Remdesivir and Mortality in Patients with COVID-19

Diaz et al., Clinical Infectious Diseases, doi:10.1093/cid/ciab698

Aug 2021

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Retrospective 1138 hospitalized patients in the USA, 286 treated with remdesivir, showing lower mortality with treatment.

Age was not included in the adjustments (authors excluded variables that contributed to another score, in this case age is in Pneumonia Severity Index).

Gérard, Zhou, Wu, Kamo, Choi show significantly increased risk of acute kidney injury with remdesivir.

Important missing comments or errors? Let us know.

risk of death, 34.7% lower, HR 0.65, p = 0.01, treatment 33 of 286 (11.5%), control 173 of 852 (20.3%), NNT 11, adjusted per study, odds ratio converted to relative risk, multivariable, Cox proportional hazards, day 60.

risk of death, 44.0% lower, HR 0.56, p = 0.04, treatment 286, control 852, adjusted per study, multivariable, Cox proportional hazards, day 30, RR approximated with OR.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

1. Gérard et al., Remdesivir and Acute Renal Failure: A Potential Safety Signal From Disproportionality Analysis of the WHO Safety Database, Clinical Pharmacology & Therapeutics, doi:10.1002/cpt.2145.wiley.com, doi.org.

2. Zhou et al., Acute Kidney Injury and Drugs Prescribed for COVID-19 in Diabetes Patients: A Real-World Disproportionality Analysis, Frontiers in Pharmacology, doi:10.3389/fphar.2022.833679.frontiersin.org, doi.org.

3. Wu et al., Acute Kidney Injury Associated With Remdesivir: A Comprehensive Pharmacovigilance Analysis of COVID-19 Reports in FAERS, Frontiers in Pharmacology, doi:10.3389/fphar.2022.692828.frontiersin.org, doi.org.

4. Kamo et al., Association of Antiviral Drugs for the Treatment of COVID-19 With Acute Renal Failure, In Vivo, doi:10.21873/invivo.13637.iiarjournals.org, doi.org.

5. Choi et al., Comparative effectiveness of combination therapy with nirmatrelvir–ritonavir and remdesivir versus monotherapy with remdesivir or nirmatrelvir–ritonavir in patients hospitalised with COVID-19: a target trial emulation study, The Lancet Infectious Diseases, doi:10.1016/S1473-3099(24)00353-0.sciencedirect.com, doi.org.

Diaz et al., 19 Aug 2021, retrospective, USA, peer-reviewed, 45 authors.

This Paper Remdesivir All

MD George A Diaz, PharmD, BCIDP Alyssa B Christensen, MD Tobias Pusch, MD Delaney Goulet, PhD Shu-Ching Chang, PhD Gary L Grunkemeier, MISM Paul A Mckelvey, MD Ari Robicsek, MS Tom French, MD Guilford T Parsons, MPH Glenn Doherty, MS Charles Laurenson, Ryan Roper, MD Jennifer Hadlock, MD, MPH Cameron J Cover, PharmD, BCPS Brent Footer, MD Philip Robinson, ARNP Mary Micikas, MD Jennifer E Marfori, Charlotte Cronenweth, Yogavedya Mukkamala, Jamie Mackiewicz, Ekra Rai, Martha Dickinson Matson, RN Jodie Davila, Justin Rueda, Reda Tipton, Heather Algren Rn, MD Brittney C Ward, MD Stephen Malkoski, MD Tyler Gluckman, PharmD Gregory B Tallman, MD Henry Arguinchona, MD Terese C Hammond, MD Steven Standaert, MD Joshua Christensen, MD, MPH Jose F Echaiz, MD, MPH Robert Choi, MD Daniel Mcclung, MD Albert Pacifico, MD Martin Fee, MD Farjad Sarafian, MD, PhD William R Berrington, MD, MPH Jason D Goldman

doi:10.1093/cid/ciab698/6352176

From an early retrospective cohort of hospitalized COVID-19 patients, remdesivir use is associated with lower mortality compared to best supportive care. The effect remains the same for the subgroup of patients requiring low flow oxygen at baseline, similar to the ACTT-1 results.

