– Double-Blind Placebo-Controlled Study
Evaluated the Efficacy of Early Use of Veklury IV in
Non-Hospitalized Patients –
– Late-breaking Data to be Presented at
IDWeek 2021 –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced positive
results from a Phase 3 randomized, double-blind, placebo-controlled
trial to evaluate the efficacy and safety of a three-day course of
Veklury® (remdesivir) for intravenous (IV) use for the treatment of
COVID-19 in non-hospitalized patients at high risk for disease
progression. This late-breaking data will be presented at the
IDWeek 2021 virtual conference.
In an analysis of 562 participants randomly assigned in a 1:1
ratio to receive Veklury or placebo, Veklury demonstrated a
statistically significant 87% reduction in risk for the composite
primary endpoint of COVID-19 related hospitalization or all-cause
death by Day 28 (0.7% [2/279]) compared with placebo (5.3%
[15/283]) p=0.008. Results also showed an 81% reduction in risk for
the composite secondary endpoint of medical visits due to COVID-19
or all-cause death by Day 28 for participants treated with Veklury
(1.6% [4/246]) compared with placebo (8.3% [21/252]) p=0.002. In
the study, no deaths were observed in either arm by Day 28.
Enrollment for this trial was stopped prior to fulfilling
enrollment targets in April 2021, reflecting the changing
epidemiology and adoption of additional treatment options at the
time; however, the study continued to collect data on enrolled
participants and both investigators and participants remained
blinded to their assignment of Veklury or placebo. These results
complement positive results from ACTT-1 and other studies in
hospitalized patients in which Veklury helped patients recover
significantly faster and reduced the likelihood of disease
progression.
“Antiviral medications provide maximal benefit when used early
in the disease course. Last summer, data from clinical trials
demonstrated the benefit of remdesivir in patients hospitalized
with COVID-19, even when not yet requiring oxygen. These latest
data show remdesivir’s potential to help high-risk patients recover
before they get sicker and stay out of the hospital altogether,”
said Robert L. Gottlieb, MD, PhD, Cardiologist and Principal
Investigator at Baylor University Medical Center and Baylor Scott
& White Research Institute. “We are seeing very high numbers of
hospitalized patients as new COVID-19 infections surge, placing
increased demands on already over-burdened healthcare systems.
Remdesivir, also known as Veklury, is an effective antiviral for
the treatment of hospitalized patients with COVID-19 and an
essential tool to help reduce disease progression.”
The use of Veklury for the treatment of non-hospitalized
patients with three days of dosing is investigational, and the
safety and efficacy for this use and dosing duration have not been
established or approved by any regulatory agency globally. In the
United States, Veklury is indicated for adults and pediatric
patients (12 years of age and older and weighing at least 40 kg)
for the treatment of COVID-19 requiring hospitalization. Veklury is
contraindicated in patients who are allergic to Veklury or any of
its components; please see below for additional Important Safety
Information for Veklury.
The safety profile was similar between Veklury and placebo in
this trial, with the most common treatment emergent adverse events
(≥5%) in patients taking Veklury being nausea and headache. Of the
279 participants who received Veklury, no new safety signals were
identified. One death was observed in the study at Day 59
(participant on placebo); no deaths occurred in either arm of the
study by the Day 28 primary endpoint. Gilead is in the process of
sharing the data with regulatory agencies.
“As the pandemic continues to evolve and new viral variants
emerge, Veklury is playing a critical role as the antiviral
standard of care for hospitalized patients, helping prevent disease
progression and speed patients’ recovery,” said Merdad Parsey, MD,
PhD, Chief Medical Officer, Gilead Sciences. “As leaders in
antiviral drug development, we welcome these findings and continue
to invest in research of Veklury and novel oral antivirals to
address the unmet need for effective and convenient therapies that
can be administered at home.”
Gilead continues to study the efficacy and safety of Veklury in
hospitalized patient populations with ongoing unmet needs, such as
patients with renal impairment, children and pregnant women, as
well as through the support of a number of externally sponsored
trials. Gilead is also developing novel oral treatment options for
non-hospitalized patients with COVID-19 and hopes to file
investigational new drug applications (IND) with the Food and Drug
Administration (FDA) by early next year.
About the IV Outpatient Study
(GS-US-540-9012) Study GS-US-540-9012 (PINETREE) was a
Phase 3, randomized, double-blind, placebo-controlled study
evaluating the efficacy and safety of a three-day course of Veklury
IV in reducing the rate of hospitalization or all-cause death among
non-hospitalized COVID-19 patients at high risk for disease
progression. The primary study endpoint was the composite of
COVID-19 hospitalization or all-cause death by Day 28. The
composite endpoint of medical visits due to COVID-19 or all-cause
death by Day 28 was a secondary outcome measure.
The study was designed to enroll 1,264 participants, randomized
in a double-blind fashion so that half of enrolled participants
would receive Veklury and the other half would receive a matched
placebo. Gilead decided to stop the study in April 2021, reflecting
the evolution of the COVID-19 landscape and changing patient needs.
At the time that enrollment was terminated, 584 participants were
enrolled. The study remained blinded and participants already
enrolled in the study were followed according to the protocol until
the last patient visit occurred, and at that point the study was
closed.
