Gilead Sciences has announced that it plans to donate its existing supply of 1.5 million doses of remdesivir—enough to treat 140,000 COVID-19 patients.
On Wednesday, Gilead Sciences Inc. announced it had concluded its clinical trial of a COVID-19 treatment—with astonishing results.
Dr Anthony Fauci, the nation’s leading expert on infectious diseases, said that the results are “highly significant.” The U.S. Food and Drug Administration will now begin the process of approving the drug for widespread use.
Remdesivir, the antiviral drug used in the trial, was shown to help coronavirus patients recover from the disease 31% faster than those who did not receive the treatment.
What are the results of the clinical trials?
The clinical trials involved the use of a double-blind study, which examined two groups of patients. While one group received the actual treatment, the other group received a placebo or fake treatment with no chemical impact.
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The process is dubbed double-blind because neither the participating patients nor the doctors know who is receiving the real drug. It is a way to remove any possible prejudice from the results.
Though the data are yet incomplete, the available information represents three different trials. The largest trial involved 1,063 patients who had been hospitalized with COVID-19.
The group that received remdesivir recovered in 11 days on average, while those who received the placebo recovered in an average of 15 days.
Of those who received remdesivir, about 8% died of virus-related complications, as opposed to the placebo group, where 11.6% of patients passed away.
The good news is that the recovery period for those who received remdesivir was 31% shorter than those in the placebo group, which experts say is significant.
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The bad news is that the difference in survival rate between the two groups is considered statistically insignificant.
Another trial, conducted in China, did not yield such optimistic results.
In this case, the study didn’t show the use of remdesivir helped patients at all, but Gilead considers these findings to be inconclusive, as the trial was ended early.
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Lastly, Gilead conducted a trial with a group of 397 patients whose cases were far more severe, and who had been sick for a longer period of time.
The trial showed greater benefits of the drug in patients who received it early on in their recovery, while those who received it late into their illness did not exhibit such benefits.
How does it work?
While a viricide would kill a virus, remdesivir is an antiviral that tries to slow the virus’ reproduction, inhibiting its ability to make copies of itself.
By slowing the rapid growth of a virus within the human body, the drug enables a patient’s immune system to overcome the virus before it gets too big to handle.
And while the present form of remdesivir only targets this single coronavirus, antivirals can be designed to disable an entire group of viruses.
Gilead will likely add other antiviral agents to the drug in the future as a means of intensifying its effectiveness.
Next Steps
President Trump said of the FDA regulatory investigation, “I want them to go as quickly as they can… We want everything to be safe, but we would like to see very quick approvals, especially with things that work.” The FDA has yet to approve the drug for use in widespread treatment.
But Gilead has announced that it plans to donate its existing supply of 1.5 million doses of remdesivir—enough to treat 140,000 patients. Once the drug is approved, the company will begin mass production.
Gilead is also exploring more convenient forms of delivery for the drug, which is currently only available intravenously.
Much like fellow biotech firm Vaxart that is working on a vaccine to be taken as an oral tablet, Gilead recognizes that a tablet form of remdesivir would make it easier for patients to treat themselves at home, as opposed the need to get it via I.V. from a health professional in a hospital.
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