How dangerous is remdesivir?
Remdesivir is an antiviral medication that targets a range of viruses. It was originally developed over a decade ago to treat hepatitis C and a cold-like virus called respiratory syncytial virus (RSV). Remdesivir wasn’t an effective treatment for either disease. But it …
When should remdesivir therapy begin?
Feb 07, 2022 · Federal agencies now recommend remdesivir as one of four options for treating early COVID-19. These medicines, when started within five to 10 days of the onset of symptoms, could help patients who...
Who gets treated with remdesivir?
Remdesivir injection is used to treat coronavirus disease 2019 (COVID-19 infection) caused by the SARS-CoV-2 virus in hospitalized adults and children 12 years of age and older who weigh at least 88 pounds (40 kg).
When should you take remdesivir?
Jan 05, 2021 · Remdesivir is an investigational antiviral medication used to treat patients with COVID-19. There is limited information on the safety and effectiveness of using remdesivir to treat people with COVID-19. However, it was shown in a clinical trial to shorten the recovery time in some people.
How does Remdesivir injection work to treat COVID-19?
Remdesivir is in a class of medications called antivirals. It works by stopping the virus from spreading in the body.
Is Remdesivir approved to treat COVID-19?
Remdesivir is a nucleotide analogue prodrug that is approved to treat COVID-19 in certain patients.Mar 2, 2022
What are the side effects of Remdesivir?
Remdesivir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:• nausea• constipation• pain, bleeding, bruising of the skin, soreness, or swelling near the place where the medication was injected
Who is eligible for Paxlovid?
The FDA authorized Paxlovid for people ages 12 and older who weigh at least 88 pounds. But in order to qualify for a prescription, you must also have had a positive COVID-19 test result and be at high risk for developing severe COVID-19.Apr 12, 2022
Is Remdesivir approved in Europe for treatment of COVID-19?
Since July 2020, remdesivir has been conditionally approved in Europe for the treatment of coronavirus disease (COVID-19) in adults and adolescents aged 12 years and older with pneumonia who require supplemental oxygen but no invasive ventilation.Jul 6, 2021
What is the first drug that was approved by the FDA to treat COVID-19?
Remdesivir is the first drug approved by the FDA for treatment of hospitalized COVID patients over the age of 12.Jan 25, 2022
Are long term side effects possible with the COVID-19 vaccine?
Benefits of Vaccination Outweigh the Risks Serious side effects that could cause a long-term health problem are extremely unusual following any vaccination, including COVID-19 vaccination.
Is it possible to have lingering symptoms of COVID-19?
"Some symptoms of COVID-19 linger longer than others," says Dr. Septimus. "In particular, fatigue and loss of taste and smell can persist beyond the period of contagion."While uncomfortable and/or inconvenient, Dr. Septimus adds that these lingering symptoms aren't too worrisome for most people.Jan 5, 2022
What are some of the side effects of the COVID-19 vaccine?
Not everyone experiences symptoms after vaccination, but those who do may experience pain, redness or swelling at the injection site and tiredness, headache, muscle pain, chills, fever and/or nausea.Mar 1, 2022
Do you need a prescription for Paxlovid?
5. Can anyone get a Paxlovid prescription? The FDA authorized Paxlovid for people ages 12 and older who weigh at least 88 pounds. But in order to qualify for a prescription, you must also have had a positive COVID-19 test result and be at high risk for developing severe COVID-19.Apr 12, 2022
Who is eligible for the COVID-19 vaccine?
Vaccines Are Widely Available for Everyone 5 Years and Older Staying up to date means getting all recommended COVID-19 vaccines, including a booster shot when eligible. People who are moderately or severely immunocompromised have specific COVID-19 vaccine recommendations, which include an additional third dose to complete their primary series, as well as a booster shot for those eligible.
Who are some groups at higher risk for serious illness from COVID-19?
Some people may be at higher risk of severe illness. This includes older adults (65 years and older) and people of any age with serious underlying medical conditions. By using strategies that help prevent the spread of COVID-19 in the workplace, you will help protect all employees, including those at higher risk.
How often is Remdesivir given?
Remdesivir is usually given once per day for 5 to 10 days. You will need frequent blood tests to check your liver function. You must remain under the care of a doctor while you are being treated with remdesivir for COVID-19.
What are the side effects of Remdesivir?
Remdesivir side effects. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Some side effects may occur during or after the injection. Tell your caregiver right away if you have:
How old is a person who takes Remdesivir?
