VV116 versus Nirmatrelvir–Ritonavir for Oral Treatment of Covid-19

作者：Zhujun Cao, Weiyi Gao, Hong Bao, Haiyan Feng, Shuya Mei, Peizhan Chen, Yueqiu Gao, Zhilei Cui, Qin Zhang, Xianmin Meng, Honglian Gui, Weijing Wang, Yimei Jiang, Zijia Song, Yiqing Shi, Jing Sun, Yifei Zhang, Qing Xie, Yiping Xu, Guang Ning, Yuan Gao, Ren Zhao · 发表于：New England Journal of Medicine · 年份：2022 · DOI：10.1056/nejmoa2208822 · 被引用次数：229 · 研究领域：SARS-CoV-2 and COVID-19 Research、COVID-19 Clinical Research Studies、Long-Term Effects of COVID-19

BACKGROUND: Nirmatrelvir-ritonavir has been authorized for emergency use by many countries for the treatment of coronavirus disease 2019 (Covid-19). However, the supply falls short of the global demand, which creates a need for more options. VV116 is an oral antiviral agent with potent activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). METHODS: We conducted a phase 3, noninferiority, observer-blinded, randomized trial during the outbreak caused by the B.1.1.529 (omicron) variant of SARS-CoV-2. Symptomatic adults with mild-to-moderate Covid-19 with a high risk of progression were assigned to receive a 5-day course of either VV116 or nirmatrelvir-ritonavir. The primary end point was the time to sustained clinical recovery through day 28. Sustained clinical recovery was defined as the alleviation of all Covid-19-related target symptoms to a total score of 0 or 1 for the sum of each symptom (on a scale from 0 to 3, with higher scores indicating greater severity; total scores on the 11-item scale range from 0 to 33) for 2 consecutive days. A lower boundary of the two-sided 95% confidence interval for the hazard ratio of more than 0.8 was considered to indicate noninferiority (with a hazard ratio of >1 indicating a shorter time to sustained clinical recovery with VV116 than with nirmatrelvir-ritonavir). RESULTS: A total of 822 participants underwent randomization, and 771 received VV116 (384 participants) or nirmatrelvir-ritonavir (387 participants). The...