Withholding Primary Pneumocystis Pneumonia Prophylaxis in Virologically Suppressed Patients With Human Immunodeficiency Virus: An Emulation of a Pragmatic Trial in COHERE.
Withholding Primary Pneumocystis Pneumonia Prophylaxis in Virologically Suppressed Patients With Human Immunodeficiency Virus: An Emulation of a Pragmatic Trial in COHERE.
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DOI：
10.1093/cid/ciaa615
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发表时间：
2021-07-15
期刊：
影响因子：
--
通讯作者：
Opportunistic Infections Project Working Group of the Collaboration of Observational HIV Epidemiological Research Europe (COHERE) in EuroCoord
中科院分区：
文献类型：
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作者：
Atkinson A;Zwahlen M;Barger D;d'Arminio Monforte A;De Wit S;Ghosn J;Girardi E;Svedhem V;Morlat P;Mussini C;Noguera-Julian A;Stephan C;Touloumi G;Kirk O;Mocroft A;Reiss P;Miro JM;Carpenter JR;Furrer H;Opportunistic Infections Project Working Group of the Collaboration of Observational HIV Epidemiological Research Europe (COHERE) in EuroCoord
使用来自COHERE合作的数据，我们研究了是否可以在所有接受抗逆转录病毒治疗（ART）且血浆人类免疫缺陷病毒（HIV） RNA（≤400拷贝/mL）被抑制的患者中，不考虑CD4计数，拒绝肺囊虫性肺炎（PcP）的初级预防。我们实施了一种既定的因果推理方法，即使用观察数据来模拟随机试验。服用PcP预防的患者如果CD4计数≤200细胞/µL符合现有建议，则有资格参加模拟试验。我们比较了以下两种停止预防的策略：(1)当CD4计数为bbb200细胞/µL，持续>3个月或(2)当患者被病毒学抑制（连续2次HIV RNA≤400拷贝/mL）。如果患者不遵守这些停止规则，他们就会被人为地审查。我们估计了ART患者原发性PcP的风险，使用风险比（HR）通过拟合一个汇集逻辑模型来比较停止策略，包括逆概率权重来调整人为审查引入的选择偏差。共有4813例患者（10 324人年）符合模拟试验的资格条件。以原发性PcP诊断为终点，调整后的HR （aHR）显示，与现有指南相比，仅基于病毒抑制的策略的风险略低，但无统计学意义（aHR, 0.8； 95%置信区间，0.6 - 1.1;P = 0.2）。这项研究表明，在经证实的抗逆转录病毒治疗的病毒学抑制患者中，无论其CD4计数如何，初级PcP预防可能是安全的。利用来自COHERE的观察性数据，我们模拟了一项随机试验，该试验显示，无论CD4计数如何，在接受抗逆转录病毒治疗的病毒学抑制患者中，原发性肺囊虫肺炎预防可以安全地停药。
Using data from the COHERE collaboration, we investigated whether primary prophylaxis for pneumocystis pneumonia (PcP) might be withheld in all patients on antiretroviral therapy (ART) with suppressed plasma human immunodeficiency virus (HIV) RNA (≤400 copies/mL), irrespective of CD4 count. We implemented an established causal inference approach whereby observational data are used to emulate a randomized trial. Patients taking PcP prophylaxis were eligible for the emulated trial if their CD4 count was ≤200 cells/µL in line with existing recommendations. We compared the following 2 strategies for stopping prophylaxis: (1) when CD4 count was >200 cells/µL for >3 months or (2) when the patient was virologically suppressed (2 consecutive HIV RNA ≤400 copies/mL). Patients were artificially censored if they did not comply with these stopping rules. We estimated the risk of primary PcP in patients on ART, using the hazard ratio (HR) to compare the stopping strategies by fitting a pooled logistic model, including inverse probability weights to adjust for the selection bias introduced by the artificial censoring. A total of 4813 patients (10 324 person-years) complied with eligibility conditions for the emulated trial. With primary PcP diagnosis as an endpoint, the adjusted HR (aHR) indicated a slightly lower, but not statistically significant, different risk for the strategy based on viral suppression alone compared with the existing guidelines (aHR, .8; 95% confidence interval, .6–1.1; P = .2). This study suggests that primary PcP prophylaxis might be safely withheld in confirmed virologically suppressed patients on ART, regardless of their CD4 count. Using observational data from COHERE, we emulated a randomized trial that showed that primary pneumocystis pneumonia prophylaxis can be safely withdrawn in virologically suppressed patients on antiretroviral therapy, irrespective of the CD4 count.
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