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Remdesivir Review: “Enormously Useful” Or Deadly?

Why remdesivir, a highly effective COVID treatment, is a last resort for providers | PLUS: Is Remdesivir Killing People?

SHOTS by NPR – In late December, as the omicron variant surged, the roster of early COVID-19 treatments was looking slim. Newly authorized pills for COVID-19 were in short supply. Several monoclonal antibody drugs didn’t seem to work.

Then an older drug, remdesivir, emerged as an effective option.

Over the past year and a half, the drug — sold in the U.S. under the brand Veklury –had been used in hospitals to treat very sick patients with COVID-19.

But new data from the drugmaker Gilead showed that remdesivir could also help high-risk patients avoid the hospital. In other words, it could help patients with medical conditions like immune suppression and diabetes prevent severe COVID-19 disease.

While the drug had shown mixed results in studies as a treatment for hospitalized patients, it has proved surprisingly effective, according to Gilead’s data, at treating patients early in the course of the disease.

“Remdesivir improves clinical outcomes in patients hospitalized with moderate-to-severe coronavirus disease 2019 (Covid-19).” – New England Journal of Medicine, January 27, 2022

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Public health experts say it could be enormously useful at a time when other early COVID-19 treatments – such as monoclonal antibodies and COVID pills – are unavailable or in short supply.

But the drug hasn’t gotten much traction among health care providers because it takes significant time, staff and resources to give out.

The appeal of remdesivir

The results of Gilead’s study on using remdesivir early in the course of illness, published in The New England Journal of Medicine, were “truly dramatic,” says Dr. Jane Kelly, assistant state epidemiologist for South Carolina, who is not affiliated with the study. “It resulted in an 87% lower risk of hospitalization or death than placebo.”

Those results put it on par with monoclonal antibodies and Paxlovid, a COVID-19 pill – the best available COVID treatments out there. Its side effects — mainly, nausea — are tame for most people.

Other traits add to remdesivir’s appeal. It’s the only early treatment available to children under 12. Plus it works against omicron …

“A phase 3 trial of remdesivir showed that both a 10-day course and a 5-day course of remdesivir shortened the recovery time in patients hospitalized with Covid-19.” – New England Journal of Medicine, January 27, 2022

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READ MORE.

Is Remdesivir Killing People?

Fact Check: Claims made during senator’s hearing that featured “disinformation docs”

by Kristina Fiore, Director of Enterprise & Investigative Reporting, January 27, 2022

MedPage Today – Remdesivir (Veklury) hasn’t been a favored therapy in hospitalists’ toolbox for treating COVID-19 patients, but rumors that the drug is killing patients are unfounded, physicians say.

The allegations appear to have spawned from testimony at a hearing earlier this week organized by Sen. Ron Johnson (R-Wis.), entitled “COVID-19: A Second Opinion.”

“If you look at the four independent studies, including the large study by the WHO, it shows the opposite effect … remdesivir increases risk of death by 3%,” said Paul Marik, MD, who has long touted the benefits of ivermectin and who recently resigned from his position at Eastern Virginia Medical School. “This is a toxic drug.”

MedPage Today conducted a fact check of Marik’s statement and could not find any evidence in the scientific literature that showed remdesivir was associated with an increased risk of death.

Overall, it appears that remdesivir is associated with a slightly lower risk of death, albeit a non-significant one, and may have some clinical benefit.

Marik’s comments come on the heels of an FDA decision to expand the use of remdesivir to outpatients with mild-to-moderate COVID-19.

The final report of the WHO’s SOLIDARITY trial referenced by Marik showed no difference in mortality for patients receiving remdesivir compared with standard care (rate ratio [RR] 0.95, 95% CI 0.81-1.11, P=0.50).

And when WHO investigators pooled previous research on remdesivir — including a study from the National Institute of Allergy and Infectious Diseases (NIAID) and two smaller trials — they found a lower but non-significant risk of death (RR 0.91, 95% CI 0.79-1.05).

Results from the NIAID study referenced there, ACTT, were announced on April 29, 2020, and showed a quicker time to recovery for hospitalized patients who got the drug. There also appeared to be a survival advantage, but it wasn’t significant (HR for death 0.70, 95% CI 0.47-1.04) … read more.

 

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