Reply to Axelrod et al.

Goldman, Mark A.

doi:10.1111/j.2153-3490.1976.tb00658.x

Cited by 5 publications

(10 citation statements)

References 6 publications

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“…Approximately 80% of patients in our cohort were non-White individuals compared with 30% to 47% in clinical trials. 9,10,32 Because underrepresented minority groups have shouldered a disproportionate burden during the COVID-19 pandemic but have not been widely represented in clinical trials, 13 our results provide important evidence that receipt of remdesivir is associated with decreased time to clinical improvement in these populations.…”

Section: Discussionmentioning

confidence: 86%

“…The vast majority of patients in the remdesivir group received 5 days of therapy, which supports recommendations for an initial 5-day course for most patients. Although ACTT-1 used a 10-day treatment course, a comparison of 5 days vs 10 days showed similar efficacy, 9 and an open-label JAMA Network Open | Infectious Diseases study found that a 5-day course, but not a 10-day course, was associated with a significant improvement in disease severity. 10 Our finding that a 5-day treatment course was associated with a clinical benefit is important, particularly given reports of both US and global shortages of remdesivir and the potential for even greater supply constraints moving forward.…”

Section: Discussionmentioning

confidence: 99%

“…Remdesivir, a nucleotide analogue prodrug with in vitro effects against a broad array of RNA viruses, [2][3][4] has received considerable attention. 3,5,6 Clinical trials assessing the effectiveness of remdesivir have yielded conflicting results [7][8][9][10][11][12] ; have not included a sufficient number of patients from groups most affected by COVID-19, such as Black or Latinx individuals 13 ; and have not examined the coadministration of remdesivir with other drugs. The US Food and Drug Administration (FDA) approved the use of remdesivir for the treatment of hospitalized patients with COVID-19 14 based mostly on the results of the Adaptive COVID-19 Treatment Trial (ACTT-1), 11 whereas the World Health Organization (WHO) recommended against the use of remdesivir 15 based on results from the Solidarity trial.…”

Section: Introductionmentioning

confidence: 99%

“…17 However, only 11% to 20% of participants in remdesivir clinical trials were Black patients, and only 17% to 23% were Latinx patients. 9,10 Because underrepresented minority groups shoulder a disproportionate burden of morbidity and mortality from COVID-19, 18 it is critical that we understand the effects of remdesivir in these populations.…”

Section: Introductionmentioning

confidence: 99%

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Comparison of Time to Clinical Improvement With vs Without Remdesivir Treatment in Hospitalized Patients With COVID-19

et al. 2021

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Key Points Question Does time to clinical improvement or time to death differ among hospitalized patients treated with vs without remdesivir (alone or with corticosteroids) for coronavirus disease 2019 outside of a clinical trial? Findings In this multicenter comparative effectiveness research study that included 2483 consecutive admissions with a high proportion of non-White individuals, treatment with remdesivir was associated with more rapid clinical improvement than no remdesivir receipt in propensity score–matched controls. The addition of corticosteroids to remdesivir was not associated with improved time to death. Meaning Remdesivir administration is associated with more rapid clinical improvement than no remdesivir receipt among patients with coronavirus disease 2019.

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Section: Discussionmentioning

confidence: 86%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Comparison of Time to Clinical Improvement With vs Without Remdesivir Treatment in Hospitalized Patients With COVID-19

et al. 2021

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“…3,4 Over time, prevention and treatment interventions for SARS-CoV-2 expanded dramatically from repurposed antivirals to highly effective vaccines and promising monoclonal antibodies (mAbs). [5][6][7] Despite the success of COVID-19 vaccine development and initial distribution, the pace of vaccination slowed in the US, with a sizeable proportion of eligible persons remaining unvaccinated. 8 Thus, observed COVID-19 cases, hospitalizations, and deaths have increased in multiple waves for several reasons, including vaccination coverage below the threshold for herd immunity, viral variants causing vaccine breakthrough infections, and declining immunity over time.…”

