This information is intended for US healthcare professionals.

About

VEKLURY® (remdesivir) improved clinical outcomes in hospitalized patients with severe COVID-19 disease1,2

Study 5773 trial design

Study GS-US-540-5773 was a randomized, open-label, multicenter, phase 3 study in adult patients with confirmed SARS-CoV-2 infection, an SpO2 ≤94% on room air, or receiving supplemental oxygen and radiological evidence of pneumonia.

Study 5773 N=397
R 1:1
n=197
n=200
VEKLURY 200 mg
VEKLURY 200 mg
VEKLURY 100 mg daily
+ Standard of care
VEKLURY 100 mg daily
+ Standard of care

Treatment with VEKLURY was stopped in subjects who were discharged from the hospital prior to completion of their protocol-defined duration of treatment. Patients on mechanical ventilation at screening were excluded.

Baseline characteristics

Characteristic 5-Day Groupn=200 10-Day Groupn=197
Median age 61 (IQR, 50-69) 62 (IQR, 50-71)
Male sex 60% 68%
Race
White 71% 70%
Black 10% 12%
Asian 10% 13%
Respiratory status
Low-flow oxygen 56% 54%
High-flow oxygen 24% 30%
Invasive mechanical ventilation/ECMO 2% 5%
Coexisting conditions of interest
Diabetes 24% 22%
Hyperlipidemia 20% 25%
Hypertension 50% 50%
Asthma 14% 11%

Clinical results

Primary endpoint: clinical status on Day 14

Clinical status was assessed on a 7-point ordinal scale consisting of the following categories: 1. death; 2. hospitalized, receiving invasive mechanical ventilation or ECMO; 3. hospitalized, receiving noninvasive ventilation or high-flow oxygen devices; 4. hospitalized, requiring low-flow supplemental oxygen; 5. hospitalized, not requiring supplemental oxygen but receiving ongoing medical care (related or not related to COVID-19); 6. hospitalized, requiring neither supplemental oxygen nor ongoing medical care (other than that specified in the protocol for VEKLURY administration); 7. not hospitalized.

5 days of treatment with VEKLURY led to similar clinical outcomes as a 10-day course

CLINICAL IMPROVEMENT OF ≥2 POINTS AT DAY 14

65% of patients
vs
54% of patients

Similar clinical status at Day 14*

Odds ratio for improvement: 0.75 [95% CI, 0.51-1.12]

PROPORTION OF PATIENTS WHO RECOVERED

64% of patients
vs
54% of patients

Recovery: those with a baseline ordinal score of 2 to 5 who improved to 6 or 7

Similar clinical status at Day 14*

Baseline-adjusted difference in proportion:
-6.3% (95% CI, -15.4-2.8)

*Once adjusted for between-group differences at baseline.

Adverse reactions in Study 5773

The most common adverse reactions occurring in ≥5% of patients in either the VEKLURY 5-day or 10-day group, respectively, were nausea (5% vs 3%), AST increased (3% vs 6%), and ALT increased (2% vs 7%).

All-cause mortality at Day 28

  • No statistically significant differences between the 2 groups
  • 12% vs 14% in the 5- and 10-day treatment groups, respectively

7-Point ordinal scale

1

death

2

hospitalized, receiving invasive mechanical ventilation or ECMO

3

hospitalized, receiving noninvasive ventilation or high-flow oxygen devices

4

hospitalized, requiring low-flow supplemental oxygen

5

hospitalized, not requiring supplemental oxygen but receiving ongoing medical care (related or not related to COVID-19)

6

hospitalized, requiring neither supplemental oxygen nor ongoing medical care (other than that specified in the protocol for VEKLURY administration)

7

not hospitalized

COVID-19=coronavirus disease 2019; ECMO=extracorporeal membrane oxygenation; IQR=interquartile range; SARS-CoV-2=severe acute respiratory syndrome coronavirus 2.

Important Safety Information

Contraindication

  • VEKLURY is contraindicated in patients with a history of clinically significant hypersensitivity reactions to VEKLURY or any of its components.

Warnings and precautions

  • Hypersensitivity, including infusion-related and anaphylactic reactions: Hypersensitivity, including infusion-related and anaphylactic reactions, has been observed during and following administration of VEKLURY. Monitor patients under close medical supervision for hypersensitivity reactions during and following administration of VEKLURY. Symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering. Slower infusion rates (maximum infusion time ≤120 minutes) can potentially prevent these reactions. If a severe infusion-related hypersensitivity reaction occurs, immediately discontinue VEKLURY and initiate appropriate treatment (see Contraindications).
  • Increased risk of transaminase elevations: Transaminase elevations have been observed in healthy volunteers and in patients with COVID-19 who received VEKLURY; these elevations have also been reported as a clinical feature of COVID-19. Perform hepatic laboratory testing in all patients (see Dosage and administration). Consider discontinuing VEKLURY if ALT levels increase to >10x ULN. Discontinue VEKLURY if ALT elevation is accompanied by signs or symptoms of liver inflammation.
  • Risk of reduced antiviral activity when coadministered with chloroquine or hydroxychloroquine: Coadministration of VEKLURY with chloroquine phosphate or hydroxychloroquine sulfate is not recommended due to antagonism observed in cell culture, which may lead to a decrease in antiviral activity of VEKLURY.

Adverse reactions

  • The most common adverse reaction (≥5% all grades) was nausea.
  • The most common lab abnormalities (≥5% all grades) were increases in ALT and AST.

