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首页> 外文期刊>AIDS Research and Human Retroviruses >Safety and immunovirologic outcomes with maraviroc combination regimens in patients with a history of past treatment failures and virologic resistance in Brazil: An open-label, multicenter phase 3b study
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Safety and immunovirologic outcomes with maraviroc combination regimens in patients with a history of past treatment failures and virologic resistance in Brazil: An open-label, multicenter phase 3b study

机译：在巴西有既往治疗失败和病毒学耐药史的患者中，使用maraviroc联合疗法的安全性和免疫病毒学结局：一项开放式，多中心3b期研究

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摘要

Maraviroc is a first-in-class chemokine coreceptor type-5 (CCR5) antagonist with demonstrated immunovirologic activity in treatment-experienced (TE) patients with CCR5 (R5)-tropic HIV-1; however, experience in regimens containing newer antiretroviral agents is limited. The primary objective of this 96-week open-label, noncomparative, multicenter Phase 3b study (NCT00478231) was to assess the safety of maraviroc in combination with optimized background therapy (OBT), which could include recently introduced agents such as darunavir and raltegravir in TE patients in Brazil with R5 HIV-1 and limited therapeutic options. Immunovirologic activity was a secondary endpoint. Of 638 patients screened, 206 were treated and 125 completed the study. Approximately 70% were male; the mean age was 43.2 years. Most patients (65.0%) received an OBT combination of protease inhibitor plus nucleoside reverse transcriptase inhibitor. Adverse event (AE) and treatment-related AE incidence was 91.3% and 36.9%, respectively. The most common AEs were diarrhea, nasopharyngitis, and headache. Serious AEs and treatment-related serious AEs occurred in 16.5% and 4.4% of patients. Only eight patients (3.9%) discontinued due to AEs. Few AIDS-defining events were observed (4.9%). The proportion of patients with viral load 400 copies/ml increased from 2.4% at baseline to 43.9% at week 8, remaining 40% until week 48. At the end of treatment, 26.7% of patients had a viral load 400 copies/ml. Median CD4+ cell count increased throughout the study; the mean change from baseline to end of treatment was 174.1 cells/μl. In conclusion, maraviroc, combined with different agents from multiple classes, was well tolerated in highly TE patients. Maraviroc plus OBT was associated with an immunovirologic response in this population.
机译：Maraviroc是一流的5型趋化因子核心受体（CCR5）拮抗剂，在治疗经验丰富（TE）的CCR5（R5）嗜性HIV-1患者中表现出免疫病毒学活性;但是，使用新型抗逆转录病毒药物的治疗方案的经验有限。这项96周的开放标签，非比较性，多中心3b期研究（NCT00478231）的主要目的是评估结合优化背景疗法（OBT）的maraviroc的安全性，其中可能包括最近引入的darunavir和raltegravir等药物。巴西的TE患者具有R5 HIV-1和有限的治疗选择。免疫病毒学活性是次要终点。在筛查的638位患者中，有206位接受了治疗，其中125位完成了研究。大约70％是男性;平均年龄为43.2岁。大多数患者（65.0％）接受了OBT联合蛋白酶抑制剂和核苷逆转录酶抑制剂的治疗。不良事件（AE）和与治疗有关的AE发生率分别为91.3％和36.9％。最常见的AE是腹泻，鼻咽炎和头痛。严重不良事件和与治疗有关的严重不良事件发生在患者的16.5％和4.4％。仅8例（3.9％）因AE停药。几乎没有人发现艾滋病定义事件（4.9％）。病毒载量<400拷贝/毫升的患者比例从基线时的2.4％增加到第8周的43.9％，在第48周之前保持> 40％。在治疗结束时，有26.7％的病毒载量<400拷贝的患者/毫升。在整个研究中，中位数CD4 +细胞数量增加;从基线到治疗结束的平均变化为174.1细胞/μl。总之，在高度TE患者中，马拉维罗克与多种类别的不同药物联合耐受性良好。 Maraviroc加OBT与该人群的免疫病毒学应答有关。

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