Section: Introductionmentioning

confidence: 99%

Estimated Health Outcomes and Costs of COVID-19 Prophylaxis With Monoclonal Antibodies Among Unvaccinated Household Contacts in the US

et al. 2022

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IMPORTANCEThe COVID-19 pandemic has led to more than 900 000 deaths in the US and continues to disrupt lives even as effective vaccines are available. OBJECTIVETo estimate the health outcomes and net cost of implementing postexposure prophylaxis (PEP) with monoclonal antibodies (mAbs) against household exposure to COVID-19. DESIGN, SETTING, AND PARTICIPANTS This study is a decision analytical model of results from a randomized clinical trial of casirivimab with imdevimab administered as subcutaneous injections to unvaccinated, SARS-CoV-2-negative household contacts of people with confirmed COVID-19 with complementary data on household demographic structure, vaccine coverage, and confirmed COVID-19 case counts. The study used US data from May 2021 for a simulated population of US individuals of all ages within low-transmission or high-transmission scenarios.

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Identification of Bradycardia Following Remdesivir Administration Through the US Food and Drug Administration American College of Medical Toxicology COVID-19 Toxic Pharmacovigilance Project

et al. 2023

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ImportanceThe rapid spread and mortality associated with COVID-19 emphasized a need for surveillance system development to identify adverse events (AEs) to emerging therapeutics. Bradycardia is a remdesivir infusion–associated AE listed in the US Food and Drug Administration–approved prescribing information.ObjectiveTo evaluate the magnitude and duration of bradycardic events following remdesivir administration.Design, Setting, and ParticipantsA multicenter cohort study of patients with recorded heart rate less than 60 beats per minute within 24 hours after administration of a remdesivir dose was conducted between November 23, 2020, and October 31, 2021. Participants included patients hospitalized with COVID-19 at 15 medical centers across the US. Patients excluded had AEs unrelated to bradycardia, AEs in addition to bradycardia, or first onset of bradycardia after 5 remdesivir doses.ExposuresRemdesivir administration.Main Outcomes and MeasuresLinear mixed-effect models for the minimum HR before starting remdesivir and within 24 hours of each dose included doses as fixed effects. Baseline covariates were age (≥65 years vs &lt;65 years), sex (male vs female), cardiovascular disease history (yes vs no), and concomitant use of bradycardia-associated medications. The interactions between variables and doses were considered fixed-effects covariates to adjust models.ResultsA total of 188 patients were included in the primary analysis and 181 in the secondary analysis. The cohort included 108 men (57.4%); 75 individuals (39.9%) were non-Hispanic White and mean (SD) age was 61.3 (15.4) years. Minimum HR after doses 1 to 5 was lower than before remdesivir. Mean minimum HR was lowest after dose 4, decreasing by −15.2 beats per minute (95% CI, −17.4 to −13.1; P &lt; .001) compared with before remdesivir administration. Mean (SD) minimum HR was 55.6 (10.2) beats per minute across all 5 doses. Of 181 patients included in time-to-event analysis, 91 had their first episode of bradycardia within 23.4 hours (95% CI, 20.1-31.5 hours) and 91 had their lowest HR within 60.7 hours (95% CI, 54.0-68.3 hours). Median time to first bradycardia after starting remdesivir was shorter for patients aged 65 years or older vs those younger than 65 years (18.7 hours; 95% CI, 16.8-23.7 hours vs 31.5 hours; 95% CI, 22.7-39.3 hours; P = .04). Median time to lowest HR was shorter for men vs women (54.2 hours; 95% CI, 47.3-62.0 hours vs 71.0 hours; 95% CI, 59.5-79.6 hours; P = .02).Conclusions and RelevanceIn this cohort study, bradycardia occurred during remdesivir infusion and persisted. Given the widespread use of remdesivir, practitioners should be aware of this safety signal.

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Reply to Axelrod et al.

Cited by 5 publications

References 6 publications

Comparison of Time to Clinical Improvement With vs Without Remdesivir Treatment in Hospitalized Patients With COVID-19

Comparison of Time to Clinical Improvement With vs Without Remdesivir Treatment in Hospitalized Patients With COVID-19

Estimated Health Outcomes and Costs of COVID-19 Prophylaxis With Monoclonal Antibodies Among Unvaccinated Household Contacts in the US

Identification of Bradycardia Following Remdesivir Administration Through the US Food and Drug Administration American College of Medical Toxicology COVID-19 Toxic Pharmacovigilance Project

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