-- Data Presented Includes a Comparative
Analysis of Clinical Recovery and Mortality Outcomes from the Phase
3 SIMPLE Trial Versus Real-World Cohort of Severe COVID-19 Patients
Receiving Standard of Care --
-- Traditionally Marginalized Racial/Ethnic
Groups Treated with Remdesivir Had Similar Clinical Outcomes as
Overall Patient Population --
Gilead Sciences, Inc. (Nasdaq: GILD) today announced additional
data on remdesivir, an investigational antiviral for the treatment
of COVID-19, adding to the available body of knowledge on treatment
outcomes with remdesivir. The data are being presented at the
Virtual COVID-19 Conference as part of the 23rd International AIDS
Conference (AIDS 2020: Virtual) and include a comparative analysis
of the Phase 3 SIMPLE-Severe trial and a real-world retrospective
cohort of patients with severe COVID-19. In this analysis,
remdesivir was associated with an improvement in clinical recovery
and a 62 percent reduction in the risk of mortality compared with
standard of care – an important finding that requires confirmation
in prospective clinical trials.
Separate subgroup analyses from the Phase 3 SIMPLE-Severe trial,
including an evaluation of the safety and efficacy of remdesivir
across different racial and ethnic patient subgroups treated in the
United States, found that traditionally marginalized racial or
ethnic groups treated with remdesivir in this study experienced
similar clinical outcomes as the overall patient population in the
study.
Gilead is also presenting new analyses of the company’s
compassionate use program, which demonstrated that 83 percent of
pediatric patients (n=77) and 92 percent of pregnant and postpartum
women (n=86) with a broad spectrum of disease severity recovered by
Day 28. No new safety signals were identified with remdesivir
across these populations. To further the understanding of these
results in individual patient cases, Gilead recently announced the
initiation of a global, open-label Phase 2/3 trial to evaluate the
safety, tolerability and pharmacokinetics of remdesivir in
pediatric patients from birth to less than 18 years of age. Gilead
is also collaborating on a study for pregnant women.
Due to the current public health emergency, the U.S. Food and
Drug Administration (FDA) has issued an Emergency Use Authorization
for remdesivir for the treatment of hospitalized patients with
severe COVID-19; please see below for additional important warnings
and information about the authorized use of remdesivir in the
United States. In the United States, remdesivir is an
investigational drug that has not been approved by the FDA, and the
safety and efficacy of remdesivir for the treatment of COVID-19 has
not been established.
“We are working to broaden our understanding of the full utility
of remdesivir. To address the urgency of the continuing pandemic,
we are sharing data with the research community as quickly as
possible with the goal of providing transparent and timely updates
on new developments with remdesivir,” said Merdad Parsey, MD, PhD,
Chief Medical Officer, Gilead Sciences. “These data presented at
the Virtual COVID-19 Conference shed additional light on the use of
remdesivir in specific patient populations, including those that
may be susceptible to higher rates of COVID-19 infection, as well
as others that are particularly vulnerable, including children and
pregnant and postpartum women.”
Comparative Analysis of Phase 3 SIMPLE-Severe Study and
Real-World Retrospective Cohort of Patients Diagnosed with Severe
COVID-19 Receiving Standard of Care
This comparative pre-planned analysis included 312 patients
treated in the Phase 3 SIMPLE-Severe study and a separate
real-world retrospective cohort of 818 patients with similar
baseline characteristics and disease severity who received standard
of care treatment in the same time period as the SIMPLE-Severe
study. Patients were primarily located in North America (92
percent, remdesivir cohort vs. 91 percent, standard-of-care
cohort), Europe (5 percent vs. 7 percent) and Asia (3 percent vs. 2
percent). The analysis demonstrated that remdesivir treatment was
associated with significantly improved clinical recovery and a 62
percent reduction in the risk of mortality compared to standard of
care. Findings from the comparative analysis showed that 74.4
percent of remdesivir-treated patients recovered by Day 14 versus
59.0 percent of patients receiving standard of care; recovery was
defined as improvement in clinical status based on a 7-point
ordinal scale. The mortality rate for patients treated with
remdesivir in the analysis was 7.6 percent at Day 14 compared with
12.5 percent among patients not taking remdesivir (adjusted odds
ratio 0.38, 95% confidence interval 0.22-0.68, p=0.001).
“This comparative analysis provides valuable additional
information regarding the benefit of remdesivir compared with
standard of care alone,” said Susan Olender, MD, Columbia
University Irving Medical Center. “While not as vigorous as a
randomized controlled trial, this analysis importantly draws from a
real-world setting and serves as an important adjunct to clinical
trial data, adding to our collective understanding of this virus
and reflecting the extraordinary pace of the ongoing pandemic.”
The results of this comparative analysis add to the previously
presented National Institute of Allergy and Infectious Disease
(NIAID) randomized, double-blind, placebo-controlled study in
hospitalized patients with COVID-19, which showed that remdesivir
shortened time to recovery by an average of four days as compared
to placebo (11 vs. 15 days; p<0.001). In the NIAID study,
patients taking remdesivir trended toward lower mortality compared
with those in the placebo group, but this result did not reach
statistical significance (7.1 percent vs. 11.9 percent at Day 14;
p=0.07).
