Updates as of June 15, 2022:
- Updated to reflect that Remdesivir (Veklury) is FDA approved to treat COVID-19 in mild to moderately ill adult and pediatric (28 days of age and older weighing at least 3 kilograms) outpatients who are at risk of disease progression.
Remdesivir (branded as Veklury) is a direct-acting nucleotide inhibitor of the SARS-CoV-2 RNA dependent RNA polymerase.
Remdesivir is one of the first drugs to be used in the inpatient setting to treat severe COVID-19. On October 22, 2020, the U.S. Food and Drug Administration (FDA) approved the new drug application (NDA) for remdesivir for the treatment of COVID-19 in hospitalized adult and pediatric patients (12 years of age and older weighing at least 40 kg). Use of the drug in younger pediatric inpatients weighing at least 3.5 kg was authorized by the FDA in an Emergency Use Authorization (EUA) (PDF).
In January 2022, published clinical trial data showed a benefit in outpatients treated with remdesivir, and the NIH updated their outpatient guidelines to include a 3-day course of intravenous (IV) remdesivir as a treatment option for non-hospitalized patients with mild-to-moderate COVID-19 at high risk of progressing to severe disease. The FDA approved a supplement to the NDA for remdesivir to include the treatment of mild-to-moderate COVID-19 in non-hospitalized adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of SARS-CoV-2 testing and high risk for progression to severe COVID-19. As of April 25, 2022, FDA expanded approval to mild to moderately ill adult and pediatric (28 days of age and older weighing at least 3 kilograms) outpatients who are at risk of disease progression.").
Clinical Trial Data
Results from a clinical trial evaluating the use of remdesivir in inpatients with severe COVID-19 showed an improved time to recovery among patients who received remdesivir compared to those who received placebo (median recovery time of 10 days as compared with 15 days).
Results from a clinical trial evaluating remdesivir in preventing the progression to severe COVID-19 disease in non-hospitalized adult patients with mild-to-moderate COVID-19 showed that a 3-day course of remdesivir administered IV once daily reduced the risk of hospitalization or death by 87% if given within seven days of symptom onset compared to placebo.
Remdesivir and SARS-CoV-2 Variants
Remdesivir is effective against the Omicron variant. Activity against Omicron has been confirmed by in vitro data.
Additional Use Considerations
Remdesivir is indicated for treatment only. The suggested outpatient treatment course is once daily for three days. For full use instructions, providers should review the drug information sheet (PDF) prior to use. Providers should carefully review dosing, administration, contraindications, and potential drug interactions prior to administration of the medication.
For inpatient treatment, and guides to the use of remdesivir in severely ill patients, providers should refer to the NIH Treatment Guidelines.
The following should be considered:
- If used as an outpatient treatment, remdesivir should be initiated as soon as possible after diagnosis of COVID-19 and within 7 days of symptom onset.
- Remdesivir is not FDA-approved or authorized for the pre-exposure or post-exposure prophylaxis of COVID-19.
- Outpatient treatment with remdesivir is not a substitute for COVID-19 vaccination; patients who are eligible for COVID-19 vaccination should be counseled to get vaccinated.
- Pediatric patients (greater than 28 days old) must have an estimated glomerular filtration rate (eGFR) determined and full-term neonates (at least 7 days to less than or equal to 28 days old) must have a serum creatinine determined before starting remdesivir and be monitored during treatment as clinically appropriate. Remdesivir is not recommended in pediatric patients (greater than 28 days old) with eGFR less than 30 mL/min or in full-term neonates (at least 7 days to less than or equal to 28 days old) with serum creatinine greater than or equal to 1 mg/dL.
- Transaminase elevations have been observed in individuals who have received remdesivir. As such, in certain cases when clinically appropriate, hepatic laboratory testing should be performed before staring remdesivir and during treatment.
- There is a potential for remdesivir to be less effective as a COVID-19 treatment when co-administered with hydroxychloroquine sulfate (HCQ) or chloroquine phosphate (CQ). The FDA recommends against taking these drugs together.
Patient Prioritization During Times of Limited Supply
At this time, supply of remdesivir is not expected to be limited. However, if scarcity does occur, the National Institutes of Health (NIH) treatment guidelines on prioritization should be followed.
Remdesivir is not part of the federal state/territory-coordinated distribution system, and the product needs to be acquired from the distributor, AmerisourceBergen. Gilead will work with distributors to make remdesivir available in qualified outpatient facilities. For questions about ordering remdesivir for outpatient use, providers should contact C19therapies@amerisourcebergen.com.
The Centers for Medicare and Medicaid Services (CMS) has approved a new Healthcare Common Procedure Coding System code J0248 for remdesivir when administered in an outpatient setting. If remdesivir is administered at a hospital outpatient department or in an outpatient physician's office, the organization should contact their Medicare Administrative Contactor (MAC) for billing instructions.
Originally published on February 18, 2022