Veklury® (remdesivir)

Hospital Readmission

This document is in response to your request for information regarding assessment of hospital readmission following the use of Veklury® (remdesivir [RDV]). This response was developed according to principles of evidence-based medicine and contains data from retrospective studies (N≥2000).

Some data may be outside of the US FDA-approved prescribing information. In providing this data, Gilead Sciences, Inc. is not making any representation as to its clinical relevance or to the use of any Gilead product(s). For information about the approved conditions of use of any Gilead drug product, please consult the FDA-approved prescribing information.

The full indication, important safety information, and boxed warnings are available at:
www.gilead.com/-/media/files/pdfs/medicines/covid-19/veklury/veklury_pi.

Summary

Real-World Studies on Hospital Readmissions Following Use of RDV

In a retrospective observational study (PINC AI Healthcare Database) that evaluated all‑cause and COVID-19–related hospital readmission to the same hospital in patients who had a discharge diagnosis of COVID-19 (N=440,601), relative to no treatment with RDV, treatment with RDV during hospitalization was associated with a statistically significant lower likelihood of 30-day all-cause and COVID-19–related readmission across VOC periods.1

In a retrospective observational study (HealthVerity Real-Time Insights and Evidence Database) that evaluated hospital readmissions in PS-matched patients who were admitted to the ICU with COVID-19 (N=8044), relative to no treatment with RDV, treatment with RDV during hospitalization was associated with a significantly lower risk of readmission at Days 30, 60, and 90 within each VOC period.2

A retrospective, observational cohort study within a network of three hospitals in Rhode Island (N=2062) that evaluated the risk of readmission at Day 30 after the index hospitalization for COVID-19 found that relative to no treatment with RDV, treatment with RDV was associated with a 19% decrease in the risk of readmission at Day 30 (RR, 0.81; 95% CI: 0.59–1.13), and among patients with mild COVID-19 disease, RDV was associated with a 69% decrease in the risk of readmission at Day 30 (RR: 0.31; 95% CI: 0.13–0.75) relative to those who did not receive RDV.3

Real-World Studies on Hospital Readmissions Following Use of RDV

PINC AI Healthcare Database

Study design and demographics1

A retrospective observational study compared rates of all-cause or COVID-related hospital readmission to the same hospital up to Day 30 between patients who did and did not receive treatment with RDV during their hospitalization and who had a discharge diagnosis of COVID-19. Data were obtained from the US-based PINC AI Healthcare Database and were analyzed overall and by three time periods (pre-Delta, Delta, and Omicron SARS-CoV-2) and maximum oxygenation requirement (no supplemental O2, low-flow O2, HFO/NIV, and IMV/ECMO).

Figure 1. Retrospective Observational Study Design1

aCovariates included age, receipt of corticosteroids, VOC period, CCI, maximum O2 requirement, and ICU admission during hospitalization.

Table 1. Select Baseline Demographics and Disease Characteristics by Receipt of RDV and by Readmission Status Within 30 Days1

aDefined as the highest level of O2 required during hospitalization.

Results

After adjustment for covariates and relative to no treatment with RDV, treatment with RDV during a hospitalization for COVID-19 was associated with a significantly lower likelihood of both all‑cause readmission and COVID-19–related readmissions up to Day 30 in the overall cohort and across each VOC period and O2 requirement level (Figure 2 and Figure 3). RDV was associated with lower rates of all-cause hospital readmission within 30 days (6.3% vs 9.1%) and COVID-19–related readmission within 30 days (3% vs 5.4%) compared with no RDV.1

Figure 2. All-Cause Readmissions Up to Day 30: Overall, by VOC Periods, and by Maximum O2 Requirement During Index Hospitalization1

Note: ORs were adjusted using the following covariates: age group, use of corticosteroids, VOC period, CCI, maximum O2 requirement, and ICU stay during hospitalization.

Figure 3. COVID-19–Related Readmissions Up to Day 30: Overall, by VOC Periods, and by Maximum O2 Requirement During Index Hospitalization1

Note: ORs were adjusted using the following covariates: age group, use of corticosteroids, VOC period, CCI, maximum O2 requirement, and ICU stay during hospitalization.

Follow-up analysis through April 20234

An updated analysis of data through April 2023 included 327,514 patients who received RDV and 262,979 who did not receive RDV. In an unadjusted analysis, and relative to no RDV treatment, patients treated with RDV had a lower all-cause readmission rate (7.7% vs 10.1%) and a lower COVID‑19–related readmission rate (3.6% vs 5.8%). After adjusting for covariates, and relative to no RDV, RDV was associated with a lower likelihood of all-cause 30‑day readmission (aOR, 0.76; 95% CI: 0.75–0.78; P<0.0001) and COVID-19–related readmission (aOR, 0.63; 95% CI: 0.61–0.65; P<0.0001). Similar benefits were observed among patients with no supplemental O2 and with any supplemental O2 requirement.

