COVID-19 is a year-round disease and remains a public health priority1
COVID-19 is still a significant cause of mortality2,3
- The CDC reported 116,188 provisional death counts involving COVID-19 in the United States from January 2023 through October 20242,*
- Within the same time frame, the CDC reported 14,273 provisional deaths attributed to influenza in the United States2,†
*Deaths with confirmed or presumed COVID-19, coded to ICD-10 code U07.1.
†Counts of deaths involving influenza (J09-J18.9) include deaths with pneumonia or COVID-19 also listed as a cause of death.
Older adults and/or patients with certain comorbidities are at higher risk for severe COVID-194
Age remains the strongest risk factor for severe COVID-194,5
People aged ≥65 years accounted for ~63% of COVID-19–associated hospitalizations and 88% of COVID-19– associated in-hospital deaths.6,‡
‡Data from January 2023 to August 2023.
Source: CDC. COVID-NET conducts population-based surveillance for laboratory-confirmed COVID-19–associated hospitalizations across 13 US states.
Comorbidities place patients at an increased risk for severe outcomes7
Among 540,667 adult patients hospitalized with COVID-19, a study found the following select comorbidities were found to be risk factors for progression to severe COVID-19, including death:
| Comorbidities | Death Risk Ratio Increase | aRR (95% CI) |
|---|---|---|
| Obesity | 30% | 1.30 (1.27 to 1.33) |
| Diabetes with complications | 26% | 1.26 (1.24 to 1.28) |
| Chronic kidney disease | 21% | 1.21 (1.19 to 1.24) |
| COPD and bronchiectasis | 18% | 1.18 (1.16 to 1.20) |
| Neurocognitive disorders | 18% | 1.18 (1.15 to 1.21) |
| CAD and other heart disease | 14% | 1.14 (1.12 to 1.16) |
Source: CDC; Premier Healthcare Database, Special COVID-19 Release, March 2020–March 2021.
COVID-19 death risk ratio increases as the number of underlying conditions increase
| Number of Conditions | Death Risk Ratio Increase | aRR (95% CI) |
|---|---|---|
| No conditions | 1x | Reference |
| 1 condition | 1.53x | 1.53 (1.41 to 1.67) |
| 2 to 5 conditions | 2.55x | 2.55 (2.32 to 2.80) |
| 6 to 10 conditions | 3.29x | 3.29 (2.98 to 3.63) |
| >10 conditions | 3.82x | 3.82 (3.45 to 4.23) |
Of patients hospitalized with COVID-19,
had ≥1 underlying condition.
had 2 to 5 conditions.
had 6 to 10 conditions.
had > 10 conditions.
Source: CDC; Premier Healthcare Database, Special COVID-19 Release, March 2020–March 2021.
VEKLURY is the #1 prescribed antiviral for patients hospitalized with COVID-198
Premier, Inc., and HealthVerity, Inc.; 08/2023 to 09/2024.
VEKLURY can be used across a broad range of patients9
Patients with any degree of renal impairment, including those on dialysis
- No dosage adjustment of VEKLURY is recommended in patients with any degree of renal impairment
- No renal laboratory testing is required before or during treatment
Patients with any stage of hepatic impairment
- No dosage adjustment of VEKLURY is recommended for patients with mild, moderate, or severe hepatic impairment
- Perform hepatic laboratory and prothrombin testing prior to initiating VEKLURY and during use as clinically appropriate
Pregnant or breastfeeding patients
- VEKLURY may be administered in patients who are pregnant and have COVID-19
- No drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes following exposure in the second and third trimesters have been identified in available data. There are insufficient data to evaluate the risk of VEKLURY exposure during the first trimester
- VEKLURY can pass into breast milk. Available data from pharmacovigilance reports (n=11) do not indicate adverse effects on breastfed infants from exposure to VEKLURY and its metabolites through breast milk
Pediatric patients as early as birth to <18 years of age weighing at least 1.5 kg
VEKLURY should be administered as soon as possible in patients hospitalized for COVID-19 to prevent progression to severe or critical disease10
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: 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
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.
aRR=adjusted risk ratio; CAD=coronary atherosclerosis disease; COPD=chronic obstructive pulmonary disease; ICD-10=International Classification of Diseases, 10th Revision.
References: 1. Auwaerter PG. Coronavirus COVID-19 (SARS-CoV-2). Johns Hopkins Medicine POC-IT Guides. Updated September 6, 2024. Accessed October 29, 2024. https://www.hopkinsguides.com/hopkins/view/Johns_Hopkins_ABX_Guide/540747/all/Coronavirus_COVID_19__SARS_CoV_2
2. Centers for Disease Control and Prevention. Deaths by week and state. Provisional death counts for COVID-19. Reviewed October 24, 2024. Accessed October 29, 2024. https://www.cdc.gov/nchs/nvss/vsrr/COVID19/index.htm 3. Centers for Disease Control and Prevention. Provisional mortality statistics, 2018 through last week results. Deaths occurring through October 12, 2024 as of October 20, 2024. Accessed October 29, 2024; search criteria: 1. “UCD - 15 Leading Causes of Death”; 2. and 3. default “All”; 4. “2024 (2024 provisional and partial)”; 5. to 7. default “All”; 8. “Show Totals.” https://wonder.cdc.gov/mcd-icd10-provisional.html 4. Centers for Disease Control and Prevention. Underlying conditions and the higher risk for severe COVID-19. Updated July 30, 2024. Accessed October 29, 2024. https://www.cdc.gov/covid/hcp/clinical-care/underlying-conditions.html?CDC_ AAref_Val=https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html 5. Centers for Disease Control and Prevention. Deaths by select demographic and geographic characteristics. Reviewed September 27, 2023 (archived document). Accessed October 29, 2024. https://www.cdc.gov/nchs/nvss/vsrr/covid_ weekly/index.html 6. Taylor CA, Patel K, Patton ME, et al. COVID-19–associated hospitalizations among U.S. adults aged ≥65 years — COVID-NET, 13 states, January– August 2023. MMWR Morb Mortal Wkly Rep. 2023;72:1089-1094. Reviewed October 18, 2023. Accessed October 29, 2024. https://www.cdc.gov/mmwr/volumes/72/wr/mm7240a3.htm 7. Kompaniyets L, Pennington AF, Goodman AB, et al. Underlying medical conditions and severe illness among 540,667 adults hospitalized with COVID-19, March 2020–March 2021. Prev Chronic Dis. 2021;18:E66. doi:10.5888/pcd18.210123 8. Data on file; January 2023 to June 2024. Gilead Sciences, Inc. 9. VEKLURY. Prescribing Information. Gilead Sciences, Inc.; 2025. 10. Mozaffari E, Chandak A, Gottlieb RL, et al. Remdesivir is associated with reduced mortality in COVID-19 patients requiring supplemental oxygen including invasive mechanical ventilation across SARS-CoV-2 variants. Open Forum Infect Dis. 2023;10(10):1-12. doi:10.1093/ofid/ofad482