Comparative Study

. 2024 Nov 22;79(5):1182-1189.

doi: 10.1093/cid/ciae336.

Remdesivir for Treatment of COVID-19 Requiring Oxygen Support: A Cross-Study Comparison From 2 Large, Open-Label Studies

Dahlene Fusco¹, Ivana Malenica^{2

3}, Huldrych F Günthard^{4

5}, Samir K Gupta⁶, Dax Kurbegov⁷, Bindu Balani⁸, Susan Olender⁹, Judith A Aberg¹⁰, Laura E Telep², Yuan Tian¹¹, Christiana Blair¹², George Wu¹², Richard H Haubrich¹³, Chen-Yu Wang¹³, Anand P Chokkalingam^{2

14}, Anu O Osinusi¹⁵, Clemens-Martin Wendtner¹⁶, Robert L Gottlieb^{17

18

19

20}

Affiliations

¹ Department of Medicine, Tulane Medical Center, New Orleans, Louisiana, USA.
² Real World Evidence, Gilead Sciences, Inc., Foster City, California, USA.
³ Department of Biostatistics, University of California, Berkeley, Berkeley, California, USA.
⁴ Department of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, Zurich, Switzerland.
⁵ Institute of Medical Virology, University of Zurich, Zurich, Switzerland.
⁶ Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, Indiana, USA.
⁷ Sarah Cannon, Nashville, Tennessee, USA.
⁸ Hackensack School of Medicine, Hackensack University Medical Center, Hackensack, New Jersey, USA.
⁹ Department of Internal Medicine, Columbia University in the City of New York, New York, New York, USA.
¹⁰ Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
¹¹ Clinical Bioinformatics and Exploratory Analytics, Gilead Sciences, Inc., Foster City, California, USA.
¹² Biostatistics, Gilead Sciences, Inc., Foster City, California, USA.
¹³ Global Medical Affairs, Gilead Sciences, Inc., Foster City, California, USA.
¹⁴ Division of Epidemiology, School of Public Health, University of California, Berkeley, California, USA.
¹⁵ Clinical Development, Gilead Sciences, Inc., Foster City, California, USA.
¹⁶ Munich Clinic Schwabing, Academic Teaching Hospital, Ludwig-Maximilians-University, Munich, Germany.
¹⁷ Center for Advanced Heart and Lung Disease, Baylor University Medical Center, Dallas, Texas, USA.
¹⁸ Department of Internal Medicine, Texas A&M Health Science Center, Dallas, Texas, USA.
¹⁹ Department of Internal Medicine, Burnett School of Medicine at TCU, Fort Worth, Texas, USA.
²⁰ Baylor Scott & White Research Institute, Dallas, Texas, USA.

PMID: 38920297
DOI: 10.1093/cid/ciae336

Comparative Study

Remdesivir for Treatment of COVID-19 Requiring Oxygen Support: A Cross-Study Comparison From 2 Large, Open-Label Studies

Dahlene Fusco et al. Clin Infect Dis. 2024.

. 2024 Nov 22;79(5):1182-1189.

doi: 10.1093/cid/ciae336.

Authors

Affiliations

¹ Department of Medicine, Tulane Medical Center, New Orleans, Louisiana, USA.
² Real World Evidence, Gilead Sciences, Inc., Foster City, California, USA.
³ Department of Biostatistics, University of California, Berkeley, Berkeley, California, USA.
⁴ Department of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, Zurich, Switzerland.
⁵ Institute of Medical Virology, University of Zurich, Zurich, Switzerland.
⁶ Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, Indiana, USA.
⁷ Sarah Cannon, Nashville, Tennessee, USA.
⁸ Hackensack School of Medicine, Hackensack University Medical Center, Hackensack, New Jersey, USA.
⁹ Department of Internal Medicine, Columbia University in the City of New York, New York, New York, USA.
¹⁰ Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
¹¹ Clinical Bioinformatics and Exploratory Analytics, Gilead Sciences, Inc., Foster City, California, USA.
¹² Biostatistics, Gilead Sciences, Inc., Foster City, California, USA.
¹³ Global Medical Affairs, Gilead Sciences, Inc., Foster City, California, USA.
¹⁴ Division of Epidemiology, School of Public Health, University of California, Berkeley, California, USA.
¹⁵ Clinical Development, Gilead Sciences, Inc., Foster City, California, USA.
¹⁶ Munich Clinic Schwabing, Academic Teaching Hospital, Ludwig-Maximilians-University, Munich, Germany.
¹⁷ Center for Advanced Heart and Lung Disease, Baylor University Medical Center, Dallas, Texas, USA.
¹⁸ Department of Internal Medicine, Texas A&M Health Science Center, Dallas, Texas, USA.
¹⁹ Department of Internal Medicine, Burnett School of Medicine at TCU, Fort Worth, Texas, USA.
²⁰ Baylor Scott & White Research Institute, Dallas, Texas, USA.

PMID: 38920297
DOI: 10.1093/cid/ciae336

Abstract

Background: Remdesivir, an RNA-polymerase prodrug inhibitor approved for treatment of coronavirus disease 2019 (COVID-19), shortens recovery time and improves clinical outcomes. This prespecified analysis compared remdesivir plus standard of care (SOC) with SOC alone in adults hospitalized with COVID-19 requiring oxygen support in the early stage of the pandemic.

