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Gilead says remdesivir shows improvement in COVID-19 patients when used early

Interest in Gilead’s drug has been high as there are currently no approved treatments or preventive vaccines for COVID-19, and doctors are desperate for anything that might alter the course of the disease that attacks the lungs and can shut down other organs in extremely severe cases.

By: Reuters | Published: April 29, 2020 10:11:46 pm
Results from that trial have been highly anticipated because it compares how patients who received remdesivir fared versus patients who did not.

Gilead Sciences Inc on Wednesday said its experimental antiviral drug remdesivir helped improve outcomes for patients with COVID-19, and provided data suggesting it worked better when given earlier in the course of infection.

The closely watched drug has moved markets in the past few weeks following the release of several studies that painted a mixed picture of its effectiveness.

Gilead provided information on two clinical trials underway. The company said a study being conducted by the National Institute of Allergy and Infectious Diseases (NIAIS) met its main goal in helping patients with COVID-19, the disease caused by the novel coronavirus.

Results from that trial have been highly anticipated because it compares how patients who received remdesivir fared versus patients who did not. The lead researcher on that trial told Reuters on Friday that results could come by mid-May, with preliminary findings possible even earlier.

More detailed information on that study will be provided at a later date, Gilead said.

Gilead also provided data on a study that it has conducted in dozens of medical centers, which does not compare the use of remdesivir against a placebo. In that trial, Gilead said 62% of patients treated early with remdesivir were discharged from the hospital, compared with 49% of patients who were treated late.

The trial included 397 patients and evaluated the safety and efficacy of five-day and 10-day dosing regimens of remdesivir in hospitalized patients with severe manifestations of COVID-19.

“The study demonstrates the potential for some patients to be treated with a five-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir,” said Merdad Parsey, chief medical officer at Gilead Sciences, in a statement.

Gilead has defended prospects for remdesivir in helping fight the coronavirus pandemic against signs that it may not provide a significant benefit.

A draft study abstract released inadvertently by the World Health Organization (WHO) last week said remdesivir failed to improve patients’ condition or reduce the pathogen’s presence in the bloodstream. The drugmaker said the findings were inconclusive because the study was terminated early.

Interest in Gilead’s drug has been high as there are currently no approved treatments or preventive vaccines for COVID-19, and doctors are desperate for anything that might alter the course of the disease that attacks the lungs and can shut down other organs in extremely severe cases.

Remdesivir, which previously failed as a treatment for Ebola, is being tried against COVID-19 because it is designed to disable the mechanism by which certain viruses, including the new coronavirus, make copies of themselves and potentially overwhelm their host’s immune system.

The Gilead-led study enrolled patients with blood oxygen levels of 94% or lower but who were not on mechanical ventilators. Normal oxygen saturation levels are 95% to 100%. The trial excluded patients with high levels of enzymes indicating possible liver or kidney damage.

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