Gilead says drug helped moderately ill coronavirus patients

Henrietta Brewer
June 2, 2020

Severely ill patients weren't included in the trial.

Shares in Gilead Sciences (GILD) traded down 3.4% on Monday after the company announced topline results from its Phase 3 SIMPLE trial in hospitalized patients with moderate Covid-19 pneumonia.

After being given emergency approval in May for use in hospitalized patients, the California-based company announced that it had donated its entire supply of the drug to the USA government to be distributed to "vulnerable" cities with patients that need the medicine, McClatchy News reported.

Remdesivir is now approved in Japan as a treatment for patients infected with SARS-CoV-2, the virus that causes Covid-19.

The new results announced by Gilead are from a study created to evaluate the safety and efficacy of 5- and 10-day treatment with remdesivir in addition to standard of care for patients with moderate COVID-19, compared with standard care alone. The 10-day course did not show improvements that were statistically significant compared to standard care, but Gilead says the odds of improvement were favorable, "trending towards" significance. Nausea and headache were a little more common among those on the drug.

"Today's results showed that when treating moderate disease, a five-day course of remdesivir led to greater clinical improvement than standard of care, adding further evidence of remdesivir's benefit to previously released study results", Merdad Parsey, chief medical officer of Gilead Sciences, said in the release.

The medicine has been issued an Emergency Use Authorization (EUA) by the United States Food and Drug Administration (FDA) for the treatment of hospitalized patients with severe COVID-19, they said.

Gilead plans to submit the full data for publication in a peer-reviewed journal in the coming weeks. "We expect remdesivir to play a prominent role in the treatment of COVID-19 given the lack of other options" Carr says. Even so, access to remdesivir may speed up recovery for some patients. The data showed that patients in the 5-day group were 65% more likely to have clinical improvements on Day 11 compared to those in the standard care group. In the 10-day group, 70% achieved this endpoint. Among the 200 patients who received only the standard of care, 121 showed at least two points of improvement and four died. Patients and their doctors knew who was getting what, which limits the objectivity of the results.

"The drug, which is administered in the form of an injection, has been approved to be sold by retail on the prescription of specialists for use in hospital or institutional set-up only".

"These study results offer additional encouraging data for remdesivir, showing that if we can intervene earlier in the disease process with a five-day treatment course, we can significantly improve clinical outcomes for these patients", Francisco Marty, an infectious diseases physician and associate professor of medicine at Harvard Medical School, said in the release.

Ten days of treatment did not prove better than standard care alone.

"The data show that there is only a small difference between the groups in improvement", Evans said.

The placebo-controlled study conducted by the National Institute of Allergy and Infectious Diseases demonstrated that remdesivir enabled more rapid recovery and that earlier treatment improved outcomes in patients with a range of disease severity.

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