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

Autor: Han B; Department of Infectious Diseases, Beijing Ditan Hospital Capital Medical University, China., Du C; Department of Respiratory Disease, QingPu Branch of Zhongshan Hospital Affiliated to Fudan University, China., Deng M; Department of Infectious Diseases, The First Hospital of Jiaxing (The Affiliated Hospital of Jiaxing University), China., Tang R; State Key Laboratory of Neurology and Oncology Drug Development, China., Dong J; Department of Infectious Diseases, Beijing Haidian Hospital, China., Song X; Department of Respiratory and Critical Care Medicine, People's Hospital of RiZhao, China., Qiao Y; Department Ⅱ of Respiratory Disease, Jilin Province People's Hospital, China., Ni Z; Department of Emergency, Beijing Shijingshan Hospital, China., Yang W; Department of Infectious Diseases, Tianjin First Central Hospital, China., Yang J; Department of Infectious Disease, Fu Xing Hospital, Capital Medical University, China., Xiang T; Department of Hospital Infection Control, The First Affiliated Hospital of Nanchang University, China., Huang Y; Department of Infectious Diseases, Xiangya Hospital Central South University, China., Zhong Y; Community Health Service Center, Shangqingsi Street, Yuzhong District, Chongqing, China., Zhang Z; Department of Respiratory Medicine, Shandong Public Health Clinical Center, China., Yang L; Department of Infectious Diseases, Beijing Shunyi Hospital, China., Yang J; Department of Infectious Diseases, Jiaozuo People's Hospital, China., Wang J; Department of Respiratory and Critical Care Medicine, The Affiliated People's Hospital of Ningbo University, China., Zheng L; Inner Mongolia Fourth Hospital, Inner Mongolia Autonomous Region, Hohhot, China., Ma L; Department of Respiratory and Critical Care Medicine, Affiliated Hospital of Guilin Medical University, China., Shou Z; Department of Respiratory and Critical Care Medicine, The First People's Hospital of Guiyang, China., Cao R; Department of Pulmonary Diseases, Hebei Yiling Hospital, China., Ma J; Taizhan Street Community Health Service Center, Taishan District, Tai'an, Shandong, China., He G; Department of infectious disease, Jiangmen Central Hospital, China., Yuan J; Department of Infectious Diseases, Shenzhen Third People's Hospital, China., Pang C; Department of Infection, Tianjin Medical University General Hospital, China., Xu J; Department for Infectious Diseases, Central Hospital of Tonghua, China., Huang J; Department of Respiratory and Critical Care Medicine, Chongqing General Hospital, China., Yuan X; Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Xinxiang Medical University, China., Wu Y; Department of Respiratory Disease, Boao Yiling Life Care Center, China., Xiong Y; Department of Infectious Diseases, Zhongnan Hospital of Wuhan University, China., Zhang X; Department of Respiratory and Critical Care Medicine, Xinxiang First People's Hospital, China., Liu H; Department of Infectious Disease, Hebei General Hospital, China., Gao B; Fengze Street Community Health Service Center, Fengze District, Quanzhou, Fujian, China., Chen H; Department of Respiratory and Critical Care Medicine, The PLA Navy Anqing Hospital, China., Ma T; Community Health Service Center, Beixia Street, Guancheng Hui District, Zhengzhou, China., Dang S; Department of Infectious Diseases, The Second Affiliated Hospital Of Xi'an Jiaotong University, China., Zhang Q; Tuanjie Xincun Street Community Health Service Center, Chengguan District, Lanzhou, Gansu, China., Yuan R; Yuhua District Street Office Community Health Service Center, Shijiazhuang, Hebei, China., Wei Y; The Fifth Hospital of Xingtai, China., Xu T; Department of Infectious Diseases, Tianjin Nankai Hospital, China., Deng Z; Pandan Community Health Service Station, Qiongshan District, Haikou, Hainan, China., Gong Y; Community Health Service Center, Caiyuanba Street, Yuzhong District, Chongqing, China., Gao J; Hangzhou Gongshu District Changqing Chaoming Street Community Health Care Centre, Hangzhou, Zhejiang, China., Jiang R; Department of Infectious Diseases, Beijing Ditan Hospital Capital Medical University, China. Electronic address: 13911900791@163.com.
Jazyk: angličtina
Zdroj: The Journal of infection [J Infect] 2024 Dec; Vol. 89 (6), pp. 106339. Date of Electronic Publication: 2024 Nov 07.
DOI: 10.1016/j.jinf.2024.106339
Abstrakt: 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 hospitalization (6/1896 [0.3%] vs. 43/1408 [3.1%]; HR: 0.110, 95% confidence interval [CI]: 0.043 to 0.283, p < 0.001 vs control), consistently with the results after PSM (4/1381 [0.3%] in S/R vs. 40/1381 patients [2.9%]; aRR: 0.12; 95% CI: 0.05, 0.29; P < 0.001). No deaths occurred in both S/R and control groups. Matched Patients over 65 and patients with risk factors who received S/R achieved significantly reduced risk of COVID-19-related hospitalization (aRR: 0.032; 95% CI: 0.004, 0.268; aRR: 0.034; 95% CI: 0.005, 0.252, respectively; all P < 0.001). Furthermore, S/R shortened the median time to viral clearance by 1 day (6.0 vs 7.0 days; 95% CI: -2.0 to -1.0; P < 0.001) and reduced the median time to symptom resolution by 2 days (8.0 days vs 10.0 days; 95% CI: -2.0 to -1.0; P < 0.001). Besides, the proportion of patients in the S/R group using combined medication was significantly lower than that in the control group (30.2% vs 49.4%). Subgroup analysis showed potential protective effect of S/R in the elderly and patients with more than 1 risk factor.
Conclusion: In real world, S/R significantly reduced the incidence of COVID-19-related hospitalization, demonstrated favorable safety profiles, and less use of combined medication.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
Databáze: MEDLINE
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