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Patients treated with VEKLURY were significantly less likely to be readmitted across variant periods1
A real-world study assessed the impact of VEKLURY treatment on hospital readmission rates. See readmission data following the ACTT-1 study overview below.
ACTT-1 study overview2,3
5 days shorter recovery time with VEKLURY
- Median 10 days to recovery with VEKLURY vs 15 days with placebo; recovery ratio: 1.29 (95% CI, 1.12 to 1.49), P < 0.001
- The primary endpoint was time to recovery within 29 days after randomization based on an 8-point ordinal scale
Adverse reaction frequency was comparable between VEKLURY and placebo–all adverse reactions (ARs), Grades ≥3: 41 (8%) with VEKLURY vs 46 (9%) with placebo; serious ARs: 2 (0.4%)* vs 3 (0.6%); ARs leading to treatment discontinuation: 11 (2%)† vs 15 (3%)
ACTT-1 study design: a randomized, double-blind, placebo-controlled, phase 3 clinical trial in hospitalized adult patients with confirmed SARS-CoV-2 infection and mild, moderate, or severe COVID-19, who received VEKLURY (n=541) or placebo (n=521) for up to 10 days. Recovery was defined as patients who were no longer hospitalized or hospitalized but no longer required ongoing medical care for COVID-19.
*Seizure (n=1), infusion-related reaction (n=1).
†Seizure (n=1), infusion-related reaction (n=1), transaminases increased (n=3), ALT increased and AST increased (n=1), GFR decreased (n=2), acute kidney injury (n=3).
Readmission study overview1
A large, real-world retrospective study examined 30-day, all-cause readmission after COVID-19 hospitalization in adult patients (≥18 years of age) who were treated with VEKLURY vs those not treated with VEKLURY across variant periods: pre-Delta (5/2020–4/2021), Delta (5/2021–11/2021), and Omicron (12/2021–4/2022).
The primary endpoint was 30-day, all-cause readmission to the same hospital after being discharged alive from the index COVID-19 hospitalization.‡
- Data were examined using multivariate logistic regression. The model adjusted for age, corticosteroid use, variant period, Charlson Comorbidity Index, maximum oxygenation requirements, and ICU admission during COVID-19 hospitalization
- This study was sponsored by Gilead Sciences, Inc.
Study limitations1
- Patients readmitted to a different hospital were not accounted for
- Since the model adjusted for multiple variables, patients were not matched
- Patients received at least 1 dose of VEKLURY; the model did not account for the number of VEKLURY doses administered§
- Real-world studies should be interpreted based on the type and size of the source datasets and the methodologies used to mitigate potential confounding or bias. Real-world data should be considered in the context of all available data. Results may differ between studies
§Refer to the Dosing and Administration section of the full Prescribing Information for dosage requirement.
Data source1
PINC AI™ Healthcare Database: This US hospital–based, service-level, all-payer (commercial, Medicare, Medicaid, others) database covered approximately 25% of all US hospitalizations from 48 states.
Study population1
- 440,601 patients from 852 hospitals with a primary diagnosis of COVID-19 who were discharged alive
- 248,785 VEKLURY patients were compared to 191,816 non-VEKLURY patients
Population characteristics1
Compared to nonreadmitted patients, readmitted patients:
- Were older: median 71 years vs 63 years
- Had more comorbidities: CCI ≥4: 36% vs 16%
- Were more likely to have NSOc: 42% vs 39%
- Were less likely to be:
- On low-flow oxygen: 40% vs 42%
- Treated with any VEKLURY: 48% vs 57%
- Had an equal proportion of:
- High-flow oxygen/NIV: 16% vs 16%
- IMV/ECMO: 3% vs 3%
- Had comparable length of stay: median 5 days vs 5 days
Compared to non-VEKLURY patients, VEKLURY patients:
- Were younger: median 62 years vs 64 years
- Were less likely to have NSOc: 30% vs 52%
- Were more likely to be on:
- Low-flow oxygen: 46% vs 36%
- High-flow oxygen/NIV: 20% vs 10%
- IMV/ECMO: 4% vs 2%
CCI=Charlson Comorbidity Index; ECMO=extracorporeal membrane oxygenation; IMV=invasive mechanical ventilation; NIV=noninvasive ventilation; NSOc=no supplemental oxygen charges.
