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在真实临床护理环境中,开始使用多替拉韦(dolutegravir)为基础方案与其他推荐方案的 HIV 感染者的病毒学失败情况。

Virologic Failure Among People Living With HIV Initiating Dolutegravir-Based Versus Other Recommended Regimens in Real-World Clinical Care Settings.

机构信息

University of Washington, Collaborative Health Studies Coordinating Center, Seattle, WA.

ViiV Healthcare, Research Triangle Park, NC.

出版信息

J Acquir Immune Defic Syndr. 2019 Aug 15;81(5):572-577. doi: 10.1097/QAI.0000000000002075.

Abstract

BACKGROUND

Guidelines for initial antiretroviral treatment (ART) regimens have evolved, with integrase strand transfer inhibitors (INSTIs) increasingly prominent. Research on virologic failure (VF) with INSTI therapy is predominantly from clinical trials not care settings, especially for recently approved medications including dolutegravir. We compared outcomes among people living with HIV (PLWH) who initiated recommended regimens in clinical care across the United States.

SETTING

We examined 2 groups of PLWH at 8 clinics who initiated ART regimens (August 1, 2013-March 31, 2017): those ART treatment-naive at initiation, and those treatment-experienced.

METHODS

The outcome in this longitudinal cohort study was VF, defined as a viral load of ≥400 copies/mL ≥6 months after ART initiation. We examined the proportion of individuals who remained on, switched, or discontinued the regimen. Associations between regimens and outcomes were examined with adjusted Cox proportional hazards models.

RESULTS

Among 5177 PLWH, a lower proportion experienced VF on dolutegravir- versus other INSTI- or darunavir-based regimens for previously treatment-naive (7% vs. 12% vs. 28%) and treatment-experienced PLWH (6% vs. 10% vs. 21%). In adjusted analyses, hazard ratios were similar across regimens for the combined outcome of regimen discontinuation or treatment switch. The hazard ratios for VF comparing dolutegravir- to darunavir-based regimens was 0.30 (95% CI: 0.2 to 0.6) among previously treatment-naive PLWH and was 0.60 (95% CI: 0.4 to 0.8) among treatment-experienced PLWH.

CONCLUSIONS

The proportion of previously treatment-naive PLWH remaining on recommended ART regimens did not differ by regimen. The likelihood of VF was lower with dolutegravir- than darunavir-based regimens for previously treatment-naive and treatment-experienced PLWH.

摘要

背景

初始抗逆转录病毒治疗 (ART) 方案的指南已经发生了变化,整合酶链转移抑制剂 (INSTI) 的应用越来越多。关于 INSTI 治疗的病毒学失败 (VF) 的研究主要来自临床试验而不是护理环境,特别是对于最近批准的药物,包括多替拉韦。我们比较了在美国临床护理中接受推荐方案治疗的艾滋病毒感染者 (PLWH) 的结局。

地点

我们检查了 8 家诊所的 2 组 PLWH,他们开始了 ART 方案 (2013 年 8 月 1 日至 2017 年 3 月 31 日):那些在开始时没有接受 ART 治疗的人,以及那些有治疗经验的人。

方法

本纵向队列研究的结果是 VF,定义为在开始 ART 后 6 个月病毒载量≥400 拷贝/ml。我们检查了仍在使用、转换或停止方案的个体比例。用调整后的 Cox 比例风险模型检查方案与结局之间的关系。

结果

在 5177 名 PLWH 中,与其他 INSTI 或达芦那韦为基础的方案相比,在以前未接受治疗的人群中,多替拉韦组的 VF 发生率较低(7%比 12%比 28%)和治疗经验丰富的 PLWH(6%比 10%比 21%)。在调整分析中,对于方案停药或转换的综合结局,不同方案的风险比相似。与达芦那韦相比,多替拉韦的风险比为 0.30(95%可信区间:0.2 至 0.6),在以前未接受治疗的 PLWH 中,风险比为 0.60(95%可信区间:0.4 至 0.8)。

结论

以前未接受治疗的 PLWH 继续接受推荐的 ART 方案的比例不因方案而异。对于以前未接受治疗和有治疗经验的 PLWH,多替拉韦组的 VF 发生率低于达芦那韦组。

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