Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for Coronavirus Disease 2019 Pneumonia: A Randomized Clinical Trial

Sise et al., Clinical Infectious Diseases, doi:10.1093/cid/ciae333, REDPINE, NCT04745351

Jun 2024

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RCT 243 hospitalized COVID-19 patients with acute kidney injury, chronic kidney disease, or kidney failure showing no significant difference in all-cause mortality or invasive mechanical ventilation with remdesivir. The lower mortality at day 29 (without statistical significance) disappeared at day 60, consistent with remdesivir studies overall.

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

Remdesivir efficacy disappears with longer followup. Mixed-effects meta-regression of efficacy as a function of followup duration across all remdesivir studies shows decreasing efficacy with longer followup7. This may reflect antiviral efficacy being offset by serious adverse effects of treatment.

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risk of death, 0.1% higher, RR 1.00, p = 1.00, treatment 51 of 163 (31.3%), control 25 of 80 (31.2%), day 60.

risk of death, 17.0% lower, HR 0.83, p = 0.39, treatment 41 of 163 (25.2%), control 23 of 80 (28.7%), NNT 28, Cox proportional hazards, day 29.

risk of death/intubation, 18.0% lower, HR 0.82, p = 0.61, treatment 48 of 163 (29.4%), control 26 of 80 (32.5%), NNT 33, Cox proportional hazards, day 29.

clinical status, 16.0% lower, OR 0.84, p = 0.50, treatment 163, control 80, day 29, RR approximated with OR.

clinical status, 5.0% higher, OR 1.05, p = 0.85, treatment 163, control 80, day 15, 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. c19early.org, c19early.org/smeta.html.c19early.org/smeta.html.

Sise et al., 24 Jun 2024, Double Blind Randomized Controlled Trial, placebo-controlled, multiple countries, peer-reviewed, mean age 69.0, 24 authors, study period March 2021 - March 2022, trial NCT04745351 (history) (REDPINE). Contact: msise@mgb.org.

This Paper Remdesivir All

Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for Coronavirus Disease 2019 Pneumonia: A Randomized Clinical Trial

Meghan E Sise, Jose Ramon Santos, Jason D Goldman, Katherine R Tuttle, J Pedro Teixeira, Allan F Seibert, Yiannis Koullias, Joe Llewellyn, Sean Regan, Yang Zhao, Hailin Huang, Robert H Hyland, Anu Osinusi, Helen Winter, Rita Humeniuk, Henry N Hulter, Robert L Gottlieb, Dahlene N Fusco, Rita Birne, Fernando F Stancampiano, Claudia R Libertin, Catherine B Small, Markus Plate, Mark J Mcphail, Redpine Investigators

doi:10.1093/cid/ciae333/7697980

Background. Few antiviral therapies have been studied in patients with coronavirus disease 2019 (COVID-19) and kidney impairment. Herein, the efficacy, safety, and pharmacokinetics of remdesivir, its metabolites, and sulfobutylether-β-cyclodextrin excipient were evaluated in hospitalized patients with COVID-19 and severe kidney impairment. Methods. In REDPINE, a phase 3, randomized, double-blind, placebo-controlled study, participants aged ≥12 years hospitalized for COVID-19 pneumonia with acute kidney injury, chronic kidney disease, or kidney failure were randomized 2:1 to receive intravenous remdesivir (200 mg on day 1; 100 mg daily up to day 5) or placebo (enrollment from March 2021 to March 2022). The primary efficacy end point was the composite of the all-cause mortality rate or invasive mechanical ventilation rate through day 29. Safety was evaluated through day 60. Results. Although enrollment concluded early, 243 participants were enrolled and treated (remdesivir, n = 163; placebo, n = 80). At baseline, 90 participants (37.0%) had acute kidney injury (remdesivir, n = 60; placebo, n = 30), 64 (26.3%) had chronic kidney disease (remdesivir, n = 44; placebo, n = 20), and 89 (36.6%) had kidney failure (remdesivir, n = 59; placebo, n = 30); and 31 (12.8%) were vaccinated against COVID-19. Composite all-cause mortality or invasive mechanical ventilation rates through day 29 were 29.4% and 32.5% in the remdesivir and placebo group, respectively (P = .61). Treatment-emergent adverse events were reported in 80.4% for remdesivir versus 77.5% for placebo, and serious adverse events in 50.3% versus 50.0%, respectively. Pharmacokinetic plasma exposure to remdesivir was not affected by kidney function. Conclusions. Although the study was underpowered, no significant difference in efficacy was observed between treatment groups. REDPINE demonstrated that remdesivir is safe in patients with COVID-19 and severe kidney impairment.

Supplementary Data Supplementary materials are available at Clinical Infectious Diseases online. Consisting of data provided by the authors to benefit the reader, the posted materials are not copyedited and are the sole responsibility of the authors, so questions or comments should be addressed to the corresponding author. Notes Acknowledgments. Medical writing and editorial support were provided by Laura Watts, PhD, of Lumanity Communications Inc. (Yardley, Pennsylvania, USA), and were funded by Gilead Sciences. Investigators thank the patients and their families for their participation Author Contributions. M. E. S. and Y. K. had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: M. E. S., K. R.

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Herein, the efficacy, safety, and ' 'pharmacokinetics of remdesivir, its metabolites, and sulfobutylether-β-cyclodextrin excipient ' 'were evaluated in hospitalized patients with COVID-19 and severe kidney impairment.\n' ' \n' ' \n' ' Methods\n' ' In REDPINE, a phase 3, randomized, double-blind, placebo-controlled ' 'study, participants aged ≥12 years hospitalized for COVID-19 pneumonia with acute kidney ' 'injury, chronic kidney disease, or kidney failure were randomized 2:1 to receive intravenous ' 'remdesivir (200 mg on day 1; 100 mg daily up to day 5) or placebo (enrollment from March 2021 ' 'to March 2022). The primary efficacy end point was the composite of the all-cause mortality ' 'rate or invasive mechanical ventilation rate through day 29. Safety was evaluated through day ' '60.\n' ' \n' ' \n' ' Results\n' ' Although enrollment concluded early, 243 participants were enrolled ' 'and treated (remdesivir, n = 163; placebo, n = 80). At baseline, 90 participants (37.0%) had ' 'acute kidney injury (remdesivir, n = 60; placebo, n = 30), 64 (26.3%) had chronic kidney ' 'disease (remdesivir, n = 44; placebo, n = 20), and 89 (36.6%) had kidney failure (remdesivir, ' 'n = 59; placebo, n = 30); and 31 (12.8%) were vaccinated against COVID-19. Composite ' 'all-cause mortality or invasive mechanical ventilation rates through day 29 were 29.4% and ' '32.5% in the remdesivir and placebo group, respectively (P = .61). Treatment-emergent adverse ' 'events were reported in 80.4% for remdesivir versus 77.5% for placebo, and serious adverse ' 'events in 50.3% versus 50.0%, respectively. Pharmacokinetic plasma exposure to remdesivir was ' 'not affected by kidney function.\n' ' \n' ' \n' ' Conclusions\n' ' Although the study was underpowered, no significant difference in ' 'efficacy was observed between treatment groups. 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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. FLCCC and WCH provide treatment protocols.

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