What are the indications for Remdesivir (Veklury) in patients with Coronavirus Disease 2019 (COVID-19)?

Indications for Remdesivir (Veklury) in COVID-19

Remdesivir is indicated for the treatment of COVID-19 in hospitalized patients requiring supplemental oxygen, and in non-hospitalized patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease. 1

FDA-Approved Indications

• Remdesivir (Veklury) is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (birth to less than 18 years of age weighing at least 1.5 kg) who are:
  • Hospitalized 1
  • Not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death 1

Recommendations for Hospitalized Patients

Based on Respiratory Support Requirements:

• Patients NOT requiring mechanical ventilation or ECMO:

  • Consider remdesivir for 5 days in hospitalized patients with COVID-19 who do not require mechanical ventilation or ECMO 2
  • Treatment should be initiated as soon as possible after diagnosis of symptomatic COVID-19 3
  • If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days 1

• Patients requiring mechanical ventilation or ECMO during treatment:

  • Consider extending the use of remdesivir to 10 days for hospitalized patients with COVID-19 who require mechanical ventilation or ECMO within a 5-day course 2
  • The recommended total treatment duration is 10 days for patients requiring invasive mechanical ventilation and/or ECMO 1

• Patients already on mechanical ventilation or ECMO at initiation:

  • Avoid initiating remdesivir in hospitalized patients with COVID-19 who are already on mechanical ventilation or ECMO 2
  • The European Respiratory Society suggests not to offer remdesivir to patients hospitalized with COVID-19 infection who require invasive mechanical ventilation (conditional recommendation, moderate quality of evidence) 2

Recommendations for Non-Hospitalized Patients

• Consider remdesivir for non-hospitalized patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease 1
• Treatment should be initiated as soon as possible after diagnosis and within 7 days of symptom onset 1
• The recommended total treatment duration is 3 days for non-hospitalized patients 1

Dosing Regimen

• Adults and pediatric patients weighing at least 40 kg:

  • Loading dose: 200 mg IV on day 1
  • Maintenance dose: 100 mg IV daily from day 2 3, 1

• Duration based on clinical scenario:

  • Hospitalized, not requiring mechanical ventilation/ECMO: 5 days
  • Hospitalized, requiring mechanical ventilation/ECMO: 10 days
  • Non-hospitalized with high risk for progression: 3 days 3, 1

Clinical Considerations and Contraindications

• Remdesivir is not recommended for patients with:

  • ALT ≥5 times the upper limit of normal 3
  • eGFR <30 mL/min/1.73 m² 3
  • History of clinically significant hypersensitivity reactions to remdesivir or any components of the product 1

• Monitoring requirements:

  • Perform hepatic laboratory testing before starting remdesivir and during treatment as clinically appropriate 1
  • Assess prothrombin time before starting remdesivir and monitor as clinically appropriate 1
  • Monitor for adverse events including hepatic, renal, and cardiovascular reactions 4

Evidence Supporting Recommendations

• Remdesivir probably has little or no effect on all-cause mortality or in-hospital mortality in patients with moderate to severe COVID-19 (moderate certainty evidence) 5
• However, remdesivir probably increases the chance of clinical improvement at up to day 28 slightly (moderate certainty evidence) 5
• Remdesivir probably decreases the risk of clinical worsening within 28 days (moderate certainty evidence) 5
• In patients receiving supplemental oxygen who did not need ventilation, remdesivir showed a mortality benefit (pooled absolute risk difference, 2.3%) 2
• In patients receiving ventilation (mechanical ventilation/ECMO), remdesivir showed no benefit and potentially increased mortality (pooled absolute risk difference, 4.9%) 2
• Remdesivir may decrease hospitalization rates in non-hospitalized patients with mild-to-moderate COVID-19 who are at high risk for disease progression 5

Common Pitfalls and Caveats

• Timing of initiation is critical - remdesivir should be started as soon as possible after diagnosis for optimal benefit 3, 1
• The benefit of remdesivir varies by disease severity and respiratory support requirements - greatest benefit is seen in those requiring low-flow oxygen 6
• Extending treatment beyond 5 days in patients not requiring mechanical ventilation should be based on clinical judgment and response to initial therapy 2
• Remdesivir may have limited efficacy in patients who have progressed to the inflammatory phase of COVID-19 2
• Effectiveness may be limited in vaccinated populations or against newer SARS-CoV-2 variants, as most studies were conducted with unvaccinated populations exposed to early variants 5