Gilead drug has only modest benefit in large trial; shares fall
03 Juin, 2020, 08:35 | Auteur: Yves Courtet
The patients were hospitalized with confirmed cases of the virus and "evidence of pneumonia without reduced oxygen levels".
Two earlier trials-the National Institute of Allergy and Infectious Diseases' (NIAID) placebo-controlled study and Gilead's own study on severe patients-had shown that 5 days of remdesivir treatment led to significantly clinical improvement among patients by reducing the time to recovery. The results are in line with a previously published trial.
Drug First, what is Remdesivir? The Indian Council of Medical Research had earlier said anti-viral medication remdesivir, which was used during the Ebola outbreak, may inhibit the SARS-CoV-2 replication and research on its efficacy in the treatment of Covid-19 is a part of the WHO's "Solidarity Trial".
With this, the COVID-19 drug can be sold "on the prescription of specialists for use in [a] hospital or institutional set-up". However, Gilead's Phase 3 study assessed the length of treatment, and its conclusions may only apply to a certain subset of patients.
But another group getting the drug for 10 days didn't show a statistically significant improvement, which is likely to raise questions about why a longer course doesn't help more. They were randomized 1:1:1. "The secondary study objective was the rate of adverse events in each remdesivir treatment group compared with standard of care".
Gilead says that a higher proportion of patients in the 5-day cohort achieved improvements in clinical status versus standard care.
The trial found it was "generally well-tolerated" in both the five-day and 10-day treatment course groups, Gilead said in the release.
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Remdesivir has been approved by India's top drug regulator for "restricted emergency use" on COVID-19-infected adults and children.
Remdesivir, which previously failed as a treatment for Ebola, is created to disable the mechanism by which certain viruses, including the new coronavirus, make copies of themselves and potentially overwhelm their host's immune system.
"Administering Remdesivir for 10 days.doesn't have any beneficial effects, so why should patients consume it for an additional five days?" The drug is being administered in some countries under compassionate use rules.
As CNBC points out, the modest benefits against the coronavirus will fuel further skepticism regarding remdesivir.
Gilead shares were down 4.21% at $74.55 at the time of publication Monday.
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