The safety profile of VEKLURY was evaluated in pediatric patients with COVID-19, starting at birth1
When compared to clinical studies of adults, adverse reactions in children were consistent1
When compared to clinical studies of adults, adverse reactions in children were consistent1
Of infants, children, and adolescents*:
- Adverse reactions (all grades) were reported in 8 (15%) patients
- The most common adverse reaction (≥5%) in patients was ALT increased
- No patients experienced serious adverse reactions
- 3 patients (6%) died
Of neonates and infants†:
- Laboratory abnormalities (Grades 3-4) were reported in 3 out of 5 patients
- No patients died
Study design1
The CARAVAN study (GS-US-540-5823) was a single-arm, open-label, phase 2/3 clinical trial to evaluate the safety, tolerability, and pharmacokinetics of up to 10 days of treatment with VEKLURY in pediatric patients (N=58) hospitalized with mild, moderate, or severe COVID-19 and confirmed SARS-CoV-2 infection. Pediatric patients, from birth (including preterm to infants) to <18 years of age and weighing ≥1.5 kg, were evaluated by age and weight. Recovery was defined as an improvement from baseline clinical status score of 2 through 5 to a score of 6 or 7, or an improvement from a baseline score of 6 to a score of 7, on a 7-point ordinal scale.
Study design cohorts1
VEKLURY treatment was evaluated for up to 10 days in pediatric patients in the following cohorts:
Infants, children, and adolescents
Infants, children, and adolescents
- Patients aged ≥28 days and weighing:
- ≥3 kg to <12 kg (n=12)
- ≥12 kg to <20 kg (n=12)
- ≥20 kg to <40 kg (n=12)
- Patients aged <12 years and weighing ≥40 kg (n=5)
- Patients aged ≥12 years and weighing ≥40 kg (n=12)
Neonates and infants
Neonates and infants
- Patients aged <14 days, GA >37 weeks, and weighing ≥2.5 kg at birth (n=1)
- Patients aged 14 days to <28 days, GA >37 weeks, and weighing ≥2.5 kg (n=3)
- Patients aged <56 days, GA ≤37 weeks, and weighing ≥1.5 kg at birth (n=1)
GA=gestational age.
Improvement in clinical status was observed in pediatric patients treated with VEKLURY1
Infants, children, and adolescents
Infants, children, and adolescents
Of 53 patients, 62% of infants, children, and adolescents had recovery reported on Day 10
- Median time to recovery was 7 days
- 83% of patients were discharged by Day 30
Neonates and infants
Neonates and infants
Of 5 patients, recovery was reported for 3 neonates and infants with up to 10 days of treatment with VEKLURY
- Time to recovery ranged from 9 to 19 days
- 3 patients were discharged by Day 30
Baseline characteristics: Infants, children, and adolescents1
| Characteristic | VEKLURY(n=53) | ||
|---|---|---|---|
| Median age (IQR), y | 7 (2-12) | ||
| Median weight (range), kg | 25 (4-192) | ||
| Female sex, % | 57 | ||
| Race or ethnic group, % | |||
| White | 70 | ||
| Black | 30 | ||
| Hispanic or Latinx | 44 | ||
| Respiratory support at baseline, n (%) | |||
| Invasive mechanical ventilation | 12 (23) | ||
| Noninvasive ventilation or high-flow oxygen | 18 (34) | ||
| Low-flow oxygen | 10 (19) | ||
| Room air | 13 (25) | ||
| Overall median duration of symptoms (IQR), days | 5 (3-7) | ||
| Hospitalization prior to first dose of VEKLURY (IQR), days | 1 (1-3) | ||
IQR=interquartile range.
Baseline characteristics: Neonates and infants1
| Characteristic | VEKLURY(n=5) | ||
|---|---|---|---|
| Age range, days | 12-30 | ||
| Weight range, kg | 2.2-3.5 | ||
| Female sex, n | 3 | ||
| Race, n | |||
| White | 4 | ||
| Black | 1 | ||
| Respiratory support at baseline, n | |||
| Invasive mechanical ventilation | 3 | ||
| High-flow oxygen | 2 | ||
| Duration of symptoms range, days | 2-9 | ||
| Hospitalization prior to first dose of VEKLURY range, days | 1-9 | ||
7-point ordinal scale1,2
Patient clinical status was assessed on a 7-point ordinal scale with a lower score indicating greater clinical severity.