Disclaimer The manufacturer of RDV (Gilead Sciences, Inc.) and the sponsor of ACTT-1 (NIH NIAID) approved the reuse of data for this study, but was not involved in study design, data preparation, data analysis or manuscript preparation. A c c e p t e d M a n u s c r i p t

References

Beigel, Tomashek, Dodd, Remdesivir for the Treatment of Covid-19 -Final Report, N Engl J Med, doi:10.1056/NEJMoa2007764

Cavalcanti, Zampieri, Rosa, Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19, N Engl J Med, doi:10.1056/NEJMoa2019014

Fine, Auble, Yealy, A prediction rule to identify low-risk patients with community-acquired pneumonia, N Engl J Med. Jan, doi:10.1056/NEJM199701233360402

Geleris, Sun, Platt, Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19, N Engl J Med, doi:10.1056/NEJMoa2012410

Goldman, Lye, Hui, Remdesivir for 5 or 10 Days in Patients with Severe Covid-19, N Engl J Med, doi:10.1056/NEJMoa2015301

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Grein, Ohmagari, Shin, Compassionate Use of Remdesivir for Patients with Severe Covid-19, New England Journal of Medicine, doi:10.1056/nejmoa2007016

Holshue, Debolt, Lindquist, First Case of 2019 Novel Coronavirus in the United States, N Engl J Med. Mar, doi:10.1056/NEJMoa2001191

Horby, Mafham, Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19, N Engl J Med, doi:10.1056/NEJMoa2022926

Olender, Perez, Go, Remdesivir for Severe Coronavirus Disease 2019 (COVID-19) Versus a Cohort Receiving Standard of Care, Clinical Infectious Diseases, doi:10.1093/cid/ciaa1041

Pan, Peto, Repurposed Antiviral Drugs for Covid-19 -Interim WHO Solidarity Trial Results, N Engl J Med, doi:10.1056/NEJMoa2023184

Rosenberg, Dufort, Udo, Association of Treatment With Hydroxychloroquine or Azithromycin With In-Hospital Mortality in Patients With COVID-19 in New York State, JAMA, doi:10.1001/jama.2020.8630

Skipper, Pastick, Engen, Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 : A Randomized Trial, Ann Intern Med, doi:10.7326/M20-4207

Spinner, Gottlieb, Criner, Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19: A Randomized Clinical Trial, JAMA. Sep, doi:10.1001/jama.2020.16349

Tang, Cao, Han, Hydroxychloroquine in patients with mainly mild to moderate coronavirus disease 2019: open label, randomised controlled trial, BMJ, doi:10.1136/bmj.m1849

Yao, Ye, Zhang, Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Clin Infect Dis, doi:10.1093/cid/ciaa237

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The purpose of this study was to assess the ' 'association of RDV with mortality rates in patients with COVID-19.\n' ' \n' ' \n' ' Methods\n' ' In this retrospective cohort study we compared persons receiving ' 'RDV with those receiving best supportive care (BSC). Patients hospitalized between 28 ' 'February and 28 May 2020 with laboratory-confirmed severe acute respiratory syndrome ' 'coronavirus 2 infection were included with the development of COVID-19 pneumonia on chest ' 'radiography and hypoxia requiring supplemental oxygen or oxygen saturation ≤94% with room ' 'air. The primary outcome was overall survival, assessed with time-dependent Cox proportional ' 'hazards regression and multivariable adjustment, including calendar time, baseline patient ' 'characteristics, corticosteroid use, and random effects for hospital.\n' ' \n' ' \n' ' Results\n' ' A total of 1138 patients were enrolled, including 286 who received ' 'RDV and 852 treated with BSC, 400 of whom received hydroxychloroquine. Corticosteroids were ' 'used in 20.4% of the cohort (12.6% in RDV and 23% in BSC). Comparing persons receiving RDV ' 'with those receiving BSC, the hazard ratio (95% confidence interval) for death was 0.46 ' '(.31–.69) in the univariate model (P &lt; .001) and 0.60 (.40–.90) in the risk-adjusted ' 'model (P = .01). In the subgroup of persons with baseline use of low-flow oxygen, the hazard ' 'ratio (95% confidence interval) for death in RDV compared with BSC was 0.63 (.39–1.00; P = ' '.049).\n' ' \n' ' \n' ' Conclusion\n' ' Treatment with RDV was associated with lower mortality rates than ' 'BSC. These findings remain the same in the subgroup with baseline use of low-flow ' 'oxygen.\n' ' ', 'DOI': '10.1093/cid/ciab698', 'type': 'journal-article', 'created': {'date-parts': [[2021, 8, 11]], 'date-time': '2021-08-11T03:12:56Z', 'timestamp': 1628651576000}, 'page': '1812-1820', 'source': 'Crossref', 'is-referenced-by-count': 21, 'title': 'Remdesivir and Mortality in Patients With Coronavirus Disease 2019', 'prefix': '10.1093', 'volume': '74', 'author': [ { 'given': 'George A', 'family': 'Diaz', 'sequence': 'first', 'affiliation': [ { 'name': 'Division of Medicine, Section of Infectious Diseases, Providence ' 'Regional Medical Center Everett , Everett, Washington , USA'}, { 'name': 'Washington State University Elson S. 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Late treatment
is less effective

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