Remdesivir has a “favourable” benefit/risk profile in COVID-19 but more data needed, DSRU review argues

pharmafile | October 5, 2020 | News story | Research and Development, Sales and Marketing COVID-19, Drug Safety Research Unit, pharma, remdesivir 

Southampton’s Drug Safety Research Unit (DSRU) has released a systematic benefit/risk analysis of Gilead’s antiviral drug remdesivir in the treatment of COVID-19, published in Drug Safety.

Remdesivir has attracted much attention as one of the few effective, commercially available treatments for COVID-19 infection, and is one that has been administered to President Donald Trump, who has been infected with the virus.

After evaluating peer-reviewed public data and pre-publication trial data on the use of the drug in this indication, remdesivir was given a “favourable” profile. The findings of the review indicated that remdesivir shortens recovery time, down to a median of 11 days from 15 days with placebo, according to one study. This is in line with data released by Gilead from compassionate and emergency-use programmes earlier this year.

Additionally, the drug was found to present a benefit in reducing mortality compared to placebo, though this was not determined to be of statistical significance: remdesivir lowered the risk of death by 8% compared to 11.6% with placebo.

The therapy also reduced the necessity for supportive oxygen and invasive or non-invasive ventilation, again echoing previous evaluations.

The review found the antiviral therapy’s benefit/risk profile to be “favourable”, but added that additional data would need to be incorporated into this evaluation as they become available. The review had difficulty determining whether reported adverse events were attributable to COVID-19 or to remdesivir treatment, including cardiovascular problems, organ dysfunction, gastrointestinal events and respiratory failure, among others.

“Following media reports that President Trump has received remdesivir, evaluation of the current evidence supporting use of this drug in COVID-19 treatment is timely,” commented Professor Saad Shakir, Director of the DSRU. “Remdesivir is a repurposed drug, originally developed for treatment of Ebola, so it’s critical we understand its benefits and risks.

“Overall our study shows a favourable benefit/risk profile with the clinically significant benefit in reducing recovery time. But the paucity of safety data means we will need to keep reviewing and updating our benefit-risk analysis. To that end, we have designed a framework for our study that means we’ll be able to update it quickly as new data becomes available. Understanding the benefit-risk balance is key to understanding the benefits of drugs in general and drugs against COVID-19 in particular.”

The DSRU has also conducted reviews into chloroquine/hydroxychloroquine and ritonavir/ lopinavir in the treatment of COVID-19, which are awaiting publication.  

Matt Fellows

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