在现实世界中，新诊断的HIV感染者中与治疗相关的早期停药和不良事件启动整合酶抑制剂

IF 1.3 4区医学 Q4 INFECTIOUS DISEASES Antiviral Therapy Pub Date : 2023-02-01 DOI:10.1177/13596535231163703

Charlotte-Paige Rolle, Jamie Castano, Vu Nguyen, Kiran Patel, Federico Hinestrosa, Edwin DeJesus

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引用次数: 2

摘要

背景:队列研究表明，与临床试验相比，整合酶链转移抑制剂(insis)的停药率更高。我们评估了treatment-naïve HIV感染者(PLWH)在开始治疗后的第一年被认为与初始INSTI相关的停药和不良事件(ae)。方法:纳入2007年10月至2020年1月期间在奥兰多免疫中心接受雷替格拉韦、埃韦替格拉韦/可比司他、多替格拉韦或比替格拉韦联合恩曲他滨/替诺福韦阿拉那胺或恩曲他滨/富马酸替诺福韦二吡酯治疗的新诊断PLWH。计算治疗相关停药的未调整发生率(IRs)和发生率比(IRRs)，以及开始治疗后第一年与初始INSTI相关的ae。结果:在331名入组患者中，26人(8%)开始使用雷替重力韦，151人(46%)开始使用依替重力韦/可比司他，74人(22%)开始使用多替重力韦，80人(24%)开始使用比替重力韦。在第一年内，3例依替格拉韦/共存司他组(IR 0.02 /人年(PPY))和5例多替格拉韦组(IR 0.08 /人年(PPY))出现治疗相关中断;在开始使用雷替重力韦或比替重力韦的患者中没有出现治疗相关的停药。7例使用瑞替格拉韦(IR 0.46 PPY)发生11例治疗相关ae, 63例使用依替格拉韦/共存司他(IR 0.72 PPY)发生100例治疗相关ae, 37例使用多替格拉韦(IR 0.97 PPY)发生66例治疗相关ae, 34例使用比替格拉韦(IR 0.88 PPY)发生65例治疗相关ae。未调整的IRRs在早期治疗相关中断或ae方面未显示出任何显著差异。结论:在我们的队列中，治疗相关不良事件发生在43%的初始inist患者中，但只有2%的患者早期停药，而在初始RAL或BIC患者中未观察到治疗相关停药。

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Treatment-related early discontinuations and adverse events among newly diagnosed people living with HIV initiating integrase inhibitors in a real-world setting.

Background: Cohort studies suggest higher discontinuation rates with integrase strand transfer inhibitors (INSTIs) than are seen in clinical trials. We assessed discontinuations and adverse events (AEs) that were considered related to the initial INSTI in the first year following initiation among treatment-naïve people living with HIV (PLWH).

Methods: Newly diagnosed PLWH initiating raltegravir, elvitegravir/cobicistat, dolutegravir or bictegravir in combination with emtricitabine/tenofovir alafenamide or emtricitabine/tenofovir disoproxil fumarate between 10/2007 and 1/2020 at the Orlando Immunology Center were included. Unadjusted incidence rates (IRs) and incidence rate ratios (IRRs) were calculated for treatment-related discontinuations and AEs associated with the initial INSTI in the first year following initiation.

Results: Of 331 enrolled, 26 (8%) initiated raltegravir, 151 (46%) initiated elvitegravir/cobicistat, 74 (22%) initiated dolutegravir and 80 (24%) initiated bictegravir. Within the first year, treatment-related discontinuations occurred in 3 on elvitegravir/cobicistat (IR 0.02 per person-years (PPY)) and 5 on dolutegravir (IR 0.08 PPY); no treatment-related discontinuations occurred among those initiating raltegravir or bictegravir. Eleven treatment-related AEs occurred in 7 on raltegravir (IR 0.46 PPY), 100 treatment-related AEs occurred in 63 on elvitegravir/cobicistat (IR 0.72 PPY), 66 treatment-related AEs occurred in 37 on dolutegravir (IR 0.97 PPY) and 65 treatment-related AEs occurred in 34 on bictegravir (IR 0.88 PPY). Unadjusted IRRs did not reveal any significant difference between INSTIs in terms of early treatment-related discontinuations or AEs.

Conclusions: In our cohort, treatment-related AEs occurred in 43% initiating INSTIs but were responsible for early discontinuation in only 2% with no treatment-related discontinuations observed among those initiating RAL or BIC.

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来源期刊

Antiviral Therapy 医学-病毒学

CiteScore

2.60

自引率

8.30%

发文量

审稿时长

4-8 weeks

期刊介绍： Antiviral Therapy (an official publication of the International Society of Antiviral Research) is an international, peer-reviewed journal devoted to publishing articles on the clinical development and use of antiviral agents and vaccines, and the treatment of all viral diseases. Antiviral Therapy is one of the leading journals in virology and infectious diseases. The journal is comprehensive, and publishes articles concerning all clinical aspects of antiviral therapy. It features editorials, original research papers, specially commissioned review articles, letters and book reviews. The journal is aimed at physicians and specialists interested in clinical and basic research.