Early remdesivir for COVID-19 lowers hospitalization, death risk by 87%
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An early 3-day course of remdesivir lowered the risk for hospitalization or death among nonhospitalized patients at high risk for severe COVID-19 by 87%, according to a study published in The New England Journal of Medicine.
In treatment guidelines for COVID-19, the Infectious Diseases Society of America suggests remdesivir for certain hospitalized patients — a departure from WHO, which does not recommend it for any patients hospitalized with COVID-19, regardless of how sick they are.
The new study by Robert L. Gottlieb, MD, PhD, FACC, a researcher at Baylor Scott and White Research Institute in Dallas, and colleagues conducted a randomized, double-blind, placebo-controlled trial involving nonhospitalized patients with COVID-19 who first experienced symptoms within the last 7 days and who had at least one risk factor for severe disease, including obesity, cardiovascular disease and diabetes.
They enrolled 562 patients between Sept. 18, 2020, and April 8, 2021 — before the emergence of the delta variant — and randomly assigned them to receive either IV remdesivir (200 mg on day 1, and 100 mg on days 2 and 3; n = 279) or placebo (n = 283).
The mean age of participants was 50 years, 47.9% were women, and 41.8% were Hispanic. The most common pre-existing conditions were diabetes (61.6%), obesity (55.2%) and hypertension (47.7%).
COVID-19-related hospitalization occurred in two people (0.7%) in the remdesivir group, and in 15 people (5.3%) in the placebo group (HR = 0.13; 95% CI, 0.03-0.59).
By day 28, four patients (1.6%) in the remdesivir group and 21 patients (8.3%) in the placebo group had received a COVID-19-related medical visit (HR = 0.19; 95% CI, 0.07-0.56).
No deaths were reported by day 28.
“Despite its beneficial clinical effects, the upper airway viral load was not lower in patients who received remdesivir than in those who received placebo,” the authors wrote. “Similar discordant findings between clinical effectiveness and viral loads in the upper respiratory tract were reported in rhesus macaques that were infected with SARS-CoV-2. In that study, remdesivir resulted in a clinical benefit and reduced SARS-CoV-2 replication in the lower respiratory tract compartment but did not significantly reduce viral load in the upper respiratory tract.”
In related editorial, Emily L. Heil, PharmD, and Shyam Kottilil, MD, PhD, from the University of Maryland, said the findings “represent the most promising of any remdesivir study to date because of the timely administration of the medication,” but also noted some limitations, including that the study excluded vaccinated patients, which “limits understanding of the utility or requirement of early antiviral therapy in vaccinated persons with breakthrough infections.”
“Second, the lack of effect of remdesivir on SARS-CoV-2 viral loads reflects that the way in which this medication improves a patient’s clinical disease course is still uncertain,” they wrote.
References:
Gottlieb RL, et al. N Engl J Med. 2021;doi:10.1056/NEJMoa2116846.
Heil EL, et al. N Engl J Med. 2021;doi:10.1056/NEJMe2118579.
IDSA. IDSA guidelines on the treatment and management of patients with COVID-19. https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/#toc-11. Accessed Dec. 27, 2021.
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