Real-world effectiveness and safety of simnotrelvir/ritonavir for COVID-19: A nationwide, multicenter, prospective, observational cohort study in China

作者：Bing Han, Chunling Du, Min Deng, Renhong Tang, Jianping Dong, Song Xu, Yunfeng Qiao, Zhouchi Ni, Wenjie Yang, Yang Jian-kun, Tianxin Xiang, Yan Huang, Yu Zhong, Zhongfa Zhang, Lisheng Yang, Jikang Yang, Jinghua Wang, Lanbing Zheng, Libing Ma, Zhinan Shou, Ran Cao, Jinghua Ma, Gang He, Jing Yuan, Chongjie Pang, Jing Xu, Jing Huang, Xiaomei Yuan, Yunfeng Wu, Yong Xiong, Xiangjie Zhang, Hongying Liu, B. Gao, Huan Chen, Tengfei Ma, Shuangsuo Dang, Qingyu Zhang, Rui Yuan, Yun-qing Wei, Tongbai Xu, Zhulian Deng, Yan Gong, Jianfen Gao, Rongmeng Jiang · 发表于：Journal of Infection · 年份：2024 · DOI：10.1016/j.jinf.2024.106339 · 被引用次数：6 · 研究领域：SARS-CoV-2 and COVID-19 Research、COVID-19 Clinical Research Studies、Pharmacological Receptor Mechanisms and Effects

BACKGROUND: Simnotrelvir has demonstrated potent anti-viral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In a Phase II/III study, Simnotrelvir plus ritonavir (S/R, co-packaged) shortened the time to the resolution of symptoms in adult COVID-19 patients. However, real-world data on effectiveness of simnotrelvir/ritonavir against SARS-CoV-2 during XBB variant surges are still limited. STUDY DESIGN AND METHODS: This was a nationwide, multicenter, prospective, observational real-world study at 42 sites in China. Adult patients with mild to moderate COVID-19 and at disease onset were eligible for participation. Patients were grouped in S/R group (treated with S/R) and control group (not receiving oral antivirals for COVID-19). The primary endpoint was the COVID-19-related hospitalization or all-cause mortality within 28 days. Secondary endpoints included the time from confirmed SARS-CoV-2 infection to negative conversion, and the time to resolution of COVID-19 symptoms. Besides, serious adverse events (SAE), adverse drug reactions (ADR) and combined medication were reported. Propensity Score-Matched (PSM) analysis (1:1) was performed for adjustment for baseline variables. Hazard ratios (HR) and adjusted risk ratios (aRR) were estimated using the Cox and Modified Poisson regression, respectively. RESULTS: Between June 6, 2023, and December 27, 2023, 3522 patients were enrolled. S/R was associated with a reduced incidence of COVID-19-related hospita...