Veklury (remdesivir)

Veklury (remdesivir)

Hello, I am Dr. Michael Anderson. I’m an intensive care physician and a senior advisor at the Department of Health and Human Services Office of the Assistant Secretary for Preparedness & Response, also known as ASPR. At ASPR I help guide the novel COVID-19 therapeutics as well as focus on a pediatric response agenda.

I want to talk about one of the therapeutics that can help people with COVID-19 remdesivir, also known as Veklury®.

What is Veklury?

Veklury is an antiviral administered with an IV, used to help fight the coronavirus infection by stopping the virus from replicating in the body. This lowers the viral load, reducing the chances of the illness progressing to more serious symptoms and hospitalization.

Who is eligible for Veklury?

Veklury is for adults and children who are at high risk for developing serious symptoms of COVID-19 that may lead to hospitalization or death. For more information about who is at risk, please see the resources provided in the description.

Veklury is for people who have tested positive for COVID-19 either through PCR or rapid antigen testing. Veklury may be used for outpatients and patients in the hospital. For people who are not in the hospital, their symptoms should be mild to moderate. Veklury should be administered as soon as possible after testing positive for COVID-19. Studies have shown it needs to be given within seven days of symptom onset to be effective at lowering your risk of progression.

How is Veklury administered?

Veklury is given as an intravenous infusion once a day for three days. The dose should be adjusted for children.

What are the limitations of use for Veklury?

Veklury is not for children weighing less than 3.5 kg or 7.7 lb. Veklury should be stopped if a liver enzyme called ALT rises to 10 times above the normal limit or if your ALT level elevation is accompanied by signs of liver inflammation. Veklury is not recommended in patients with severe kidney disease or an eGFR of less than 30 mL/min. This also applies to full-term neonates with a serum creatinine of 1 mg/dL or greater. Unlike some COVID-19 therapies, the chances of drug interactions with Veklury are really very low.

Veklury is one of several COVID-19 therapeutic options. I urge you to watch the other videos in this outpatient series. Also visit us online at https://aspr.hhs.gov/COVID-19 and please see the resources linked in the description to learn more. You can also connect with ASPR on social media platforms to stay up to date on our latest posts and information. And if you have any questions, I urge you to email us at COVID19therapeutics@hhs.gov.

Thank you for your time.

• Hospitalized: Veklury is given by IV infusion one time each day for up to 10 days.
• Not hospitalized: Veklury is given by IV infusion one time each day for 3 days.
• Carefully follow the product-specific preparation instructions found in the full prescribing information.

• NIH Therapeutic Management of Non-hospitalized Adults With COVID-19
• For further information on Veklury, please refer to the full prescribing information.
• Visit us online at https://aspr.hhs.gov/veklury.
• Side-by-Side Outpatient Therapeutics Overview
• Therapeutics Clinical Implementation Guide
• COVID-19 Therapeutics Decision Aid
• Email any questions to COVID19therapeutics@hhs.gov.

• Veklury is approved by FDA for the treatment of COVID-19 in adults and children (28 days of age and older and weighing at least 3 kg) who are:
  • Hospitalized or
  • Not hospitalized and have mild to moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death
• Veklury should be considered for non-hospitalized patients who meet the following criteria:
  • Have mild to moderate COVID-19 and are within 7 days of symptom onset, AND
  • Have one or more risk factorfor severe COVID-19

• Per the current Centers for Disease Control and Prevention’s Interim Clinical Considerations for COVID-19 Treatment in Outpatient, risk factors include:
  • Age 50 years or older, with risk increasing substantially at age ≥ 65 years
  • Being unvaccinated or not being up to date on COVID-19 vaccinations
  • Specific medical conditions and behaviors
• Health care providers should also proactively counsel patients at high risk of severe COVID-19 about the availability of effective therapeutics and discuss a COVID-19 action plan with their patients.

• The benefit of a 3-day treatment course of Veklury was demonstrated in a Phase 3 placebo-controlled trial.
  • Analysis of 562 participants randomly assigned demonstrated treatment with Veklury resulted in a statistically significant 87% reduction in risk of hospitalization or death by Day 28 compared to placebo.¹
  • In the study, treatment with remdesivir had an acceptable safety profile across a variety of outpatient settings, with incidence of adverse events similar to that in the placebo group.

References:

• Gottlieb RL et al. N Engl J Med 2022; 386:305-31 DOI: 10.1056/NEJMoa2116846

Yes, health care providers and patients must be aware of the following warnings and precautions:

• Hypersensitivity, including infusion-related and anaphylactic reactions
• Increased risk of transaminase elevations
• Risk of reduced antiviral activity when co-administered with chloroquine or hydroxychloroquine

• Paxlovid (nirmatrelvir co-packaged with ritonavir) (oral antiviral) is a preferred treatment for mild to moderate COVID-19 illness. Patients take a combination of pills twice a day for 5 days.
• Lagevrio (molnupiravir) (oral antiviral) is an alternative treatment for mild to moderate COVID-19 when other FDA authorized or approved therapies are not clinically appropriate, feasible, or available.

Veklury may be prescribed by health care providers.

Veklury may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion or hypersensitivity reaction, such as anaphylaxis, and the ability to activate the emergency medical system.

• Veklury is commercially available and can be ordered through multiple distributors, including ordering for outpatient use through AmerisourceBergen Specialty and Cardinal Specialty.
• Veklury should be considered for any COVID-19 patient who meets the eligibility criteria, particularly when Paxlovid cannot be used. While there are no drug supply constraints for Veklury, the NIH Prioritization Guidelines provides guidance on prioritizing when staffing or other resources needed for infusion are constrained.

• Testing before starting and during treatment with Veklury.
  • Perform hepatic laboratory testing in all patients before starting and while receiving Veklury as clinically appropriate due to increased risk of transaminase elevations.
  • Determine prothrombin time in all patients before starting and monitor while receiving Veklury as clinically appropriate.
• Specific information on clinical evaluation considerations to prescribe are in the full prescribing information.

Due to potential antagonism based on data from cell culture experiments, concomitant use of Veklury (remdesivir) with chloroquine phosphate or hydroxychloroquine sulfate is not recommended. Remdesivir and its metabolites are in vitro substrates and/or inhibitors of certain drug metabolizing enzymes and transporters. Based on a drug interaction study conducted with Veklury, no clinically significant drug interactions are expected with inducers of cytochrome P450 (CYP) 3A4 or inhibitors of Organic Anion Transporting Polypeptides (OATP) 1B1/1B3, and P-glycoprotein (P-gp).

Intravenous antivirals are medications that stop the virus that causes COVID-19 from making copies of itself in your body. These medications are delivered to the patient through intravenous infusion.

• Patients are encouraged to discuss a COVID-19 Action Plan with their health care providers.
• Have available your electronic or printed health records from the past year, including the most recent blood work relating to kidney and liver problems. In addition, you will need a list of all medications you are taking, including over-the-counter medications.
• Learn more about COVID-19 Treatment Information for Patients.
• Fact Sheet for Patients, Parents, and Caregivers