The Food and Drug Administration (FDA) is expanding the use of the antiviral remdesivir drug Veklury to certain non-hospitalised adults and paediatric patients for the treatment of mild-to-moderate COVID-19 disease.
Previously, the use of the oral Gilead Sciences drug was limited to those requiring hospitalisation, reports Fox News.
“This will bolster the arsenal of therapeutics to treat COVID-19 and respond to the surge of the Omicron variant,” said Patrizia Cavazzoni, director of the FDAʼs Center for Drug Evaluation and Research.
“It will also provide adults and paediatric patients, who have mild-to-moderate infection and who are at high risk of severe COVID-19, with a treatment option outside a traditional inpatient hospital setting, including at nursing and outpatient facilities and home healthcare settings,” she added.
The paediatric patients must be 12 and older, weigh at least 40kg, with positive results of direct SARS-CoV-2 viral testing and who are not hospitalised, who have mild-to-moderate COVID-19 and are at high risk for progression to severe disease.
The FDA also revised Veklury’s emergency use authorisation (EUA) for treatment of children under 12, weighing between 3.5kg and 40kg.
High-risk, non-hospitalised patients may receive Veklury via intravenous infusion for a period of three days.
The FDA said that the approval of Veklury for use in these patients was supported by a randomised, placebo-controlled clinical trial, which was published in the New England Journal of Medicine.
The trial included 562 hospitalised participants with mild-to-moderate COVID-19 who were at high risk for progression to severe COVID-19.
“The main outcome measured in the trial was whether a patient was hospitalised for any COVID-19 related reason or died from any reason within 28 days of treatment. Overall, two of 279 patients who received Veklury (0.7%) required COVID-19 related hospitalisation compared with 15 of 283 patients who received a placebo (5.3%). There were no deaths in either group,” the FDA said.
It also noted that paediatric patients, for whom the drug is authorised, will receive doses adjusted to their body weight, “to achieve comparable exposures to adults and paediatric patients receiving the approved dose”.
In addition, FDA said that the authorisation is based on extrapolation of efficacy from adequate and well-controlled studies in adults.
“Remdesivir has now helped to treat more than 10m million people worldwide with COVID-19, and continues to play a key role in helping to reduce the burden of the pandemic. Based on the most recent data, we now understand that it is also effective in the early stages of COVID-19 infection, in addition to helping patients who are hospitalised with the disease,” said Daniel OʼDay, CEO of Gilead Sciences.
“While we continue to advance remdesivir to benefit more patients in multiple settings, we are also advancing our investigational oral compounds. These are based on the same antiviral mechanism of action as remdesivir and a Phase 1 trial for our oral COVID- 19 antiviral, GS-5245 is now under way.”
Veklury is not a substitute for vaccination against COVID-19 in individuals for whom vaccination and boosters are recommended.
The FDA initially approved Veklury for use in adults and children over 12 on 22 October 2020.
Notably, in December, Gilead Sciences announced that it was voluntarily recalling two lots of Veklury after a complaint of the presence of glass particulates. In an FDA announcement, the company said then it had not received any reports of adverse events related to the recall.
Previous studies on remdesivir have shown conflicting results. In November 2020, the WHO recommended against the use of remdesivir in COVID-19 patients.
Study details
Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatient
Robert Gottlieb, Carlos Vaca, Roger Paredes,Jorge Mera, Brandon Webb, Gilberto Perez, Godson Oguchi, Pablo Ryan, Bibi Nielsen, Michael Brown, Ausberto Hidalgo, Yessica Sachdeva, et al.
Published in NEJM on 22 December 2021
Abstract
Background
Remdesivir improves clinical outcomes in patients hospitalised with moderate-to-severe coronavirus disease 2019 (COVID-19). Whether the use of remdesivir in symptomatic, non-hospitalised patients with COVID-19 who are at high risk for disease progression prevents hospitalisation is uncertain.
Methods
We conducted a randomised, double-blind, placebo-controlled trial involving non-hospitalised patients with COVID-19 who had symptom onset within the previous 7 days and who had at least one risk factor for disease progression (age ≥60 years, obesity, or certain coexisting medical conditions). Patients were randomly assigned to receive intravenous remdesivir (200 mg on day 1 and 100 mg on days 2 and 3) or placebo. The primary efficacy end point was a composite of COVID-19–related hospitalisation or death from any cause by day 28. The primary safety end point was any adverse event. A secondary end point was a composite of a COVID-19–related medically attended visit or death from any cause by day 28.
Results
A total of 562 patients who underwent randomisation and received at least one dose of remdesivir or placebo were included in the analyses: 279 patients in the remdesivir group and 283 in the placebo group. The mean age was 50 years, 47.9% of the patients were women, and 41.8% were Hispanic or Latinx. The most common coexisting conditions were diabetes mellitus (61.6%), obesity (55.2%), and hypertension (47.7%). COVID-19–related hospitalisation or death from any cause occurred in 2 patients (0.7%) in the remdesivir group and in 15 (5.3%) in the placebo group (hazard ratio, 0.13; 95% confidence interval [CI], 0.03 to 0.59; P=0.008). A total of 4 of 246 patients (1.6%) in the remdesivir group and 21 of 252 (8.3%) in the placebo group had a COVID-19–related medically attended visit by day 28 (hazard ratio, 0.19; 95% CI, 0.07 to 0.56). No patients had died by day 28. Adverse events occurred in 42.3% of the patients in the remdesivir group and in 46.3% of those in the placebo group.
Conclusions
Among non-hospitalised patients who were at high risk for COVID-19 progression, a 3-day course of remdesivir had an acceptable safety profile and resulted in an 87% lower risk of hospitalisation or death than placebo.
See more from MedicalBrief archives:
Intravenous remdesivir reduced hospitalisation by 87% in high-risk COVID patients
Interferon worse than placebo in severe COVID — US NIAID trial
Remdesivir did not affect COVID-19 outcomes or mortality — DisCoVeRy trial
Remdesivir linked with clinical improvement and safety — Johns Hopkins hospital study