Mozaffari Essy, Chandak Aastha, Gottlieb Robert L, Chima-Melton Chidinma, Berry Mark, Amin Alpesh N, Sax Paul E, Kalil Andre C
Medical Affairs, Gilead Sciences, Foster City, California, USA.
Evidence and Access, Certara, New York, New York, USA.
Clin Infect Dis. 2024 Dec 13;79(Suppl 4):S149-S159. doi: 10.1093/cid/ciae510.
Patients with immunocompromising conditions are at increased risk for coronavirus disease 2019 (COVID-19)-related hospitalizations and deaths. Randomized clinical trials provide limited enrollment, if any, to provide information on the outcomes in such patients treated with remdesivir.
Using the US PINC AI Healthcare Database, we identified adult patients with immunocompromising conditions, hospitalized for COVID-19 between December 2021 and February 2024. The primary outcome was all-cause inpatient mortality examined in propensity score-matched patients in remdesivir vs nonremdesivir groups. Subgroup analyses were performed for patients with cancer, hematological malignancies, and solid organ or hematopoietic stem cell transplant recipients.
Of 28 966 patients included in the study, 16 730 (58%) received remdesivir during the first 2 days of hospitalization. After propensity score matching, 8822 patients in the remdesivir and 8822 patients in the nonremdesivir group were analyzed. Remdesivir was associated with a significantly lower mortality rate among patients with no supplemental oxygen (adjusted hazard ratio [95% confidence interval], 0.73 [.62-.86] at 14 days and 0.79 [.68-.91] at 28 days) and among those with supplemental oxygen (0.75 [.67-.85] and 0.78 [.70-.86], respectively). Remdesivir was also associated with lower mortality rates in subgroups of patients with cancer, hematological malignancies (leukemia, lymphoma, or multiple myeloma), and solid organ or hematopoietic stem cell transplants.
In this large cohort of patients with immunocompromising conditions hospitalized for COVID-19, remdesivir was associated with significant improvement in survival, including patients with varied underlying immunocompromising conditions. The integration of current real-world evidence into clinical guideline recommendations can inform clinical communities to optimize treatment decisions in the evolving COVID-19 era, extending beyond the conclusion of the public health emergency declaration.
免疫功能低下的患者因2019冠状病毒病(COVID-19)住院和死亡的风险增加。随机临床试验纳入此类患者的人数有限(若有纳入的话),难以提供有关接受瑞德西韦治疗的此类患者预后的信息。
利用美国PINC AI医疗数据库,我们确定了2021年12月至2024年2月期间因COVID-19住院的成年免疫功能低下患者。主要结局是在倾向评分匹配的患者中,比较瑞德西韦组和非瑞德西韦组的全因住院死亡率。对癌症患者、血液系统恶性肿瘤患者以及实体器官或造血干细胞移植受者进行亚组分析。
在纳入研究的28966例患者中,16730例(58%)在住院的前两天接受了瑞德西韦治疗。经过倾向评分匹配后,对瑞德西韦组的8822例患者和非瑞德西韦组的8822例患者进行了分析。瑞德西韦与未接受补充氧气的患者(14天时调整后的风险比[95%置信区间]为0.73[0.62 - 0.86],28天时为0.79[0.68 - 0.91])以及接受补充氧气的患者(分别为0.75[0.67 - 0.85]和0.78[0.70 - 0.86])的死亡率显著降低相关。瑞德西韦还与癌症患者、血液系统恶性肿瘤(白血病、淋巴瘤或多发性骨髓瘤)患者以及实体器官或造血干细胞移植患者亚组的较低死亡率相关。
在这一因COVID-19住院的大量免疫功能低下患者队列中,瑞德西韦与生存的显著改善相关,包括各种潜在免疫功能低下情况的患者。将当前的真实世界证据纳入临床指南建议中,可为临床界提供参考,以便在不断演变的COVID-19时代优化治疗决策,这一影响将延伸至公共卫生紧急声明结束之后。