Real World Evidence, Gilead Sciences Inc, Foster City, California.
Division of Epidemiology, School of Public Health, University of California, Berkeley.
JAMA Netw Open. 2022 Dec 1;5(12):e2244505. doi: 10.1001/jamanetworkopen.2022.44505.
SARS-CoV-2, which causes COVID-19, poses considerable morbidity and mortality risks. Studies using data collected during routine clinical practice can supplement randomized clinical trials to provide needed evidence, especially during a global pandemic, and can yield markedly larger sample sizes to assess outcomes for important patient subgroups.
To evaluate the association of remdesivir treatment with inpatient mortality among patients with COVID-19 outside of the clinical trial setting.
DESIGN, SETTING, AND PARTICIPANTS: A retrospective cohort study in US hospitals using health insurance claims data linked to hospital chargemaster data from December 1, 2018, to May 3, 2021, was conducted among 24 856 adults hospitalized between May 1, 2020, and May 3, 2021, with newly diagnosed COVID-19 who received remdesivir and 24 856 propensity score-matched control patients.
Remdesivir treatment.
All-cause inpatient mortality within 28 days of the start of remdesivir treatment for the remdesivir-exposed group or the matched index date for the control group.
A total of 24 856 remdesivir-exposed patients (12 596 men [50.7%]; mean [SD] age, 66.8 [15.4] years) and 24 856 propensity score-matched control patients (12 621 men [50.8%]; mean [SD] age, 66.8 [15.4] years) were included in the study. Median follow-up was 6 days (IQR, 4-11 days) in the remdesivir group and 5 days (IQR, 2-10 days) in the control group. There were 3557 mortality events (14.3%) in the remdesivir group and 3775 mortality events (15.2%) in the control group. The 28-day mortality rate was 0.5 per person-month in the remdesivir group and 0.6 per person-month in the control group. Remdesivir treatment was associated with a statistically significant 17% reduction in inpatient mortality among patients hospitalized with COVID-19 compared with propensity score-matched control patients (hazard ratio, 0.83 [95% CI, 0.79-0.87]).
In this retrospective cohort study using health insurance claims and hospital chargemaster data, remdesivir treatment was associated with a significantly reduced inpatient mortality overall among patients hospitalized with COVID-19. Results of this analysis using data collected during routine clinical practice and state-of-the-art methods complement results from randomized clinical trials. Future areas of research include assessing the association of remdesivir treatment with inpatient mortality during the circulation of different variants and relative to time from symptom onset.
导致 COVID-19 的 SARS-CoV-2 带来了相当大的发病率和死亡率风险。使用在常规临床实践中收集的数据进行的研究可以补充随机临床试验，提供所需的证据，尤其是在全球大流行期间，并且可以产生明显更大的样本量来评估重要患者亚组的结果。
评估瑞德西韦治疗在临床试验环境外 COVID-19 患者住院死亡率中的作用。
设计、地点和参与者：这是一项在美国医院进行的回顾性队列研究，使用健康保险索赔数据与 2018 年 12 月 1 日至 2021 年 5 月 3 日的医院收费主数据相关联，研究对象为 2020 年 5 月 1 日至 2021 年 5 月 3 日期间新诊断为 COVID-19 且接受过瑞德西韦治疗的 24856 名成年住院患者，以及 24856 名经倾向评分匹配的对照患者。
瑞德西韦治疗。
瑞德西韦暴露组开始瑞德西韦治疗后 28 天内或对照组匹配指数日期内的全因住院死亡率。
共纳入 24856 名接受瑞德西韦治疗的暴露患者（12596 名男性[50.7%]；平均[SD]年龄，66.8[15.4]岁）和 24856 名经倾向评分匹配的对照患者（12621 名男性[50.8%]；平均[SD]年龄，66.8[15.4]岁）。在瑞德西韦组和对照组中，中位随访时间分别为 6 天（IQR，4-11 天）和 5 天（IQR，2-10 天）。瑞德西韦组有 3557 例（14.3%）死亡事件，对照组有 3775 例（15.2%）死亡事件。瑞德西韦组的 28 天死亡率为 0.5 人月，对照组为 0.6 人月。与匹配的对照患者相比，住院 COVID-19 患者使用瑞德西韦治疗与住院死亡率降低 17%具有统计学意义（风险比，0.83[95%CI，0.79-0.87]）。
在这项使用健康保险索赔和医院收费主数据的回顾性队列研究中，与匹配的对照患者相比，瑞德西韦治疗与 COVID-19 住院患者的整体住院死亡率显著降低相关。本分析使用常规临床实践中收集的数据和最先进的方法，补充了随机临床试验的结果。未来的研究领域包括评估瑞德西韦治疗与不同变异体循环期间和症状出现后时间相关的住院死亡率的相关性。
