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Remdesivir works against COVID-19, but does it work well enough to turn the tide?

7 Comments on Remdesivir works against COVID-19, but does it work well enough to turn the tide?

The results of a pair of randomized controlled clinical trials were announced today, both showing antiviral drug Remdesivir to be effective in treating hospitalized COVID-19 patients. As a result, the FDA is expected to issue an emergency approval for Remdesivir very soon.

It’s still unclear how much this will matter in the overall course of the pandemic, due to limited supplies of Remdesivir and the underwhelming character of the observed effect. Nevertheless, this is extremely happy news.

The first trial was sponsored by the NIH, and compared a 10-day course of intravenous Remdesivir with a placebo in 1063 patients at sites across the USA. This is the trial whose Chicago arm we previously reported on. It showed that patients receiving Remdesivir were discharged from the hospital 31% sooner, and trended toward showing that they had a somewhat lower mortality rate (8% vs 11.6%, p=.059). The time result was statistically significant, but the mortality result was not.

The second trial was sponsored by Gilead, the manufacturer of Remdesivir. It compared a 10-day course of Remdesivir to a 5-day course, and found that both were equally effective in terms of clinical improvement and mortality.

Remdesivir is only administered intravenously in a hospital setting. Both studies showed safety signals consistent with prior data on Remdesivir.

It’s unclear how much this news will change the big picture. While Remdesivir does work, it appears to reduce time to discharge by only about 31%, i.e. it would theoretically be able to increase the capacity of an overcrowded hospital system by about 45%, if this number bears out.

If the survival result of the NIH study is true, Remdesivir may reduce fatality, but again, not by much. So it’s unlikely to empty crowded epidemic wards or drastically plunge fatality rates.

More study could reveal more upside

These two studies aren’t necessarily the last word in Remdesivir’s effectiveness, though.

Doctors around the world will now be working to figure out how to use Remdesivir for maximal effect. It could be that Remdesivir works much better in a combination, with different dosing, or in particular subtypes of patients who could be identified. In addition, it may work better if administered early, which is a pattern observed with some antivirals including the familiar oseltamivir.

This last possibility could exacerbate another problem: a shortage.

Gilead says that with the reduced 5-day course of treatment, it aims to make 280,000 courses by the end of May, 1 million by the end of October, and 2 million by the end of the year. While this is a lot, it may be too small for the scale of the pandemic if global growth rates aren’t controlled, especially if it needs to be used early en masse rather than for rescuing the most severe cases.

As we previously reported, generic pharmaceutical companies in China and India are working on copying Remdesivir, and some Chinese companies have even reported success. If Gilead gives them licenses, or if they successfully ignore them, this may alleviate the potential shortage somewhat.

Despite all the caveats, this news marks an exciting landmark in the pandemic: the very first therapy known to be effective. If you’re well stocked on celebratory beverages, it would be a suitable occasion to crack open a bottle.

Ari Allyn-Feuer | LinkedIn

Ari Allyn-Feuer is an Artificial Intelligence engineer at a major pharmaceutical company. He has a Ph.D. in Bioinformatics from the University of Michigan and studied Math and Biology at the University of Chicago.

  • 7 Comments
    • Cia April 30, 2020

      I think the major incentive for using Remdesivir is that it costs a thousand dollars per dose. HCQ is a better choice most, especially when started early and used with Zithromax and zinc. They’re saying it causes heart arrythmias and sudden cardiac arrest, but it was used for seventy years with hundreds of millions of doses given, without a single mention of these problems ever reported. Effects like rash, nausea, vision problems, retina problems usually after ten years or more of use, and even these were rare. It has always been considered a very safe drug. I think the big problem is that it costs only pennies a dose. Dr. Didier Raoult in his recently-published study on 800 patients just excluded 200 patients with certain heart problems from getting HCQ. And he showed how amazingly well it treated CV in these patients. Much more successful than the remdesivir in this study.

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      • Christina Bo Beena Cia April 30, 2020

        Normally I would agree with the conspiracy but HCQ is related to Levaquin/Cipro and the fluoroquinolone antibiotics (formerly chemo drugs). They damage mitochondria and cause a slew of catastrophic damage to multiple systems, including retina damage and heart rhythm abnormalities. It’s not rare and it’s not a coincidence, sadly. I for one am VASTLY relieved we have moved on from HCQ.

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      • Cia Christina Bo Beena June 28, 2020

        Hundreds of millions of doses of chloroquine and HCQ were given starting in the ‘30s and there was not a single report of damage to the heart. Side effects like corneal damage were occasionally seen after continuous use for over ten years. These drugs were considered remarkably safe until the present situation with Covid.

