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expert reaction to Gilead press releases on remdesivir in patients with COVID-19

The pharmaceutical company Gilead, have press released the findings of studies into the use of remdesivir in patients with COVID-19.

A further SMC Roundup covering the second press release is here.

 

Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said:

“The first* of these releases relate to the data from trials where remdesivir is given to all groups so no evaluation of remdesivir compared with no remdesivir or other treatment is possible.

“The second** suggests that the NIAID trial, which does have a placebo control is recruiting to ensure that at least 400 patients have recovered in the trial, has a “positive” result.  We await the publication of these results.

“It will be important to check the mortality rates in this trial.”

 

Prof Philip Bath, Chair & Head Division of Clinical Neuroscience, University of Nottingham, said:

“The SIMPLE trial* compared to treatment periods 5 vs 10 days of treatment with remdesivir.  In the absence of a control group I am not sure what two active groups tell us since we do not know whether the drug works.  There was no difference between the two groups but the trial does not appear to be a non-inferiority design.  Also open label so open to bias from differences in other aspects of care, especially since other treatments may have varied over the second 5 days period.

“Apparently the NIH funded trial** met its primary endpoint.  Need more information from NIH and certainly not a time to start using this drug until we know more.”

 

* https://www.gilead.com/news-and-press/press-room/press-releases/2020/4/gilead-announces-results-from-phase-3-trial-of-investigational-antiviral-remdesivir-in-patients-with-severe-covid-19

** https://www.gilead.com/news-and-press/press-room/press-releases/2020/4/gilead-sciences-statement-on-positive-data-emerging-from-national-institute-of-allergy-and-infectious-diseases-study-of-investigational-antiviral-rem

 

All our previous output on this subject can be seen at this weblink:

www.sciencemediacentre.org/tag/covid-19

 

Declared interests

None received.

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