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May Drug of the Month: Remdesivir

Remdesivir - Emerging Information for COVID-19 Treatment

Remdesivir is a drug that has made news lately due to its possible use in treating coronavirus disease 2019 (COVID-19). Currently, this drug is un-approved for use in the United States.1 However, the Federal Drug Administration (FDA) permitted the emergency use authorization (EUA) "for treatment of suspected or laboratory-confirmed coronavirus disease 2019 (COVID-19) in adults and children hospitalized with severe disease.”1 So what is the deal with this emerging drug?

The biopharmaceutical company Gilead Sciences, Inc. manufactures Remdesivir, and is a nucleoside ribonucleic acid (RNA) polymerase inhibitor.2 The mechanism of action of Remdesivir is as an adenosine triphosphate (ATP) analog that competes with natural ATP by RNA polymerase. The enzyme, RNA polymerase, is critical in the duplication and growth of life within cells. This competition with natural ATP results in a delay of viral replication. Remdesivir is a weak inhibitor of mammalian DNA and RNA polymerases with low mitochondrial toxicity.1 This weak inhibition means, it doesn’t affect the DNA replication in humans as much as you see in viral replication.

On May 1st, 2020, the FDA authorized the emergency use of Remdesivir for the treatment of hospitalized COVID-19 patients.2 This decision was based on the scientific evidence available, showing the Remdesivir meet specific criteria such as safety and performance. Remdesivir is administered through a vein, once daily, for up to 10 days or dependent on the provider. As more data from clinical trials becomes available, the updating of dosing and duration continues. Some tests to be performed on patients before initiating treatment include kidney and liver function screening. Side effects include infusion-related reactions such as: low blood pressure, vomiting, sweating, and shivering.2

On May 22nd, 2020, The New England Journal of Medicine recently published results of a double-blind, randomized, placebo-controlled trial study of Remdesivir. In this study, 538 patients received Remdesivir, and 521 received a placebo. The patients who received Remdesivir, had a median recovery time of 11 days compared to 15 days for the patients given placebo. The death rate estimates by 14 days in the trial, were 7.1% with the group receiving Remdesivir vs. 11.9% in the group receiving the placebo.3

The use of Remdesvir is authorized only during the duration of the emergency declaration or unless this authorization is canceled sooner or terminated. As more data comes in on the use of Remdesivir, a better understanding of its safety and efficacy will progress.

References:

1. Remdesivir. Fact Sheet for Health Care Providers. Gilead Sciences, Inc.; 2020. Accessed May 22, 2020. https://www.gilead.com/-/media/files/pdfs/remdesivir/eua-fact-sheet-for-hcps_01may2020.pdf?la=en&hash=B56F8C441364B7EDA15543F75E8EC88F

2. Remdesivir. FDA Emergency Use Authorization Letter. Gilead Sciences, Inc.; 2020. Accessed May 23rd, 2020. https://www.gilead.com/-/media/files/pdfs/remdesivir/eua-fda-authorization-letter_01may2020.pdf?la=en&hash=1333AAA128ECE91DDBB9BC4F9467C843

3. Beigel JH, Tomashek KM, Dodd LE, et al. Remdesivir for the Treatment of Covid-19 — Preliminary Report. N Engl J Med. Published online May 22, 2020. doi:10.1056/NEJMoa2007764

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