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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Effect of low-dose omeprazole (20 mg daily) on the pharmacokinetics of multiple-dose atazanavir with ritonavir in healthy subjects.
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Effect of low-dose omeprazole (20 mg daily) on the pharmacokinetics of multiple-dose atazanavir with ritonavir in healthy subjects.

机译：小剂量奥美拉唑（每天20 mg）对健康受试者中多剂量阿扎那韦和利托那韦药代动力学的影响。

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摘要

Atazanavir, a potent protease inhibitor of human immunodeficiency virus (HIV), exhibits pH-dependent solubility. Previous studies have indicated that coadministration with omeprazole 40 mg once daily significantly decreased atazanavir exposure by approximately 75%. Concomitant use of omeprazole and atazanavir is currently not recommended. This study investigated a clinically effective, low dose of omeprazole (20 mg daily) on atazanavir pharmacokinetics in 56 healthy volunteers given atazanavir/ritonavir 300/100 and 400/100 mg once daily. All atazanavir/ritonavir plus omeprazole combinations resulted in atazanavir area under the concentration-time curve (AUC) and trough concentrations (C(min)) comparable to or exceeding those observed with atazanavir 400 mg without omeprazole. Compared with atazanavir/ritonavir 300/100 mg without omeprazole, atazanavir/ritonavir 300/100 mg plus omeprazole reduced atazanavir AUC and C(min) by 42% and 46%, respectively. Increasing the atazanavir/ritonavir dose to 400/100 mg attenuated the effect of omeprazole, resulting in approximately 30% lower atazanavir C(min), with all individual C(min) values exceeded by greater than 10-fold the population mean protein binding-adjusted EC(90) against wild-type HIV. The effect of omeprazole on atazanavir/ritonavir 400/100 mg was similar whether given 1 hour prior to atazanavir/ritonavir or separated by 12 hours. No unexpected adverse events were noted. This study found that omeprazole 20 mg once daily has significantly less profound effects on atazanavir pharmacokinetics than previously observed with omeprazole 40 mg.
机译：Atazanavir是一种有效的人类免疫缺陷病毒（HIV）蛋白酶抑制剂，具有pH依赖性。先前的研究表明，每天一次与奥美拉唑40 mg共同给药可显着降低阿扎那韦的暴露量约75％。目前不建议同时使用奥美拉唑和阿扎那韦。这项研究调查了56名健康受试者的阿扎那韦/阿扎那韦/利托那韦300/100和400/100 mg每天一次的临床有效，低剂量的奥美拉唑（每天20 mg）对阿扎那韦的药物代谢动力学的影响。所有的阿扎那韦/利托那韦与奥美拉唑的组合均导致阿扎那韦在浓度-时间曲线（AUC）和谷浓度（C（min））下的面积与使用无奥美拉唑的阿扎那韦400 mg相当或超过。与不加奥美拉唑的阿扎那韦/利托那韦300/100 mg相比，阿扎那韦/利托那韦300/100 mg加奥美拉唑使阿扎那韦AUC和C（min）分别降低42％和46％。将阿扎那韦/利托那韦剂量增加至400/100 mg会减弱奥美拉唑的作用，导致阿扎那韦C（min）降低约30％，所有单个C（min）值均超过群体平均蛋白结合率的10倍以上，调整了针对野生型HIV的EC（90）。无论在阿扎那韦/利托那韦之前1小时给予还是分开12小时，奥美拉唑对阿扎那韦/利托那韦400/100 mg的作用相似。没有发现意外的不良事件。这项研究发现，每天一次20毫克的奥美拉唑对阿扎那韦的药代动力学影响远不如以前的40毫克的奥美拉唑。

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