65% in the 5-day arm and 54% in the 10-day arm; odds ratio for improvement: 0.75 (95% CI, 0.51 to 1.12)*
*Once adjusted for between-group differences at baseline.
64% in the 5-day arm and 54% in the 10-day arm; baseline-adjusted difference in proportion: -6.3% (95% CI, -15.4 to 2.8)
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
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 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.
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.
LFT=liver function test; SpO2=oxygen saturation.