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Gilead drug shows positive signs in early coronavirus testing

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Via Financial Times

Gilead’s remdesivir drug has shown early positive signs that it might be effective in treating coronavirus, in a study of patients who have taken it on a compassionate use basis. 

The New England Journal of Medicine published a small study analysing data from 53 patients, which found that about 68 per cent improved after being treated with remdesivir, an antiviral that some experts hope could stop the Sars-CoV-2 virus from replicating. The drug was originally developed for Ebola, but has never been approved.

But the study did not have a control arm, so the results cannot be compared against patients who did not receive the drug, and should not be treated as conclusive. Large randomised control trials evaluating the drug — and others — are underway across the world. 

Jonathan Grien, the epidemiologist who was the lead author of the journal article, said they cannot draw “definitive conclusions from these data, but the observations from this group of hospitalised patients who received remdesivir are hopeful”. 

Remdesivir is one of the most prominent of the many drugs being explored for treating Covid-19 patients. Other antivirals include HIV drugs developed by AbbVie and a flu treatment from Fujifilm. Many trials are also testing hydroxychloroquine and chloroquine, antimalarials, as well as anti-inflammatories to help calm the body’s immune response if it goes into overdrive in the latter stages of the disease. 

The NEJM study, which took in data from patients in the US, Europe and Japan, found no new safety issues, other than those already reported, which include kidney and liver problems. Without a randomised trial it is hard to tell if those problems are complications of the disease or caused by the drug. 

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Scientists are researching whether the drug may work better if it is delivered during the early stages of the disease. In this study, the patients were already hospitalised when they were given the drug and more than half were receiving ventilation. Patients who did not improve were more likely to be on invasive ventilation and 70-years-old or over.

Gilead, the California-based biotech company that developed the drug, funded the study. The company initially applied for “orphan status” for the drug, designed to expand intellectual property protection to drugs for rare diseases, but has since rescinded the status

Merdad Parsey, chief medical officer at Gilead, said the outcomes were “encouraging” but the data are “limited”. 

“Gilead has multiple clinical trials underway for remdesivir with initial data expected in the coming weeks,” he said. “Our goal is to add to the growing body of evidence as quickly as possible to more fully evaluate the potential of remdesivir and, if appropriate, support broader use of this investigational drug.”

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