Veklury® (remdesivir)

Solidarity Study

This document is in response to your request for information regarding Solidarity study, which evaluated the safety and efficacy of Veklury® (remdesivir [RDV]) and other potential therapies in comparison to standard of care in patients hospitalized with COVID-19.

Please note that this document only summarizes the data obtained from the RDV and accompanying control groups, as the other active comparator groups were discontinued.

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

Summary1

The Solidarity study was a randomized, open-label, phase 3 clinical trial which included four treatment options (RDV, hydroxychloroquine, LPV/r, and IFN-β1a) that were compared with local SOC (control group) to assess their relative abilities to affect in-hospital mortality rates (primary endpoint).

• Overall, mortality rates were not significantly lower with RDV than with controls: RDV, 14.5% (602/4146); control, 15.6% (643/4129); RR: 0.91 (95% CI: 0.82–1.02); P=0.12 (Figure 2).
• Compared with controls, treatment with RDV was associated with decreased mortality among nonventilated participants (RDV vs control: 11.9% vs 13.5%; RR: 0.86 [95% CI: 0.76–0.98]; P=0.02; Figure 3).
• Fewer participants in the RDV group than the control group met the non-prespecified composite outcome of death or ventilation initiation (19.6% vs 22.5%, respectively; RR: 0.84 [95% CI: 0.75–0.93]; P=0.001; Figure 4).
• The rates of ventilation initiation were similar between the RDV and control groups: 14.1% vs 15.7%, respectively (RR: 0.88 [95% CI: 0.77–1]; P=0.04; Figure 4).
• Safety data were not reported.

Solidarity

Study Design1

The WHO and partners launched Solidarity, an international, randomized, open-label, adaptive, phase 3 clinical trial, to assess potential treatment options for COVID-19. Treatment groups were compared pairwise with control groups for primary endpoint of in-hospital mortality; prespecified subgroup analyses of mortality were performed separately for participants with moderate or severe COVID-19 (severity was not defined in the protocol; analyses were conducted for those who required supplemental O2 or ventilation at the time of randomization.)

Figure 1. WHO Solidarity Study Design1

*The LPV/r treatment group was discontinued on July 4, 2020, and the hydroxychloroquine treatment group was discontinued on June 19,2020. IFN-β1a was administered with LPV until July 4, 2020, and the treatment group was discontinued on October 16, 2020.

Participant Disposition and Demographics1

Participants who were enrolled from March 22, 2020 to January 29, 2021 and had follow-up data were included in the ITT analyses (N=14,221). Midway through the treatment course, the rate of treatment adherence in the RDV group was high (95.5%). More than half (67.1%) of all participants in the RDV group also received corticosteroids.

Table 1. Baseline Demographics and Disease Characteristics According to Treatment Group (ITT)1,2

Results1

Primary Endpoint: Mortality

The overall rates of in-hospital mortality at Day 28 were not significantly different between those in the RDV (14.5% [602/4146]) and control groups (15.6% [643/4129] RR: 0.91 [95% CI: 0.82–1.02]; P=0.12; Figure 2). The in-hospital mortality rate included 15 and 11 participants in the RDV and control groups, respectively, who had palliative discharges.

Among those who initially required low- or high-flow O2 without ventilation, a significant decrease in the mortality rate was observed for those in the RDV group compared with the control group; however, no between-group differences were observed for those who were not on O2 initially or were ventilated (Figure 2).1

Figure 2. In-Hospital Mortality at Day 28 Overall and According to Respiratory Support at Baseline1

Note: Kaplan-Meier graphs provided through Day 28 (solid lines), and overall in-hospital mortality rates are provided after Day 28 (dashed lines). Denominators for the Kaplan-Meier graphs include all participants except those who died in the hospital and those who were lost to follow-up. Mortality RRs were standardized for participants’ ages and level of respiratory support and incorporated all in-hospital deaths (i.e., before or after Day 28). Numbers under each figure represent the weekly denominators and numbers of participants who died in the hospital.

Figure 3. Mortality at Day 28 in Ventilated and Non-Ventilated Participants1

Note: Kaplan-Meier graphs are provided through Day 28 (solid lines), and overall in-hospital mortality rates are provided after Day 28 (dashed lines). The denominators for the Kaplan-Meier graphs include all participants except those who died in the hospital and those who were lost to follow-up. The mortality RRs were standardized for the participants’ ages and level of respiratory support and incorporated all in-hospital deaths (ie, before or after Day 28).

Of all the participants who were not ventilated at study entry, fewer participants who received RDV than controls died (11.9% vs 13.5%; P=0.02; Figure 3). Fewer participants in the RDV group than in the control group achieved the non‑prespecified composite outcome of death or ventilation initiation (19.6% vs 22.5%; P=0.001).1

Secondary Endpoint: Time to Hospital Discharge1

Participants allocated to RDV treatment that lasted >7 days were more likely to remain hospitalized on Day 7 (Table 2). RDV group had a longer hospital stay during the 10-day treatment but similar discharge rates after Day 10 compared to the control group.

Table 2. Proportions of Participants Reported as Discharged Who Were Still Hospitalized at Days 7, 14, and 211

Secondary Endpoint: Initiation of Ventilation1

Participants in the RDV group who did not require ventilation at baseline had a lower rate of ventilation initiation or death (19.6% vs 22.5%) relative to those in the control group (Figure 4). Ventilation initiation rates were similar between the RDV and control groups (14.1% vs 15.7%) (Figure 4).

Figure 4. Progression to Ventilation* or Composite Endpoint of Death or Progression to Ventilation After Randomization1

*Ventilation includes invasive or non-invasive mechanical ventilation. The use of high- or low-flow O2 was not recorded separately at entry into the Solidarity Study.

Meta-Analyses of RDV in Studies with Hospitalized Participants1

In meta-analyses of randomized studies that included RDV, compared with SOC, treatment with RDV was associated with a significant decrease in mortality among participants who required O2 supplementation but were not ventilated (RR 0.85 [95% CI: 0.75–0.96]; Figure 5); however, the RR for mortality among all participants was not significant (RR: 0.91 [95% CI: 0.82–1.01]; P=0.08).

Figure 5. Meta-Analyses of the Effect of RDV on Mortality in Solidarity and Other Studies1

Note: Ventilation included non-invasive ventilation, and the presence of high- or low-flow O2 support was not recorded separately at entry into the Solidarity study.

Safety1

Safety results were not reported.

References

1. WHO Solidarity Trial Consortium. Remdesivir and three other drugs for hospitalised patients with COVID-19: final results of the WHO Solidarity randomised trial and updated meta-analyses. Lancet. 2022(22).
2. WHO Solidarity Trial Consortium. Remdesivir and three other drugs for hospitalised patients with COVID-19: final results of the WHO Solidarity randomised trial and updated meta-analyses [Supplementary Appendix]. Lancet. 2022.

Abbreviations

COVID-19 =coronavirus 2019
IFN=interferon
LPV/r=lopinavir/ritonavir
O2=oxygen
RDV=remdesivir
RR=rate ratio
SOC=standard of care
WHO=World Health Organization

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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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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