Remdesivir is used to treat people with coronavirus disease 2019 (COVID-19) who are in a hospital. Remdesivir is for use in adults and children at least 12 years old and weighing at least 88 pounds (40 kilograms). Remdesivir may also be used for purposes not listed in this medication guide.
How does Remdesivir work?
Remdesivir works by interrupting production of the virus. Coronaviruses have genomes made up ribonucleic acid (RNA). Remdesivir interferes with one of the key enzymes the virus needs to replicate RNA. This prevents the virus from multiplying.
How long does it take to recover from remdesivir?
The median recovery time was 10 days with remdesivir compared to 15 days for the placebo group. Patients given remdesivir were more likely to have improved by day 15.
Is Remdesivir an antiviral?
Xavierarnau / E+ via Getty Images. Remdesivir is an antiviral medication that targets a range of viruses . It was originally developed over a decade ago to treat hepatitis C and a cold-like virus called respiratory syncytial virus (RSV). Remdesivir wasn’t an effective treatment for either disease. But it showed promise against other viruses.
Is Remdesivir safe for patients?
Other investigational medications worked better, but it was shown to be safe for patients. Studies in cells and animals suggested that remdesivir was effective against viruses in the coronavirus family, such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS).
Does Remdesivir help with respiratory disease?
The study also suggested that remdesivir treatment may prevent patients from progressing to more severe respiratory disease. Those treated with remdesivir were less likely to need high levels of respiratory support. Remdesivir appeared to most benefit patients who were receiving supplemental oxygen.
Does Remdesivir improve mortality?
Remdesivir also improved mortality rates for those receiving supplemental oxygen (4% with remdesivir versus 13% with placebo at day 29 of treatment). All-cause mortality among all patients was 11% with remdesivir and 15% with placebo at day 29, but this difference between the treatment groups was not large enough to rule out chance.
What is Remdesivir used for?
Remdesivir was originally created and developed by Gilead Sciences in 2009, to treat hepatitis C and respiratory syncytial virus (RSV). It did not work against hepatitis C or RSV, but was then repurposed and studied as a potential treatment for Ebola virus disease and Marburg virus infections. According to the Czech News Agency, this new line of research was carried out under the direction of scientist Tomáš Cihlář. A collaboration of researchers from the Centers for Disease Control and Prevention (CDC) and Gilead Sciences subsequently discovered that remdesivir had antiviral activity in vitro against multiple filoviruses, pneumoviruses, paramyxoviruses, and coronaviruses.
When was Remdesivir approved?
Remdesivir was approved for medical use in the United States in October 2020. The U.S. Food and Drug Administration (FDA) approved remdesivir based on the agency's analysis of data from three randomized, controlled clinical trials that included participants hospitalized with mild-to-severe COVID‑19.
How many Remdesivir courses are there in 2020?
On 8 October 2020, Gilead Sciences and the European Commission announced they had signed a joint procurement framework contract in which Gilead agreed to provide up to 500,000 remdesivir treatment courses over the next six months to 37 European countries.
How is Remdesivir synthesized?
Remdesivir can be synthesized in multiple steps from ribose derivatives. The figure to the right is one of the synthesis routes of remdesivir invented by Chun and coauthors from Gilead Sciences. In this method, intermediate a is firstly prepared from L- alanine and phenyl phosphorodichloridate in presence of triethylamine and dichloromethane; triple benzyl-protected ribose is oxidized by dimethyl sulfoxide with acetic anhydride and give the lactone intermediate b; pyrrolo [2,1-f] [1,2,4]triazin-4-amine is brominated, and the amine group is protected by excess trimethylsilyl chloride. n-Butyllithium undergoes a halogen-lithium exchange reaction with the bromide at −78 °C (−108 °F) to yield the intermediate c. The intermediate b is then added to a solution containing intermediate c dropwise. After quenching the reaction in a weakly acidic aqueous solution, a mixture of 1:1 anomers was obtained. It was then reacted with an excess of trimethylsilyl cyanide in dichloromethane at −78 °C (−108 °F) for 10 minutes. Trimethylsilyl triflate was added and reacts for one additional hour, and the mixture was quenched in an aqueous sodium hydrogen carbonate. A nitrile intermediate was obtained. The protective group, benzyl, was then removed with boron trichloride in dichloromethane at −20 °C (−4 °F). The excess of boron trichloride was quenched in a mixture of potassium carbonate and methanol. A benzyl-free intermediate was obtained. The isomers were then separated via reversed-phase HPLC. The optically pure compound and intermediate a are reacted with trimethyl phosphate and methylimidazole to obtain a diastereomer mixture of remdesivir. In the end, optically pure remdesivir can be obtained through chiral resolution methods.
