What is the recommended dosing regimen for Remdesivir (Veklury) in hospitalized patients with COVID-19?

Remdesivir Dosing Regimen for Hospitalized COVID-19 Patients

The recommended dosing regimen for remdesivir (Veklury) in hospitalized COVID-19 patients is 200 mg IV on day 1 followed by 100 mg IV daily, with a 5-day course for those not requiring mechanical ventilation/ECMO and a 10-day course for those requiring mechanical ventilation/ECMO. 1, 2, 3

Standard Dosing Protocol

• For adults and pediatric patients weighing at least 40 kg, administer a single loading dose of 200 mg IV on day 1, followed by once-daily maintenance doses of 100 mg IV from day 2 3
• Treatment should be initiated as soon as possible after diagnosis of symptomatic COVID-19 3
• Remdesivir must be administered by intravenous infusion only, typically over 30 to 120 minutes 3

Treatment Duration Based on Disease Severity

• For hospitalized patients requiring invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 10 days 3
• For hospitalized patients not requiring invasive mechanical ventilation and/or ECMO, the recommended treatment duration is 5 days 1, 2, 3
• If a patient does not demonstrate clinical improvement within the initial 5-day course, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days 3

Clinical Efficacy Considerations

• Early administration of remdesivir (within 2 days of admission) has been associated with reduced 30-day in-hospital mortality, particularly for patients receiving supplemental oxygen on the day of admission 4
• The strongest mortality benefit has been observed in patients requiring low-flow oxygen, with a risk ratio of 0.21 (95% CI 0.09-0.46) for early mortality 5
• Recent evidence suggests remdesivir may also benefit patients requiring high-flow oxygen/non-invasive ventilation or even invasive mechanical ventilation, with adjusted hazard ratios for 14-day mortality of 0.83 and 0.73, respectively 6

Monitoring Requirements

• Perform hepatic laboratory testing in all patients before starting remdesivir and while receiving treatment as clinically appropriate 3
• Determine prothrombin time in all patients before starting remdesivir and monitor during treatment 3
• Assess kidney function at baseline and during treatment 1

Contraindications and Precautions

• Remdesivir is contraindicated in patients with a history of clinically significant hypersensitivity reactions to remdesivir or any components of the product 3
• The FDA recommends not using remdesivir in patients with an estimated glomerular filtration rate <30 mL/min/1.73 m² 1, 2
• Discontinue remdesivir if ALT increases to >10 times the upper limit of normal or if ALT elevation is accompanied by signs or symptoms of liver inflammation 1, 2, 3
• Monitor patients during infusion and observe for at least one hour after infusion completion for signs of hypersensitivity reactions 3

Special Populations

• No dosage adjustment is recommended in patients with any degree of renal impairment, including patients on dialysis 3
• The guidelines do not apply to pregnant women or patients with severe renal or hepatic dysfunction as they were excluded from pivotal studies 1, 2
• Effectiveness may not vary by age, sex, or race in hospitalized patients with COVID-19 1, 2

Preparation and Administration

• There are two different formulations of remdesivir: lyophilized powder (requiring reconstitution) and solution for injection 3
• For the lyophilized powder, reconstitute with 19 mL of Sterile Water for Injection per vial, then dilute in 0.9% sodium chloride 3
• For the solution formulation, further dilute in 250 mL of 0.9% sodium chloride injection 3
• Administer as an intravenous infusion over 30 to 120 minutes 3

Common Pitfalls and Caveats

• Remdesivir should only be administered in settings where healthcare providers have immediate access to medications to treat severe infusion or hypersensitivity reactions 3
• Hypersensitivity reactions, including infusion-related and anaphylactic reactions, have been observed during and after remdesivir administration 3
• The decision to initiate remdesivir should be based on clinical judgment; it should not necessarily be started in patients hospitalized for a primary diagnosis unrelated to COVID-19 who have incidentally tested positive for SARS-CoV-2 1
• While Cochrane reviews suggest remdesivir may have limited effect on all-cause mortality, it appears to improve clinical outcomes and reduce hospitalization rates in appropriate patients 7