The drug received emergency-use authorization on May 1 for experimental and compassionate-use treatment for COVID-19 by the U.S. Food and Drug Administration. The results are promising news in the management of the deadly disease, which has killed 578,000 people worldwide and sickened 13.3 million as of July 14.
The study also found remdesivir is equally effective in patients who are from traditionally marginalized racial and ethnic backgrounds -- groups that have seen a higher rate of complications and death due to the prevalence of pre-existing conditions and health care disparities.
Gilead presented its findings during the July 10-11 Virtual COVID-19 Conference as part of the 23rd International AIDS Conference.
The mortality and demographic research was part of a larger Phase 3 study, which examined the safety and efficacy of remdesivir in severely ill COVID-19 patients receiving five-day and 10-day intravenous doses in hospitals. The preliminary results of the larger study were published in The New England Journal of Medicine in May.
Gilead's comparative analysis in mortality and the larger Phase 3 studies reinforces the findings in the National Institute of Allergy and Infectious Diseases' study in hospitalized COVID-19 patients, which showed remdesivir shortened recovery time by an average of four days compared to a placebo. In the NIAID study, patients taking remdesivir trended toward lower mortality compared with the placebo group, but the results did not reach statistical significance (7.1% versus 11.9%), Gilead noted.
The news was also promising for patients of traditionally marginalized races and ethnic backgrounds.
In a subgroup study along with the mortality findings, 84% of African American patients, 75% of Hispanic white patients, 67% of Asian patients, 67% of non-Hispanic white patients and 63% of patients who did not identify with any of these groups showed clinical improvements by day 14 during treatment with remdesivir, according to Gilead.
Another study looked at the use of remdesivir and hydroxychloroquine, the anti-malarial drug touted by President Donald Trump. Patients who were treated simultaneously with both drugs fared worse than those treated with remdesivir alone.
The recovery rates were 57% for those who received both drugs versus 69% for those who only received remdesivir. The analysis also showed that patients in the hydroxychloroquine-remdesivir group experienced overall higher rates of adverse effects, the study noted.
During the July 10 virtual COVID-19 conference, Gilead also presented analyses of its "compassionate use" program, which provides the drug in hospital settings to select groups of patients. The data showed that 83% of pediatric patients and 92% of pregnant and postpartum women with a wide range of COVID-19 severity recovered by day 28.
Among pediatric patients and pregnant and postpartum women in the compassionate-use group, the vast majority of those who were on supplemental oxygen improved by day 28, with 73% discharged from the hospital; 12% that remained hospitalized but no longer needed extra oxygen and 4% that died.
Drilling down deeper, of the 39 pediatric patients who required mechanical ventilators, 80% of these critically ill patients recovered; of the 38 pediatric patients not requiring invasive ventilation, 87% recovered.
Among the 86 pregnant and postpartum women treated with remdesivir in the compassionate use program, 96% of pregnant and 89% of postpartum women achieved improvement in their oxygen-support levels. Pregnant and postpartum women who had more severe illness achieved similarly high rates of recovery, at 93% and 89%, respectively.
Gilead also announced on July 8 that the company is working on developing an inhaled solution of remdesivir for outpatient treatment.