Remdesivir
1 Overview of Remdesivir
Remdesivir: A Review of Its Discovery and Development Leading to Emergency Use Authorization for Treatment of COVID-19
Source: NIH
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7202249/
Remdesivir COVID-19 Treatment Guidelines
Source: NIH
https://www.covid19treatmentguidelines.nih.gov/therapies/antiviral-therapy/remdesivir/
"The antiviral medicine remdesivir from Gilead Sciences failed to speed the improvement of patients with Covid-19 or prevent them from dying, according to results from a long-awaited clinical trial conducted in China."
"According to the summary of the China study, remdesivir was “not associated with a difference in time to clinical improvement” compared to a standard of care control. After one month, it appeared 13.9% of the remdesivir patients had died compared to 12.8% of patients in the control arm."
Source: New data on Gilead’s remdesivir, released by accident, show no benefit for coronavirus patients. Company still sees reason for hope, Stat News
Fauci on remdesivir: "This will be the standard of care"
President Donald Trump used and promoted remdesivir
8 drugs Trump has been given for his COVID-19 treatment
"The Wuhan Institute of Virology of the China Academy of Sciences ... applied to patent the use of Remdesivir, an antiviral drug developed by Gilead"
Source: China lab seeks patent on use of Gilead's coronavirus treatment, Reuters
9 members of the NIH Panel on COVID-19 Treatment Guidelines have financial ties to Gilead Sciences, the lab behind Veklury (remdesivir). Those members are:
-Rajesh Gandhi, on advisory board of Gilead Sciences
-David Glidden, consultant for Gilead Sciences
-Adaora Adimora, consultant for recieves research support from Gilead Sciences
-Eric Daar, consultant for recieves research support from Gilead Sciences
-Judith Aberg, research support from Gilead Sciences
-Jason Baker, research support from Gilead Sciences
-Susanna Naggie, research support from Gilead Sciences
-Pablo Tebas, research support from Gilead Sciences
-Roger Bedimo, honoraria from Gilead Sciences
Source: NIH
https://www.covid19treatmentguidelines.nih.gov/about-the-guidelines/panel-financial-disclosure/
Remdesivir was developed by Dr. Ralph Baric of UNC Chapel Hill, which is the same lab that applied for coronavirus gain-of-function research grant.
"Remdesivir was developed through an academic-corporate partnership between Gilead Sciences and the Baric Lab at the University of North Carolina at Chapel Hill’s Gillings School of Global Public Health."
"they hoped to inoculate them with chimeric S proteins, which were proposed to be developed through a subcontract in the grant in Ralph Baric’s lab at the University of North Carolina at Chapel Hill, not in Wuhan. Baric did not respond to The Intercept’s request for comment."
https://theintercept.com/2021/09/23/coronavirus-research-grant-darpa/
"There are at least 700 patients enrolled in multiple trials across the Northwell healthcare system, according to Dr. Marcia Epstein, a lead investigator working on the trials at the Feinstein Institutes for Medical Research at Northwell Health. She declined to comment on the outcome of the trials, which began in March."
https://nypost.com/article/coronavirus-treatment-drug-remdesivir-what-you-need-to-know/
"In our cohort of mechanically ventilated patients, RDV was not associated with a significant reduction of mortality"
Remdesivir Use in Patients Requiring Mechanical Ventilation due to COVID-19
Source: Infectious Diseases Unit, San Gerardo Hospital, Monza, Italy
https://pubmed.ncbi.nlm.nih.gov/33204761/
https://web.archive.org/web/20211222122446/https://pubmed.ncbi.nlm.nih.gov/33204761/
Full Study: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7651598/
Remdesivir mutates immune escape variant of SARS-CoV-2
"We present a case of an immunocompromised patient with acquired B-cell deficiency who developed an indolent, protracted course of SARS-CoV-2 infection. Remdesivir therapy alleviated symptoms and produced a transient virologic response, but her course was complicated by recrudescence of high-grade viral shedding. . . . this case illustrates the importance of monitoring for remdesivir resistance and the potential benefit of combinatorial therapies in immunocompromised patients with SARS-CoV-2 infection."
