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| This information is promotional and intended for healthcare professionals only. |
| Prescribing information and adverse events reporting for the EU, GB and Spain can be found at the end of this document. |
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ESCMID GLOBAL 2024:
EXPLORE THE LATEST
VEKLURY DATA |
ESCMID GLOBAL 2024:
EXPLORE THE LATEST
VEKLURY DATA |
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Thank you for being part of ESCMID Global 2024. We hope you enjoyed
the opportunity to connect with fellow attendees in Barcelona. |
Thank you for being part of ESCMID Global 2024. We hope you enjoyed the opportunity to connect with fellow attendees in Barcelona. |
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| Have you seen the latest VEKLURY abstracts? |
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| Drug-drug interactions: |
| New findings from a Phase 1, fixed sequence DDI study in healthy participants
(N=14) who received oral midazolam on separate days, alone or with
VEKLURY, found that VEKLURY coadministered with midazolam did not
result in clinically relevant CYP3A4 induction or inhibition.*1 VEKLURY
was well tolerated; one incident of treatment-related increase in hepatic
enzymes was reported and resolved after study treatment was completed. All
other AEs were Grade 1 without clinically significant laboratory abnormalities.1 |
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| Mortality: |
| In two real-world analyses of the US PINC AI database (Dec 2021–April
2023):†2,3 |
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| VEKLURY (n=45,038) was associated with a lower mortality risk in US patients aged 65+ hospitalised for COVID-19 compared to non-VEKLURY (n=45,038).‡2 |
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| VEKLURY in combination with dexamethasone (n=33,037) was associated with lower mortality risk across all supplemental oxygen requirements in US adults hospitalised with COVID-19 vs dexamethasone alone (n=33,037).§3 |
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| Initiate VEKLURY right away in your eligible COVID-19 patients‖4,5 |
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Discover new insights presented at
our Gilead-sponsored symposium |
Discover new insights presented at
our Gilead-sponsored symposium |
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| COVID is here to stay: What is the current role
of antiviral treatment in hospitalised patients? |
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| Prof. Andrew Ustianowski |
| North Manchester |
| General Hospital |
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| ID specialist, UK |
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| Prof. Veronika Müller |
| Semmelweis University |
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| Pulmonologist, Hungary |
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| Prof. Nicola Montano |
| University of Milan |
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| Internal Medicine, Italy |
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| Dr. Roger Paredes |
| Hospital Universitari |
| Germans Trias i Pujol |
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| ID specialist, Spain |
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We look forward to seeing you at ESCMID Global 2025 in Vienna, 11–15 April. |
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| VEKLURY is indicated for the treatment of coronavirus disease 2019 (COVID-19) in:5 |
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Adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg) with pneumonia
requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of
treatment) |
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Adults and paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen
and who are at increased risk of progressing to severe COVID-19 |
Adults and paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen
and who are at increased risk of progressing to severe COVID-19 |
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| VEKLURY may not be commercially available for paediatric patients in all markets. |
| Indicación en pediatría aún no financiada. |
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| * |
This study was conducted in healthy volunteers the clinical relevance is unknown. Drug-drug interactions
with midazolam were investigated following multiple doses of VEKLURY. Plasma concentrations of
MDZ, VEKLURY, and respective metabolites were measured by validated liquid chromatography-mass
spectrometry methods. Pharmacokinetic parameters (Cmax, AUClast AUCinf) of MDZ were estimated for Day 1
vs. Day 11 by noncompartmental analysis and compared between treatments using a mixed-effects model
with geometric least-squares mean and 90% confidence intervals.1 No CYP3A4 induction was observed,
as MDZ exposure was not decreased following multiple-doses of VEKLURY. There was weak inhibition of
CYP3A4 signal, seen in increased MDZ levels, but these were generally within no-effect bounds. The ratio
of MDZ:1’-OH-MDZ was unchanged, indicating no meaningful changes in MDZ metabolism.1 |
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The US PINC AI Healthcare Database is a large hospital administrative database that captures diagnosis,
procedure, and medication data for ~25% of all hospitalisations occurring in the US.2,3 |
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Results from a retrospective, comparative PS-matched study. Patients were matched using 1:1 preferential
within-hospital propensity matching; 45,038 VEKLURY-treated patients were matched to 20,425 unique
non-VEKLURY patients.2 The primary endpoints were 14- and 28-day mortality rate and time to 14- and
28-day mortality assessed using Cox Proportional Hazards model.2 |
