-- Final Day 29 Data Show Superior Efficacy
of Veklury Compared with Placebo in Hospitalized Patients Receiving
Standard of Care --
-- Overall, Treatment with Veklury Resulted
in Five Days Faster Recovery and Reduced Disease Progression
Compared with Placebo --
-- Veklury Reduced Mortality by 70 Percent
at Day 29 in Patients on Low-Flow Oxygen at Baseline in Post-Hoc
Analysis --
The New England Journal of Medicine (NEJM) today published the
final results from the National Institute of Allergy and Infectious
Diseases’ (NIAID) double-blind, placebo-controlled, Phase 3 ACTT-1
trial of Gilead’s (Nasdaq: GILD) investigational antiviral Veklury®
(remdesivir) for the treatment of adults hospitalized with
mild-moderate or severe COVID-19. The final ACTT-1 study results
build on the preliminary results published in NEJM in May 2020,
showing that treatment with Veklury resulted in consistent,
clinically meaningful improvements across multiple outcome
assessments compared with placebo in COVID-19 patients. The final
results demonstrate that treatment with Veklury resulted in a
faster time to recovery than previously reported.
In the preliminary Day 15 results, Veklury plus standard of care
shortened the time to recovery by four days, compared with placebo
plus standard of care (11 vs. 15 days). The primary endpoint of the
study was time to clinical recovery through Day 29. The study met
its primary endpoint, demonstrating Veklury plus standard of care
was superior in shortening the time to recovery through Day 29
compared with placebo plus standard of care. In the final Day 29
results, patients receiving Veklury (n=541) achieved clinical
recovery five days faster than those receiving placebo, with a
median time to recovery of 10 days with Veklury and 15 days with
placebo and an increased recovery rate by 29 percent compared with
placebo (rate ratio for recovery, 1.29; 95% confidence interval
[CI], 1.12 to 1.49; p<0.001). This result was most pronounced in
patients who required oxygen support at baseline (n=957); in this
group, patients receiving Veklury achieved clinical recovery seven
days faster than those receiving placebo, with a median time to
recovery of 11 days with Veklury and 18 days with placebo (rate
ratio for recovery, 1.31; 95% CI, 1.12 to 1.52).
The key secondary study endpoint of clinical status at Day 15
was also met. Patients receiving Veklury were 50 percent more
likely to have improved by Day 15 compared with those receiving
placebo (OR, 1.5; 95% CI, 1.2 to 1.9), and the effect was
maintained through Day 29. The benefit of Veklury was greater when
given within 10 days of symptom onset, though benefit was observed
across most ranges of symptom duration.
In the overall study population, there was a trend toward
reduced mortality, a secondary study endpoint, at Day 15 (6.7% vs.
11.9%; HR, 0.55; 95% CI, 0.36 to 0.83) and Day 29 (11.4% vs. 15.2%,
HR 0.73; 95% CI, 0.52 to 1.03) in Veklury-treated patients compared
with placebo. Given the range of disease severity in the overall
study population, a post-hoc analysis with no adjustment for
multiple testing was conducted to determine whether there were
differences in mortality based on patients’ baseline clinical
status and to better understand where Veklury may have the most
benefit. In this analysis, patients requiring low-flow oxygen at
baseline who received Veklury achieved a statistically significant
72 percent reduction in mortality at Day 15 (3.1% vs. 10.5%; HR,
0.28; 95% CI, 0.12 to 0.66) and a statistically significant 70
percent reduction in mortality at Day 29 (4% vs. 13%; HR, 0.30; 95%
CI, 0.14 to 0.64). The difference in mortality in other subgroups
based on baseline clinical status was not statistically
significant.
“The ACTT-1 trial results demonstrate that in hospitalized
patients with COVID-19 pneumonia, remdesivir is the first antiviral
medication significantly associated with a shorter time to
recovery—five days shorter for all patients and seven days shorter
for the more severely ill patients—in combination with a lower
progression to mechanical ventilation,” said Andre Kalil, MD, MPH,
Professor of Internal Medicine, Division of Infectious Diseases,
Director, Transplant Infectious Diseases Program at the University
of Nebraska Medical Center, and principal ACTT-1 trial
investigator. “Based on clinical experience, we have seen that
patient response and mortality risk differ across the disease
spectrum. With this mortality subgroup post-hoc analysis, we now
have data suggesting that giving remdesivir to patients on oxygen
may significantly reduce their chances of death as compared to
other subgroups. These data provide clinicians with important
information to help optimize patient care.”
Other secondary endpoints including time to discharge, oxygen
use, and incidence and duration of new oxygen use or other
respiratory support, were also met. Patients in the Veklury
treatment group had a shorter time to discharge or National Early
Warning Score of ≤ 2 compared with placebo, with a median time to
discharge or NEWS ≤ 2 of 8 days with Veklury and 12 days with
placebo (HR, 1.27; 95% CI, 1.10 to 1.46). Veklury reduced disease
progression among those who received the investigational antiviral,
resulting in fewer median days on oxygen support (13 days vs. 21
days) and a significantly lower incidence of new ventilation or
ECMO (13%; 95% CI, 10% to 17%) compared with those on placebo (23%;
95% CI, 19% to 27%).