How many steps are needed to make Remdesivir?
Remdesivir requires "70 raw materials, reagents, and catalysts" to make, and approximately "25 chemical steps." Some of the ingredients are extremely dangerous to humans, especially trimethylsilyl cyanide. The original end-to-end manufacturing process required 9 to 12 months to go from raw materials at contract manufacturers to finished product, but after restarting production in January, Gilead Sciences was able to find ways to reduce the production time to six months.
When did Canada get Remdesivir?
On 27 July 2020, Health Canada conditionally approved the application. On 22 September 2020, Minister of Public Services and Procurement Anita Anand announced that Canada had entered into a deal to obtain up to 150,000 vials of remdesivir from Gilead starting in October.
What mutations in the RNA replicase of a mouse cause partial resistance to Remdesivir?
Mutations in the mouse hepatitis virus RNA replicase that cause partial resistance to remdesivir were identified in 2018. These mutations make the viruses less effective in nature, and the researchers believe they will likely not persist where the drug is not being used.
What is Remdesivir used for?
Dosage and Administration. Side Effects. Remdesivir is an intravenous antiviral drug currently being tested for effectiveness in treating the SARS-CoV-2 virus that causes COVID-19. Unlike the standard medications your doctor prescribes, it is not a treatment officially approved by the Food and Drug ...
How long does Remdesivir last?
Remdesivir is given through an intravenous line over the course of 30 minutes to two hours. It may be given once a day for up to ten days, but that may depend on your condition. People who are not as ill may only receive the drug for five days.
What are the side effects of Remdesivir?
Some of the most common known side effects from remdesivir are: 4 1 Diarrhea 2 Abnormal liver function (as assessed by blood tests) 3 Rash 4 Kidney problems 5 Low blood pressure 6 Nausea and vomiting
Is Remdesivir a controlled trial?
This was an uncontrolled trial, which means that outcomes weren’t compared to people with COVID-19 who didn’t take remdesivir. 4 . A more rigorous “controlled” clinical trial sponsored by the National Institute of Allergy and Infectious Diseases earned remdesivir EUA status from the FDA.
Is Remdesivir well tolerated?
It’s important to emphasize that remdesivir has still only been studied in a limited way in people. The drug may cause other important side effects in some individuals that we don’t yet know about. The clinical trials looking at remdesivir in COVID-19 may demonstrate it's effective and well-tolerated, but they could also reveal additional safety concerns.
Can Remdesivir cause low blood pressure?
This is a type of allergic reaction that might cause problems like very low blood pressure, and it might make it necessary to stop taking remdesivir. 9 . In one study, 23% of people treated with remdesivir had serious side effects, including dysfunction of multiple organs and septic shock.
Does Remdesivir cause kidney problems?
Kidney problems. Low blood pressure. Nausea and vomiting. Since remdesivir is given through an intravenous infusion, certain other side effects are possible, like bruising of the skin, soreness, or swelling where the needle is inserted.
The FDA limits the use of some monoclonal antibodies treatments
While the drug had shown mixed results in studies as a treatment for hospitalized patients, it has proved surprisingly effective, according to Gilead's data, at treating patients early in the course of the disease.
The appeal of remdesivir
The results of Gilead's study on using remdesivir early in the course of illness, published in The New England Journal of Medicine, were "truly dramatic," says Dr. Jane Kelly, assistant state epidemiologist for South Carolina, who is not affiliated with the study. "It resulted in an 87% lower risk of hospitalization or death than placebo."
Expensive and hard to give to patients
But remdesivir has drawbacks. It takes more resources to administer than the antiviral pills and comes with substantial upfront costs, which stand in the way of widespread use.
Remdesivir on the backburner
For these reasons, health care providers consider remdesivir to be low on the list of treatment options – available if necessary, but hard to implement.
What are the side effects of Remdesivir?
Remdesivir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: 1 nausea 2 pain, bleeding, bruising of the skin, soreness, or swelling near the place where the medication was injected
How long should I take Remdesivir?
It is usually given once daily for 5 to 10 days.
What to do before taking Remdesivir?
Before receiving remdesivir, tell your doctor and pharmacist if you are allergic to remdesivir, any other medications, or any of the ingredients in remdesivir injection. Ask your pharmacist for a list of the ingredients. tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, ...
