Gilead Sciences said Friday that in a trial involving more than 1,100 patients, remdesivir was associated with improved recovery and a 62% reduced risk of death compared with standard care.
The study also showed that 74% of remdesivir-treated patients recovered by Day 14 of treatment compared with 59% of patients receiving standard care.
The new findings add to those from a prior U.S. National Institute of Allergy and Infectious Diseases study of hospitalized COVID-19 patients. That study found that remdesivir shortened time to recovery by an average of four days as compared to placebo (11 versus 15 days).
“This comparative analysis provides valuable additional information regarding the benefit of remdesivir compared with standard of care alone,” Dr. Susan Olender, of Columbia University Irving Medical Center in New York City, said in a Gilead news release. “While not as vigorous as a randomized controlled trial, this analysis importantly draws from a real-world setting and serves as an important adjunct to clinical trial data, adding to our collective understanding of this virus and reflecting the extraordinary pace of the ongoing pandemic.”
Remdesivir made headlines earlier this year when it became the first therapeutic to curb COVID-19. Since then, a second drug, the steroid dexamethasone, has also showed real effectiveness in cutting the odds for serious illness and death in patients battling the new coronavirus.
Remdesivir’s rise has not been without controversy, however: The Trump administration faced global criticism after it bought up the near-total supply of the drug for use in American patients.
According to CNN, the U.S. Department of Health and Human Services announced June 29 that it had snapped up 100% of drug-maker Gilead’s projected output of the drug for July, and 90% of its production for August and September — plus more for clinical trials.
At the time, Dr. Mike Ryan, executive director of the Health Emergencies Program at the World Health Organization, said that “obviously, there are many people around the world who are very sick with this disease and we want to ensure that everybody has access to the necessary lifesaving interventions.”
Gilead also announced a U.S. price for remdesivir against COVID-19: $520 per vial, or $3,120 per full five-day course of treatment.
Still, those costs might be recouped if the drug does reduce days spent in the hospital. The findings released Friday come from a comparative analysis of 312 patients treated in the Phase 3 SIMPLE-Severe study of remdesivir, and 818 patients who weren’t in the study and received standard care.
The death rate for patients treated with remdesivir was 7.6% at Day 14, compared with 12.5% among patients who didn’t receive the drug, Gilead reported.
Certain COVID-19 patients seemed to do better on the drug than others. Black patients fared especially well, the study found, and those under the age of 65 seemed to do better than older patients. Patients who weren’t on a ventilator — breathing either room air or low-flow oxygen — seemed to benefit more compared to those who did require a ventilator.
The results were presented at a virtual COVID-19 conference and have not been published in a peer-reviewed journal. Gilead also stressed that the findings should be considered preliminary and they require confirmation in prospective clinical trials.
Gilead also said that new analyses of its “compassionate use program” showed that 83% of 77 children, and 92% of 86 pregnant and postpartum women — all with a broad range of COVID-19 disease severity and who were treated with remdesivir — recovered by Day 28.
To learn more about these groups of patients, Gilead recently announced a global, open-label Phase 2/3 trial to evaluate the safety, tolerability and action of remdesivir in patients aged 0 to 18 years, and is also collaborating on a study involving pregnant women.
Remdesivir has not been approved by the U.S. Food and Drug Administration, but the FDA issued an emergency use authorization for remdesivir for treatment of hospitalized patients with severe COVID-19.
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Posted: July 2020