About

VEKLURY improved clinical outcomes in hospitalized patients with moderate COVID-191-3

Study 5774 trial design

Study GS-US-540-5774 was a randomized, open-label, multicenter, phase 3 study of hospitalized adult patients with confirmed SARS-CoV-2 infection, an SpO2 of >94% on room air, and radiological evidence of pneumonia.

Study 5774 N=584
R 1:1:1
n=193
n=191
VEKLURY 200 mg + Standard of care
VEKLURY 200 mg + Standard of care
VEKLURY 100 mg daily
+ Standard of care
VEKLURY 100 mg daily
+ Standard of care
n=200
Standard of care

Treatment with VEKLURY® (remdesivir) was stopped in subjects who were discharged from the hospital prior to completion of their protocol-defined duration of treatment.

Primary endpoint: clinical status on Day 11 based on ordinal scale

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.

Baseline characteristics

Characteristic 5-day VEKLURYn=191 10-day VEKLURYn=193 Standard of caren=200
Median age 58
(IQR, 48-66)
56
(IQR, 45-66)
57
(IQR, 45-66)
Male sex 60% 61% 63%
Race
White 59% 57% 58%
Black 19% 20% 14%
Asian 18% 16% 19%
Ethnicity: Hispanic/Latinx 13% 23% 18%
Respiratory status
Not on oxygen, requiring care 84% 84% 80%
Low-flow oxygen 15% 12% 18%
High-flow oxygen 1% 1% 1%
Coexisting conditions
Cardiovascular disease 58% 58% 54%
Hypertension 43% 44% 41%
Diabetes 37% 44% 38%
Asthma 12% 16% 14%

The likelihood of clinical improvement with VEKLURY was evaluated vs standard of care in patients with moderate COVID-19

5 days of treatment with VEKLURY resulted in a significantly greater likelihood of improvement in clinical status based on ordinal score vs standard of care

Patients were

more likely to show clinical improvement with the 5-day regimen of VEKLURY

vs standard of care at Day 11
Odds ratio for improvement: 1.65 (95% CI, 1.09-2.48), p=0.017

The odds of improvement in clinical status with VEKLURY in the 10-day treatment group were not statistically significant (odds ratio for improvement: 1.31 [95% CI, 0.88-1.95]).

7-point ordinal scale

1
death
2
hospitalized, receiving invasive mechanical ventilation or ECMO
3
hospitalized, receiving noninvasive ventilation or high-flow oxygen
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

Adverse reactions in Study 5774

The most common adverse reaction occurring in ≥5% of patients in the VEKLURY groups was nausea (7% in the 5-day group, 4% in the 10-day group).

All-cause mortality at Day 28

  • ≤2% in all treatment groups

Important Safety Information

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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 based on data from cell culture experiments, demonstrating potential antagonism, which may lead to a decrease in the 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

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For patients hospitalized with COVID-19: VEKLURY is indicated for treatment of adults and pediatric patients ≥12 years old and weighing ≥40 kg requiring hospitalization for COVID-19. VEKLURY is indicated for the 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 weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg, please see the EUA Fact Sheet and FDA Letter of Authorization available at gilead.com/remdesivir.

Please see full Prescribing Information for VEKLURY.

COVID-19=coronavirus disease 2019; ECMO=extracorporeal membrane oxygenation; IQR=interquartile range; SARS-CoV-2=severe acute respiratory syndrome coronavirus 2; SpO2=oxygen saturation.

References: 1. Veklury. Package insert. Gilead Sciences, Inc.; 2020. 2. Spinner CD, Gottlieb RL, Criner GJ, et al. Effect of remdesivir vs standard care on clinical status at 11 days in patients with moderate COVID-19: a randomized clinical trial. JAMA. 2020;324(11):1048-1057. 3. Spinner CD, Gottlieb RL, Criner GJ, et al. Effect of remdesivir vs standard care on clinical status at 11 days in patients with moderate COVID-19: a randomized clinical trial. Supplement 1. Trial protocol. JAMA. 2020;324(11):1048-1057. Accessed February 1, 2021. https://cdn.jamanetwork.com/ama/content_public/journal/jama/938555/joi200097supp1_prod_1600070022.50408.pdf



View All

INDICATION

View All

Collapse

For patients hospitalized with COVID-19: VEKLURY is indicated for treatment of adults and pediatric patients ≥12 years old and weighing ≥40 kg requiring hospitalization for COVID-19. VEKLURY is indicated for the 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 weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 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

Collapse

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 based on data from cell culture experiments, demonstrating potential antagonism, which may lead to a decrease in the 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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