COVID-19 Rebound After VV116 vs Nirmatrelvir-Ritonavir Treatment

作者：Zhitao Yang, Yu Xu, Ruizhi Zheng, Lei Ye, Gang Lv, Zhujun Cao, Rulai Han, Mian Li, Yuanyue Zhu, Qiuyu Cao, Yi Ding, Jiqiu Wang, Yun Tan, Feng Liu, Wei Dong, Wei Tan, Weiwei Jiang, Jing Sun, Shouyue Sun, Jie Shao, Yang Deng, Weiyi Gao, Weiqing Wang, Ren Zhao, Liping Qiu, Erzhen Chen, Xinxin Zhang, Shengyue Wang, Guang Ning, Yiping Xu, Yufang Bi · 发表于：JAMA Network Open · 年份：2024 · DOI：10.1001/jamanetworkopen.2024.1765 · 被引用次数：17 · 研究领域：SARS-CoV-2 and COVID-19 Research、COVID-19 Clinical Research Studies、Respiratory viral infections research

Importance: With the widespread use of anti-SARS-CoV-2 drugs, accumulating data have revealed potential viral load rebound after treatment. Objective: To compare COVID-19 rebound after a standard 5-day course of antiviral treatment with VV116 vs nirmatrelvir-ritonavir. Design, Setting, and Participants: This is a single-center, investigator-blinded, randomized clinical trial conducted in Shanghai, China. Adult patients with mild-to-moderate COVID-19 and within 5 days of SARS-CoV-2 infection were enrolled between December 20, 2022, and January 19, 2023, and randomly allocated to receive either VV116 or nirmatrelvir-ritonavir. Interventions: Participants in the VV116 treatment group received oral 600-mg VV116 tablets every 12 hours on day 1 and 300 mg every 12 hours on days 2 through 5. Participants in the nirmatrelvir-ritonavir treatment group received oral nirmatrelvir-ritonavir tablets with 300 mg of nirmatrelvir plus 100 mg of ritonavir every 12 hours for 5 days. Participants were followed up every other day until day 28 and every week until day 60. Main Outcomes and Measures: The primary outcome was viral load rebound (VLR), defined as a half-log increase in viral RNA copies per milliliter compared with treatment completion. Secondary outcomes included a reduction in the cycle threshold value of 1.5 or more, time until VLR, and symptom rebound, defined as an increase of more than 2 points in symptom score compared with treatment completion. The primary outcome and secondar...