Gilead’s Remdesivir meets main goal of trial in COVID-19 patients

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Gilead Sciences today announced that preliminary results of a coronavirus drug trial showed at least 50% of patients treated with a five-day dosage of remdesivir improved and more than half were discharged from the hospital within two weeks. The company also said another trial by the National Institute of Allergy and Infectious Diseases met its main goal. It did not provide further details, however.

Later, White House health advisor Dr. Anthony Fauci said NIAID’s remdesivir drug trial, which enrolled about 800 patients, showed “quite good news” and that the drug would set a new standard of care for Covid-19 patients. Speaking to reporters from the White House, Fauci said he was told data from the trial showed a “clear-cut positive effect in diminishing time to recover.”

The Food and Drug Administration, in the meantime, has been in “sustained and ongoing” discussions with Gilead to make remdesivir available to Covid-19 patients “as quickly as possible, as appropriate,” said FDA senior advisor Michael Felberbaum.

Gilead’s smaller clinical trial involved 397 patients with severe cases of Covid-19. The severe study is “single-arm,” meaning it did not evaluate the antiviral drug against a control group of patients who didn’t receive the drug.

The study tracked two groups of patients who were hospitalized with Covid-19. One group received a five-day treatment of remdesivir, while the other group took the drug for 10 days. The researchers said more than half the patients in both treatment groups were discharged from the hospital within 14 days. They said 64.5% of the patients who received the shorter treatment were discharged, compared with 53.8% of the group who were treated for 10 days.

“These data are encouraging as they indicate that patients who received a shorter, five-day course of remdesivir experienced similar clinical improvement as patients who received a 10-day treatment course,” said Aruna Subramanian, a lead investigator of the study.

Dr. Scott Gottlieb, shortly after the Gilead news was released, described remdesivir as “part of a better toolbox” for dealing with the coronavirus. But he said on CNBC’s “Squawk Box” that it’s “not a home run, a cure by any means.” “It’s not going to be a cure, but it is going to be a drug potentially that if you use it particularly early in the course of the disease … it could reduce their chances of having a really bad outcome,” he said.

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