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    • Cia April 30, 2020

      I just saw a report comparing a new Chinese study on Remdesivir just published in The Lancet. It was almost identical to the American study on Remdesivir discussed here. Neither study found a statistical difference in mortality. Remdesivir did NOT produce a statistically significant improvement in mortality. The American study found that Remdesivir shortened improvement time, meaning release from the hospital in those who recovered to eleven days, versus fifteen days for those taking the placebo. The Chinese study found no statistical difference in either mortality or recovery time in its two groups.

       

      Meanwhile, NO comparable study has been done in HCQ/Zpac/zinc, even though the studies which have been done show much more promise. Yes, hundreds of articles have been published saying that HCQ is too dangerous to use because it allegedly causes heart arrythmias and cardiac arrest, but with no examples being cited. With none being reported pre-Covid out of hundreds of millions of doses being given. Among other benefits, HCQ interrupts the autoimmune cytokine storm which is often what kills. It also forces the introduction of zinc into cells which is vital for recovery. It protects the cells from the virus attacking the hemoglobin and releasing iron, just as it does when treating malaria. Its big advantage is that it’s inexpensive and easy to produce, when drug makers would prefer a much more expensive drug, like Remdesivir.

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    • Scott H April 30, 2020

      Please explain why you have concern of overcrowded medical facilities when there wasn’t even 1 in the US that was seriously stressed.  The excess capacity cost 10’s of thousands of jobs and billions of dollars in lost revenue.

      You have been relentless in asserting the likelihood of a doomsday scenario yet it has not been borne out anywhere in the world, even in Iran and Italy.  While severe, it’s far from the scary guesses you’ve been making.  And, don’t bother quoting some death rate number since they have zero idea of the number of people who have been infected.  Confirmed cases means nothing.

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      • Cia Scott H April 30, 2020
        1. There was a doomsday scenario in Milan as well as all of northern Italy, as well as in New York City, New Orleans, Ecuador, and now Manaus, in which the hospitals have been overwhelmed and could do very little to relieve the suffering of thousands laid to die on any available surface, their bodies cremated in overloaded crematoria running 24/7 or their bodies shoveled into mass graves. My definition of apocalyptic. A 10% death rate when appropriate medical care was not available. And high mortality even when it is. Look at the charts in the Financial Times report with the mortality in many countries spiking sharply during their time with CV. A 150% increase in usual mortality for March and April all over the world.

        You need to distinguish between case and infection mortality rate. It’s true that we don’t know how many have been infected but had mild or subclinical cases. There’s evidence that mild cases don’t give any antibodies. And evidence that there are at least thirty strains with no certainty of there being immunity to the others even if there were immunity to one. And it may not last long, maybe as little as eight months. So it really doesn’t matter if maybe two percent can be proven to have antibodies. In any case, there are still billions of vulnerable worldwide, and even those with antibodies are still vulnerable to reinfection. Even many young, healthy people have died of it, depending on genetic factors, the viral load they were exposed to, and the virulence of the strain(s) they were exposed to. Even previously healthy people are recovering with permanent lung damage, and the disease is not limited to damaging the lungs, but in many cases causes blood coagulation cascades all over the body, causing strokes even in young people, and amputation of limbs. Also kidney, liver, heart, GI tract, and neurological damage, often multi-organ failure. It is now the number one cause of death in the US. I hope the virus becomes attenuated over time, as most viruses do. At this time it is the most serious public health threat since the Spanish flu. The lockdown has helped, but just letting the disease burn through would result in most hospitals being overwhelmed and unable to treat most of the sick. About 15-20% of the sick need to go to the hospital, about a third of those need the ICU. Most of these hospital patients would die if the hospitals are overwhelmed.

         

        Yes, under ordinary circumstances, it’s wasteful to have unused beds and ICU resources maintained and not used. But if you have an extremely severe pandemic like this one sweep the world, if you can’t quickly ready hospital facilities and staff, ten many thousands will die. Have died. Have you looked at the statistics and charts at Worldometers.info? I don’t understand how you can contend that this is not a world-changing catastrophe.

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      • SeaBee Scott H April 30, 2020

        Welcome, Scott, good to have you here. All perspectives are encouraged, but there is a baseline expectation of being well-informed if you are commenting. reddit, this ain’t.

        I’m writing from New York City, where a host of factors precluded my leaving the city. Our healthcare infrastructure was absolutely at the brink: that’s not a political statement and it needs no validation, as plenty of reporting across multiple media platforms have clearly borne this out.

        It is true that other areas of the US are not suffering as NYC has, but that is a clear consequence of shelter in place orders having the desired effect.

        Lots of new folks here, so let’s all strive to keep things civil, thoughtful and, ideally, concise.

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