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@EMA_News

@EMA_News

Dear @EMA_News, there is a serious flaw in your recent recommendations/review on the compassionate use of Remdesivir, regarding the guidelines for the 5 day duration of treatment vs 10, for patients that are not mechanically ventilated. I describe the issue in this thread. 1/

In your latest News article (11 May) regarding the recommendation of the CHMP committee on the use of remdesivir, you mention "..for patients not requiring mechanical ventilation or ECMO, the treatment course may be shortened from 10 to 5 days".
ema.europa.eu/en/news/ema-re… 2/

The recommendation refers to the EMA rolling review for the remdesivir. Reading the referred review, I found the topic on the last page (p43) in a section entitled "5 days vs 10 days", which I quote in the picture below. 3/
ema.europa.eu/en/documents/o…

The issue in that section is found in the first paragraph, in the sentence: "Patients who receive a 5-day treatment course but do not demonstrate clinical improvement will be eligible to continue to receive RDV for an additional 5 days." 4/

The ACTT trial showed that the improvement of patients after 10 days treatment, was observed at 11 days AFTER the last dose. In your "5 day treatment" section you do NOT mention how long should the physician wait to observe if the patient improved, before +5 days treatment. 5/

If you insinuate that the decision should be taken right at the end of the last dose of the first 5 day treatment, you are hypothesizing something that there is complete lack of evidence for and most likely won't be applied in practice. 6/

If, on the other hand, you insinuate a specific time-gap between the last dose of the 1st treatment and the beginning of the 2nd treatment, this should be clearly stated (or at least suggested) given that it leaves too much room for speculation. 7/

This vagueness on the course of the treatment will (most likely) lead to physicians opting directly for the 10 day treatment option for non-mecahnically-ventilated patients as well as for the the mechanically-ventilated, rendering your recommendation useless. 8/

Lastly, in Annex I of the review, regarding the conditions of use, in the section entitled "Treatment Duration & Monitoring", there is NOTHING about the treatment duration... Perhaps it would be a good place to add the clarifications regarding the 5 day treatment option. -End.