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Results from a retrospective, comparative PS-matched study. Among 151,215 patients hospitalised for
COVID-19, 61,226 (40%) initiated VEKLURY+DEX and 36,489 (24%) DEX monotherapy in the first 2 days
of admission.3 Analyses were stratified by oxygen requirement, however the use of VEKLURY in patients
on invasive mechanical ventilation is an indication not approved in some countries. Patients were matched
using 1:1 preferential within-hospital propensity matching. The primary endpoints were 14- and 28-day
all-cause inpatient mortality (defined as a discharge status of “expired” or “hospice”) and were assessed
using Cox Proportional Hazards model.3 |
Results from a retrospective, comparative PS-matched study. Among 151,215 patients hospitalised for
COVID-19, 61,226 (40%) initiated VEKLURY+DEX and 36,489 (24%) DEX monotherapy in the first 2 days
of admission.3 Analyses were stratified by oxygen requirement, however the use of VEKLURY in patients
on invasive mechanical ventilation is an indication not approved in some countries. Patients were matched
using 1:1 preferential within-hospital propensity matching. The primary endpoints were 14- and 28-day
all-cause inpatient mortality (defined as a discharge status of “expired” or “hospice”) and were assessed
using Cox Proportional Hazards model.3 |
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ACTT-1: Reduced time to recovery with VEKLURY (n=541) vs placebo (n=521) in hospitalised patients
with COVID-19 (primary endpoint; 10 vs 15 days; p<0.001).4 Recovery defined as discharge from hospital
or hospitalisation for non-medical reasons.4 Reduced disease progression was an additional secondary
endpoint: VEKLURY (n=402) vs placebo (n=364) reduced incidence of new MV/ECMO initiation
in patients not receiving either at baseline (VEKLURY 13% vs placebo 23% [95% CI, -15 to -4]).4 |
ACTT-1: Reduced time to recovery with VEKLURY (n=541) vs placebo (n=521) in hospitalised patients
with COVID-19 (primary endpoint; 10 vs 15 days; p<0.001).4 Recovery defined as discharge from hospital
or hospitalisation for non-medical reasons.4 Reduced disease progression was an additional secondary
endpoint: VEKLURY (n=402) vs placebo (n=364) reduced incidence of new MV/ECMO initiation
in patients not receiving either at baseline (VEKLURY 13% vs placebo 23% [95% CI, -15 to -4]).4 |
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| 1’-OH-MDZ, 1'-hydroxymidazolam; ACTT, Adaptive COVID-19 Treatment Trial; AE, adverse event; AUCinf, area under the concentration-time curve extrapolated to infinite time; AUClast, area under the concentration-time curve from dosing to last measurable concentration; CI, confidence interval; Cmax, maximum observed concentration; COVID-19, coronavirus disease 2019; CYP3A4, cytochrome P450 3A4; DDI, drug-drug interaction; DEX, dexamethasone; ESCMID Global, European Society of Clinical Microbiology and Infectious Diseases; ECMO, extracorporeal membrane oxygenation; GLSM, geometric least-squares mean; ID, infectious disease specialist; MDZ, midazolam; MV, mechanical ventilation; US, United States. |
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| References: |
| 1. |
Chang J, et al. Impact of Multiple-dose Remdesivir, a COVID-19 Antiviral, on Cytochrome P450 3A4 Activity: A Clinical Drug-Drug Interaction Study With Midazolam. Poster P0474. Presented at ESCMID Global. 27–30 April 2024. |
| 2. |
Mozaffari E, et al. Remdesivir reduces mortality in elderly patients 65+ years hospitalised for COVID-19 during Omicron. Oral presentation presented at ESCMID Global. 27–30 April 2024. |
| 3. |
Mozaffari E, et al. Comparative effectiveness of remdesivir and dexamethasone combination therapy vs. dexamethasone monotherapy in patients hospitalised for COVID-19. Poster AQO0704. Presented at ESCMID Global. 27–30 April 2024. |
| 4. |
Beigel JH, et al. Remdesivir for the Treatment of Covid-19 — Final Report. N Engl J Med.
2020; 383: 1813–1826 DOI: 10.1056/NEJMoa2007764. |
Beigel JH, et al. Remdesivir for the Treatment of Covid-19 — Final Report. N Engl J Med. 2020; 383: 1813–1826 DOI: 10.1056/NEJMoa2007764. |
| 5. |
VEKLURY (RDV). Summary of Product Characteristics. |
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| For the EU, please click here to access VEKLURY prescribing information. |
| For Spain, please click here to access VEKLURY prescribing information. |
| For the UK, please click here to access VEKLURY prescribing information. |
| Ficha Técnica disponible |
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This medicinal product is subject to additional monitoring. This will allow quick identification of new safety
information. |
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Este medicamento está sujeto a seguimiento adicional, es prioritaria la notificación de sospechas
de reacciones adversas asociadas a este medicamento. |
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Adverse events should be reported. Healthcare professionals are asked to report any suspected
adverse events via their national reporting system. Adverse events should also be reported to Gilead at
safety_FC@gilead.com. For the UK, reporting information can be found at https://yellowcard.mhra.gov.uk
Comunicación de Reacciones Adversas: Gilead.es |
Adverse events should be reported. Healthcare professionals are asked to report any suspected
adverse events via their national reporting system. Adverse events should also be reported to Gilead at
safety_FC@gilead.com. For the UK, reporting information can be found at https://yellowcard.mhra.gov.uk
Comunicación de Reacciones Adversas: Gilead.es |
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| This material is developed & wholly funded by Gilead Sciences Europe Ltd. |
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