Abstract：
OBJECTIVE: Previous research reported inconsistent results on the efficacy of molnupiravir in treating COVID-19. Moreover, efficacy was not assessed in the intended-use population (IUP), as defined by the FDA. Therefore, we aimed to evaluate the effectiveness and safety of molnupiravir for the treatment of COVID-19 in the IUP.
METHODS: We performed a retrospective cohort study on all IUP in Israel\'s Clalit Health Services from January 16, 2022, to February 16, 2023. The effectiveness outcome was the incidence of hospitalization or death due to COVID-19, and the safety outcome was the incidence of all-cause mortality within 35 days of SARS-CoV-2 infection. Cox-proportional hazard models were used to analyse the data after 1:5 propensity-score matching.
RESULTS: A total of 49 515 patients met the eligibility criteria. Of them, 3957 molnupiravir-treated patients were matched to 19 785 untreated patients. In molnupiravir-treated patients, 70 out of 3957 (5.1 per 10 000 person per day) experienced COVID-19-related hospitalization or death, compared with 699 out of 19 785 untreated patients (10.4 per 10 000 person per day); RR: 0.50 (95% CI, 0.39-0.64). All-cause mortality was also lower in the treated group, with 41 out of 3957 (3.0 per 10 000 person per day) experiencing mortality compared with 414 out of 19 785 untreated patients (6.1 per 10 000 person per day); RR: 0.50 (0.36-0.68).
CONCLUSIONS: In a real-world cohort of IUP, molnupiravir therapy was associated with a significant reduction in hospitalizations or deaths due to COVID-19 and all-cause mortality.
METHODS: We performed a retrospective cohort study on all IUP in Israel\'s Clalit Health Services from January 16, 2022, to February 16, 2023. The effectiveness outcome was the incidence of hospitalization or death due to COVID-19, and the safety outcome was the incidence of all-cause mortality within 35 days of SARS-CoV-2 infection. Cox-proportional hazard models were used to analyse the data after 1:5 propensity-score matching.
RESULTS: A total of 49 515 patients met the eligibility criteria. Of them, 3957 molnupiravir-treated patients were matched to 19 785 untreated patients. In molnupiravir-treated patients, 70 out of 3957 (5.1 per 10 000 person per day) experienced COVID-19-related hospitalization or death, compared with 699 out of 19 785 untreated patients (10.4 per 10 000 person per day); RR: 0.50 (95% CI, 0.39-0.64). All-cause mortality was also lower in the treated group, with 41 out of 3957 (3.0 per 10 000 person per day) experiencing mortality compared with 414 out of 19 785 untreated patients (6.1 per 10 000 person per day); RR: 0.50 (0.36-0.68).
CONCLUSIONS: In a real-world cohort of IUP, molnupiravir therapy was associated with a significant reduction in hospitalizations or deaths due to COVID-19 and all-cause mortality.
摘要：
目的：先前的研究报道了莫努比拉韦治疗COVID-19的疗效不一致。此外，未在预期使用人群（IUP）中评估疗效，由FDA定义。因此,我们的目的是评估莫努比拉韦治疗IUP中COVID-19的有效性和安全性。
方法：我们从1月开始对以色列Clalit卫生服务（CHS）的所有IUP进行了回顾性队列研究16,2022,至2月2023年16日。有效性结果是因COVID-19导致住院或死亡的发生率，安全性结果是SARS-CoV-2感染35天内全因死亡的发生率。在1:5倾向评分匹配后，使用Cox比例风险模型分析数据。
结果：49,515名患者符合资格标准。其中,3,957名接受莫努比拉韦治疗的患者与19,785名未经治疗的患者相匹配。在莫努比拉韦治疗的病人中，3957人中有70人（每10,000人天5.1人）经历了与COVID-19相关的住院或死亡，与19,785例未经治疗的患者中的699例相比（10.4/10,000人日）；RR：0.50，（95％CI：0.39-0.64）。全因死亡率在治疗组中也较低，3,957人中有41人(3.0人/10,000人-日)死亡,而19,785名未治疗患者中有414人死亡(6.1人/10,000人-日);RR:0.50(0.36-0.68).
结论：在IUP的真实世界队列中，莫努比拉韦治疗显著降低了因COVID-19导致的住院或死亡以及全因死亡率。
方法：我们从1月开始对以色列Clalit卫生服务（CHS）的所有IUP进行了回顾性队列研究16,2022,至2月2023年16日。有效性结果是因COVID-19导致住院或死亡的发生率，安全性结果是SARS-CoV-2感染35天内全因死亡的发生率。在1:5倾向评分匹配后，使用Cox比例风险模型分析数据。
结果：49,515名患者符合资格标准。其中,3,957名接受莫努比拉韦治疗的患者与19,785名未经治疗的患者相匹配。在莫努比拉韦治疗的病人中，3957人中有70人（每10,000人天5.1人）经历了与COVID-19相关的住院或死亡，与19,785例未经治疗的患者中的699例相比（10.4/10,000人日）；RR：0.50，（95％CI：0.39-0.64）。全因死亡率在治疗组中也较低，3,957人中有41人(3.0人/10,000人-日)死亡,而19,785名未治疗患者中有414人死亡(6.1人/10,000人-日);RR:0.50(0.36-0.68).
结论：在IUP的真实世界队列中，莫努比拉韦治疗显著降低了因COVID-19导致的住院或死亡以及全因死亡率。
