Remdesivir and Mortality in Patients with COVID-19

Diaz et al., Clinical Infectious Diseases, doi:10.1093/cid/ciab698, Aug 2021

https://c19early.org/diaz.html

Retrospective 1,138 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, Kim show increased risk of acute kidney injury with remdesivir. Leo, Briciu, Muntean, Petrov show increased risk of liver injury with remdesivir.

Standard of Care (SOC) for COVID-19 in the study country, the USA, is very poor with very low average efficacy for approved treatments11. Only expensive, high-profit treatments were approved. Low-cost treatments were excluded, reducing the probability of treatment—especially early—due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments. This may explain in part the very high mortality seen in this study. Results may differ in countries with improved SOC.

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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.

6. Kim et al., Investigating the Safety Profile of Fast‐Track COVID‐19 Drugs Using the FDA Adverse Event Reporting System Database: A Comparative Observational Study, Pharmacoepidemiology and Drug Safety, doi:10.1002/pds.70043.wiley.com, doi.org.

7. Leo et al., Hepatocellular liver injury in hospitalized patients affected by COVID-19: Presence of different risk factors at different time points, Digestive and Liver Disease, doi:10.1016/j.dld.2021.12.014.sciencedirect.com, doi.org.

8. Briciu et al., Evolving Clinical Manifestations and Outcomes in COVID-19 Patients: A Comparative Analysis of SARS-CoV-2 Variant Waves in a Romanian Hospital Setting, Pathogens, doi:10.3390/pathogens12121453.mdpi.com, doi.org.

9. Muntean et al., Effects of COVID-19 on the Liver and Mortality in Patients with SARS-CoV-2 Pneumonia Caused by Delta and Non-Delta Variants: An Analysis in a Single Centre, Pharmaceuticals, doi:10.3390/ph17010003.mdpi.com, doi.org.

10. Petrov et al., The Effect of Potentially Hepatotoxic Medicinal Products on Alanine Transaminase Levels in COVID-19 Patients: A Case–Control Study, Safety and Risk of Pharmacotherapy, doi:10.30895/2312-7821-2025-458.risksafety.ru, doi.org.

11. c19early.org, c19early.org/soc/usa.html.c19early.org/soc/usa.html.

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

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DOI record: { "DOI": "10.1093/cid/ciab698", "ISSN": [ "1058-4838", "1537-6591" ], "URL": "http://dx.doi.org/10.1093/cid/ciab698", "abstract": "Abstract\n \n Background\n The impact of remdesivir (RDV) on mortality rates in coronavirus disease 2019 (COVID-19) is controversial, and the mortality effect in subgroups of baseline disease severity has been incompletely explored. 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. 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"2022053122502159300_CIT0015" }, { "DOI": "10.1093/cid/ciaa237", "article-title": "In vitro antiviral activity and projection of optimized dosing design of hydroxychloroquine for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)", "author": "Yao", "doi-asserted-by": "crossref", "first-page": "732", "journal-title": "Clin Infect Dis", "key": "2022053122502159300_CIT0016", "volume": "71", "year": "2020" }, { "DOI": "10.1056/NEJM199701233360402", "article-title": "A prediction rule to identify low-risk patients with community-acquired pneumonia", "author": "Fine", "doi-asserted-by": "crossref", "first-page": "243", "journal-title": "N Engl J Med", "key": "2022053122502159300_CIT0017", "volume": "336", "year": "1997" }, { "author": "World Health Organization.", "key": "2022053122502159300_CIT0018" }, { "author": "R Core Team.", "key": "2022053122502159300_CIT0019" }, { "DOI": "10.1056/NEJMoa2021436", "article-title": "Dexamethasone in hospitalized patients with 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Late treatment
is less effective

Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. IMA and WCH provide treatment protocols.

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