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Single-dose suraxavir marboxil for acute uncomplicated influenza in adults and adolescents: a multicenter, randomized, double-blind, placebo-controlled phase 3 trial 期刊论文

编号：

5B65AE0D4BF4B6DCAA8D1ACF5A26A598
作者：

Wang, Yeming#^{[1,2,3,4,5,6,7,8]}Wang, Hong#^[9]Zhang, Yu#^[10]Ma, Anlin#^[11]Liu, Dong#^[12,13]Li, Xiaoguang^[14];Yang, Guoru^[15];Deng, Min^[16];Wang, Shaofang^[17];Liu, Yuanyuan^[18];Liu, Chuanmiao^[19];Ge, Fangqi^[20];Wang, Sikui(王思奎)^[21]Yu, Yunsong^[22];Feng, Ganzhu^[23];Xiao, Zuke^[24,25];Li, Xing^[24,25];Sun, Yilan^[26];Chen, Xuyan^[27];Cao, Zhaolong^[28];Ding, Yan^[29];Wu, Xiaoping^[30];Wei, Jun^[31];Cao, Bin*^{[1,2,3,4,5,6,7,8]}
语种：

英文
期刊：

NATURE MEDICINE ISSN：1078-8956 2025 年 ; 2025 JAN 7
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摘要：

Suraxavir marboxil (GP681) is an antiviral drug inhibiting the polymerase acidic protein (PA) of RNA polymerase, of influenza. It has shown therapeutic activity against influenza A and B virus infections in preclinical studies. In this multicenter randomized, double-blind, placebo-controlled, phase 3 trial, we aimed to investigate the efficacy and safety of single-dose suraxavir marboxil (40-mg oral dose) in otherwise healthy outpatients aged 5-65 years with uncomplicated influenza unaccompanied by severe issues. From 28 July 2022 to 31 October 2023, 591 outpatients aged 5-65 years with uncomplicated influenza underwent randomization in 46 research centers in China and were randomly assigned in a 2:1 ratio to receive suraxavir marboxil (40 mg) or placebo within 2 days of symptom onset. The primary outcome was time to alleviation of influenza symptoms (TTAS) (from the start of treatment until body temperature returned to 37.2 degrees C or less and all seven influenza symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) resolved for at least 21.5 h) within 15 days by treatment. The secondary endpoints included virological indicators, system and respiratory symptoms, PA variant mutation and adverse events. The median TTAS was significantly shorter in the group that received suraxavir marboxil compared to the placebo group (42.0 h versus 63.0 h, P = 0.002). Suraxavir marboxil was associated with more rapid decrease in viral load from baseline than placebo by 1 day after administration, with a mean change of -2.2 +/- 1.3 compared to -1.3 +/- 1.7 log(10) copies per ml (P < 0.001) in the placebo group. Adverse events were reported in 28.4% (112 of 395) of suraxavir marboxil recipients and 23.3% (45 of 193) of placebo recipients, most of which were mild or moderate. The incidences of PA variants with the I38T mutation in the H1N1pdm and H3N2 subtypes were 0.7% (1 of 138) and 0.9% (2 of 213), respectively. Low acquired drug resistance was observed. In this trial, timely single-dose suraxavir marboxil was effective in shortening TTAS and reducing the influenza viral load in patients aged 5-65 years with uncomplicated influenza safely.
推荐引用方式
GB/T 7714：

Wang Yeming,Wang Hong,Zhang Yu, et al. Single-dose suraxavir marboxil for acute uncomplicated influenza in adults and adolescents: a multicenter, randomized, double-blind, placebo-controlled phase 3 trial [J].NATURE MEDICINE,2025.
APA：

Wang Yeming,Wang Hong,Zhang Yu,Ma Anlin,&Cao Bin.(2025).Single-dose suraxavir marboxil for acute uncomplicated influenza in adults and adolescents: a multicenter, randomized, double-blind, placebo-controlled phase 3 trial .NATURE MEDICINE.
MLA：

Wang Yeming, et al. "Single-dose suraxavir marboxil for acute uncomplicated influenza in adults and adolescents: a multicenter, randomized, double-blind, placebo-controlled phase 3 trial" .NATURE MEDICINE(2025).
入库时间：

1/22/2025 9:21:53 PM
更新时间：

1/22/2025 9:21:53 PM
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