HealthVerity Real-Time Insights and Evidence Database2

Study design and demographics

A retrospective observational study compared rates of all-cause hospital readmission between patients admitted to the ICU who did and did not receive treatment with RDV during their hospitalization and who had a discharge diagnosis of COVID-19. Data were obtained from the US-based HealthVerity Real-Time Insights and Evidence Database and were analyzed across two VOC time periods (Delta and Omicron SARS-CoV-2). Readmission rates at 30, 60, and 90 days after the index date (date of RDV initiation or corresponding match date) were examined. No baseline demographics were provided.

Figure 4. Retrospective Observational Study Design2

aReceived ≥1 dose of RDV during hospitalization. Participants in the no RDV cohort were censored at the time of RDV initiation, if applicable.

bAge ranges: <18, 18–29, 30–39, 40–49, 50–59, 60–74, and ≥75 years.

Results

Readmission rates at each time point were lower in the RDV cohort than in the no RDV cohort. In a Cox proportional hazards model with multivariable adjustment, treatment with RDV was associated with a significantly lower risk of readmission at each time point assessed across both VOC periods (Figure 5).

Figure 5. Risk of Readmission at Days 30, 60, and 90 During the Delta and Omicron VOC Periods2

Retrospective, Multicenter Cohort Study in Rhode Island3

Study design and demographics

A retrospective, observational, multicenter cohort study evaluated the association between readmission at Day 30 after the index hospitalization for patients who tested positive for SARS-CoV-2 and treatment with RDV during their stay. Data were obtained from the electronic health records of eligible patients who were admitted to three hospitals in Rhode Island, USA, between April 1, 2020, and December 31, 2020. Patients were followed through postdischarge Day 30 to determine the Day 30 readmission rate and all-cause mortality and the LOS. Socioeconomic (gender, age, race, insurance type, smoking status, and medical history) and clinical data were leveraged in IPTW and IPCW models to address potential confounders of indication and selective survival, respectively. Baseline characteristics were generally similar between groups; however, a greater proportion of patients in the RDV group were older, were male, and required some degree of respiratory support.

Table 2. Select Baseline Demographics and Disease Characteristics3

Results

Table 3. Treatment Outcomes Overall and by Treatment Cohort3

Relative to no treatment with RDV, treatment with RDV was associated with a 19% decrease in the risk of readmission at Day 30, though the difference was not significant; among patients with mild COVID-19 disease, RDV was significantly associated with a 69% decrease in risk of readmission at Day 30 compared with non-receipt of RDV (Table 4).

Table 4. Day 30 Readmission Overall and by COVID-19 Severity3

aGeneralized models used IPCW and IPTW to decrease the impact of confounders that could have affected treatment assignment and survival; additionally, the model controlled for the month of hospital admission and whether the patient had a respiratory rate >30 breaths/minute within the first 24 hours of admission.

bDid not require supplemental O2.

cRequired 0.5–6 L/minute of maximal O2 support.

dRequired ≥6.5 L/min O2 support (including HFO, NIV, and mechanical ventilation).

References

1. Mozaffari E, Chandak A, Gottlieb RL, et al. Treatment of patients hospitalized for COVID-19 with remdesivir is associated with lower likelihood of 30-day readmission: a retrospective observational study. J Comp Eff Res. 2024;13(4):e230131.

2. Bansode S, Singh PK, Tellis M, et al. A Comprehensive Molecular and Clinical Investigation of Approved Anti-HCV Drugs Repurposing against SARS-CoV-2 Infection: A Glaring Gap between Benchside and Bedside Medicine. Vaccines (Basel). 2023;11(3). https://www.ncbi.nlm.nih.gov/pubmed/36992099

3. Finn A, Jindal A, Andrea SB, Selvaraj V, Dapaah-Afriyie K. Association of Treatment with Remdesivir and 30-day Hospital Readmissions in Patients Hospitalized with COVID-19. Am J Med Sci. 2022;363(5):403-410. https://www.ncbi.nlm.nih.gov/pubmed/35151637

4. Mozaffari E, Chandak A, Gottlieb RL, et al. Remdesivir Reduces All-cause and COVID-19 Related Readmission after Initial Hospitalization [Poster 105]. Paper presented at: The Society for Hospital Medicine (SHM); April 12-15, 2024; San Diego, CA.

Abbreviations

aOR=adjusted odds ratio
CCI=Charlson Comorbidity Index
ECMO=extracorporeal membrane oxygenation
HFO=high-flow O2
HR=hazard ratio
ICU=intensive care unit
IMV=invasive mechanical ventilation
IPCW=inverse probability of censoring weights
IPTW=inverse probability of treatment weights
LOS=length of stay
NIV=non-invasive ventilation
O2=oxygen
PINC AI=Premier Inc. Artificial Intelligence
PS=propensity score
RDV=remdesivir
RR=relative risk
VOC=variants of concern
 

Product Label

For the full indication, important safety information, and boxed warning(s), please refer to the Veklury US Prescribing Information available at:
www.gilead.com/-/media/files/pdfs/medicines/covid-19/veklury/veklury_pi.

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