Drug interactions

  • Drug interaction trials of VEKLURY and other concomitant medications have not been conducted in humans.

Dosage and administration

  • Dosage: For adults and pediatric patients ≥12 years old and weighing ≥40 kg: 200 mg on Day 1, followed by once-daily maintenance doses of 100 mg from Day 2 administered only via intravenous infusion over 30 to 120 minutes.
  • Treatment duration: For patients not requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO): 5 days; may be extended up to 5 additional days (10 days total) if clinical improvement is not observed. For patients requiring invasive mechanical ventilation and/or ECMO: 10 days.
  • Testing prior to and during treatment: Perform eGFR, hepatic laboratory, and prothrombin time testing prior to initiating VEKLURY and during use as clinically appropriate.
  • Renal impairment: VEKLURY is not recommended in individuals with eGFR <30 mL/min.
  • Dose preparation and administration: See full Prescribing Information.

Pregnancy and lactation

  • Pregnancy: There are insufficient human data on the use of VEKLURY during pregnancy. Pregnant women hospitalized with COVID-19 are at risk for serious morbidity and mortality. VEKLURY should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus.
  • Lactation: It is not known whether VEKLURY can pass into breast milk. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.

Indication

VEKLURY is indicated for treatment of adults and pediatric patients ≥12 years old and weighing ≥40 kg requiring hospitalization for COVID-19. VEKLURY should only be administered in a hospital or healthcare setting capable of providing acute care comparable to inpatient hospital care.

For information about emergency use to treat suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients <12 years of age or weighing 3.5 kg to <40 kg, please see the EUA Fact Sheet and FDA Letter of Authorization available at gilead.com/remdesivir.

Please see full Prescribing Information for VEKLURY.

References: 1. Veklury. Package insert. Gilead Sciences, Inc.; 2020. 2. Goldman JD, Lye DCB, Hui DS, et al. Remdesivir for 5 or 10 days in patients with severe Covid-19. N Engl J Med. Published online May 27, 2020. doi:10.1056/NEJMoa2015301



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Indication

VEKLURY is indicated for treatment of adults and pediatric patients ≥12 years old and weighing ≥40 kg requiring hospitalization for COVID-19. VEKLURY should only be administered in a hospital or healthcare setting capable of providing acute care comparable to inpatient hospital care.

For information about emergency use to treat suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients <12 years of age or weighing 3.5 kg to <40 kg, please see the EUA Fact Sheet and FDA Letter of Authorization available at gilead.com/remdesivir.

Please see full Prescribing Information for VEKLURY.

Important Safety Information

Contraindication

  • VEKLURY is contraindicated in patients with a history of clinically significant hypersensitivity reactions to VEKLURY or any of its components.

Warnings and precautions

  • Hypersensitivity, including infusion-related and anaphylactic reactions: Hypersensitivity, including infusion-related and anaphylactic reactions, has been observed during and following administration of VEKLURY. Monitor patients under close medical supervision for hypersensitivity reactions during and following administration of VEKLURY. Symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering. Slower infusion rates (maximum infusion time ≤120 minutes) can potentially prevent these reactions. If a severe infusion-related hypersensitivity reaction occurs, immediately discontinue VEKLURY and initiate appropriate treatment (see Contraindications).
  • Increased risk of transaminase elevations: Transaminase elevations have been observed in healthy volunteers and in patients with COVID-19 who received VEKLURY; these elevations have also been reported as a clinical feature of COVID-19. Perform hepatic laboratory testing in all patients (see Dosage and administration). Consider discontinuing VEKLURY if ALT levels increase to >10x ULN. Discontinue VEKLURY if ALT elevation is accompanied by signs or symptoms of liver inflammation.
  • Risk of reduced antiviral activity when coadministered with chloroquine or hydroxychloroquine: Coadministration of VEKLURY with chloroquine phosphate or hydroxychloroquine sulfate is not recommended due to antagonism observed in cell culture, which may lead to a decrease in antiviral activity of VEKLURY.

Adverse reactions

  • The most common adverse reaction (≥5% all grades) was nausea.
  • The most common lab abnormalities (≥5% all grades) were increases in ALT and AST.

Drug interactions

  • Drug interaction trials of VEKLURY and other concomitant medications have not been conducted in humans.

Dosage and administration

  • Dosage: For adults and pediatric patients ≥12 years old and weighing ≥40 kg: 200 mg on Day 1, followed by once-daily maintenance doses of 100 mg from Day 2 administered only via intravenous infusion over 30 to 120 minutes.
  • Treatment duration: For patients not requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO): 5 days; may be extended up to 5 additional days (10 days total) if clinical improvement is not observed. For patients requiring invasive mechanical ventilation and/or ECMO: 10 days.
  • Testing prior to and during treatment: Perform eGFR, hepatic laboratory, and prothrombin time testing prior to initiating VEKLURY and during use as clinically appropriate.
  • Renal impairment: VEKLURY is not recommended in individuals with eGFR <30 mL/min.
  • Dose preparation and administration: See full Prescribing Information.

Pregnancy and lactation

  • Pregnancy: There are insufficient human data on the use of VEKLURY during pregnancy. Pregnant women hospitalized with COVID-19 are at risk for serious morbidity and mortality. VEKLURY should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus.
  • Lactation: It is not known whether VEKLURY can pass into breast milk. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.

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