Methods: Data for 10-day remdesivir treatment plus SOC from the extension phase of an open-label study (NCT04292899) were compared with real-world, retrospective data on SOC alone (EUPAS34303). Both studies included patients aged ≥18 years hospitalized with severe acute respiratory syndrome coronavirus 2 up to 30 May 2020, with oxygen saturation ≤94% on room air or supplemental oxygen (all forms), and with pulmonary infiltrates. Propensity score weighting was used to balance patient demographics and clinical characteristics across treatment groups. The primary endpoint was time to all-cause mortality or end of study (day 28). Time to discharge, with a 10-day landmark to account for duration of remdesivir treatment, was a secondary endpoint.

Results: A total of 1974 patients treated with remdesivir plus SOC, and 1426 with SOC alone, were included after weighting. Remdesivir significantly reduced mortality versus SOC (hazard ratio [HR], 0.46; 95% confidence interval, .39-.54). This association was observed at each oxygen support level, with the lowest HR for patients on low-flow oxygen. Remdesivir significantly increased the likelihood of discharge at day 28 versus SOC in the 10-day landmark analysis (HR, 1.64; 95% confidence interval: 1.43-1.87).

Conclusions: Remdesivir plus early-2020 SOC was associated with a 54% lower mortality risk and shorter hospital stays compared with SOC alone in patients hospitalized with COVID-19 requiring oxygen support. Clinical Trials Registration. ClinicalTrials.gov NCT04292899 and EUPAS34303.

Keywords: SARS-CoV-2; antiviral; discharge; hospitalization; mortality.

© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.

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Conflict of interest statement

Potential conflicts of interest. D. F. has served on advisory boards for Gilead Sciences, Inc. and Axcella, and as site principal investigator for clinical trials sponsored by Gilead Sciences, Inc., MetroBiotech, LLC, the National Institutes of Health (NIH; DMID COVAIL), and Regeneron. H. F. G. has received honoraria as a member of DMC or advisory boards for Gilead Sciences, Inc., GSK, Janssen, Johnson and Johnson, Merck, Novartis, and ViiV Healthcare. Furthermore, he has received grants outside of this work from the NIH, Swiss HIV Cohort Study, Swiss National Science Foundation, and Yvonne Jacob Foundation; and has received unrestricted research grants from Gilead Sciences, Inc. All grants were paid to his institution. He has also received a travel grant from Gilead Sciences, Inc. for conference attendance. S. K. G. has received independent grant funding from Indiana University, the NIH, and ViiV Healthcare; and has received consulting/advisory fees from Gilead Sciences, Inc. and ViiV Healthcare. D. K. has received consulting fees from E.R. Squibb & Sons, LLC, and holds stock options in HCA Healthcare. B. B. has received grants from AstraZeneca, Gilead Sciences, Inc., and NIH; has received consulting fees, speaker honoraria, and travel support from Gilead Sciences, Inc.; has participated on a Data Safety Monitoring Board (DSMB) or advisory board for Gilead Sciences, Inc. and is a Gilead Sciences, Inc. speaker for their hepatitis C virus antiviral agent. S. O. has received research funding from HRSA Ryan White Funds. J. A. A. has received institutional research support for clinical trials from Emergent BioSolutions, Frontier Technologies, Gilead Sciences, Inc., GSK, Janssen, Merck, Pfizer, Regeneron, and ViiV Healthcare; has received personal fees for advisory boards from GSK/ViiV Healthcare and Merck; and has participated on a DSMB for Kintor Pharmaceutical, all outside the submitted work. I. M., L. E. T., Y. T., C. B., G. W., R. H., C.-Y. W., A. P. C., and A. O. O. are employees of, and stockholders in, Gilead Sciences, Inc. C.-M. W. has received research funding and travel grants from Gilead Sciences, Inc. for this study; has received research grants or contracts; consulting fees, payment, or honoraria for lectures, presentations, or educational events; and travel support from AbbVie, AstraZeneca, BeiGene, BioNTech, Hoffmann-La Roche, Janssen, and Moderna; and has participated on a Data DSMB or advisory board for AbbVie, AstraZeneca, BeiGene, BioNTech, Hoffmann-La Roche, Janssen, and Moderna. R. L. G. has received grants or contracts to his institution from Eli Lilly, Gilead Sciences, Inc., Johnson & Johnson, Pfizer, Regeneron, and Roivant Sciences (Kinevant Sciences); has received consulting fees from AbbVie, Eli Lilly, Gilead Sciences, Inc., GSK, and Roche; has received payment or honoraria for lectures/speaker fees from Gilead Sciences, Inc. and Pfizer (for an unrelated field); has received travel support from Gilead Sciences, Inc.; has participated on advisory boards for AbbVie, AstraZeneca, Eli Lilly, Gilead Sciences, Inc., GSK, Johnson & Johnson, Kinevant Sciences, and Roche/Genentech; is a de minimis stockholder at AbCellera; and received a gift-in-kind to his institution for an unrelated clinical trial (NCT03383419) from Gilead Sciences, Inc. during the conduct of this study. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

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Remdesivir for Treatment of COVID-19 Requiring Oxygen Support: A Cross-Study Comparison From 2 Large, Open-Label Studies

Affiliations

Remdesivir for Treatment of COVID-19 Requiring Oxygen Support: A Cross-Study Comparison From 2 Large, Open-Label Studies

Authors

Affiliations

Abstract

Conflict of interest statement

References

Publication types

MeSH terms

Substances

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

Miscellaneous