Remdesivir has been evident to speed up the recovery rate for the COVID-19 patients in a major US-led trial, and which is becoming the first proven drug with benefits to combat the deadly coronavirus.
Remdesivir can be described as an experimental, broad spectrum antiviral made by the United States pharmaceutical Gilead Sciences that was first developed to treat Ebola, a viral hemorrhagic fever.
It posed a promising study in primates in 2016, and was subsequently made available for a major trial at the epicenter of the Ebola virus, which is Democratic Republic of Congo to make comparison with three other drugs.
In February, the US National Institute of Allergy and Infectious Diseases (NIAID) announced it was dusting off remdesivir to investigate against SARS-CoV-2, the pathogen that causes COVID-19, because it had shown a promising result in animal testing against fellow coronaviruses SARS and MERS.
Meanwhile, in terms of efficacy, the NIAID announced the results of its trial involving more than 1,000 people on Wednesday, finding that hospitalized COVID-19 patients with respiratory difficulty got better quicker than those on a placebo.
Specifically, patients on the drug had a 31 percent fast recovery rate.
“Although the results were clearly positive from a statistically significant standpoint, they were modest,” Anthony Fauci, the scientist who leads the NIAID told NBC News on Thursday.
In other words, while it works, it’s not a miracle cure.
It is however considered a “proof of concept” that could make it possible for better treatments, just as the early medicines developed to treat HIV in the 1980s weren’t nearly as effective as those used today.
The results suggested remdesivir might reduce mortality rates from 11.7 percent to 8.0 percent, but this data is considered less reliable because it was above the cut-off of statistical significance.
There has been mixed results following this effort, as the US-led trial came out the same time a result published on The Lancet infer no statistical relevance of remdesivir.
“The numbers in the trial are too small to draw strong conclusions,” said Stephen Evans, a medical statistics expert at London School of Hygiene & Tropical Medicine.
Remdesivir, which is readily making available to fight the infectious disease, its administration to coronavirus patients is ongoing globally, in and outside clinical trials, with Gilead responding to “compassionate use requests” for emergency access.
The health body saddled with the monitoring and authorization of food and drugs in the United States, USFDA, has been given the green light to issue an “emergency use authorization” for the new drug in a bid to expand its further use.
“I was speaking with the commissioner of the FDA yesterday evening, last night, and he’s moving along very quickly,” Fauci said Thursday.
“They have not made a final decision yet, they have not announced it, but I would project that we’re going to be seeing that reasonably soon.”
Since the manufacture of the drug is expensive and is administered via injection, instead of a pill, this is already raising concerns for the drug to readily available across with unlimited supply.
In an open letter published late Wednesday, Daniel O’Day, Gilead’s chairman, wrote that the company currently had 1.5 million doses either finished or nearly finished.
“We had estimated that this would be 140,000 treatment courses based on a 10-day treatment duration,” he said, but another trial has shown that five-day courses are as effective as ten.
This means “we can significantly increase the number of courses available, all of which Gilead has committed for donation,” said O’Day.
The company is also planning an initiative whereby there can be an inhaled formulation in the place of the injection one, perhaps, there can be choice of drug administration.
Remdesivir descriptively belongs to a class of drugs that directly attack viruses.
It is called a “nucleotide analog” that mimics adenosine, one of the four building blocks of RNA and DNA.
“The virus is not very careful about what it incorporates,” said virologist Benjamin Neuman, of Texas A&M University.
“Viruses usually try to go fast and they trade speed for caution.”
Remdesivir slowly and in-disguise incorporates itself into the virus’s genome instead of adenosine, which in turn short cut its replication process.
Speaking during an earnings call Thursday, Gilead’s chief medical officer Merdad Parsey said that while patients who had had symptoms for less time seemed to respond better to the medicine, there also appeared to be some benefit for those who were more critical.
This is because the virus triggers an abnormal immune reaction called cytokine storm responsible for lung injury.
“By limiting the viral replication, you’re going to limit the inflammation, you’re going to reduce the number of people who develop lung injury, and you’re going to get them off the ventilator faster,” said Parsey.
