Real versus virtual phenotype to guide treatment in heavily pretreated patients: 48-week follow-up of the Genotipo-Fenotipo di Resistenza (GenPheRex) trial.
Real versus virtual phenotype to guide treatment in heavily pretreated patients: 48-week follow-up of the Genotipo-Fenotipo di Resistenza (GenPheRex) trial.
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真实表型与虚拟表型指导接受过多次治疗的患者的治疗：Genotipo-Fenotipo di Resistenza (GenPheRex) 试验的 48 周随访。
DOI：
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发表时间：
2003
期刊：
影响因子：
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通讯作者：
G. Carosi
中科院分区：
文献类型：
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作者：
F. Mazzotta;S. Lo Caputo;C. Torti;C. Tinelli;P. Pierotti;F. Castelli;A. Lazzarin;G. Angarano;R. Maserati;N. Gianotti;N. Ladisa;E. Quiros;A. Rinehart;G. Carosi
我们比较了在高效抗逆转录病毒治疗（HAART）失败的患者中，真实表型（r-PHT）和虚拟表型（v-PHT）后的病毒免疫反应。共有201名患者接受了2年以上的药物治疗，经历了6种以上的药物治疗，HIV RNA拷贝数达到了1000个/mL， HAART治疗持续了6个月，随机分为r-PHT组和v-PHT组。主要终点是HIV血浆病毒载量(pVL) <400拷贝/mL的比例。次要终点为pVL绝对变化、pVL减少比例>.5 log(10) copies/mL、CD4细胞绝对变化。在意向至最后一次治疗的随访分析中，在48周的随访中，两组之间的研究结果无显著差异：20%和24% pVL <400拷贝/mL；58%和61% pVL还原>0.5 log(10) copies/mL；pVL平均降低-0.92和-0.94（10）个log拷贝/mL；和+41.6和+94.4细胞/毫米(3)的平均绝对CD4增加在r-PHT和v-PHT组分别。治疗分析也给出了类似的结果。在pVL <400拷贝/mL的多变量分析中，以下共变量是48周时的独立预测因子：依从性（OR = 0.25; p= 0.002）、基线CD4 （OR = 4.39; p= 0.007）、静脉注射药物作为HIV感染的危险因素（OR = 0.33; p= 0.024）和新方案的生物切断敏感性评分（OR = 1.84; p= 0.029）。初诊患者使用的处方药导致边际预测（OR = 1.93; p= 0.054）。总之，在这组重度预处理患者中使用r-PHT或v-PHT时，病毒学和免疫学结果没有差异。为了更好地利用耐药检测，应考虑几个因素，包括治疗史、临床状况和患者坚持治疗的能力。
We compared viroimmunologic response after real phenotype (r-PHT) versus virtual phenotype (v-PHT) in patients failing highly active antiretroviral therapy (HAART). A total of 201 patients with >2 years of exposure, more than six experienced drugs, >1000 HIV RNA copies/mL, and on stable HAART for >6 months were randomized to the r-PHT or v-PHT arm. The primary end point was the proportion of HIV plasma viral load (pVL) <400 copies/mL. Secondary end points were absolute pVL change, proportion of pVL reduction >0.5 log(10) copies/mL, and absolute CD4 cell change. In the intention-to-treat-last observation carried forward analysis, study outcomes were not significantly different between arms over 48 weeks of follow-up: 20% and 24% pVL <400 copies/mL; 58% and 61% pVL reduction >0.5 log(10) copies/mL; -0.92 and -0.94(10) log copies/mL mean pVL decrease; and +41.6 and +94.4 cells/mm(3) mean absolute CD4 increase in the r-PHT and v-PHT arms, respectively. On-treatment analyses gave similar results. In the multivariate analysis of pVL <400 copies/mL, the following covariates were independent predictors at week 48: adherence (OR p= 0.25; p=.002), baseline CD4 (OR = 4.39; p=.007), intravenous drug use as risk factor for HIV acquisition (OR = 0.33; p=.024), and sensitivity score of the new regimens by biologic cut-offs (OR = 1.84; p=.029). Prescribed drugs for which patients were naive resulted in marginal prediction (OR = 1.93; p=.054). In conclusion, virologic and immunologic outcomes did not differ when r-PHT or v-PHT was used in this cohort of heavily pretreated patients. Several factors should be considered to take better advantage of resistance testing, including treatment history, clinical status, and patients' ability to adhere to treatment.
影响因子：
120.7
作者：
Grant, RM;Hecht, FM;Kahn, JO
通讯作者：
Kahn, JO