EBioMedicine (Oct 2021)

Clinical efficacy and safety evaluation of favipiravir in treating patients with severe fever with thrombocytopenia syndrome

  • 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

Journal volume & issue
Vol. 72
p. 103591

Abstract

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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).

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