Gilead reports compassionate use data of remdesivir in Covid-19

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Gilead Sciences has reported positive data from analysis of an international cohort of patients treated with remdesivir as a potential treatment for Covid-19.

The analysis reviewed 53 patients who were hospitalised with severe complications related to the novel coronavirus infection in the US, Europe, Canada and Japan.

Patients received the experimental antiviral drug on an individual compassionate use basis. The planned treatment was a 10-day course of remdesivir, consisting of a 200 mg loading dose administered intravenously on day 1, followed by 100 mg daily for the remaining nine treatment days. Of the 53 patients included in the analysis, 75 percent received the full 10-day course of remdesivir, 19 percent received 5-9 days of treatment, and 6 percent received fewer than 5 days of treatment. Follow-up continued through 28 days after initiation of remdesivir treatment. Four patients discontinued remdesivir prematurely, one due to worsening of pre-existing renal failure, one due to multiple organ failure and two due to elevated liver enzymes, including one patient with a maculopapular rash.

According to the data, most of the patients treated with remdesivir experienced clinical improvement without any new safety signals.

Gilead noted that around 64% of patients in the cohort were on mechanical ventilation at baseline, including four on extracorporeal membrane oxygenation (ECMO).

After treatment with Gilead’s drug, an improvement in oxygen support class was observed in 68% of patients, with a median follow-up of 18 days from the first dose.

Nearly 57% of patients on mechanical ventilation were extubated and 47% were discharged from the hospital.

A 28 days follow-up showed that the cumulative incidence of clinical improvement was 84% on Kaplan-Meier analysis.

The company added that the frequency of clinical improvement was less among patients on invasive ventilation compared to those on noninvasive ventilation.

In this cohort, the overall mortality rate was 13% and was higher in patients on invasive ventilation versus those on noninvasive oxygen support.

The company noted that compassionate use data has limitations because of the small size, shorter duration of follow-up and no randomised control group.

Gilead Sciences chief medical officer Merdad Parsey said: “While the outcomes observed in this compassionate use analysis are encouraging, the data are limited. Gilead has multiple clinical trials underway for remdesivir with initial data expected in the coming weeks.

“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.”

Currently, Gilead is performing two Phase III trials of remdesivir in countries with high Covid-19 prevalence. Data from these trials is expected to offer further insights into the clinical use of the drug

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