How much does Remdesivir weigh?
The FDA has approved an Emergency Use Authorization (EUA) to allow children weighing 8 pounds (3.5 kg) to less than 88 pounds (40 kg) or children less than 12 years of age weighing at least 8 pounds (3.5 kg) who are hospitalized with severe COVID-19 to receive remdesivir.
Does Remdesivir cause swelling?
Remdesivir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: pain, bleeding, bruising of the skin, soreness, or swelling near the place where the medication was injected. Some side effects can be serious.
How long does Remdesivir last?
Remdesivir is given to a patient through IV once per day for up to 10 days, depending on how critically ill the patient is. According to the FDA, the medication may help decrease the amount of coronavirus in your body, which may help you get better faster.
When will Regeneron be available for emergency use?
In addition to remdesivir, FDA granted emergency use to two monoclonal antibody treatments, bamlanivimab and Regeneron in November 2020. These medicines can be used to treat symptomatic COVID-19 positive individuals who not yet need to be hospitalized.
Is Remdesivir a drug?
Remdesivir is an investigational antiviral medication used to treat patients with COVID-19. There is limited information on the safety and effectiveness of using rem desivir to treat people with COVID-19. However, it was shown in a clinical trial to shorten the recovery time in some people. This is why the Food and Drug Administration (FDA) ...
What is Remdesivir used for?
Currently there are more than 30 of these types of drugs that have been approved for use in treating viruses, cancers, parasites, as well as bacterial and fungal infections, with many more currently in clinical and preclinical trials . ...
How does Remdesivir work?
Remdesivir works when the enzyme replicating the genetic material for a new generation of viruses accidentally grabs this nucleoside analogue rather than the natural molecule and incorporates it into the growing RNA strand.
What is the active form of Remdesivir?
The active form of Remdesivir contains three phosphate groups; it is this form that is recognized by the virus’s RNA polymerase enzyme. A naturally occurring nucleotide (left) which is a building block of RNA and DNA and Remdesivir (right) which is a variation on its natural counterpart. Katherine Seley-Radtke, CC BY-SA.
What are the modifications of nucleosides?
The early nucleosides had only simple modifications, typically either to the sugar or the base, while today’s nucleosides, such as Remdesivir, typically have several modifications to their structure. These modifications are essential to their therapeutic activity.
Can Remdesivir be removed by enzyme?
But by changing this chemical bond, Remdesivir cannot be removed by the enzyme, allowing it to stay in the growing chain and block replication.
Does Remdesivir work against viruses?
Remdesivir Explained – What Makes This Drug Work Against Viruses? - UMBC Magazine. With the FDA approving Gilead’s Remdesivir as an emergency use treatment for the most acute cases of COVID-19, many people are wondering what type of a drug it is. Remdesivir is a member of one of the oldest and most important classes of drugs – known as nucleoside ...
Is Remdesivir a prodrug?
The first is that Remdesivir, as it is administered, is not the actual active drug; it is actually a “prodrug,” meaning it must be modified once in the body before it becomes an active drug.
Considerations in Patients with Renal Insufficiency
In the US, remdesivir is approved by the FDA to treat coronavirus infection, also known as COVID-19, for certain patients who are in the hospital. In Canada, remdesivir has not been approved by Health Canada for general use. However, Health Canada is allowing remdesivir to be used in human studies and for conditional use in hospitalized patients. More information about remdesivir is available from the US manufacturer's Patient Information leaflet, or should be provided by the doctor from the Informed Consent form for a study or the Health Canada Patient Medication Information for conditional use.
