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.
Treatment with VEKLURY was stopped in patients who were discharged from the hospital prior to completion of their protocol-defined duration of treatment.
Clinical status on Day 11 as assessed on a 7-point ordinal scale.
R=randomization.
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).
Types of adverse reactions | VEKLURY 5 days(n=191)n (%) | VEKLURY 10 days(n=193)n (%) |
---|---|---|
Any adverse reaction, all grades | 36 (19) | 25 (13) |
Serious adverse reactions | 1 (<1)† | 0 |
Adverse reactions leading to treatment discontinuation | 4 (2)‡ | 4 (2)‡ |
*Attribution of events to study drug was not performed for the SOC group.
†Heart rate decreased.
‡ALT increased (n=2), ALT increased and AST increased (n=1), hypertransaminasemia (n=1), blood alkaline phosphatase increased (n=1), rash (n=2), heart rate decreased (n=1).
Laboratory parameter abnormality§ | VEKLURY 5 days(n=191) | VEKLURY 10 days(n=193) | Standard of care(n=200) |
---|---|---|---|
ALT increased | 2% | 3% | 8% |
Creatinine clearance decreased|| | 2% | 5% | 8% |
Glucose increased | 4% | 3% | 2% |
Hemoglobin decreased | 3% | 1% | 6% |
§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.
Characteristic | 5-day group(n=191) | 10-day group(n=193) | Standard of care(n=200) |
---|---|---|---|
Median age (IQR), y | 58 (48-66) | 56 (45-66) | 57 (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% |
IQR=interquartile range.
Patient clinical status was assessed on a 7-point ordinal scale with a lower score indicating greater clinical severity.
ECMO=extracorporeal membrane oxygenation.
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
Warnings and precautions
Adverse reactions
Dosage and administration
Pregnancy and lactation
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.
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
Warnings and precautions
Adverse reactions
Dosage and administration
Pregnancy and lactation
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.
SOC=standard of care; SpO2=oxygen saturation.