Saturday, 31 October, 2020

Big global study finds remdesivir doesn't help COVID-19 patients

Coronavirus: Remdesivir has 'little effect' on death risks, says WHO WHO defends data after concluding Gilead's remdesivir flopped Covid trial
Ginger Lawrence | 17 October, 2020, 06:52

"These remdesivir, hydroxychloroquine, lopinavir and interferon regimens appeared to have little or no effect on hospitalized covid-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay", according to the trial results.

WHO said in a statement: "The progress achieved by the Solidarity Therapeutics Trial shows that large worldwide trials are possible, even during a pandemic, and offer the promise of quickly and reliably answering critical public health questions concerning therapeutics".

Remdesivir, which was originally developed as a treatment for Ebola and hepatitis C, interferes with the reproduction of viruses by jamming itself into new viral genes.

A World Health Organization (WHO) trial that concluded Gilead Sciences Inc's remdesivir did not significantly help Covid-19 patients is reliable, a scientist who evaluated the data said on Friday, as the United States company criticized its methodology.

While Gilead said other remdesivir trials, including with 1,062 patients that compared it with a placebo, showed the treatment cut Covid-19 recovery time, Peto, a professor emeritus at Oxford University, said the smaller trial's perceived benefit could have been mere "chance". Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, acknowledged at the time that remdesivir was not a "knockout" drug.

"The outcome of in-hospital mortality is imperfect because deaths can of course occur outside of the hospital", Spinelli said, adding that remdesivir requires participants to remain in the hospital for the 10-day treatment.

Because of its design, there was "significant heterogeneity" in the way the trial was conducted.

The findings, one senior critical care medicine specialist said, imply that affordable steroids such as dexamethasone and methylprednisolone, also approved for Covid-19 are the "only things proven to reduce mortality".

Mexico's ex-defense minister detained in United States on DEA warrant
Several of Mexico's former top-ranking "drug war" officials have been implicated in narcotics. US authorities did not warn their counterparts of the operation.

The WHO trial's results are yet to be reviewed and were uploaded on the preprint server medRxiv.

Remdesivir was approved for use in people who were sick enough to need supplemental oxygen or breathing support, as per ICMR protocol, but has now emerged as standard of care for treating hospitalised Covid-19 patients.

The move was criticized by some experts, who said the FDA had made the shift without sufficient evidence.

The WHO's Solidarity Trial also involved the HIV treatment lopinavir/ritonavir, the malaria drug hydroxychloroquine and multiple sclerosis drug Interferon.

The data from the ACTT-1 trial on 1,062 patients by the U.S. government's National Institute of Allergy and Infectious Diseases (NIAID) published in the New England Journal of Medicine (NEJM) has found that hospitalized patients with COVID-19 pneumonia who received Remdesivir recovered five days faster than patients receiving placebo at day 29, and had evidence of lower respiratory tract infection. Some received a combination of the drugs.

Within the study, HCQ was discontinued for futility on June 18 and lopinavir on July 4. Less data has been published on interferon, a molecule produced by the immune system in response to viruses.

"For each of these four re-purposed non-specific antivirals, several thousand patients have now been randomised in various trials".

Administering remdesivir after that point may be pointless, Schwartz said, adding, "The horse is out of the barn".