ECMO=extracorporeal membrane oxygenation.
See clinical outcomes for VEKLURY in hospitalized patients
ACTT-1 STUDYSee clinical outcomes for VEKLURY in patients, who are not hospitalized and at high risk for disease progression
OUTPATIENT STUDY
Important Safety Information
Important Safety
Information and Indication
Tap for Important Safety Information, including contraindication for history of clinically significant hypersensitivity to VEKLURY.
VEKLURY is indicated for the treatment of COVID-19 in adults and pediatric patients (birth to <18 years of age weighing ≥1.5 kg, who are hospitalized, or not hospitalized, with mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
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 hepatic laboratory and prothrombin time testing prior to initiating VEKLURY and during use as clinically appropriate.
- Renal impairment: No dosage adjustment of VEKLURY is recommended in patients with any degree of renal impairment, including patients on dialysis. VEKLURY may be administered without regard to the timing of dialysis.
Pregnancy and lactation
- Pregnancy: Available clinical trial data for VEKLURY in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes following second- and third-trimester exposure. There are insufficient data to evaluate the risk of VEKLURY exposure during the first trimester. Maternal and fetal risks are associated with untreated COVID-19 in pregnancy.
- Lactation: VEKLURY can pass into breast milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VEKLURY and any potential adverse effects on the breastfed child from VEKLURY or from an underlying maternal condition. 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 the treatment of COVID-19 in adults and pediatric patients (birth to <18 years of age weighing ≥1.5 kg), who are hospitalized, or not hospitalized, with mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
Please see full Prescribing Information for VEKLURY.
Important Safety Information
Important Safety
Information and Indication
Tap for Important Safety Information, including contraindication for history of clinically significant hypersensitivity to VEKLURY.
VEKLURY is indicated for the treatment of COVID-19 in adults and pediatric patients (birth to <18 years of age weighing ≥1.5 kg, who are hospitalized, or not hospitalized, with mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
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 hepatic laboratory and prothrombin time testing prior to initiating VEKLURY and during use as clinically appropriate.
- Renal impairment: No dosage adjustment of VEKLURY is recommended in patients with any degree of renal impairment, including patients on dialysis. VEKLURY may be administered without regard to the timing of dialysis.
Pregnancy and lactation
- Pregnancy: Available clinical trial data for VEKLURY in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes following second- and third-trimester exposure. There are insufficient data to evaluate the risk of VEKLURY exposure during the first trimester. Maternal and fetal risks are associated with untreated COVID-19 in pregnancy.
- Lactation: VEKLURY can pass into breast milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VEKLURY and any potential adverse effects on the breastfed child from VEKLURY or from an underlying maternal condition. 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 the treatment of COVID-19 in adults and pediatric patients (birth to <18 years of age weighing ≥1.5 kg), who are hospitalized, or not hospitalized, with mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
Please see full Prescribing Information for VEKLURY.
*Patients evaluated in the infants, children, and adolescent cohorts were aged ≥28 days to <18 years and ranged in weight, starting from ≥3 kg.
†Patients evaluated in the neonate and infant cohorts included term neonates, preterm neonates, and infants. Term neonatal patients ranged in age (from birth to <28 days) and weight (≥2.5 kg at birth or screening). Preterm neonates and infants ranged in age (from birth to <56 days) and weight (≥1.5 kg at birth).
References: 1. VEKLURY. Prescribing Information. Gilead Sciences, Inc.; 2025.
2. Study of remdesivir in participants 18 years old and younger with COVID-19 (CARAVAN).
ClinicalTrials.gov identifier: NCT04431453. Updated February 6, 2024. Accessed March 18, 2024. https://clinicaltrials.gov/ct2/show/NCT04431453