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Darunavir/Cobicistat Is Associated with Negative Outcomes in HIV-Negative Patients with Severe COVID-19 Pneumonia
AIDS Research and Human Retroviruses ( IF 1.5 ) Pub Date : 2021-03-31 , DOI: 10.1089/aid.2020.0305
Jovana Milic 1, 2 , Alessio Novella 3 , Marianna Meschiari 4 , Marianna Menozzi 4 , Antonella Santoro 4 , Andrea Bedini 4 , Gianluca Cuomo 4 , Erica Franceschini 4 , Margherita Digaetano 4 , Federica Carli 5 , Giacomo Ciusa 4 , Sara Volpi 4 , Erica Bacca 4 , Giacomo Franceschi 4 , Dina Yaacoub 4 , Carlotta Rogati 4 , Marco Tutone 4 , Giulia Burastero 4 , Matteo Faltoni 4 , Vittorio Iadisernia 4 , Giovanni Dolci 4 , Andrea Cossarizza 6 , Cristina Mussini 7 , Luca Pasina 3 , Giovanni Guaraldi 8
Affiliation  

The aim of this study was to evaluate both positive outcomes, including reduction of respiratory support aid and duration of hospital stay, and negative ones, including mortality and a composite of invasive mechanical ventilation or death, in patients with coronavirus disease 2019 (COVID-19) pneumonia treated with or without oral darunavir/cobicistat (DRV/c, 800/150 mg/day) used in different treatment durations. The secondary objective was to evaluate the percentage of patients treated with DRV/c who were exposed to potentially severe drug–drug interactions (DDIs) and died during hospitalization. This observational retrospective study was conducted in consecutive patients with COVID-19 pneumonia admitted to a tertiary care hospital in Modena, Italy. Kaplan–Meier survival curves and Cox proportional hazards regression were used to compare patients receiving standard of care with or without DRV/c. Adjustment for key confounders was applied. Two hundred seventy-three patients (115 on DRV/c) were included, 75.8% males, mean age was 64.6 (±13.2) years. Clinical improvement was similar between the groups, depicted by respiratory aid switch (p > .05). The same was observed for duration of hospital stay [13.2 (±8.9) for DRV/c vs. 13.4 (±7.2) days for no-DRV/c, p = .9]. Patients on DRV/c had higher rates of mortality (25.2% vs. 10.1%, p < .0001. The rate of composite outcome of mechanical ventilation and death was higher in the DRV/c group (37.4% vs. 25.3%, p = .03). Multiple serious DDI associated with DRV/c were observed in the 19 patients who died. DRV/c should not be recommended as a treatment option for COVID-19 pneumonia outside clinical trials.

中文翻译:

Darunavir / Cobicistat与严重COVID-19肺炎的HIV阴性患者的阴性结果相关

这项研究的目的是评估2019年冠状病毒病患者的阳性结果(包括减少呼吸支持和住院时间)以及阴性结果(包括死亡率和有创机械通气或死亡)(COVID-19) )在不同治疗持续时间内使用或不使用口服darunavir / cobicistat(DRV / c,800/150 mg / day)治疗的肺炎。次要目标是评估接受DRV / c治疗且可能会遭受严重的药物-药物相互作用(DDI)并在住院期间死亡的患者的百分比。这项观察性回顾性研究是在意大利摩德纳的一家三级医院连续收治的COVID-19肺炎患者中进行的。Kaplan–Meier生存曲线和Cox比例风险回归用于比较接受或不接受DRV / c的接受标准治疗的患者。调整了关键混杂因素。其中包括273例患者(DRV / c为115),男性为75.8%,平均年龄为64.6(±13.2)岁。两组之间的临床改善情况相似,如呼吸辅助开关(p  > .05)。住院时间相同[DRV / c为13.2(±8.9)天,无DRV / c为13.4(±7.2)天,p  = .9]。接受DRV / c治疗的患者死亡率较高(25.2%比10.1%,p  <.0001。)DRV / c组机械通气和死亡的综合结局发生率更高(37.4%vs. 25.3%,p  = .03)。在19例死亡的患者中观察到多发严重DDI与DRV / c相关,不建议将DRV / c作为临床试验以外的COVID-19肺炎的治疗选择。
更新日期:2021-04-04
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