Coronavirus: the High Authority for Health points to the "low" effectiveness of remdesivir

The High Authority of Health (HAS) deemed "low" the effectiveness of the antiviral remdesivir to accelerate the recovery of patients suffering from severe forms of Covid-19, in an opinion published on Thursday.

According to the HAS, there are "still a lot of uncertainties about the effectiveness and tolerance of remdesivir", the antiviral for which the Gilead laboratory had requested reimbursement for the treatment of severe forms of pneumonia due to Covid-19, before withdrawing this request very recently.

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"Remdesivir does not show an overall effect on 14-day mortality at this stage"

"The actual benefit is considered low, given the current preliminary data" because it only shortens the patient's recovery time by 4 days (11 days instead of 15) compared to placebo, notes the institution in charge drug evaluation.

In addition, "remdesivir does not show at this stage an overall effect on mortality at 14 days, with a possible effect suggested only in patients who require low flow oxygen therapy", further notes the Authority, which requests additional mortality assessments. 

A "favorable opinion" for reimbursement to treat severe pneumonia

The HAS nevertheless issued a "favorable opinion" for the reimbursement of remdesivir to treat cases of severe pneumonia due to Covid-19, but for more limited indications than Gilead could wish and than those granted at European level.

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Reimbursement "is only justified" in patients aged 12 or over and weighing at least 40 kg, hospitalized for Covid-19 with pneumonia requiring low flow oxygen therapy "but not" for more severe forms such as pneumonia requiring high flow oxygen therapy, or assisted ventilation (including the ventilator) or an extracorporeal assistance technique. The available data having suggested "no clinical benefit" for these patients, it is specified.

Gilead had withdrawn its request for reimbursement after having taken note of the provisional conclusions of the HAS Transparency Commission, indicates the latter, which recalls that remdesivir (Veklury of its trade name) was the first drug against Covid-19 to obtain, on July 3, a European marketing authorization (AMM).

A "conditional" authorization granted pending additional data.