WHO pours cold water on Remdisivir, plasma hope

The high hope pinned on using Remdesivir and plasma therapy for treating Covid-19 infection fades fast as the World Health Organisation (WHO) has expressed its reserves against using them outside clinical trials.

Wide media coverage of Remdesivir and plasma therapy raised hope for an escape from the clutches of the novel coronavirus – with the messages of caution ignored largely.

The overlooking of the risks on one hand may raise undue expectations, while on the other hand doctors may face mounting pressure to use the drug even when it is not necessary.

The debate over Remdesivir and plasma therapy ensued when the World Health Organisation (WHO) said those should not be used for treating coronavirus patients "outside of the context of clinical trials."

Any drug should be advised weighing the benefits against the harms.

The WHO recommendation is based on the lack of evidence of the benefits of Remdesivir. For the same reasons, it does not suggest plasma therapy, in which convalescent plasma is collected from an individual who has recently recovered from Covid-19 and then administered to another person infected with the virus.

The WHO guidelines come at a time when the US Food and Drug Administration (FDA) has issued an Emergency Use Authorisation (EUA) for Remdesivir by American biopharmaceutical company Gilead Sciences, Inc, followed by a similar move by the Directorate General of Drug Administration (DGDA) in Bangladesh.

And that move led to launching of the drug in Bangladesh – first by Beximco and then by Eskayef.

But none of the authorisations amounts to approval. There is a clear distinction – an authorisation is given to allow access to the drug, while an approval would be tantamount to recommending the drug. Simply put, the authorisations came along with restrictions.

The FDA on May 1 said Remdesivir can be given to hospitalised patients with serious illness "requiring supplemental oxygen or mechanical ventilation."

When contacted by The Business Standard, the DGDA refused to provide copies of the authorisation letters for the drugs manufactured by Beximco or Eskayef.

As the name goes, such an authorisation is given only in emergency situations, considering that the due process of validation of a drug can be bypassed to give access to it during the pandemic.

The preliminary results of a trial in the US showed that the drug can "block the virus."

The Lancet in a report published on April 29, however, said no significant benefit of remdesivir could be confirmed in any clinical trial. The first large-scale trial was initiated at Wuhan in China on February 6. That ended on March 29 without any conclusive findings.

During that trial, The Lancet said "there was no signal that the viral load decreased differentially" after the application of Remdesivir. Use of Remdesivir was stopped early because of adverse events in 12 percent patients, while 66 percent patients suffered adverse impacts.

In fact, there is no proven safe and effective treatment for Covid-19 yet, globally. Scientists and researchers have been scrambling to find one.

"Against this backdrop, doctors use whatever is available in their arsenal to save lives of critical patients when other medical interventions have already been exhausted, and this is called compassionate use of a drug," said Dr Harun Ur Rashid, registrar of the intensive care unit (ICU) of the Kurmitola General Hospital.

"We have been providing Remdesivir to serious patients over the last two weeks, and have seen many of them improving," he said, "But it cannot be said that the improvement happened because of remdesivir. That can be confirmed only through clinical trials."

Likewise, plasma therapy is also applicable for the critically-ill patients.

According to Prof Sayedur Rahman, of the pharmacology department at Bangabandhu Sheikh Mujib Medical University, drugs such as Remdesivir that are yet to be validated through clinical trials should not be promoted.

It is up to the doctors to decide under particular circumstances whether to use the drug or go for something else like the plasma therapy.

"And the decisions should be rationale, based on evidence and should be supported by collective wisdom," Sayedur added.