Drug-Drug Interactions
Considerations in Pregnancy
Considerations in Children
- Each 100 mg vial of remdesivir lyophilized powder contains 3 g of sulfobutylether beta-cyclodextrin sodium (SBECD), and each 100 mg/20 mL vial of remdesivir solution contains 6 g of SBECD.8 SBECD is a vehicle that is primarily eliminated through the kidneys. A patient with COVI…
Clinical Trials
- Currently, no clinical drug-drug interaction studies of remdesivir have been conducted. In vitro, remdesivir is a minor substrate of cytochrome P450 (CYP) 3A4 and a substrate of the drug transporters organic anion transporting polypeptide (OATP) 1B1 and P-glycoprotein. It is also an inhibitor of CYP3A4, OATP1B1, OATP1B3, and multidrug and toxin extrusion protein 1 (MATE1).…
Overview
- Remdesivir should not be withheld from pregnant patients if it is otherwise indicated. Pregnant patients were excluded from the clinical trials that evaluated the safety and efficacy of remdesivir for the treatment of COVID-19, but preliminary reports of remdesivir use in pregnant patients from small studies and case reports are reassuring.13 Among 86 pregnant and postpartum hospitaliz…
Medical uses
- Remdesivir is available through an FDA EUA for the treatment of COVID-19 in hospitalized pediatric patients weighing 3.5 kg to <40 kg or aged <12 years and weighing ≥3.5 kg. There are insufficient data on the safety and efficacy of using remdesivir to treat COVID-19 in hospitalized pediatric patients aged <12 years or weighing <40 kg because these populations have not been …
Side effects
- Several clinical trials that are evaluating the use of remdesivir for the treatment of COVID-19 are currently underway or in development. Please see ClinicalTrials.govfor the latest information.
Pharmacology
Remdesivir, sold under the brand name Veklury, is a broad-spectrum antiviral medication developed by the biopharmaceutical company Gilead Sciences. It is administered via injection into a vein. During the COVID‑19 pandemic, remdesivir was approved or authorized for emergency use to treat COVID‑19 in numerous countries.
Interactions
In the European Union, remdesivir is indicated for the treatment of coronavirus disease 2019 (COVID‑19) in adults and adolescents (aged twelve years and older with body weight at least 40 kilograms (88 lb)) with pneumonia requiring supplemental oxygen.
In the United States, remdesivir is indicated for use in adults and adolescents (aged twelve years and older with body weight at least 40 kilograms (88 lb)) for the treatment of COVID‑19 requirin…
Synthesis
The most common adverse effects in people treated with remdesivir were respiratory failure and blood biomarkers of organ impairment, including low albumin, low potassium, low count of red blood cells, low count of thrombocytes, and elevated bilirubin (jaundice). Other reported adverse effects include gastrointestinal distress, elevated transaminase levels in the blood (liver enzymes), infusion site reactions, and electrocardiogram abnormalities. Remdesivir may cause infusion-relatedreact…
In vitro experiments
Remdesivir is a protide (prodrug of nucleotide) able to diffuse into cells, where it is converted to GS-441524 monophosphate via the actions of esterases (CES1 and CTSA) and a phosphoamidase (HINT1); this in turn is further phosphorylated to its active metabolite triphosphate by nucleoside-phosphate kinases. This pathway of bioactivation is meant to occur intracellularly, but a substantial am…
Manufacturing
Remdesivir is at least partially metabolized by the cytochrome P450 enzymes CYP2C8, CYP2D6, and CYP3A4. Blood plasma concentrations of remdesivir are expected to decrease if it is administered together with cytochrome P450 inducers such as rifampicin, carbamazepine, phenobarbital, phenytoin, primidone, and St John's wort.
Using chloroquine or hydroxychloroquinewith remdesivir may reduce the antiviral activity of rem…
Uses
Remdesivir can be synthesized in multiple steps from ribose derivatives. The figure to the right is one of the synthesis routes of remdesivir invented by Chun and coauthors from Gilead Sciences. In this method, intermediate a is firstly prepared from L-alanine and phenyl phosphorodichloridate in presence of triethylamine and dichloromethane; triple benzyl-protected ribose is oxidized by dimethyl …
What to Tell Your Doctor
An in vitro study of remdesivir assessing antiviral activity against SARS-CoV-2 was performed. Cells were pre-treated with the different doses of remdesivir for 1 hour, and the virus (MOI of 0.05) was subsequently added to allow infection for 2 hours. The results found that remdesivir functioned well as an inhibitor of the infection. The study was published as a letter to the editor, and as such did not undergo peer review.
Dosage and Administration
Remdesivir requires "70 raw materials, reagents, and catalysts" to make, and approximately "25 chemical steps." Some of the ingredients are extremely dangerous to humans, especially trimethylsilyl cyanide. The original end-to-end manufacturing process required 9 to 12 months to go from raw materials at contract manufacturers to finished product, but after restarting production in January 2020, Gilead Sciences was able to find ways to reduce the production tim…
Side Effects
Summary
- Make sure your medical provider knows about your medical history before you start taking remdesivir. It's important that they know if you have kidney or liver problems, or if you have any other serious medical conditions.8 You should also let your clinician know if you are pregnant or might be pregnant. Your medical provider should also know about any medicines you are taking…