-- Study Demonstrates 5-Day Treatment Course
of Remdesivir Resulted in Significantly Greater Clinical
Improvement Versus Treatment with Standard of Care Alone --
-- Data Add to Body of Evidence from Prior
Studies Demonstrating Benefit of Remdesivir in Hospitalized
Patients with COVID-19 --
Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline
results from the Phase 3 SIMPLE trial in hospitalized patients with
moderate COVID-19 pneumonia. This open-label study evaluated 5-day
and 10-day courses of the investigational antiviral remdesivir plus
standard of care, versus standard of care alone. The study
demonstrated that patients in the 5-day remdesivir treatment group
were 65 percent more likely to have clinical improvement at Day 11
compared with those in the standard of care group (OR 1.65 [95% CI
1.09-2.48]; p=0.017). The odds of improvement in clinical status
with the 10-day treatment course of remdesivir versus standard of
care were also favorable, trending toward but not reaching
statistical significance (OR 1.31 [95% CI 0.88-1.95]; p=0.18). No
new safety signals were identified with remdesivir across either
treatment group. Gilead plans to submit the full data for
publication in a peer-reviewed journal in the coming weeks.
“Our understanding of the spectrum of SARS-CoV-2 infection
severity and presentations of COVID-19 continues to evolve,” said
Francisco Marty, MD, an infectious diseases physician at Brigham
and Women’s Hospital, and associate professor of medicine at
Harvard Medical School. “These study results offer additional
encouraging data for remdesivir, showing that if we can intervene
earlier in the disease process with a 5-day treatment course, we
can significantly improve clinical outcomes for these
patients.”
Remdesivir is currently approved in Japan as a treatment for
patients infected with SARS-CoV-2, the virus that causes COVID-19.
Outside of Japan, remdesivir is an investigational, unapproved
drug. The U.S. Food and Drug Administration (FDA) granted
remdesivir an Emergency Use Authorization for the treatment of
hospitalized patients with severe COVID-19; the authorization is
temporary and does not take the place of the formal new drug
application submission, review and approval process.
In this study, hospitalized patients with confirmed COVID-19
infection and evidence of pneumonia without reduced oxygen levels
were randomized (1:1:1) to receive open-label remdesivir for 5 or
10 days or standard of care alone. The primary endpoint was the
clinical status as assessed by a 7-point ordinal score at Day 11,
ranging from hospital discharge to increasing levels of oxygen and
ventilatory support to death. The secondary study objective was the
rate of adverse events in each remdesivir treatment group compared
with standard of care.
At Day 11, a higher proportion of patients in the 5-day
treatment group achieved improvement in clinical status versus the
standard of care group, achieving statistical significance for a ≥
1-point improvement in ordinal scale (p=0.026). In addition,
non-statistically significant increases in clinical worsening or
death were observed in the standard of care only group compared
with the remdesivir groups.
“We now have three randomized, controlled clinical trials
demonstrating that remdesivir improved clinical outcomes by several
different measures. Today’s results showed that when treating
moderate disease, a 5-day course of remdesivir led to greater
clinical improvement than standard of care, adding further evidence
of remdesivir’s benefit to previously released study results. The
National Institute of Allergy and Infectious Diseases’
placebo-controlled study showed that remdesivir enabled more rapid
recovery and that earlier treatment improved clinical outcomes. Our
SIMPLE-Severe study showed that when treating patients with severe
disease, 5 days of remdesivir led to similar clinical improvements
as a 10-day course,” said Merdad Parsey, MD, PhD, Chief Medical
Officer, Gilead Sciences. “The additional data we have in hand
today will further guide our research efforts, including evaluating
treatment earlier in the course of disease, combination studies
with other therapies for the most critically ill patients,
pediatric studies and the development of alternate
formulations.”
Remdesivir was generally well-tolerated in both the 5-day and
10-day treatment groups. The most common adverse events occurring
in more than 5 percent of patients in both treatment groups were
nausea (5-day: 10% / 10-day: 9% / SOC: 3%), diarrhea (5-day: 5% /
10-day: 5% / SOC: 7%) and headache (5-day: 5% / 10-day: 5% / SOC:
3%).
Key efficacy and safety results from the study are included in
the table below.
5-Day RDV n=191
10-Day RDV n=193
SOC n=200
Clinical Efficacy Outcomes at Day
11
≥ 2-point improvement in ordinal scale
134 (70)
126 (65)
121 (61)
≥ 1-point improvement in ordinal scale
146 (76)
135 (70)
132 (66)
Requiring any oxygen support
12 (6)
13 (7)
22 (11)
≥ 1-point worsening in ordinal scale
6 (3)
12 (6)
22 (11)
Death
0
2 (1)
4 (2)
Safety
Any adverse event (AE)
97 (51)
106 (55)
90 (45)
Grade ≥3 AE
20 (10)
21 (11)
24 (12)
Any serious adverse event (SAE)
8 (4)
7 (4)
18 (9)
About the SIMPLE Trials
Gilead initiated two randomized, open-label, multi-center Phase
3 clinical trials for remdesivir, the SIMPLE studies, in countries
with a high prevalence of COVID-19 infections. The studies were
conducted at more than 180 trial sites around the world, including
sites in the United States, China, France, Germany, Hong Kong,
Italy, Japan, Korea, the Netherlands, Singapore, Spain, Sweden,
Switzerland, Taiwan and the United Kingdom.
The first SIMPLE trial is evaluating 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. Topline
results were announced on April 29 and the full data were published
in The New England Journal of Medicine on May 27. An expansion
phase of the study was added to enroll up to 5,600 additional
patients, including those on mechanical ventilation.
The second SIMPLE trial is evaluating the safety and efficacy of
5-day and 10-day dosing durations of remdesivir administered
intravenously in hospitalized patients with moderate manifestations
of COVID-19, compared with standard of care. The initial phase of
the study randomized 600 patients in a 1:1:1 ratio to receive
either a 5-day or a 10-day treatment course of remdesivir in
addition to standard of care, compared with standard of care alone.
An expansion phase of the study was added to enroll up to 1,000
additional patients with moderate disease. The initial study
results are announced in this press release, and results from the
expansion phase are expected in the coming months.
Important Information about Remdesivir
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. SARS-CoV-2 is the coronavirus that causes COVID-19
disease. 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. It is not yet known if remdesivir is safe
and effective for the treatment of COVID-19. This use of remdesivir
is authorized only for the duration of the declaration that
circumstances exist justifying the authorization of the emergency
use, unless the authorization is terminated or revoked sooner. The
FDA Letter of Authorization for the EUA is 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. Warnings: In clinical
studies with remdesivir, infusion-related reactions and liver
transaminase elevations have been observed. Remdesivir should not
be used in patients who are hypersensitive to any ingredient of
remdesivir. If signs and symptoms of a clinically significant
infusion reaction occur, immediately discontinue administration of
remdesivir and initiate appropriate treatment. 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. 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.
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.
This is not all of the important information for remdesivir. The
FDA has authorized distribution of this medicine with accompanying
Fact Sheets, which can be accessed at www.gilead.com/remdesivir.
Healthcare providers should review the Fact Sheet for Healthcare
Providers for more information on the authorized use of remdesivir
and mandatory requirements of the EUA.
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/20200601005310/en/
Douglas Maffei, PhD, Investors (650) 522-2739
Sonia Choi, Media (650) 425-5483
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