Analyses from the Phase 3 SIMPLE-Severe Study
The Phase 3 SIMPLE-Severe trial evaluated the safety and
efficacy of 5-day and 10-day dosing durations of remdesivir
administered intravenously in hospitalized patients with severe
manifestations of COVID-19. The initial phase of the study
randomized 397 patients in a 1:1 ratio to receive either a 5-day or
a 10-day treatment course of remdesivir in addition to standard of
care. The results were published in The New England Journal of
Medicine in May. An expansion phase of the study was added to
enroll up to 5,600 additional patients, including those on
mechanical ventilation; results from the expansion phase are
pending.
Additional new data on the safety and efficacy of remdesivir
presented at the Virtual COVID-19 Conference feature subgroup
analyses, including race and ethnicity of patients treated in the
United States, and global baseline characteristics associated with
improved clinical status, and concomitant use of
hydroxychloroquine.
In this study, 229 patients were enrolled at trial sites in the
United States; clinical improvement was defined as a ≥ 2-point
improvement on a 7-point ordinal scale. Among these patients, rates
of clinical improvement at Day 14 were 84 percent in African
American patients (n=43), 76 percent in Hispanic white (HW)
patients (n=17), 67 percent in Asian patients (n=18), 67 percent in
non-Hispanic white (NHW) patients (n=119) and 63 percent in
patients who did not identify with any of these groups (n=32). Key
efficacy and safety results with remdesivir treatment across race
and ethnicity in the United States are included in the following
table.
NHW n=119
Black n=43
HW n=17
Asian n=18
Other n=32
Mortality, Clinical
Improvement and Discharge by Race – U.S. Patients Only at Day
14
≥ 2-point clinical improvement
80 (67%)
36 (84%)
13 (76%)
12 (67%)
20 (63%)
Discharge
80 (67%)
32 (74%)
13 (76%)
12 (67%)
20 (63%)
Death
13 (11%)
3 (7%)
1 (6%)
2 (11%)
3 (9%)
Among the 397 patients who received remdesivir treatment
globally, Black race, age under 65 years, treatment outside of
Italy and requirement of only low-flow oxygen support or room air
at baseline were factors significantly associated with clinical
improvement of at least two points at Day 14.
Following the availability of in vitro data demonstrating
chloroquine inhibits the antiviral activity of remdesivir in a
dose-dependent manner, Gilead conducted an analysis of clinical
outcomes with patients who were treated with both remdesivir and
hydroxychloroquine concomitantly, versus patients who were treated
with remdesivir and who did not receive concomitant
hydroxychloroquine. Through a median follow-up of 14 days, the
rates and likelihood of recovery were lower in patients who
received concomitant hydroxychloroquine compared with patients
treated with remdesivir who did not receive hydroxychloroquine (57
percent vs. 69 percent, covariate-adjusted HR [95% CI] 0.61 [0.45,
0.83], p=0.002). Concomitant hydroxychloroquine use was not
associated with increased mortality in the 14-day analysis window.
The analysis also showed that patients in the concomitant
hydroxychloroquine group experienced overall higher rates of
adverse events. After adjusting for baseline variables, this
difference was significant for Grade 3-4 adverse events.
Additional Data from Gilead’s Compassionate Use Program for
Remdesivir
Gilead has previously reported the safety and efficacy results
in 53 patients hospitalized with severe COVID-19 who were receiving
remdesivir treatment as part of the company’s compassionate use
program. Additional analyses from the compassionate use program are
being presented at the conference, including data on the use of
remdesivir in pediatric patients and in pregnant and postpartum
women. In these analyses, recovery was defined as improvement to
room air for patients who required oxygen support at baseline, and
discharge for those not requiring oxygen support at baseline.
An analysis of 77 pediatric patients treated with remdesivir in
the compassionate use program demonstrated that the vast majority
improved in clinical status by Day 28, with 73 percent discharged
from the hospital. By Day 28, 12 percent remained hospitalized but
on ambient air and four percent had died. Of the 39 pediatric
patients who required invasive mechanical ventilation at baseline,
80 percent of these critically ill patients recovered; of the 38
patients not requiring invasive ventilation, 87 percent
recovered.
Among the 86 pregnant and postpartum women treated with
remdesivir in the compassionate use program (median age of 33), 96
percent of pregnant and 89 percent of postpartum women achieved
improvement in oxygen support levels. Pregnant and postpartum women
who had more severe illness at baseline achieved similarly high
rates of clinical recovery, at 93 percent and 89 percent,
respectively. Pregnant women not on invasive oxygen support at
baseline had the shortest median time to recovery (5 days), and
both pregnant and postpartum women on invasive ventilation at
baseline had similar median times to recovery (13 days). No new
safety signals were identified; the most common AEs were due to
underlying disease and most laboratory abnormalities were Grades
1–2.
