Remdesivir Prevents COVID-19-Related Hospitalisation, Death in High-Risk Patients
By Brian Hoyle
VIRTUAL -- October 4, 2021 -- A 3-day course of intravenous remdesivir was safe, well tolerated, and highly effective at preventing coronavirus disease 2019 (COVID-19) related hospitalisation or death in high-risk non-hospitalised individuals, according to a study presented at ID Week 2021, the Annual Meeting of the Infectious Diseases Society of America (IDSA).
Compared with placebo, treatment with remdesivir significantly reduced COVID-19 hospitalisation or all-cause death by 87% through day 28 (hazard ratio [HR] = 0.13; 95% confidence interval [CI], 0.03-0.59).
Remdesivir also significantly lowered the risk of hospital visits due to COVID-19-related symptoms or all-cause death through day 28 by 81% (HR = 0.19; 95% CI, 0.07-0.56).
The findings were presented by Joshua A. Hill, MD, Fred Hutchinson Cancer Research Center, and the University of Washington, Seattle, Washington.
The study randomised 562 patients to a 3-day treatment with intravenous remdesivir (200 mg on day 1 and 100 mg on days 2 to 3) or treatment with placebo for the same time and injection schedule. The primary efficacy endpoint was composite COVID-19 hospitalisation or all-cause death by day 28. R
Slightly over half the patients were male (52%), 44% were Hispanic/Latino ethnicity, and 30% were ≥60 year. Comorbidities at baseline included diabetes (62%), obesity (56%), and hypertension (48%).
The benefits of remdesivir appeared not to come at the expense of increased frequency or types of adverse events (AEs). The rates of AEs were similar between patients treated with remdesivir and those treated with placebo. AEs associated with remdesivir included nausea (11%), headache (6%), and diarrhoea (4%).
The average change in nasopharyngeal viral loads from baseline to day 7 was similar in patients treated with remdesivir compared to those who were not.
The study would have been larger but enrollment was terminated early. In a press release prior to ID Week, the drugs’ manufacturer, Gilead, noted that this decision reflected the changing epidemiology and adoption of additional treatment options at the time. Data have continued to be collected from patients who were already enrolled.
Funding for this study was provided by Gilead.
[Presentation title:Remdesivir for the Treatment of High-Risk Non-Hospitalized Individuals With COVID-19: a Randomized, Double-Blind, Placebo-Controlled Trial. Abstract LB1]