Remdesivir: The COVID-19 drug helping patients recover faster
In this file photo one vial of the drug Remdesivir is viewed during a press conference about the start of a study with the Ebola drug Remdesivir in particularly severely ill patients at the University Hospital Eppendorf (UKE) in Hamburg, northern Germany on April 8, 2020, amidst the new coronavirus COVID-19 pandemic. Gilead Science's remdesivir, one of the most highly anticipated drugs being tested against the new coronavirus, showed positive results in a large-scale US government trial, the company said on April 29, 2020."We understand that the trial has met its primary endpoint and that NIAID (National Institute of Allergy and Infectious Diseases) will provide detailed information at an upcoming briefing," the company said.
AFP/Ulrich Perrey/Pool
Remdesivir: The COVID-19 drug helping patients recover faster
Issam Ahmed (Agence France-Presse) - May 1, 2020 - 8:47am

WASHINGTON, United States — Remdesivir has been shown to speed up recovery times for patients with COVID-19 in a major US-led trial, becoming the first drug with proven benefit against the disease.

Here is what you need to know.

What is remdesivir?

Remdesivir is an experimental, broad spectrum antiviral made by US pharmaceutical Gilead Sciences that was first developed to treat Ebola, a viral hemorrhagic fever.

It showed early promise in a primate study in 2016 and was later rolled out for a major trial in the Democratic Republic of Congo, where it was compared against three other medicines.

That study concluded in 2019 when it was discontinued because it did not boost survival rates as greatly as two monoclonal antibody drugs, which are lab-engineered immune system proteins.

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 promise in animal testing against fellow coronaviruses SARS and MERS.

How effective is it?

The NIAID announced the results of its trial involving more than 1,000 people on Wednesday, finding that hospitalized COVID-19 patients with respiratory distress got better quicker than those on a placebo.

Specifically, patients on the drug had a 31 percent faster time to recovery.

"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 pave the way 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 lower 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.

Why have there been mixed results?

The findings from the US-led trial were announced on the same day as the results of a smaller study were published in The Lancet, which found no statistical benefit from remdesivir.

This study involved just over 200 people in Wuhan, China, and was also a randomized controlled trial — considered the gold standard for evaluating treatments.

Importantly, however, it had to be stopped early because it could not recruit enough patients, and was roughly five times smaller than the NIAID study.

"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.

When might it be available?

Remdesivir has already been given to patients around the world, both in clinical trials and outside, with Gilead responding to "compassionate use requests" for emergency access.

In the United States, the Food and Drug Administration (FDA) is soon expected to issue an "emergency use authorization" which would expand its use further, prior to its formal approval.

"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 medicine is complex to manufacture and is administered via injection, rather than a pill, there have been questions about whether supply could initially be limited.

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 looking into potentially developing an inhaled formulation, but hasn't given a timeline.

How does it work?

Remdesivir belongs to a class of drugs that directly attack viruses.

It is what's 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 sneakily incorporates itself into the virus's genome instead of adenosine, which in turn short circuits 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.

NOVEL CORONAVIRUS
As It Happens
LATEST UPDATE: November 26, 2020 - 5:37pm

Follow this page for updates on a mysterious pneumonia outbreak that has struck dozens of people in China.

November 26, 2020 - 5:37pm

Russia on Thursday registered record numbers for daily infections and deaths from the coronavirus for the second time in less than a week. 

Health officials reported 25,487 new infections, bringing the national total to 2,187,990 cases since the beginning of the pandemic — the fifth-highest caseload in the world.

Health authorities also reported 524 deaths, raising Russia's total fatalities from COVID-19 to 38,062. — AFP

November 26, 2020 - 2:14pm

South Korea reported its highest daily number of coronavirus cases since March on Thursday, with a surge of new infections sparking fears of a major third wave.

Officials announced 583 new cases after several weeks of fresh infections ranging between around 100 and 300.

The latest cases have mostly been clusters at offices, schools, gyms and small gatherings in the greater Seoul area, the Korea Disease Control and Prevention Agency said.

New infections also emerged within the military, including dozens of newly enlisted soldiers at a boot camp — prompting the defense ministry to bolster its virus measures. — AFP

November 26, 2020 - 1:29pm

South Korea reported its highest daily number of coronavirus cases since March on Thursday, with a surge of new infections sparking fears of a major third wave.

Officials announced 583 new cases after several weeks of fresh infections ranging between around 100 and 300.

The latest cases have mostly been clusters at offices, schools, gyms and small gatherings in the greater Seoul area, the Korea Disease Control and Prevention Agency said. — AFP

November 26, 2020 - 8:31am

The coronavirus pandemic is no excuse for not getting enough exercise, the World Health Organization says Wednesday, warning that even before the crisis many were getting too little physical activity. 

In an update of its physical activity guidelines, the UN health agency stressed that exercise was vital to physical and mental health, while sedentary behaviour can have serious repercussions.

"WHO urges everyone to continue to stay active through the Covid-19 pandemic," the agency's head of health promotion Ruediger Krech told reporters.

"If we do not remain active, we run the risk of creating another pandemic of ill-health as a result of sedentary behavior." — AFP

November 25, 2020 - 8:29pm

The coronavirus crisis has hit Italy's already historically-low birth rate, new projections from the national statistics agency reveal. 

Italy had last year already recorded its lowest number of births for 150 years, at 420,000, but this could fall to 408,000 in 2020 and 393,000 in 2021, according to Istat.

The projections were presented by Istat chief, Gian Carlo Blangiardo, to lawmakers on Tuesday.

"The climate of fear and uncertainty as well as financial difficulties... caused by recent events will have a negative effect on the fertility of Italian couples," he said. — AFP

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