De novo emergence of a remdesivir resistance mutation during treatment of persistent SARS-CoV-2 infection in an immunocompromised patient
Source: Yale School of Medicine, 2021
https://www.medrxiv.org/content/10.1101/2021.11.08.21266069v1
Comment from Blaze article: "Researchers from the Yale School of Medicine posted a preprint study in which they discovered a mutated version of SARS-CoV-2 that appears to have redeveloped in a previously infected immunocompromised woman who was treated with remdesivir. Researchers were able to sequence the genome in a way that made it clear it was related to the remdesivir use in the patient. The patient was later cured by monoclonal antibodies."
Blaze article: https://www.theblaze.com/op-ed/horowitz-remdesivir-is-the-greatest-scandal-of-the-pandemic
2 Remdesivir Emergency Use Authorization
"Science has learned that both FDA's decision and the EU deal came about under unusual circumstances that gave the company important advantages. FDA never consulted a group of outside experts that it has at the ready to weigh in on complicated antiviral drug issues."
FDA Approves Remdesivir under EUA
"FDA approved Veklury (remdesivir), the first drug approved to treat COVID-19, for use in adults and pediatric patients 12 years of age and older and weighing at least 40 kg (about 88 pounds) requiring hospitalization."
Remdesivir EUA
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/EUA%20Review%20Remdesivir_050120.pdf
"Healthcare providers must submit a report on all medication errors and ALL SERIOUS ADVERSE EVENTS related to VEKLURY."
Remdesivir Fact Sheet for Healthcare Providers
https://www.fda.gov/media/137566/download
https://web.archive.org/web/20211212183608/https://www.fda.gov/media/137566/download
Remdesivir Fact Sheet for Parents and Caregivers
https://www.fda.gov/media/137565/download
https://web.archive.org/web/20211202091727/https://www.fda.gov/media/137565/download
FDA authorizes combination of barticitinib and remdesivir
"Baricitinib is a janus kinase inhibitor, which blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation."
3 Remdesivir Ineffectiveness
WHO recommends against the use of remdesivir in COVID-19 patients
"These Remdesivir, Hydroxychloroquine, Lopinavir and Interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay."
Source: WHO Solidarity trial consortium
https://www.medrxiv.org/content/10.1101/2020.10.15.20209817v1
4 Remdesivir Adverse Reactions
Remdesivir and Acute Renal Failure: A Potential Safety Signal From Disproportionality Analysis of the WHO Safety Database
Source: Department of Nephrology-Dialysis-Transplantation, Centre Hospitalier Universitaire de Nice, Nice Cedex, France
https://pubmed.ncbi.nlm.nih.gov/33340409/
Kidney disorders as serious adverse drug reactions of remdesivir in coronavirus disease 2019: a retrospective case–noncase study
Source: Regional Center of Pharmacovigilance, Department of Pharmacology, Cochin Hospital, AP-HP, Centre–Université de Paris, Paris, France
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7907730/
NIH warns of renal and liver toxicity with remdesivir usage
https://www.covid19treatmentguidelines.nih.gov/tables/antiviral-characteristics/
"A total of 32 patients (60%) reported adverse events during follow-up (Table 2). The most common adverse events were increased hepatic enzymes, diarrhea, rash, renal impairment, and hypotension. In general, adverse events were more common in patients receiving invasive ventilation. A total of 12 patients (23%) had serious adverse events. The most common serious adverse events — multiple-organ-dysfunction syndrome, septic shock, acute kidney injury, and hypotension — were reported in patients who were receiving invasive ventilation at baseline."
