含有利匹韦林加达那韦/利托那韦的核苷保留双重方案在treatment-naïve hiv -1感染者中的药代动力学和药效学

Q2 Medicine
HIV Clinical Trials Pub Date : 2018-02-01 Epub Date: 2017-11-30 DOI:10.1080/15284336.2017.1408928
Akil Jackson, Laura Else, Christopher Higgs, Zeenat Karolia, Saye Khoo, David Back, Emma Devitt, Anton Pozniak, Marta Boffito
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引用次数: 4

摘要

背景:我们旨在研究利匹韦林加达那韦/利托那韦25/800/100 mg每日一次的双重抗逆转录病毒(ARV)联合治疗在naïve hiv -1感染个体(NHII)中具有不同基线病毒载量的抗病毒活性和药代动力学。背景:ARV-naïve hiv感染者的药代动力学/药效学研究。结果:纳入36例患者,18例基线病毒载量为100,000拷贝/mL (B组)。除1例(HIV-RNA = 63拷贝/mL)外,所有受试者均达到病毒载量最大值,Ctrough, AUC分别为183 (165-239),114 (104-109)ng/mL, 2966 (2704-3820) ng h/mL。未见QTcF时间间隔变化。结论:利匹韦林/达那韦/利托那韦对ARV-naïve患者有效,短期毒性有限。虽然利匹韦林与利托那韦同时给药,但其暴露量在III期试验期间测量的范围内。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Pharmacokinetics and pharmacodynamics of the nucleoside sparing dual regimen containing rilpivirine plus darunavir/ritonavir in treatment-naïve HIV-1-infected individuals.

Background: We aimed at investigating the antiviral activity and the pharmacokinetics of the dual antiretroviral (ARV) combination of rilpivirine plus darunavir/ritonavir 25/800/100 mg once-daily in naïve HIV-1-infected individuals (NHII) with different baseline viral loads.

Settings: Pharmacokinetic/pharmacodynamics study in ARV-naïve HIV-infected individuals.

Methods: The primary endpoint was the number of NHII with HIV-RNA < 40 copies/mL at week 48. Secondary endpoints included rilpivirine/darunavir/ritonavir pharmacokinetics, HIV-RNA decay, and changes in ECG QT interval.

Results: Thirty-six individuals were enrolled, 18 with a baseline viral load < 100,000 copies/mL (group A) and 18 with a baseline viral load > 100,000 copies/mL (group B). All but 1 (HIV-RNA = 63 copies/mL) subjects achieved viral load < 50 copies/mL by week 36, and all at week 48. Median (range) HIV-RNA reduction (Log10 copies/mL) was 1.3 (0.6-1.9) over the first week, with no differences between groups A and B. Geometric mean and 95%CI rilpivirine Cmax, Ctrough, AUC were 183 (165-239), 114 (104-109) ng/mL, 2966 (2704-3820) ng h/mL. No QTcF interval changes were recorded.

Conclusions: rilpivirine/darunavir/ritonavir could be efficacious, with limited short-term toxicity in ARV-naïve patients. Although rilpivirine was co-administered with ritonavir, its exposure was within ranges measured during phase III trials.

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来源期刊
HIV Clinical Trials
HIV Clinical Trials 医学-传染病学
CiteScore
1.76
自引率
0.00%
发文量
0
审稿时长
>12 weeks
期刊介绍: HIV Clinical Trials is devoted exclusively to presenting information on the latest developments in HIV/AIDS clinical research. This journal enables readers to obtain the most up-to-date, innovative research from around the world.
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