HIV Clin Trials：评估Lersivirine和 Etravirine在HIV-1患者中的药效

2014-11-06 MedSci MedSci原创

试验目的：为了评估Lersivirine和 Etravirine在HIV-1患者及预先使用NNRTI的HIV-1患者的药效及用药安全性，以及NNRT1抗药性。试验方法:该临床2B试验持续96周，97名患者按照随机的原则分组进行用药。 Lersivirine用药量为750mg (n = 31，qd)， lersivirine为 100mg (n = 32，qd)，etravirine 为200mg

试验目的：

为了评估Lersivirine和 Etravirine在HIV-1患者及预先使用NNRTI的HIV-1患者的药效及用药安全性，以及NNRT1抗药性。

试验方法:

该临床2B试验持续96周，97名患者按照随机的原则分组进行用药。 Lersivirine用药量为750mg (n = 31，qd)， lersivirine为 100mg (n = 32，qd)，etravirine 为200mg (n = 34，bid)和已经优化了剂量的NRTI药物 darunavir（用药量600mg，bid）或是ritonavir （用药量100 mg，bid）。本次试验的初始终点是观察24周时患者HIV-1mRNA每毫升拷贝数小于 50的百分比。

试验结果：

在24周时，HIV-1mRNA每毫升拷贝数小于 50的的百分比在 lersivirine两种用药量的数值为48.4% (750 mg) 及 43.8% (1,000 mg) ，这比etravirine 200 mg 用药量的百分比(67.7%)要低得多 [ITT，MSDF]。48周时，少数服用lersivirine的患者中 HIV-1 RNA每毫升拷贝数小于50 和小于400 的百分比分别为：750 mg 用量为41.9% 和 41.9%, 1,000 mg 用量为31.3% 和 34.4%。而在 etravirine （200 mg bid）用药组中这两个数值分别高达 61.8% 和70.6%(ITT, MSDF)。最小二乘平均值（LSM）换成对数后， lersivirine 750 mg用药量和1,000 mg用量在48周时的数值分别为 -1.42 (0.27) 和 -0.95 (0.28)，而 etravirine 200 mg用药量为 -2.02 (0.26) 。 Lersivirine 和 etravirine从整体来讲较安全并具有较好的耐受性。

结论:

24周和48周时，与etravirine和其他类NNRTI组合用药相比Lersivirine 750mg和1000mg的用药量对病毒抑制率较低。

原文出处：

DeJesus E, Fätkenheuer G, Orrell C, Wang C, Jones J, Craig C, Tawadrous M, Heera J. Efficacy and Safety of Lersivirine Versus Etravirine for the Treatment of HIV-1 Infection in Patients with Prior Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Use and Evidence of NNRTI Resistance: A Randomized Phase 2B Trial.HIV Clin Trials. 2014 Sep-Oct;15(5):209-17. doi: 10.1310/hct1505-209.

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2015-04-17 lsndxfj

#药效#

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2015-05-09 bsmagic9140

#TRA#

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2015-05-29 zhzhxiang

#trials#

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2015-06-17 anminleiryan

#ERS#

61 0
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2014-11-07 feifers

#Trial#

64 0

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