Redsyvir: WHO does not recommend new coronary therapy for FDA-approved use in association with anti-inflammatory drugs

According to the WHO Guidelines Development Group, "The use of antiviral rydesivir is not recommended for COVID-19 hospitalized patients, regardless of their severity, as there is no evidence that the antiviral drug rydesivir improves survival or the need for a breathing device."
's latest guidelines on the use of drugs in COVID-19 are published in the British Medical Journal (BMJ).
researchers said the guidelines take into account the ongoing results of the WHO SOLIDARITY trial, which tracks patients hospitalized for COVID-19 and receiving treatments including Redsiway.
team said its recommendations also "results from systematic reviews and web-based meta-analysis of four randomized trials involving 7,333 COVID-19 inpatients."
" BMJ visual recommendation chart of the WHO COVID-19 drug guidelines However, the recommendation not to recommend redsivir is generally based on low-certainty evidence of the outcome of the study' concerns, so the Panel clarifies that the available evidence does not clearly prove that Redsyvir did not benefit from the treatment of COVID-19, but they found no evidence that actually improved the outcome.
WHO, in announcing the recommendations of the guidelines development group, said, "But given the potential for significant harm and the relatively high cost and resource impact associated with Redsyve, which must be administered intravenously), this recommendation (recommendation not to use Redsyve to treat COVID-19) is appropriate."
.S., Redsiway is $3,120 for private insurers and $2,340 for some government insurance plans.
addition, WHO researchers said they did not study Redsiway's use in children, and there are some data showing that Redsyve benefited in patients with non-critical COVID-19.
statement issued the same day, Gilead strongly defended Redsiway's benefits, citing trials and other studies by NIH that have shown the drug can help patients.
"We are disappointed that the WHO guidelines appear to ignore this evidence as cases have increased dramatically worldwide and doctors are relying on Veklury, the first and only approved antiviral drug, to treat COVID-19 patients in about 50 countries," Gilliard said.
" FDA authorized Barrettinib and Redsyvir to treat seriously ill patients on the same day that the WHO issued recommendations against Redsivir's use in the treatment of COVID-19, the FDA released a new emergency use authorization (EUA) for the combined use of Lilly's anti-inflammatory drug baricitinib (product name Olumiant) and Redsivir.
the new EUA allows Barrettinib and Redsyve to use a joint treatment for adult or child patients who require hospitalization for two years or more with supplemental oxygen, invasive mechanical aeration, or in-body membrane oxygenation (ECMO).
is a JAK inhibitor that blocks the activity of one or more specific enzyme families and interferes with the path of inflammation.
is an FDA-approved prescription oral tablet drug for the treatment of moderate to severe active rheumatoid arthritis.
the FDA, the EUA is authorized based on a randomized, double-blind, placebo-controlled clinical trial (ACTT-2) in COVID-19 hospitalized patients.
the trial showed that baritinib and Redsywey were associated with reduced recovery time within 29 days of starting treatment compared to patients who received a placebo and Redsiwe.
ACTT-2 trial was conducted by the National Institute of Allergy and Infectious Diseases (NIAID).
clinical trial assessed whether Barrettinib affected the time it took for subjects to recover from COVID-19 in subjects who were also treated with Redsivi.
the trial, which followed participants for 29 days, included 1,033 patients with moderate or severe COVID-19, of whom 515 were treated with barrettinib and redsiwe, and 518 patients were treated with placebo and redsiwe.
rehabilitation is defined as being discharged from a hospital or still hospitalized but does not require additional oxygen and no longer requires ongoing medical attention.
test results were as follows: The mid-time time of recovery from COVID-19 in the Barrettini-Redsiwe group was 7 days, while the placebo-Redsiwe group was 8 days.
on the 29th day, patients in the Barrettini-Redsiwe group had a lower rate of death or breathing than in the placebo-Redsiwe group.
were more likely to improve clinically on the 15th day of the placebo-redsiwe group.
are statistically significant for all these endpoints.
-related background In the immediate afterfest of the COVID-19 pandemic, Redsywe began to come to the fore after a randomized double-blind placebo-controlled clinical trial overseen by the National Institutes of Health (NIH) found that intravenous Redsyweed helped COVID-19 patients recover and be discharged from the hospital more quickly than a placebo.
but other studies have found no benefit, most notably the WHO's Solidarity Experiment.
study last month by the Solidarity Trials found that Redsyvir and other research drugs "appear to have had little effect on indicators such as overall mortality, breathability, and length of stay in COVID-19 hospitalizations."
Gilead questioned the results of the Solidarity Trial, which Gilead said in a statement last month "appears to be inconsistent with stronger evidence from other trials" and said the trial had "limitations" that meant it was "unclear whether the results can be drawn from the findings."
week after The Solidarity Data was released, the FDA approved Redsiway for the treatment of hospitalized patients, and the FDA did not mention the Solidarity Trial in its approval, citing NIH studies and other studies that showed That Redsyve could improve symptoms in patients.
many infectious disease doctors believe that even if Redsyve is not a specific drug, it may be helpful for some patients, especially if it can be used early in the disease in some patients.
the drug is designed to work by preventing virus replication, so in theory, if the process can be slowed down before the infection develops too severely, it should have a greater impact.
, some doctors said they had no other treatment options for the virus itself , so it was worth continuing to use Redsyvir .
(steroid steroid dexamizosun) inhibits an overactive immune response in some patients with COVID-19 severity and has been shown to reduce mortality in severe patients.
) [1] Rochwerg Bram, Agoritsas Thomas, Lamontagne François, Leo Yee-Sin, Macdonald Helen, Agarwal Arnav et al. A living WHO guideline on drugs for covid-19 BMJ 2020; 370:m3379 Lin-Pepper