在一项为期48周的3期试验中，用考比司他增强的达芦那韦治疗老年HIV-1感染受试者。
Treating Older HIV-1-infected Subjects With Cobicistat-boosted Darunavir in a 48-week Phase 3 Trial.
作者信息
Brown Kimberley, Patterson-Browning Brooke, Liu Chris, Patel Meera, Stewart Lisa, Nettles Richard E
机构信息
Janssen Scientific Affairs, LLC, Titusville, NJ, USA.
Janssen Research & Development, LLC, Titusville, NJ, USA.
出版信息
Rev Recent Clin Trials. 2017;12(3):174-181. doi: 10.2174/1574887112666170407171106.
BACKGROUND
An aging HIV-1-infected population warrants examination of the acceptability of individual antiretroviral regimens. In a previous study of ritonavir-boosted darunavir (ARTEMIS), similar safety/efficacy profiles were observed in younger (≤45 years) and older (>45 years) HIV-1-infected subjects.
OBJECTIVE
To evaluate safety and efficacy outcomes in HIV-1-infected younger versus older subjects treated with cobicistat-boosted darunavir.
METHOD
In a 48-week, phase 3b, open-label trial, HIV-1-infected adults were administered darunavir 800 mg and cobicistat 150 mg once-daily with 2 nucleos(t)ide reverse transcriptase inhibitors (N[t]RTIs). Post hoc analyses examined safety and efficacy outcomes in subjects ≤45 and >45 years.
RESULTS
Of 313 subjects, 76% were ≤45 years (median [range] age, 31 [18-45]) and 24% were >45 years (49 [46-72]). Baseline median (range) viral loads were 4.75 (2.6-6.8) and 4.83 (2.7-7.0) log10 copies/mL, and CD4+ counts were 379.0 (5-1473) and 310.5 (6-757) cells/mm3 in younger and older subjects, respectively. Through Week 48, similar proportions of younger and older subjects had ≥1 adverse event (AE; 93% vs 88%), ≥1 grade 2-4 AE possibly related to study drug (13% vs 15%), and discontinued study due to AE (3% vs 3%). At Week 48, 82% of younger and 78% of older subjects had viral load <50 copies/mL (95% CI of the difference: -7.4% to 13.8%). A higher proportion of older versus younger subjects took >4 concomitant medications during the study (69% vs 57%).
CONCLUSION
Safety and efficacy profiles of cobicistat-boosted darunavir with 2 N(t)RTIs were similar in HIV-1-infected subjects ≤45 and >45 years.
背景
感染人类免疫缺陷病毒1型（HIV-1）的人群老龄化，这使得有必要对个体化抗逆转录病毒治疗方案的可接受性进行研究。在先前一项关于利托那韦增强达芦那韦的研究（ARTEMIS）中，在年龄较小（≤45岁）和年龄较大（>45岁）的HIV-1感染受试者中观察到了相似的安全性/疗效概况。
目的
评估接受考比司他增强达芦那韦治疗的HIV-1感染的年轻与年长受试者的安全性和疗效结果。
方法
在一项为期48周的3b期开放标签试验中，给HIV-1感染的成年人每日一次服用800mg达芦那韦和150mg考比司他，并联合两种核苷（酸）逆转录酶抑制剂（N[t]RTIs）。事后分析检查了年龄≤45岁和>45岁受试者的安全性和疗效结果。
结果
在313名受试者中，76%年龄≤45岁（中位[范围]年龄，31[18 - 45]岁），24%年龄>45岁（49[46 - 72]岁）。年轻和年长受试者的基线中位（范围）病毒载量分别为4.75（2.6 - 6.8）和4.83（2.7 - 7.0）log10拷贝/mL，CD4 +细胞计数分别为379.0（5 - 1473）和310.5（6 - 757）个细胞/mm³。至第48周时，年轻和年长受试者中发生≥1次不良事件（AE）的比例相似（93%对88%），发生≥1次可能与研究药物相关的2 - 4级AE的比例相似（13%对15%），因AE而停药的比例相似（3%对3%）。在第48周时，82%的年轻受试者和78%的年长受试者病毒载量<50拷贝/mL（差异的95%CI：-7.4%至13.8%）。在研究期间，年长受试者服用>4种伴随药物的比例高于年轻受试者（69%对57%）。
结论
考比司他增强达芦那韦联合两种N(t)RTIs在年龄≤45岁和>45岁的HIV-1感染受试者中的安全性和疗效概况相似。
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