Dwyer Dominic E, Workman Cassy, Hales Gillian, Amin Janaki, Cooper David, Miller John
Centre for Infectious Diseases and Microbiology Laboratory Services, Institute of Clinical Pathology and Medical Research, Westmead Hospital, Westmead, Australia.
Antivir Ther. 2006;11(4):409-19.
The role of the fusion inhibitor enfuvirtide in nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimens was assessed in an open-label study of fifty-nine highly antiretroviral drug exposed HIV-1-infected individuals. There was a reduction in plasma HIV-1 RNA of 1.43 (95% confidence interval [Cl]: -2.06, -1.22) log10 copies/ml plasma over 96 weeks, and 44% (95% CI: 31, 58) of individuals had a viral load less than 400 copies/ml. A viral load below detection at 96 weeks was predicted by a baseline genotypic sensitivity score greater than 1. There was an average increase of 67 cells/microl (95% Cl: 15, 120) from baseline CD4+ T-cell count to week 96, and the percentage of patients with CD4+ T-cell counts above 100 and 200 cells/microl increased over the trial. Injection site reactions (ISRs) were less common in people with CD4+ T-cell counts >250 cells/microl at any time during follow-up, and were more severe in patients with lower baseline peripheral fat. Adherence over 48 weeks to enfuvirtide injections ranged from 96.3-99.5%. During the 96 week trial there were two discontinuations due to ISRs and two discontinuations following hypersensitivity reactions. Over the 96 weeks of study lean body mass increased by an average 2.7 kg (95% Cl; 1.7, 3.6 kg). Mean peripheral fat increased by 0.2 kg (95% Cl; -0.2, 0.6 kg). Baseline NRTI-associated toxicities resolved in 17% of participants during follow-up. Enfuvirtide is an important component of antiretroviral therapy in highly treatment-experienced individuals where NRTI sparing may be desirable.
在一项针对59名长期接受抗逆转录病毒药物治疗的HIV-1感染者的开放性研究中，评估了融合抑制剂恩夫韦肽在无核苷类逆转录酶抑制剂（NRTI）治疗方案中的作用。在96周内，血浆HIV-1 RNA水平下降了1.43（95%置信区间[CI]：-2.06，-1.22）log10拷贝/毫升血浆，44%（95%CI：31，58）的个体病毒载量低于400拷贝/毫升。基线基因型敏感性评分大于1可预测96周时病毒载量低于检测下限。从基线CD4+T细胞计数到96周时，平均增加了67个细胞/微升（95%CI：15，120），试验期间CD4+T细胞计数高于100和200个细胞/微升的患者百分比有所增加。在随访期间任何时间CD4+T细胞计数>250个细胞/微升的人群中，注射部位反应（ISR）较少见，而基线外周脂肪较低的患者反应更严重。48周内恩夫韦肽注射的依从率为96.3%-99.5%。在96周的试验中，有2例因ISR停药，2例因过敏反应停药。在96周的研究中，瘦体重平均增加了2.7千克（95%CI；1.7，3.6千克）。外周脂肪平均增加了0.2千克（95%CI；-0.2，0.6千克）。随访期间，17%的参与者基线NRTI相关毒性消失。在那些可能需要避免使用NRTI的高度经治个体中，恩夫韦肽是抗逆转录病毒治疗的重要组成部分。
