Remdesivir (Veklury) decreased threat of hospitalizations by 87% in contrast with placebo in outpatients at excessive threat of development to extreme COVID-19, a researcher mentioned.
While the uncooked numbers have been small — two within the remdesivir arm versus 15 within the placebo arm — the remdesivir arm had a considerably decrease threat of hospitalization (0.7% vs 5.3%, respectively; HR 0.13, 95% CI 0.03-0.59, P=0.008), reported Joshua Hill, MD, of Fred Hutchinson Cancer Research Center in Seattle, throughout a late-breaking presentation at digital IDWeek.
That means 95% of sufferers didn’t progress to extreme illness, he famous, suggesting that there may be subgroups, reminiscent of these with hematologic malignancies or transplant sufferers, who may profit from the remedy.
“More precision research, particularly in high-risk populations, could be actually useful,” added session moderator Adarsh Bhimraj, MD, of the Cleveland Clinic.
Remdesivir additionally decreased threat of COVID-related medically attended visits or all-cause demise by day 28 — a secondary end result of the research — by 81%. Again, the numbers have been small: 5 within the remdesivir group versus 21 within the placebo group.
Adverse occasions (AEs) have been comparable between the teams, with no new security alerts reported.
However, enrollment was halted as a result of availability of single-infusion monoclonal antibodies and “rising vaccine charges within the high-risk affected person inhabitants,” which have been each exclusion standards for the research, Hill mentioned. While the aim of the trial was to enroll 1,264 sufferers, there have been 584 randomized, and 562 who obtained no less than one dose of the research drug.
The NIH COVID-19 therapy pointers presently advocate remdesivir for sufferers who’re hospitalized and on supplemental oxygen, in addition to remdesivir plus dexamethasone for hospitalized sufferers requiring high-flow oxygen or non-invasive air flow, however there’s inadequate proof for remdesivir in hospitalized sufferers who don’t require supplemental oxygen.
Bhimraj, who was not concerned with the analysis, commented that clinicians are “on the lookout for new remedy in [COVID] sufferers who should not hospitalized.”
“From many years of expertise within the area of virology … early initiation of antiviral therapy could also be the simplest strategy to stop illness development, notably for many who are at highest threat,” Hill mentioned.
He additionally identified that there are monoclonal antibody shortages and rationing in some elements of the nation, in addition to restricted availability of monoclonal antibodies outdoors the U.S. He highlighted remdesivir’s “distinct mechanism of motion” which may very well be efficient in opposition to variants of concern that escape monoclonal antibody therapies.
The part III PINETREE research enrolled COVID outpatients and people in expert nursing services, and included members ages 12 and older who have been at excessive threat for extreme illness, in addition to all adults ages 60 and up. Study enrollment began Sept. 18, 2020 and ended on April 8, 2021.
The major end result was a composite of COVID-19 hospitalization and all-cause demise at day 28, in addition to the proportion of sufferers with treatment-emergent AEs.
Hill famous that this was a shorter course of the drug (3 days vs the same old 5-day course), with sufferers receiving 200 mg IV on day 1, and 100 mg IV on days 2 and three. Control members obtained matching placebo.
Mean affected person age was 50; 30% have been 60 and older. Most have been white, although Hill mentioned that about 42%-46% recognized as being of Hispanic ethnicity. Median physique mass index was 30, and the commonest comorbidities have been weight problems, diabetes, and hypertension. About 3% of members obtained infusions at a talented nursing facility.
Rates of AEs was comparable within the remdesivir and placebo teams (42% vs 46%, respectively), mostly nausea and headache. There was the next price of grade ≥3 AEs within the placebo group (4% vs 7%), which Hill mentioned mirrored the next hospitalization price. There was one grade 3 AE within the remdesivir group, a rise in transaminase ranges, which resolved in a few week, he famous.
Molly Walker is deputy managing editor and covers infectious illnesses for MedPage Today. She is a 2020 J2 Achievement Award winner for her COVID-19 protection. Follow
IDWeek is the annual joint assembly of the Infectious Diseases Society of America, Society for Healthcare Epidemiology of America, Pediatric Infectious Diseases Society, HIV Medicine Association, and Society of Infectious Diseases Pharmacists.
This research was sponsored by Gilead Sciences, Inc.
Hill disclosed assist from Gilead, Amplyx, AlloVir, Allogene, Takeda, CRISPR, CSL Behring, Karius, and Merck.