Veklury® (remdesivir)

Use in Dialysis

This document is in response to your request for information regarding the use of Veklury® (remdesivir [RDV]) in patients on dialysis. This response was developed according to principles of evidence-based medicine and contains data from prospective and retrospective studies (N≥80).

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

Product Labeling1

No dosage adjustment of RDV is recommended in patients with any degree of renal impairment, including patients on dialysis. RDV may be administered without regard to the timing of dialysis.

Clinical Data on RDV Use in Patients on Dialysis

The REDPINE study evaluated the safety and efficacy of RDV (n=163) compared to placebo (n=80) in participants with severely reduced kidney function (eGFR <30 mL/min/1.73 m2, including patients with ESRD on chronic dialysis) who were hospitalized for COVID‑19. The study stopped enrollment early due to recruitment challenges. The decision was not based on efficacy or safety concerns.2

• At baseline, 89 participants (37%) had ESRD on chronic dialysis: 59 participants (36%) in the RDV group and 30 (38%) in the placebo group.2
• Among participants with ESRD on chronic dialysis, there was not a significant difference between the RDV and placebo groups in the incidence of the composite endpoint of all‑cause death or IMV through Day 29.2
• In the overall population, safety outcomes were similar between participants treated with RDV and those treated with placebo. Safety outcomes were not reported based on baseline kidney disease status.2

In a retrospective study of 392 Japanese patients who required dialysis, a multivariate analysis of the entire study population revealed that the mortality risk was significantly lower among those treated with RDV than among those who did not receive RDV (P=0.041).3

Product Labeling1

Renal impairment

No dosage adjustment of RDV is recommended in patients with any degree of renal impairment, including patients on dialysis. RDV may be administered without regard to the timing of dialysis.

Use of RDV in patients with COVID-19 and renal impairment, including those on dialysis, is supported by safety and pharmacokinetic data from the following:

• a randomized, double-blind, placebo-controlled trial (Study 5912) in adults
• an open-label, parallel-group, single-dose trial in subjects with normal renal function and renal impairment (Study 9015)

Please refer to the US FDA-approved prescribing information for additional information regarding renal impairment in Sections 2.4 Renal Impairment, 6.1 Clinical Trials Experience, 8.4 Pediatric Use, 8.6 Renal Impairment, and 12.3 Pharmacokinetics.

Clinical Data on RDV Use in Patients on Dialysis

REDPINE: RDV and Severely Reduced Kidney Function

Study design

A phase 3, randomized (2:1), double-blind, placebo-controlled, multicenter study evaluated the safety and efficacy of RDV (n=163; 200 mg loading dose via IV infusion on Day 1, followed by 100 mg daily IV infusion up to Day 5) compared to placebo (n=80; IV saline daily4) in participants with moderately to severely reduced kidney function (eGFR <30 mL/min/1.73 m2, including participants with ESRD on chronic dialysis) who were hospitalized for COVID‑19 pneumonia. Participants in both arms received standard-of-care. Participants aged ≥12 years were eligible for study enrollment; however, no participants <18 years of age enrolled in the study. Participants who required IMV, NIV, ECMO, or renal replacement therapy for AKI were not eligible for study enrollment. The primary endpoint was a composite of all-cause mortality and the initiation of IMV through Day 29. No renal dose adjustment was required for those assigned to receive RDV. There were 249 participants enrolled in the study; 6 of those participants were not treated.2

Of the 243 participants who received treatment, 89 (37%) had ESRD on chronic dialysis: 59 participants (36%)  in the RDV group and 30 (38%) in the placebo group.2

Efficacy results2

In the Kaplan-Meier estimates there was no significant difference between the RDV and placebo groups in the composite endpoint of all-cause death or IMV through Day 29 (RDV: 30%; placebo: 34%; HR, 0.82; 95% CI: 0.5–1.32; P=0.61). This remained true regardless of baseline kidney disease status (ESRD on chronic dialysis: HR, 1.06; 95% CI: 0.48–2.36; P=0.88; AKI: HR, 0.84; 95% CI: 0.4–1.77; P=0.65; chronic kidney disease: HR, 0.81; 95% CI: 0.3–2.18; P=0.67). However, due to insufficient enrollment, the study was not powered to determine a difference between the study arms in efficacy outcomes.

