Study 5773

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

5 days of treatment with VEKLURY led to similar clinical outcomes as a 10-day course1,2

  • Recovery was defined as those with a baseline ordinal score of 2 to 5 who improved to a score of 6 or 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

Study GS-US-540-5773 was a randomized, open-label, multicenter, phase 3 study in hospitalized adult patients with confirmed SARS-CoV-2 infection, an SpO2 of ≤94% on room air or receiving supplemental oxygen, and radiological evidence of pneumonia.1,2

Study design1,2

A graphic showing the 5773-study design A graphic showing the 5773-study design

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

Primary endpoint

Clinical status on Day 14 as assessed on a 7-point ordinal scale.

R=randomization.

Safety parameters in Study 57731

VEKLURY had a similar safety profile in 5- and 10-day treatment courses

Adverse reactions were similar in both VEKLURY study arms

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%).

Types of adverse reactions VEKLURY 5 days(n=200)n (%) VEKLURY 10 days(n=197)n (%)
Any adverse reaction, all Grades 33 (17) 40 (20)
Serious adverse reactions 3 (2)* 4 (2)*
Adverse reactions leading to treatment discontinuation 5 (3) 9 (5)

*Transaminases increased (n=5), hepatic enzyme increased (n=1), hypertransaminasemia (n=1).

Transaminases increased (n=4), hepatic enzyme increased (n=2), LFT increased (n=2), hypertransaminasemia (n=1), ALT increased (n=1), ALT increased and AST increased (n=2), injection site erythema (n=1), rash (n=1).

Laboratory abnormalities (Grades 3–4) reported in ≥3% of patients

Laboratory parameter abnormality VEKLURY 5 days(n=200) VEKLURY 10 days(n=197)
ALT increased 6% 8%
AST increased 7% 6%
Creatinine clearance decreased§ 10% 19%
Creatinine increased 5% 15%
Glucose increased 11% 8%
Hemoglobin decreased 6% 8%

Frequencies are based on treatment-emergent laboratory abnormalities graded per Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, dated July 2017.

§Based on the Cockcroft-Gault formula.

Baseline characteristics2

Characteristic 5-day group(n=200) 10-day group(n=197)
Median age (IQR), y 61 (50-69) 62 (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%

ECMO=extracorporeal membrane oxygenation; IQR=interquartile range.

7-point ordinal scale1,3

Patient clinical status was assessed on a 7-point ordinal scale with a lower score indicating greater clinical severity.

A graphic showing the patient's clinical status assessed on a 7-point ordinal scale A graphic showing the patient's clinical status assessed on a 7-point ordinal scale

ECMO=extracorporeal membrane oxygenation.

See VEKLURY data on disease progression and recovery time

ACTT-1 STUDY

See improved clinical outcomes from earlier use of VEKLURY

STUDY 5774

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; most reactions occurred within 1 hour. Monitor patients during infusion and observe for at least 1 hour after infusion is complete for signs and symptoms of hypersensitivity as clinically appropriate. Symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering. Slower infusion rates (maximum infusion time of up to 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.

Dosage and administration

  • Administration should take place under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible.
  • Treatment duration:
    • For patients who are hospitalized, VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19.
    • For patients who are hospitalized and do not require invasive mechanical ventilation and/or ECMO, the recommended treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended up to 5 additional days, for a total treatment duration of up to 10 days.
    • For patients who are hospitalized and require invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 10 days.
    • For patients who are not hospitalized, diagnosed with mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death, the recommended total treatment duration is 3 days. VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19 and within 7 days of symptom onset for outpatient use.
  • 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.

Pregnancy and lactation

  • Pregnancy: A pregnancy registry has been established. There are insufficient human data on the use of VEKLURY during pregnancy. COVID-19 is associated with adverse maternal and fetal outcomes, including preeclampsia, eclampsia, preterm birth, premature rupture of membranes, venous thromboembolic disease, and fetal death.
  • 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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VEKLURY is indicated for the treatment of COVID-19 in adults and pediatric patients (≥28 days old and weighing ≥3 kg) with positive results of SARS-CoV-2 viral testing, who are: VEKLURY is indicated for the treatment of COVID-19 in adults and pediatric patients (≥28 days old and weighing ≥3 kg) with positive results of SARS-CoV-2 viral testing, who are:

  • Hospitalized, or
  • Not hospitalized, have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.

LFT=liver function test; SpO2=oxygen saturation.

References: 1. Veklury. Prescribing Information. Gilead Sciences, Inc.; 2022. 2. Goldman JD, Lye DCB, Hui DS, et al; GS-US-540-5773 Investigators. Remdesivir for 5 or 10 days in patients with severe COVID-19. N Engl J Med. 2020;383(19):1827-1837. doi:10.1056/NEJMoa2015301 3. Goldman JD, Lye DCB, Hui DS, et al; GS-US-540-5773 Investigators. Remdesivir for 5 or 10 days in patients with severe COVID-19. Supplementary appendix. N Engl J Med. 2020;383(19):1827-1837. Accessed August 16, 2022. https://www.nejm.org/doi/full/10.1056/NEJMoa2015301


View All

INDICATION

View All

Collapse

VEKLURY is indicated for the treatment of COVID-19 in adults and pediatric patients (≥28 days old and weighing ≥3 kg) with positive results of SARS-CoV-2 viral testing, who are: VEKLURY is indicated for the treatment of COVID-19 in adults and pediatric patients (≥28 days old and weighing ≥3 kg) with positive results of SARS-CoV-2 viral testing, who are:

  • Hospitalized, or
  • Not hospitalized, have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.

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; most reactions occurred within 1 hour. Monitor patients during infusion and observe for at least 1 hour after infusion is complete for signs and symptoms of hypersensitivity as clinically appropriate. Symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering. Slower infusion rates (maximum infusion time of up to 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.

Dosage and administration

  • Administration should take place under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible.
  • Treatment duration:
    • For patients who are hospitalized, VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19.
    • For patients who are hospitalized and do not require invasive mechanical ventilation and/or ECMO, the recommended treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended up to 5 additional days, for a total treatment duration of up to 10 days.
    • For patients who are hospitalized and require invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 10 days.
    • For patients who are not hospitalized, diagnosed with mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death, the recommended total treatment duration is 3 days. VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19 and within 7 days of symptom onset for outpatient use.
  • 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.

Pregnancy and lactation

  • Pregnancy: A pregnancy registry has been established. There are insufficient human data on the use of VEKLURY during pregnancy. COVID-19 is associated with adverse maternal and fetal outcomes, including preeclampsia, eclampsia, preterm birth, premature rupture of membranes, venous thromboembolic disease, and fetal death.
  • 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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