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首页> 外文期刊>Antimicrobial agents and chemotherapy. >Model-based approach for optimization of atazanavir dose recommendations for HIV-infected pediatric patients.
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Model-based approach for optimization of atazanavir dose recommendations for HIV-infected pediatric patients.

机译：基于模型的方法可优化针对HIV感染小儿患者的atazanavir剂量推荐。

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摘要

Atazanavir (Reyataz; ATV) is a well-tolerated protease inhibitor (PI) that is indicated as a once-daily treatment for HIV infections. These features of ATV, combined with its virologic potency, make it particularly desirable for the treatment of HIV-infected pediatric patients. The objective of this study was to use a model-based approach to recommend body weight-based ATV capsule doses for pediatric patients. ATV concentration-time data from three adult studies and one pediatric study were described by a C(0)-delinked one-compartment model to guard against introducing bias in pharmacokinetic (PK) parameter estimates due to the potential nonadherence in outpatient studies. The apparent clearance (CL/F) and apparent volume of distribution (V/F) were determined to increase with body weight, and CL/F was 40.9% lower in patients receiving ATV comedication with ritonavir (RTV). The relative bioavailability (F(rel)) of ATV was 132% higher with RTV comedication and was 35.5% lower for the ATV powder formulation than the capsule formulation. Model-based simulations were used to recommend weight-based ATV capsule doses of 150 to 300 mg boosted with 100 mg RTV for pediatric patients weighing >/=15 kg, such that the exposures in these patients are similar to those obtained in HIV-infected adults treated with the recommended ATV/RTV dose of 300/100 mg.
机译：Atazanavir（Reyataz; ATV）是一种耐受良好的蛋白酶抑制剂（PI），被指定为每天一次的HIV感染治疗。 ATV的这些功能，加上其病毒学功效，使其特别适合治疗HIV感染的小儿患者。这项研究的目的是使用一种基于模型的方法为儿科患者推荐基于体重的ATV胶囊剂量。 C（0）脱链的一室模型描述了来自三项成人研究和一项儿科研究的ATV浓度-时间数据，以防止由于门诊研究中潜在的不依从性而在药代动力学（PK）参数估计中引入偏差。确定表观清除率（CL / F）和表观分布体积（V / F）随着体重的增加而增加，接受利托那韦（RTV）的ATV喜剧患者的CL / F降低40.9％。使用RTV喜剧，ATV的相对生物利用度（F（rel））高132％，而ATV粉末制剂的相对生物利用度比胶囊制剂低35.5％。基于模型的模拟被用于推荐体重> / = 15 kg的儿科患者，以体重为基础的ATV胶囊剂量为150到300 mg，再加上100 mg RTV，以使这些患者的暴露水平与HIV感染者相似成人接受建议的ATV / RTV剂量300/100 mg治疗。

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