were calculated by noncompartmental assay. Annualized bleeding rates were collected through participant' bleed logs.
RESULTS
Longer half-life time (Kogenate FS group: 14.4 vs 11.9 hours, < .0001; Advate group: 13.4 vs 9.7 hours, < .0001; GreenMono group: 15.1 vs 10.7 hours, < .001]) and lower clearance (Kogenate FS group: 3.3 vs 3.9 mL/kg/h, < .01; Advate group: 3.7 vs 5.9 mL/kg/h, < .01; GreenMono group: 3.0 vs 5.1 mL/kg/h, < .01) were observed with Kovaltry. In addition, longer mean residential time (< .01) and higher area under the curve (< .01) were demonstrated. No statistical difference was found in in vivo recovery between Kovaltry and the other FVIII products. Participants who switched to Kovaltry from three other FVIII concentrates with the same dosing regimens obtained higher trough FVIII levels and better protection with reduced annualized bleeding rates.
CONCLUSION
Compared with Kogenate FS, Advate, and GreenMono, Kovaltry showed enhanced PK profiles, which contributed to reduced bleeding rates.
背景
与其他一些标准半衰期（SHL）的凝血因子 VIII（FVIII）浓缩物相比，BAY81 - 8973（Kovaltry；拜耳公司，美国加利福尼亚州伯克利）具有增强的药代动力学（PK）特征。在实际应用中进行的直接比较研究有限。
目的
对 Kovaltry 与其他三种 SHL FVIII 浓缩物进行 PK 和临床结果的直接比较。
方法
招募了 47 名重度甲型血友病男孩，根据他们之前使用的 FVIII 浓缩物将其分为三组（Kogenate FS，N = 22；Advate，N = 14；GreenMono，N = 11）。在每位参与者中进行了两次单独的 PK 测试，在从转换前 6 个月到转换后 6 个月的研究期间采用五点分析法。通过一步法检测 FVIII 水平，并通过非房室分析法计算 PK 特征。通过参与者的出血日志收集年化出血率。
结果
与其他产品相比，Kovaltry 的半衰期更长（Kogenate FS 组：14.4 小时对 11.9 小时，<0.0001；Advate 组：13.4 小时对 9.7 小时，<0.0001；GreenMono 组：15.1 小时对 10.7 小时，<0.001），清除率更低（Kogenate FS 组：3.3 对 3.9 mL/kg/h，<0.01；Advate 组：3.7 对 5.9 mL/kg/h，<0.01；GreenMono 组：3.0 对 5.1 mL/kg/h，<0.01）。此外，还显示出平均驻留时间更长（<0.01）和曲线下面积更高（<0.01）。Kovaltry 与其他 FVIII 产品在体内回收率方面未发现统计学差异。从其他三种 FVIII 浓缩物以相同给药方案转换为 Kovaltry 的参与者获得了更高的谷值 FVIII 水平，并通过降低年化出血率获得了更好的保护。
结论
与 Kogenate FS、Advate 和 GreenMono 相比，Kovaltry 显示出增强的 PK 特征，这有助于降低出血率。
Zotero 插件