What Should Be Learned From Repurposed Antivirals Against SARS-CoV-2?

Martı́nez, Miguel Ángel

doi:10.3389/fmicb.2022.843587

Cited by 1 publication

(2 citation statements)

References 37 publications

(37 reference statements)

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“…98 Data from repurposing screens for SARS-CoV-2, in particular for host cell targeted molecules, show more variability based on the assay used and the cell type used, making it difficult to estimate if an antiviral effect can be expected at the previously established clinical exposure (for example, maintaining exposure over the anti-viral EC 90 as noted above). [99][100][101][102][103] This would again support the need for robust clinical investigation, in particular, for generic medicines where the antiviral mechanism is incompletely understood.…”

Section: Discussionmentioning

confidence: 87%

“…Treatment guidelines for the use of antibody therapies for COVID‐19 are based on “current knowledge of the in vitro activities of the available products against the circulating SARS‐CoV‐2 variants and subvariants.” 97 In vitro data were are also prominently noted in the decision to authorize bebtelovimab 98 . Data from repurposing screens for SARS‐CoV‐2, in particular for host cell targeted molecules, show more variability based on the assay used and the cell type used, making it difficult to estimate if an antiviral effect can be expected at the previously established clinical exposure (for example, maintaining exposure over the anti‐viral EC 90 as noted above) 99–103 . This would again support the need for robust clinical investigation, in particular, for generic medicines where the antiviral mechanism is incompletely understood.…”

Section: Discussionmentioning

confidence: 99%

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A review of clinical efficacy data supporting emergency use authorization for COVID‐19 therapeutics and lessons for future pandemics

Yoo

Kim

Lü

et al. 2022

Clinical Translational Sci

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Emergency Use Authorization (EUA) allows the US Food and Drug Administration (FDA) to expedite the availability of therapeutics in the context of a public health emergency. To date, an evidentiary standard for clinical efficacy to support an EUA has not yet been established. This review examines the clinical data submitted in support of EUA for antiviral and anti‐inflammatory therapeutics for coronavirus disease 2019 (COVID‐19) through December of 2021 and the resilience of the authorization as new clinical data arose subsequent to the authorization. In the vast majority of cases, EUA was supported by at least one well‐powered randomized controlled trial (RCT) where statistically significant efficacy was demonstrated. This included branded medications already approved for use outside of the context of COVID‐19. When used, the standard of a single RCT seemed to provide adequate evidence of clinical efficacy, such that subsequent clinical studies generally supported or expanded the EUA of the therapeutic in question. The lone generic agent that was granted EUA (chloroquine/hydroxychloroquine) was not supported by a well‐controlled RCT, and the EUA was withdrawn within 3 months time. This highlighted not only the ambiguity of the EUA standard, but also the need to provide avenues through which high quality clinical evidence for the efficacy of a generic medication could be obtained. Therefore, maintaining the clinical trial networks assembled during the COVID‐19 pandemic could be a critical component of our preparation for future pandemics. Consideration could also be given to establishing a single successful RCT as regulatory guidance for obtaining an EUA.

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