About Remdesivir
Remdesivir is an antiviral product that is being studied in
multiple ongoing international clinical trials. In recognition of
the current public health emergency and based on available clinical
data, the approval status of remdesivir varies by country. In
countries where remdesivir has not been approved by the regional
health authority, remdesivir is an investigational drug, and the
safety and efficacy of remdesivir have not been established.
Important Information about Remdesivir
in the United States
In the United States, remdesivir (GS-5734™) is authorized for
use under an Emergency Use Authorization (EUA) only for the
treatment of patients with suspected or laboratory-confirmed
SARS-CoV-2 infection and severe COVID-19. Severe disease is defined
as patients with an oxygen saturation (SpO2) ≤ 94% on room air or
requiring supplemental oxygen or requiring mechanical ventilation
or requiring extracorporeal membrane oxygenation (ECMO). Remdesivir
is authorized for adult or pediatric patients who are admitted to a
hospital and for whom use of an IV agent is clinically appropriate,
as remdesivir must be administered intravenously.
Remdesivir is an investigational drug that has not been approved
by the FDA for any use, and the safety and efficacy of remdesivir
for the treatment of COVID-19 have not been established. This
authorization is temporary and may be revoked, and does not take
the place of the formal new drug application submission, review and
approval process. For information about the authorized use of
remdesivir and mandatory requirements of the EUA in the U.S.,
please review the Fact Sheets and FDA Letter of Authorization
available at www.gilead.com/remdesivir.
There are limited clinical data available for remdesivir.
Serious and unexpected adverse events may occur that have not been
previously reported with remdesivir use. Hypersensitivity
reactions, including infusion-related and anaphylactic reactions,
have been observed during and following administration of
remdesivir. The use of remdesivir is contraindicated in patients
with known hypersensitivity to remdesivir. Transaminase elevations
have been observed in healthy volunteers and patients with COVID-19
in clinical trials who received remdesivir. Patients should have
appropriate clinical and laboratory monitoring to aid in early
detection of any potential adverse events. Monitor renal and
hepatic function prior to initiating and daily during therapy with
remdesivir; additionally monitor serum chemistries and hematology
daily during therapy. Do not initiate remdesivir in patients with
ALT ≥5x ULN or with an eGFR <30 mL/min. The decision to continue
or discontinue remdesivir therapy after development of an adverse
event should be made based on the clinical risk/benefit assessment
for the individual patient.
Due to a risk of reduced antiviral activity, coadministration of
remdesivir and chloroquine phosphate or hydroxychloroquine sulfate
is not recommended.
Healthcare providers and/or their designee are responsible for
mandatory FDA MedWatch reporting of all medication errors and
serious adverse events or deaths occurring during remdesivir
treatment and considered to be potentially attributable to
remdesivir. These events must be reported within 7 calendar days
from the onset of the event. MedWatch adverse event reports can be
submitted to FDA online at www.fda.gov/medwatch or by calling
1-800-FDA-1088.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical
company that discovers, develops and commercializes innovative
medicines in areas of unmet medical need. The company strives to
transform and simplify care for people with life-threatening
illnesses around the world. Gilead has operations in more than 35
countries worldwide, with headquarters in Foster City,
California.
For more information on Gilead’s response to the coronavirus
outbreak please visit the company’s dedicated page:
https://www.gilead.com/purpose/advancing-global-health/covid-19.
Forward Looking
Statement
This press release includes forward-looking statements, within
the meaning of the Private Securities Litigation Reform Act of
1995, that are subject to risks, uncertainties and other factors.
Remdesivir is an investigational drug that has not been approved by
the FDA for any use, and it is not yet known if remdesivir is safe
or effective for the treatment of COVID-19. There is the
possibility of unfavorable results from ongoing and additional
clinical trials involving remdesivir and the possibility that
Gilead and other parties may be unable to complete one or more of
such trials in the currently anticipated timelines or at all.
Further, it is possible that Gilead may make a strategic decision
to discontinue development of remdesivir or that FDA and other
regulatory agencies may not approve remdesivir, and any marketing
approvals, if granted, may have significant limitations on its use.
As a result, remdesivir may never be successfully commercialized.
These risks, uncertainties and other factors could cause actual
results to differ materially from those referred to in the
forward-looking statements. The reader is cautioned not to rely on
these forward-looking statements. These and other risks are
described in detail in Gilead’s Quarterly Report on Form 10-Q for
the quarter ended March 31, 2020, as filed with the U.S. Securities
and Exchange Commission. All forward-looking statements are based
on information currently available to Gilead, and Gilead assumes no
obligation to update any such forward-looking statements.
For more information about the emergency use of
remdesivir in the United States, please see the Emergency Use
Authorization Fact Sheets available at
www.gilead.com/remdesivir.
GS-5734, Gilead and the Gilead logo are
trademarks of Gilead Sciences, Inc. or its related companies.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on Twitter
(@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5
or 1-650-574-3000.
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version on businesswire.com: https://www.businesswire.com/news/home/20200710005081/en/
Douglas Maffei, PhD, Investors (650) 522-2739
Sonia Choi, Media (650) 425-5483
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