Veronese Nicola, Di Gennaro Francesco, Frallonardo Luisa, Ciriminna Stefano, Papagni Roberta, Carruba Luca, Agnello Diletta, De Iaco Giuseppina, De Gennaro Nicolò, Di Franco Giuseppina, Naro Liliana, Brindicci Gaetano, Rizzo Angelo, Bavaro Davide Fiore, Garlisi Maria Chiara, Santoro Carmen Rita, Signorile Fabio, Balena Flavia, Mansueto Pasquale, Milano Eugenio, Giannitrapani Lydia, Fiordelisi Deborah, Mariani Michele Fabiano, Procopio Andrea, Lattanzio Rossana, Licata Anna, Vernuccio Laura, Amodeo Simona, Guido Giacomo, Segala Francesco Vladimiro, Barbagallo Mario, Saracino Annalisa
Geriatrics Section, Department of Internal Medicine, University of Palermo, Palermo, Italy.
Department of Precision and Regenerative Medicine and Ionian Area (DiMePRe-J), Clinic of Infectious Diseases, University of Bari "Aldo Moro", Piazza Giulio Cesare N. 11 Cap, 70124, Bari, Italy.
Sci Rep. 2024 Apr 23;14(1):9303. doi: 10.1038/s41598-024-59957-w.
Remdesivir (RDV) was the first Food and Drug Administration (FDA)-approved medication for COVID-19, with discordant data on efficacy in reducing mortality risk and disease progression. In the context of a dynamic and rapidly changing pandemic landscape, the utilization of real-world evidence is of utmost importance. The objective of this study is to evaluate the impact of RDV on patients who have been admitted to two university referral hospitals in Italy due to COVID-19. All patients older than 18 years and hospitalized at two different universities (Bari and Palermo) were enrolled in this study. To minimize the effect of potential confounders, we used propensity score matching with one case (Remdesivir) and one control that never experienced this kind of intervention during hospitalization. Mortality was the primary outcome of our investigation, and it was recorded using death certificates and/or medical records. Severe COVID-19 was defined as admission to the intensive care unit or a qSOFAscore ≥ 2 or CURB65scores ≥ 3. After using propensity score matching, 365 patients taking Remdesivir and 365 controls were included. No significant differences emerged between the two groups in terms of mean age and percentage of females, while patients taking Remdesivir were less frequently active smokers (p < 0.0001). Moreover, the patients taking Remdesivir were less frequently vaccinated against COVID-19. All the other clinical, radiological, and pharmacological parameters were balanced between the two groups. The use of Remdesivir in our cohort was associated with a significantly lower risk of mortality during the follow-up period (HR 0.56; 95% CI 0.37-0.86; p = 0.007). Moreover, RDV was associated with a significantly lower incidence of non-invasive ventilation (OR 0.27; 95% CI 0.20-0.36). Furthermore, in the 365 patients taking Remdesivir, we observed two cases of mild renal failure requiring a reduction in the dosage of Remdesivir and two cases in which the physicians decided to interrupt Remdesivir for bradycardia and for QT elongation. Our study suggests that the use of Remdesivir in hospitalized COVID-19 patients is a safe therapy associated with improved clinical outcomes, including halving of mortality and with a reduction of around 75% of the risk of invasive ventilation. In a constantly changing COVID-19 scenario, ongoing research is necessary to tailor treatment decisions based on the latest scientific evidence and optimize patient outcomes.
瑞德西韦(RDV)是美国食品药品监督管理局(FDA)批准的首款用于治疗新型冠状病毒肺炎(COVID-19)的药物,但其在降低死亡风险和疾病进展方面的疗效数据并不一致。在动态且迅速变化的疫情形势下,利用真实世界证据至关重要。本研究的目的是评估瑞德西韦对因COVID-19入住意大利两家大学附属医院的患者的影响。本研究纳入了所有年龄大于18岁且在两所不同大学(巴里和巴勒莫)住院的患者。为尽量减少潜在混杂因素的影响,我们采用倾向得分匹配法,将一名使用瑞德西韦的患者与一名住院期间从未接受过此类干预的对照患者进行匹配。死亡率是我们调查的主要结局,通过死亡证明和/或病历记录。重症COVID-19定义为入住重症监护病房或快速序贯器官衰竭评估(qSOFA)评分≥2或改良英国医学研究委员会(CURB65)评分≥3。采用倾向得分匹配后,纳入了365例使用瑞德西韦的患者和365例对照患者。两组在平均年龄和女性百分比方面无显著差异,但使用瑞德西韦的患者当前吸烟者较少(p<0.0001)。此外,使用瑞德西韦的患者接种COVID-19疫苗的频率较低。两组在所有其他临床、影像学和药理学参数方面均保持平衡。在我们的队列中,使用瑞德西韦与随访期间显著较低的死亡风险相关(风险比[HR]0.56;95%置信区间[CI]0.37 - 0.86;p = 0.007)。此外,瑞德西韦与显著较低的无创通气发生率相关(比值比[OR]0.27;95%CI 0.20 - 0.36)。此外,在365例使用瑞德西韦的患者中,我们观察到2例轻度肾衰竭需要减少瑞德西韦剂量,以及2例医生因心动过缓和QT延长而决定停用瑞德西韦的病例。我们的研究表明,在住院的COVID-19患者中使用瑞德西韦是一种安全的治疗方法,与改善临床结局相关,包括死亡率减半以及有创通气风险降低约75%。在不断变化的COVID-19疫情形势下,需要持续开展研究,以便根据最新科学证据制定治疗决策并优化患者结局。