奈韦拉平与低剂量利托那韦联合治疗 HIV-1 感染患者时的药物动力学相互作用。
Pharmacokinetic interaction between nevirapine and darunavir with low-dose ritonavir in HIV-1-infected patients.
机构信息
Tibotec Inc., 1020 Stony Hill Road, Yardley, PA 19067, USA.
出版信息
Br J Clin Pharmacol. 2009 Jul;68(1):116-9. doi: 10.1111/j.1365-2125.2009.03430.x.
Abstract
AIM
To investigate the pharmacokinetic interaction between darunavir/ritonavir (DRV/r) and nevirapine (NVP) in 19 HIV-infected patients.
METHODS
An open-label, randomized, crossover study. Patients received Treatment A [NVP 200 mg b.i.d. plus > or =2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)] and Treatment B [A plus DRV/r 300/100 mg b.i.d. (DRV oral solution)] or Treatment B2 [A plus DRV/r 400/100 mg b.i.d. (DRV tablet)] in two 14-day sessions.
RESULTS
Mean NVP AUC(12h) increased by 27% [least square means ratio 1.27 (95% confidence interval 1.02, 1.58)]. Mean DRV and ritonavir exposures were similar to historical data. Co-administration was well tolerated.
CONCLUSIONS
DRV/r and NVP have no clinically relevant interaction. No dose adjustments are required.
摘要
目的
研究 19 例 HIV 感染患者中达芦那韦/利托那韦（DRV/r）与奈韦拉平（NVP）之间的药代动力学相互作用。
方法
一项开放标签、随机、交叉研究。患者接受治疗 A[NVP 200mg 每日两次+≥2 种核苷/核苷酸逆转录酶抑制剂（NRTIs）]和治疗 B[A+DRV/r 300/100mg 每日两次（DRV 口服溶液）]或治疗 B2[A+DRV/r 400/100mg 每日两次（DRV 片剂）]，每个治疗周期为 14 天，共进行 2 个周期。
结果
平均 NVP AUC（12h）增加 27%[最小二乘均数比值 1.27（95%置信区间 1.02，1.58）]。DRV 和利托那韦的暴露量与历史数据相似。联合用药耐受良好。
结论
DRV/r 和 NVP 之间无临床相关的相互作用，无需调整剂量。
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