Safety results2

Safety data are only available from all participants, including participants with ESRD on chronic dialysis. Overall, 131 participants (80%) in the RDV group and 62 participants (78%) in the placebo group experienced ≥1 TEAE. The most frequently reported TEAEs were hypotension (RDV: n=18 [11%]; placebo: n=4 [5%]), respiratory failure (RDV: n=10 [6%]; placebo: n=10 [13%]), and constipation (RDV: n=12 [7%]; placebo: n=7 [9%]). Serious TEAEs occurred in 82 participants (50%) in the RDV group and 40 participants (50%) in the placebo group; none of these were considered treatment related. Premature study drug discontinuation due to a TEAE occurred in 8 participants (5%) in the RDV group and 1 participant (1%) in the placebo group.

Retrospective Analysis of Survival Outcomes and Predictors of Survival in Japanese Patients on Dialysis3

Study design and demographics

Kikuchi et al performed a retrospective analysis of the survival rate and the risk factors associated with mortality among Japanese patients who required dialysis and were hospitalized for COVID-19. The COVID-19 Task Force Committee in Japan established a registry to follow new cases of COVID-19 in Japanese dialysis facilities on April 8, 2020, and patient data registered by June 19, 2021, were included for this analysis.

In the overall patient population (N=1010), 699 patients (69.2%) recovered, and 311 (30.8%) died. A total of 392 patients were included in the analysis of patients stratified by administration of RDV, which included 98 patients treated with RDV, and PS-matched to 294 patients who did not receive RDV.

Table 1. Select Baseline Demographics of PS-Matched Patients According to RDV Treatment3

aP=0.046.

Results

According to multivariate analyses of the entire study population, the mortality risk was significantly lower among those treated with RDV than those who did not receive RDV (HR, 0.6; 95% CI: 0.37–0.98; P=0.041).

For the analysis of mortality among those who did and did not receive RDV in the PS‑matched cohort, overall survival was significantly greater among those who received RDV than those who did not (Figure 1). The mean (SD) duration of hospitalization was significantly shorter among those who received RDV than those who did not: 16.2 (8.1) days vs 20.9 (13.2) days, respectively; difference, 4.7 days (95% CI: 2.2–7.4); P<0.001.

Figure 1. Overall Survival of PS-Matched Patients According to RDV Treatment3

Abbreviation: PCR=polymerase chain reaction.

References

1. Veklury, Gilead Sciences Inc. VEKLURY® (remdesivir) for injection, for intravenous use. U. S. Prescribing Information. Foster City, CA.

2. Ramon-Santos J, Goldman JD, Tuttle KR, et al. The REDPINE Study: Efficacy and Safety of Remdesivir in People With Moderately and Severely Reduced Kidney Function Hospitalised for COVID-19 Pneumonia [Poster P2635]. Paper presented at: 33rd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID),; April 15-18, 2023; Copenhagen, Denmark.

3. Kikuchi K, Nangaku M, Ryuzaki M, et al. Survival and predictive factors in dialysis patients with COVID-19 in Japan: a nationwide cohort study. Ren Replace Ther. 2021;7(1):59. https://www.ncbi.nlm.nih.gov/pubmed/34697570

4. ClinicalTrials.gov. Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19). ClinicalTrials.gov Identifier: NCT04745351. Available at: https://clinicaltrials.gov/ct2/show/NCT04745351.

Abbreviations

AKI=acute kidney injury
DM=diabetes mellitus
ECMO=extracorporeal membrane oxygenation
ESRD=end‑stage renal disease
HR=hazard ratio
IMV=invasive mechanical ventilation
NIV=non-invasive ventilation
PS=propensity score
RDV=remdesivir
TEAE=treatment-emergent adverse event

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.

Follow-Up

For any additional questions, please contact Gilead Medical Information at:

☎1‐866‐MEDI‐GSI (1‐866‐633‐4474) or  www.askgileadmedical.com

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Please report all adverse events to:

Gilead Global Patient Safety ☎ 1-800-445-3235, option 3 or
 https://www.gilead.com/utility/contact/report-an-adverse-event

FDA MedWatch Program by ☎ 1-800-FDA-1088 or MedWatch, FDA, 5600 Fishers Ln, Rockville, MD 20852 or  www.accessdata.fda.gov/scripts/medwatch

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