TY - JOUR
T1 - Assessing efficacy of antiviral therapy for COVID-19 patients
T2 - A case study on remdesivir with bayesian synthesis design and multistate analysis
AU - Liao, Sih Han
AU - Hung, Chien Ching
AU - Chen, Chiung Nien
AU - Yen, Jui Yi
AU - Hsu, Chen Yang
AU - Yen, Ming-Fang
AU - Chen, Chi Ling
N1 - Funding Information:
This work was supported by Ministry of Science and Technology, Taiwan ( MOST 108-2118-M-038-001-MY3 , MOST 109-2327-B-002 -009 ).
Publisher Copyright:
© 2021
PY - 2021/6
Y1 - 2021/6
N2 - Background/purpose: A synthesis design and multistate analysis is required for assessing the clinical efficacy of antiviral therapy on dynamics of multistate disease progression and in reducing the mortality and enhancing the recovery of patients with COVID-19. A case study on remdesivir was illustrated for the clinical application of such a novel design and analysis. Methods: A Bayesian synthesis design was applied to integrating the empirical evidence on the one-arm compassion study and the two-arm ACTT-1 trial for COVID-19 patients treated with remdesivir. A multistate model was developed to model the dynamics of hospitalized COVID-19 patients from three transient states of low, medium-, and high-risk until the two outcomes of recovery and death. The outcome measures for clinical efficacy comprised high-risk state, death, and discharge. Results: The efficacy of remdesivir in reducing the risk of death and enhancing the odds of recovery were estimated as 31% (95% CI, 18–44%) and 10% (95% CI, 1–18%), respectively. Remdesivir therapy for patients with low-risk state showed the efficacy in reducing subsequent progression to high-risk state and death by 26% (relative rate (RR), 0.74; 95% CI, 0.55–0.93) and 62% (RR, 0.38; 95% CI, 0.29–0.48), respectively. Less but still statistically significant efficacy in mortality reduction was noted for the medium- and high-risk patients. Remdesivir treated patients had a significantly shorter period of hospitalization (9.9 days) compared with standard care group (12.9 days). Conclusion: The clinical efficacy of remdesvir therapy in reducing mortality and accelerating discharge has been proved by the Bayesian synthesis design and multistate analysis.
AB - Background/purpose: A synthesis design and multistate analysis is required for assessing the clinical efficacy of antiviral therapy on dynamics of multistate disease progression and in reducing the mortality and enhancing the recovery of patients with COVID-19. A case study on remdesivir was illustrated for the clinical application of such a novel design and analysis. Methods: A Bayesian synthesis design was applied to integrating the empirical evidence on the one-arm compassion study and the two-arm ACTT-1 trial for COVID-19 patients treated with remdesivir. A multistate model was developed to model the dynamics of hospitalized COVID-19 patients from three transient states of low, medium-, and high-risk until the two outcomes of recovery and death. The outcome measures for clinical efficacy comprised high-risk state, death, and discharge. Results: The efficacy of remdesivir in reducing the risk of death and enhancing the odds of recovery were estimated as 31% (95% CI, 18–44%) and 10% (95% CI, 1–18%), respectively. Remdesivir therapy for patients with low-risk state showed the efficacy in reducing subsequent progression to high-risk state and death by 26% (relative rate (RR), 0.74; 95% CI, 0.55–0.93) and 62% (RR, 0.38; 95% CI, 0.29–0.48), respectively. Less but still statistically significant efficacy in mortality reduction was noted for the medium- and high-risk patients. Remdesivir treated patients had a significantly shorter period of hospitalization (9.9 days) compared with standard care group (12.9 days). Conclusion: The clinical efficacy of remdesvir therapy in reducing mortality and accelerating discharge has been proved by the Bayesian synthesis design and multistate analysis.
KW - Antiviral therapy
KW - Bayesian synthesis sequential design
KW - Clinical efficacy
KW - COVID-19
KW - Remdesivir
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U2 - 10.1016/j.jfma.2021.04.026
DO - 10.1016/j.jfma.2021.04.026
M3 - Article
C2 - 34074579
AN - SCOPUS:85107023839
SN - 0929-6646
VL - 120
SP - S77-S85
JO - Journal of the Formosan Medical Association
JF - Journal of the Formosan Medical Association
ER -