Remdesivir Therapy Tied to Lower Mortality in Severe COVID-19

By Will Boggs MD

July 31, 2020

NEW YORK (Reuters Health) - Remdesivir treatment is associated with reduced odds of death and improved odds of recovery in patients with severe COVID-19, according to an interim analysis of two ongoing studies.

"Remdesivir is the first antiviral treatment for COVID-19 to demonstrate patient improvement in clinical studies," Dr. Richard H. Haubrich of Gilead Sciences, Inc., in Foster City, California, told Reuters Health by email. "This comparative analysis provides valuable additional information regarding the benefit of remdesivir compared with standard of care alone."

Two U.S. studies have indicated benefits of remdesivir in patients with COVID-19, while one study in China failed to demonstrate significant clinical benefits.

Dr. Haubrich and colleagues used interim data from a prospective randomized trial of two doses of intravenous remdesivir and a concurrent retrospective cohort of patients with severe COVID-19 not treated with remdesivir to compare the efficacy of remdesivir versus standard care.

The co-primary endpoints were clinical status (with an ordinal scale from 1=death to 7=discharged alive) and all-cause mortality at day 28.

After an inverse probability of treatment weighting (IPTW) procedure, 312 remdesivir patients and 818 non-remdesivir patients were included in the analysis.

Recovery - defined as a baseline score of 2-4 improved to 5-7, a baseline score of 5 improved to 6-7, or a baseline score of 6 improved to 7 - was reached at day 14 by 74.4% of patients in the remdesivir group versus 59.0% in the non-remdesivir group, after stabilized IPTW.

The adjusted odds of recovery for the remdesivir group were 2.03-fold higher than for the non-remdesivir group in a weighted multivariable logistic regression model (P<0.001).

Up to day 14, the weighted mortality was significantly lower in the remdesivir group (7.6%) than in the non-remdesivir group (12.5%), the researchers report in Clinical Infectious Diseases.

"In the midst of ongoing outbreaks, we shared the data from this retrospective analysis to add to the available body of knowledge about treatment with remdesivir," Dr. Haubrich said. "While the mortality benefit seen in this data analysis is encouraging, it requires confirmation in prospective clinical trials. We anticipate mortality data will be available from the Day 28 results of the NIAID ACTT-I trial in the near future, and other ongoing studies will provide additional data."

"We are actively developing formulations with the potential to reach patients in early stages of disease and in alternative care settings outside of hospitals," he added. "We also have initiated a study of a new, investigational inhaled solution of remdesivir. Additionally, we are collaborating with other companies to evaluate combination treatment of remdesivir with immune-modulating therapies, with the hope of continuing to improve upon patient outcomes."

Dr. Robin E. Ferner of the University of Birmingham, in the U.K., who recently reviewed the available evidence for the use of remdesivir in COVID-19, told Reuters Health by email, "This is another company-sponsored interim analysis of observational data on remdesivir, when what we need is a proper, large, masked, randomized, controlled trial."

"The complex analysis makes correction for some things, such as use of azithromycin, but not others, such as use of dexamethasone or other corticosteroids," he said. "There was no correction for socioeconomic status between or within countries (in many of which, the standard of medical care will depend on socioeconomic status), and a cohort of Italian patients was omitted from the study 'given differences in mortality outcomes seen in Italy compared to other sites.'"

Dr. Shixue Dai of Guangdong Academy of Medical Sciences, South China University of Technology, in Guangzhou, who also recently evaluated the evidence for remdesivir for COVID-19, told Reuters Health by email, "I think remdesivir is more suitable for preventive treatment or early treatment. At the same time, it should also be used in the treatment of critically ill patients."

Gilead Sciences employed 15 of the 32 authors of this report and had various relationships with 11 other authors.

SOURCE: https://bit.ly/2DluI3R Clinical Infectious Diseases, online July 24, 2020.

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