CMAAO
CORONA FACTS and MYTH BUSTER 103 Remdesevir will be in India soon
Dr K K Aggarwal
President Confederation of Medical Associations of
Asia and Oceania, HCFI, Past National President IMA, Chief Editor Medtalks
With inputs from Dr Monica Vasudev
917: For hospitalized patients with severe
COVID-19, start remdesevir if available (Grade 1C).
918: Remdesivir
for the Treatment of Covid-19 — Preliminary Report
A
double-blind, randomized, placebo-controlled trial of intravenous remdesivir in
adults hospitalized with Covid-19 with evidence of lower respiratory tract
involvement. Patients were randomly assigned to receive either remdesivir (200
mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days)
or placebo for up to 10 days. The primary outcome was the time to recovery,
defined by either discharge from the hospital or hospitalization for
infection-control purposes only.
A total
of 1063 patients underwent randomization. The data and safety monitoring board
recommended early unblinding of the results on the basis of findings from an
analysis that showed shortened time to recovery in the remdesivir group.
Preliminary results from the 1059 patients (538 assigned to remdesivir and 521
to placebo) with data available after randomization indicated that those who
received remdesivir had a median recovery time of 11 days (95% confidence
interval [CI], 9 to 12), as compared with 15 days (95% CI, 13 to 19) in those
who received placebo (rate ratio for recovery, 1.32; 95% CI, 1.12 to 1.55;
P<0.001). The Kaplan-Meier estimates of mortality by 14 days were 7.1% with
remdesivir and 11.9% with placebo (hazard ratio for death, 0.70; 95% CI, 0.47
to 1.04). Serious adverse events were reported for 114 of the 541 patients in
the remdesivir group who underwent randomization (21.1%) and 141 of the 522
patients in the placebo group who underwent randomization (27.0%).
CONCLUSIONS: Remdesivir was superior to
placebo in shortening the time to recovery in adults hospitalized with Covid-19
and evidence of lower respiratory tract infection. (Funded by the National
Institute of Allergy and Infectious Diseases and others; New
England Journal of Medicine].
919: In contrast, in a randomized trial from China of
237 patients with severe COVID-19, remdesivir and placebo had similar times to
clinical improvement (median 21 versus 23 days) and mortality rates (14 versus
13 percent); however, confidence in the finding of no effect was reduced by use
of concomitant therapies, differences in baseline comorbidities between the
groups, and failure to meet the target enrollment [Wang Y, Zhang D, Du G, et al. Remdesivir in adults with severe COVID-19:
A randomised, double-blind, placebo-controlled, multicentre trial. Lancet 2020.]
920: Remdesivir is
a novel nucleotide analogue that has activity against severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) in vitro.
921: In the United States, the Food and Drug Administration (FDA)
has issued an emergency use authorization for remdesivir for hospitalized
children and adults with severe COVID-19 (SpO2 ≤94
percent on room air, requiring supplemental oxygen, mechanical ventilation, or
extracorporeal membrane oxygenation [ECMO]).
922: The suggested adult dose is 200 mg intravenously on day 1
followed by 100 mg daily for 10 days total in patients on mechanical
ventilation or ECMO and 5 days total in other patients (with extension to 10
days if there is no clinical improvement).
923: Remdesivir is not recommended in patients with an alanine
aminotransferase ≥5 times the upper limit of normal (and should be discontinued
if it rises above this level during treatment or if there are other signs of
liver injury).
924: The pharmacokinetics of remdesivir in the setting of renal
impairment are uncertain, and it is prepared in a cyclodextrin vehicle that
accumulates in renal impairment and may be toxic; thus, remdesivir is not
recommended in patients with an estimated glomerular filtration rate (eGFR)
<30 mL/min per 1.73 m2 unless the potential benefit
outweighs the potential risk.
925: Reported
side effects include nausea, vomiting, and transaminase elevations. In a
preliminary report from a trial of remdesevir among
patients with severe COVID-19, grade 3 aminotransferase elevations occurred in
7 percent and led to drug discontinuation in 3 percent. Other adverse events
described in patients who received remdesivir include worsening kidney injury,
multiple organ failure, and worsened cardiopulmonary status
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