Patients treated with VEKLURY had significantly reduced readmission rates across variant periods1
Reduction of 30-day, all-cause readmission was observed with VEKLURY
In the overall cohort, patients treated with VEKLURY were 27% less likely to be readmitted within 30 days; aOR 0.73 (95% CI, 0.72 to 0.75), P < 0.0001
30-day, all-cause readmission across variant periods and by maximum oxygenation in index hospitalization (May 2020 through April 2022)1
- A statistically significant reduction was observed for all supplemental oxygen levels, except in the IMV/ECMO group, which did not meet statistical significance due to low sample size in this group
- The lower readmission rate for VEKLURY patients was observed despite this group having a higher supplemental oxygen requirement during their index COVID-19 hospitalization, as compared to the non-VEKLURY group
Patients treated with VEKLURY who did not receive supplemental oxygen at index hospitalization showed the greatest reduction in all-cause readmission
Baseline characteristics: VEKLURY use1
| Characteristic | VEKLURY(n=248,785) | Non-VEKLURY(n=191,816) |
|---|---|---|
| Median age (IQR), n | 62 (51-73) | 64 (52-76) |
| Age group, % | ||
| 18-49 y | 23 | 21 |
| 50-64 y | 33 | 29 |
| 65+ y | 44 | 50 |
| Maximum supplemental oxygenation support (highest level of oxygenation during the hospitalization), % |
||
| No supplemental oxygen | 30 | 52 |
| Low-flow oxygen | 46 | 36 |
| High-flow oxygen/NIV | 20 | 10 |
| IMV/ECMO | 4 | 2 |
| Variant period, % | ||
| Pre-Delta | 49 | 57 |
| Delta | 34 | 23 |
| Omicron | 17 | 20 |
ECMO=extracorporeal membrane oxygenation; IMV=invasive mechanical ventilation; IQR=interquartile range; NIV=noninvasive ventilation.
Baseline characteristics: Overall1
| Characteristic | Readmitted(n=33,217) | Nonreadmitted(n=407,384) | Overall(N=440,601) |
|---|---|---|---|
| Median age (IQR), n | 71 (60-80) | 63 (51-74) | 63 (51-74) |
| Age group, % | |||
| 18-49 y | 11 | 23 | 22 |
| 50-64 y | 24 | 32 | 31 |
| 65+ y | 65 | 45 | 47 |
| Gender, % | |||
| Female | 48 | 49 | 49 |
| Race, % | |||
| White | 73 | 69 | 70 |
| Black | 18 | 17 | 17 |
| Asian | 2 | 2 | 2 |
| Other | 7 | 12 | 11 |
| Ethnicity, % | |||
| Hispanic | 11 | 17 | 16 |
| Non-Hispanic | 79 | 73 | 73 |
| Unknown | 10 | 11 | 11 |
| CCI, % | |||
| 0 | 15 | 33 | 32 |
| 1-3 | 49 | 51 | 50 |
| ≥4 | 36 | 16 | 18 |
| Maximum supplemental oxygenation support(highest level of oxygenation during the hospitalization),% |
|||
| No supplemental oxygen | 42 | 39 | 39 |
| Low-flow oxygen | 40 | 42 | 42 |
| High-flow oxygen/NIV | 16 | 16 | 16 |
| IMV/ECMO | 3 | 3 | 3 |
CCI=Charlson Comorbidity Index; ECMO=extracorporeal membrane oxygenation; IMV=invasive mechanical ventilation; IQR=interquartile range; NIV=noninvasive ventilation.
Explore real-world VEKLURY readmission data
This retrospective analysis examined the impact of VEKLURY on readmission rates for patients hospitalized due to COVID-19.
REAL-WORLD READMISSION DATA
Clinical insights on VEKLURY
Learn more about treatment with VEKLURY for your patients with a broad spectrum of COVID-19 severity.
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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 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: A pregnancy registry has been established for VEKLURY. 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
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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:
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:
Please see full Prescribing Information for VEKLURY.
‡Index COVID-19 hospitalization was defined as the first admission to the hospital between May 1, 2020, and April 30, 2022, with a primary discharge diagnosis of COVID-19.
aOR=adjusted odds ratio; ECMO=extracorporeal membrane oxygenation; IMV=invasive mechanical ventilation; NIV=noninvasive ventilation.
PINC AI™ is a trademark of Premier, Inc. (formerly Premier Healthcare Database).
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INDICATION
View All
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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:
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:
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; 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: A pregnancy registry has been established for VEKLURY. 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.