“There is a critical need to generate data that can help
healthcare providers make informed treatment decisions and offer
their patients the best chance at recovery. These data from a
rigorous, double-blind, placebo-controlled trial add to the breadth
of evidence from additional randomized clinical trials supporting
the use of Veklury as a standard of care for the treatment of
COVID-19 in hospitalized patients,” said Merdad Parsey, MD, PhD,
Chief Medical Officer, Gilead Sciences. “The robust evidence on the
clinical benefits of Veklury, coupled with significantly expanded
global supply, puts an important treatment option in the hands of
healthcare providers around the world.”
Overall, the incidence of adverse events associated with Veklury
was similar to placebo, with no new safety signals identified as
compared to the interim analysis. Rates of serious adverse events
(SAEs) were numerically higher in the placebo group compared with
the Veklury group (PBO + SOC: 32%; Veklury + SOC: 25%). Treatment
discontinuation, all cause grade 3 and 4 adverse events and
laboratory abnormalities were similar across groups.
Please see below for important warnings and information about
the authorized use of Veklury in the United States. In the United
States, Veklury is an investigational drug that has not been
approved by the FDA, and the safety and efficacy of Veklury for the
treatment of COVID-19 have not been established.
About the ACTT-1 Trial
The Adaptive COVID-19 Treatment Trial (ACTT-1) is an
international, randomized, placebo-controlled Phase 3 trial that
evaluated a 10-day course of Veklury plus standard of care in more
than 1,000 hospitalized adult patients with mild/moderate to severe
symptoms of COVID-19, including those who were critically ill and
required mechanical ventilation at screening. The trial was
conducted by the National Institute of Allergy and Infectious
Diseases, with input from and study drug donated by Gilead.
About Veklury
Veklury (remdesivir) is an investigational nucleotide analog
invented by Gilead, building on more than a decade of the company’s
antiviral research. Veklury has broad-spectrum antiviral activity
both in vitro and in vivo in animal models against multiple
emerging viral pathogens, including Ebola, SARS, Marburg, MERS and
SARS-CoV-2, the virus that causes COVID-19.
Multiple ongoing international Phase 3 clinical trials are
evaluating the safety and efficacy of Veklury for the treatment of
COVID-19, in different patient populations, formulations, and in
combination with other therapies. Based on available data from
these studies, Veklury has been approved or authorized for
temporary use as a COVID-19 treatment in approximately 50 countries
worldwide.
As announced on October 1, 2020, Gilead is now meeting real-time
demand for Veklury in the United States and anticipates meeting
global demand for Veklury in October, even in the event of
potential future surges of COVID-19.
Important Information about Veklury in
the United States
In the United States, Veklury (remdesivir) is authorized for use
under an Emergency Use Authorization (EUA) only for the treatment
of hospitalized adult and pediatric patients with suspected or
laboratory-confirmed COVID-19. Veklury must be administered via
intravenous (IV) infusion and is supplied two ways: Veklury
(remdesivir) for injection, 100 mg, lyophilized powder, or Veklury
(remdesivir) injection, 100 mg/20 mL (5 mg/mL), concentrated
solution.
Veklury is an investigational drug that has not been approved by
the FDA for any use, and the safety and efficacy of Veklury for the
treatment of COVID-19 have not been established. This authorization
is temporary and may be revoked, and it does not take the place of
the formal new drug application submission, review and approval
process. For information about the authorized use of Veklury 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.
Serious and unexpected adverse events may occur that have not
been previously reported with Veklury use. Hypersensitivity
reactions, including infusion-related and anaphylactic reactions,
have been observed during and following administration of Veklury.
The use of Veklury is contraindicated in patients with known
hypersensitivity to Veklury. Transaminase elevations have been
observed in healthy volunteers and patients with COVID-19 in
clinical trials who received Veklury. 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
Veklury; additionally monitor serum chemistries and hematology
daily during therapy. Do not initiate Veklury in patients with ALT
≥5x ULN or with an eGFR <30 mL/min. The decision to continue or
discontinue Veklury 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
Veklury 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 Veklury treatment
and considered to be potentially attributable to Veklury. 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. Veklury
is an investigational drug that has not been approved by the FDA
for any use, and it is not yet known if Veklury is safe or
effective for the treatment of COVID-19. There is the possibility
of unfavorable results from ongoing and additional clinical trials
involving Veklury 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 Veklury or that FDA and other regulatory agencies
may not approve Veklury, and any marketing approvals, if granted,
may have significant limitations on its use. As a result, Veklury
may never be successfully commercialized. In addition, there is
also the risk that Gilead may be unable to effectively manage the
global supply and distribution of Veklury. 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 June 30, 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
Veklury in the United States, please see the Emergency Use
Authorization Fact Sheets available at
www.gilead.com/remdesivir.
Gilead, the Gilead logo and Veklury 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/20201008006042/en/
Douglas Maffei, PhD, Investors (650) 522-2739
Sonia Choi, Media (650) 425-5483
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