Source: Compassionate Use of Remdesivir for Patients with Severe Covid-19, New England Journal of medicine, June 11, 2020
https://www.nejm.org/doi/full/10.1056/NEJMoa2007016
71% of remdesivir trial participants experienced adverse events within 5 days 74% within 10 days, and 35% suffered a serious adverse event in the 10-day study:
"In a randomized, open-label clinical trial (Study GS-US-540-5773) of remdesivir in 397 subjects with severe COVID-19 treated with remdesivir for 5 (n=200) or 10 days (n=197), adverse events were reported in 71 percent and 74 percent of subjects, respectively, serious adverse events were reported in 21 percent and 35 percent of subjects, respectively, and Grade=3 adverse events were reported in 31 percent and 43 percent of subjects, respectively. Nine (5 percent) subjects in the 5-day group and 20 (10 percent) subjects in the 10-day group discontinued treatment due to an adverse event. All cause mortality at Day 28 was 10 percent vs 13 percent in the 5- and 10-day treatment groups, respectively."
Source: FDA Fact Sheet for Healthcare Providers
https://www.fda.gov/media/137566/download
https://web.archive.org/web/20200603145642/https://www.fda.gov/media/137566/download
Study: Remdesivir for 5 or 10 Days in Patients with Severe Covid-19, New England Journal of Medicine
https://www.nejm.org/doi/10.1056/NEJMoa2015301
Clinical Trial: https://www.clinicaltrials.gov/ct2/show/study/NCT04292899
Remdesivir causes liver damage in majority of trial participants and has been known to since animal trials:
"Transaminase elevations have been observed in the remdesivir clinical development program, including in healthy volunteers and patients with COVID19. In healthy volunteers who received up to 150 mg daily for 14 days, alanine aminotransferase (ALT) elevations were observed in the majority of patients, including elevations to up to 10 times baseline values in one subject without evidence of clinical hepatitis." "intravenous administration (slow bolus) of remdesivir to rats at dosage levels of =3 mg/kg/day for up to 4 weeks resulted in findings indicative of kidney injury and/or dysfunction."
Source: FDA Fact Sheet for Healthcare Providers
https://www.fda.gov/media/137566/download
https://web.archive.org/web/20200603145642/https://www.fda.gov/media/137566/download
"The Kaplan–Meier estimates of mortality were 6.7% with remdesivir and 11.9% with placebo by day 15 and 11.4% with remdesivir and 15.2% with placebo by day 29 (hazard ratio, 0.73; 95% CI, 0.52 to 1.03). Serious adverse events were reported in 131 of the 532 patients who received remdesivir (24.6%) and in 163 of the 516 patients who received placebo (31.6%)."
Source: New England Journal of Medicine
https://www.nejm.org/doi/10.1056/NEJMoa2007764
https://web.archive.org/web/20200523161004/https://www.nejm.org/doi/10.1056/NEJMoa2007764
"The most common adverse events occurring in more than 10 percent of patients in either group were nausea (5-day: 10.0%, n=20/200 vs. 10-day: 8.6%, n=17/197) and acute respiratory failure (5-day: 6.0%, n=12/200 vs. 10-day: 10.7%, n= 21/197). Grade 3 or higher liver enzyme (ALT) elevations occurred in 7.3 percent (n=28/385) of patients, with 3.0 percent (n=12/397) of patients discontinuing remdesivir treatment due to elevated liver tests."
Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19
Source: Gilead
"The antiviral medicine remdesivir from Gilead Sciences failed to speed the improvement of patients with Covid-19 or prevent them from dying, according to results from a long-awaited clinical trial conducted in China."
"According to the summary of the China study, remdesivir was “not associated with a difference in time to clinical improvement” compared to a standard of care control. After one month, it appeared 13.9% of the remdesivir patients had died compared to 12.8% of patients in the control arm."
Source: New data on Gilead’s remdesivir, released by accident, show no benefit for coronavirus patients. Company still sees reason for hope, Stat News
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