Clinical efficacy and safety evaluation of favipiravir in treating patients with severe fever with thrombocytopenia syndrome
Background: Severe fever with thrombocytopenia syndrome (SFTS) is an emerging infectious disease with high mortality, however with no effective therapy available. Methods: The effect of favipiravir (FPV) in treating SFTS was evaluated by an integrated analysis on data collected from a single-arm stu...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2021-10-01
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| Series: | EBioMedicine |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2352396421003844 |
| _version_ | 1818826510933426176 |
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| author | Yang Yuan Qing-Bin Lu Wen-Si Yao Jing Zhao Xiao-Ai Zhang Ning Cui Chun Yuan Tong Yang Xue-Fang Peng Shou-Ming Lv Jia-Chen Li Ya-Bin Song Dong-Na Zhang Li-Qun Fang Hong-Quan Wang Hao Li Wei Liu |
| author_facet | Yang Yuan Qing-Bin Lu Wen-Si Yao Jing Zhao Xiao-Ai Zhang Ning Cui Chun Yuan Tong Yang Xue-Fang Peng Shou-Ming Lv Jia-Chen Li Ya-Bin Song Dong-Na Zhang Li-Qun Fang Hong-Quan Wang Hao Li Wei Liu |
| author_sort | Yang Yuan |
| collection | DOAJ |
| description | Background: Severe fever with thrombocytopenia syndrome (SFTS) is an emerging infectious disease with high mortality, however with no effective therapy available. Methods: The effect of favipiravir (FPV) in treating SFTS was evaluated by an integrated analysis on data collected from a single-arm study (n=428), a surveillance study (n=2350) and published data from a randomized controlled trial study (n=145). A 1:1 propensity score matching was performed to include 780 patients: 390 received FPV and 390 received supportive therapy only. Case fatality rates (CFRs), clinical progress, and adverse effects were compared. Findings: FPV treatment had significantly reduced CFR from 20.0% to 9.0% (odds ratio 0.38, 95% confidence interval 0.23-0.65), however showing heterogeneity when patients were grouped by age, onset-to-admission interval, initial viral load and therapy duration. The effect of FPV was significant only among patients aged ≤70 years, with onset-to-admission interval ≤5 days, therapy duration ≥5 days or baseline viral load ≤1 × 106 copies/mL. Age-stratified analysis revealed no benefit in the aging group >70 years, regardless of their sex, onset-to-admission interval, therapy duration or baseline viral load. However, for both ≤60 and 60-70 years groups, therapy duration and baseline viral load differentially affected FPV therapy efficiency. Hyperuricemia and thrombocytopenia, as the major adverse response of FPV usage, were observed in >70 years patients. Interpretation: FPV was safe in treating SFTS patients but showed no benefit for those aged >70 years. Instant FPV therapy could highly benefit SFTS patients aged 60-70 years. Funding: China Natural Science Foundation (No. 81825019, 82073617 and 81722041) and China Mega-project for Infectious Diseases (2018ZX10713002 and 2015ZX09102022). |
| first_indexed | 2024-12-19T00:28:49Z |
| format | Article |
| id | doaj.art-39c537e43d1b4f2a93c6b2bfccccfb96 |
| institution | Directory Open Access Journal |
| issn | 2352-3964 |
| language | English |
| last_indexed | 2024-12-19T00:28:49Z |
| publishDate | 2021-10-01 |
| publisher | Elsevier |
| record_format | Article |
| series | EBioMedicine |
| spelling | doaj.art-39c537e43d1b4f2a93c6b2bfccccfb962022-12-21T20:45:10ZengElsevierEBioMedicine2352-39642021-10-0172103591Clinical efficacy and safety evaluation of favipiravir in treating patients with severe fever with thrombocytopenia syndromeYang Yuan0Qing-Bin Lu1Wen-Si Yao2Jing Zhao3Xiao-Ai Zhang4Ning Cui5Chun Yuan6Tong Yang7Xue-Fang Peng8Shou-Ming Lv9Jia-Chen Li10Ya-Bin Song11Dong-Na Zhang12Li-Qun Fang13Hong-Quan Wang14Hao Li15Wei Liu16Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing 100071, PR ChinaDepartment of Laboratorial Science and Technology, School of Public Health, Peking University, Beijing 100191, PR ChinaThe 990th Hospital of Joint Logistic Support Force of Chinese People's Liberation Army, Xinyang, Henan 464000, PR ChinaBeijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing 100071, PR ChinaBeijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing 100071, PR ChinaThe 990th Hospital of Joint Logistic Support Force of Chinese People's Liberation Army, Xinyang, Henan 464000, PR ChinaThe 990th Hospital of Joint Logistic Support Force of Chinese People's Liberation Army, Xinyang, Henan 464000, PR ChinaBeijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing 100071, PR ChinaBeijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing 100071, PR ChinaBeijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing 100071, PR China; Graduate School of Anhui Medical University, Hefei 230601, PR ChinaBeijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing 100071, PR ChinaBeijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing 100071, PR ChinaBeijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing 100071, PR ChinaBeijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing 100071, PR ChinaBeijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing 100071, PR China; Corresponding authors at: Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, 20 Dong-Da Street, Fengtai District, Beijing 100071, China.Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing 100071, PR China; Graduate School of Anhui Medical University, Hefei 230601, PR China; Corresponding authors at: Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, 20 Dong-Da Street, Fengtai District, Beijing 100071, China.Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing 100071, PR China; Department of Laboratorial Science and Technology, School of Public Health, Peking University, Beijing 100191, PR China; Graduate School of Anhui Medical University, Hefei 230601, PR China; Beijing Key Laboratory of Vector Borne and Natural Focus Infectious Diseases, Beijing 100191, PR China; Corresponding authors at: Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, 20 Dong-Da Street, Fengtai District, Beijing 100071, China.Background: Severe fever with thrombocytopenia syndrome (SFTS) is an emerging infectious disease with high mortality, however with no effective therapy available. Methods: The effect of favipiravir (FPV) in treating SFTS was evaluated by an integrated analysis on data collected from a single-arm study (n=428), a surveillance study (n=2350) and published data from a randomized controlled trial study (n=145). A 1:1 propensity score matching was performed to include 780 patients: 390 received FPV and 390 received supportive therapy only. Case fatality rates (CFRs), clinical progress, and adverse effects were compared. Findings: FPV treatment had significantly reduced CFR from 20.0% to 9.0% (odds ratio 0.38, 95% confidence interval 0.23-0.65), however showing heterogeneity when patients were grouped by age, onset-to-admission interval, initial viral load and therapy duration. The effect of FPV was significant only among patients aged ≤70 years, with onset-to-admission interval ≤5 days, therapy duration ≥5 days or baseline viral load ≤1 × 106 copies/mL. Age-stratified analysis revealed no benefit in the aging group >70 years, regardless of their sex, onset-to-admission interval, therapy duration or baseline viral load. However, for both ≤60 and 60-70 years groups, therapy duration and baseline viral load differentially affected FPV therapy efficiency. Hyperuricemia and thrombocytopenia, as the major adverse response of FPV usage, were observed in >70 years patients. Interpretation: FPV was safe in treating SFTS patients but showed no benefit for those aged >70 years. Instant FPV therapy could highly benefit SFTS patients aged 60-70 years. Funding: China Natural Science Foundation (No. 81825019, 82073617 and 81722041) and China Mega-project for Infectious Diseases (2018ZX10713002 and 2015ZX09102022).http://www.sciencedirect.com/science/article/pii/S2352396421003844Severe fever with thrombocytopenia syndromeFavipiravirEfficacySafetyHeterogeneity |
| spellingShingle | Yang Yuan Qing-Bin Lu Wen-Si Yao Jing Zhao Xiao-Ai Zhang Ning Cui Chun Yuan Tong Yang Xue-Fang Peng Shou-Ming Lv Jia-Chen Li Ya-Bin Song Dong-Na Zhang Li-Qun Fang Hong-Quan Wang Hao Li Wei Liu Clinical efficacy and safety evaluation of favipiravir in treating patients with severe fever with thrombocytopenia syndrome EBioMedicine Severe fever with thrombocytopenia syndrome Favipiravir Efficacy Safety Heterogeneity |
| title | Clinical efficacy and safety evaluation of favipiravir in treating patients with severe fever with thrombocytopenia syndrome |
| title_full | Clinical efficacy and safety evaluation of favipiravir in treating patients with severe fever with thrombocytopenia syndrome |
| title_fullStr | Clinical efficacy and safety evaluation of favipiravir in treating patients with severe fever with thrombocytopenia syndrome |
| title_full_unstemmed | Clinical efficacy and safety evaluation of favipiravir in treating patients with severe fever with thrombocytopenia syndrome |
| title_short | Clinical efficacy and safety evaluation of favipiravir in treating patients with severe fever with thrombocytopenia syndrome |
| title_sort | clinical efficacy and safety evaluation of favipiravir in treating patients with severe fever with thrombocytopenia syndrome |
| topic | Severe fever with thrombocytopenia syndrome Favipiravir Efficacy Safety Heterogeneity |
| url | http://www.sciencedirect.com/science/article/pii/S2352396421003844 |
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