Remdesivir Trial Shows Positive Effects On Patients

FDA expected to allow an emergency-use authorization next week

KUALA LUMPUR, April 30 – The remdesivir drug has been found to be showing positive impact on patients of the coronavirus.

The US Food and Drug Administration (FDA) is yet to approve the drug for the treatment, but CNN reported that it plans to allow an emergency-use authorization, which could come as soon as next Wednesday. 

Remdesivir is an antiviral drug that was originally developed by Gilead Sciences to fight Ebola and other related viruses, while lopinavir/ ritonavir is a combination antiretroviral medicine, sold under the brand name Kaletra, to help control HIV infection.

“As part of the FDA’s commitment to expediting the development and availability of potential COVID-19 treatments, the agency has been engaged in … discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate,” FDA spokesman Michael Felberbaum said.

Dr Anthony Fauci, who leads the White House Covid-19 taskforce, and the director of the National Institute of Allergy and Infectious Diseases (NIAID), also welcomed the results. 

“The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery,” Dr Fauci was quoted as saying. 

The preliminary trial proved that remdesivir provided an improved recovery time for coronavirus patients from 15 to 11 days, and may reduce the mortality rate.

“Although a 31% improvement doesn’t seem like a knockout 100%, it is very important proof of concept. What it has proven is that a drug can block this virus,” added Fauci.

“Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group,” the NIAID said.

Preliminary data of drug efficacy are not usually released, but Fauci said “whenever you have clear-cut evidence that a drug works, you have an ethical obligation to immediately let the people in the placebo group know so that they can have access.”

The medicine is among many drugs that are in research now as cure for Covid-19, but the NIAID trial is the first conducted according to rules aimed at gaining FDA approval.

But the WHO is reserved on the results. 

“Typically, you don’t have one study that will come out that will be a game changer,” said Dr. Maria Van Kerkhove, the WHO’s technical lead for the coronavirus response, adding that the organization usually collects evidence from various studies before reviewing and critiquing the results.

But as for the research, it is not yet victory.

“We have work to do. We are looking for other therapies. This trial is going to continue,” said Dr. Andre Kalil, the principal investigator behind the clinical trial.

“Four days (fewer) in a hospital is, for me as a clinician — as a clinical practitioner — it is not only significant but very meaningful,” he added.

Separately, Gilead Sciences released the finding so its own trial on the drug. 

“The company said it found patients did just as well taking remdesivir for five days as those who took it for 10,” said CNN.

“For this study, remdesivir was not tested against a placebo to see whether it was an effective treatment for the virus — more evidence is needed to prove that. The study used 397 patients with severe Covid-19.”

A statement from Gilead as viewed by CNN said that the most common adverse events in more than 10% of patients in some of the groups in the Gilead trial were nausea and acute respiratory failure.

“Our goal with these studies was to answer the question of treatment duration, comparing safety and efficacy with five or 10 days of remdesivir treatment. A placebo control was not necessary to answer this question. The open-label study design was necessary to understand whether shortening the duration of therapy can lead to earlier discharge from the hospital,” the statement was quoted.

Now the research is being conducted in 180 locations in the world, including in the United States, China, France, Italy and the United Kingdom.

“The company’s chief executive officer, Daniel O’Day, said in an open letter that Gilead’s existing supply of the drug could cover at least 140,000 treatment courses for patients with Covid-19,” said CNN.

“The estimate is based on 10 days of treatment with the drug.”

Earlier this month, Malaysia joined the WHO’s worldwide “Solidarity Trial” in an international effort to test several medicines to treat Covid-19.

The globally coordinated trial is what WHO described as an unprecedented effort to collect reliable data and compare the safety and effectiveness of four treatment protocols using different combinations of remdesivir, lopinavir/ritonavir, interferon beta, chloroquine and hydroxychloroquine.

“The global pandemic is affecting more than 180 countries, and one of these drugs may be our best hope for treating people infected with Covid-19,” said Dr Ying-Ru Lo, the Head of Mission and WHO Representative to Malaysia, Brunei Darussalam and Singapore, in a joint statement  with the Ministry of Health (MOH).

“This is our chance, as a global community, to turn the tide against the pandemic. Malaysia will be a valued partner in this trial to evaluate potential treatments that are more effective, and to save lives in the global battle to fight this virus.”

“Malaysia’s participation in this worldwide trial could help find life-saving medicines for Covid-19 through evaluating their safety and effectiveness,” said Dr Noor Hisham.

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