This trial was designed to evaluate the potential role of
Veklury in helping patients diagnosed with COVID-19 who were
considered high-risk for disease progression based on comorbidities
and age but had not recently been hospitalized due to the
infection. Common comorbidities in study participants included
obesity, hypertension, and diabetes. A third of the participants
were aged 60 or older. Participants in the study must have received
a positive diagnosis within four days of initiating treatment and
experienced symptoms for seven days or less.
About Veklury Veklury
(remdesivir) is a nucleotide analog invented by Gilead, building on
more than a decade of the company’s antiviral research. Veklury is
the antiviral standard of care for the treatment of hospitalized
patients with COVID-19. At this time, more than half of patients
hospitalized with COVID-19 in the United States are treated with
Veklury. Veklury is approved or authorized for temporary use in
approximately 50 countries worldwide and generic remdesivir,
manufactured by our voluntary licensing partners, is provided to
127 middle- and low-income countries. Veklury and generic
remdesivir have been made available to more than seven million
patients around the world. Veklury has broad-spectrum antiviral
activity both in vitro and in vivo in animal models against
multiple emerging viral pathogens, including Ebola, SARS, Marburg,
and MERS.
Veklury is a nucleotide analog that directly inhibits viral
replication of SARS-CoV-2 by targeting the viral RNA polymerase
inside of the cell. On entering the body Veklury is transformed
into the active metabolite remdesivir triphosphate, which is then
incorporated into the viral RNA and stops replication of the virus
within the host cell. No known variations have significantly
altered the viral RNA polymerase. All known novel virus variants
show mutations at different locations in the SARS-CoV-2 spike
protein, which is on the outer surface of the virus and can cause
decreased affinity of anti-SARS-CoV-2 antibodies.
Veklury’s antiviral activity has been tested against isolates of
variants of concern (VOCs), including Alpha, Beta, Gamma and Delta,
and Epsilon, as well as one variant of interest (VOI) of
SARS-CoV-2. These laboratory findings suggest that Veklury will
continue to be active against the currently identified variations
in the SARS-CoV-2 virus.
U.S. Indication for Veklury
Veklury® (remdesivir 100 mg for injection) is indicated for adults
and pediatric patients (12 years of age and older and weighing at
least 40 kg) for the treatment of COVID-19 requiring
hospitalization. Veklury should only be administered in a hospital
or in a healthcare setting capable of providing acute care
comparable to inpatient hospital care.
U.S. Important Safety Information for
Veklury Contraindication Veklury is contraindicated in
patients with a history of clinically significant hypersensitivity
reactions to Veklury or any of its components.
Warnings and precautions
- Hypersensitivity, including infusion-related and anaphylactic
reactions: Hypersensitivity, including infusion-related and
anaphylactic reactions, has been observed during and following
administration of Veklury. Monitor patients under close medical
supervision for hypersensitivity reactions during and following
administration of Veklury. Symptoms may include hypotension,
hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea,
wheezing, angioedema, rash, nausea, diaphoresis, and shivering.
Slower infusion rates (maximum infusion time ≤120 minutes) can
potentially prevent these reactions. If a severe infusion-related
hypersensitivity reaction occurs, immediately discontinue Veklury
and initiate appropriate treatment (see Contraindications).
- Increased risk of transaminase elevations: Transaminase
elevations have been observed in healthy volunteers and in patients
with COVID-19 who received Veklury; these elevations have also been
reported as a clinical feature of COVID-19. Perform hepatic
laboratory testing in all patients (see Dosage and administration).
Consider discontinuing Veklury if ALT levels increase to >10x
ULN. Discontinue Veklury if ALT elevation is accompanied by signs
or symptoms of liver inflammation.
- Risk of reduced antiviral activity when coadministered with
chloroquine or hydroxychloroquine: Coadministration of Veklury with
chloroquine phosphate or hydroxychloroquine sulfate is not
recommended based on data from cell culture experiments,
demonstrating potential antagonism, which may lead to a decrease in
antiviral activity of Veklury.
Adverse reactions
- The most common adverse reaction (≥5% all grades) was
nausea.
- The most common lab abnormalities (≥5% all grades) were
increases in ALT and AST.
Drug interactions
- Drug interaction trials of Veklury and other concomitant
medications have not been conducted in humans.
Dosage and administration
- Dosage: For adults and pediatric patients ≥12 years old and
weighing ≥40 kg: 200 mg on Day 1, followed by once-daily
maintenance doses of 100 mg from Day 2 administered only via
intravenous infusion over 30 to 120 minutes.
- Treatment duration: For patients not requiring invasive
mechanical ventilation and/or extracorporeal membrane oxygenation
(ECMO): 5 days; may be extended up to 5 additional days (10 days
total) if clinical improvement is not observed. For patients
requiring invasive mechanical ventilation and/or ECMO: 10
days.
- Testing prior to and during treatment: Perform eGFR, hepatic
laboratory, and prothrombin time testing prior to initiating
Veklury and during use as clinically appropriate.
- Renal impairment: Veklury is not recommended in individuals
with eGFR <30 mL/min.
- Dose preparation and administration: See full Prescribing
Information.
Pregnancy and lactation
- Pregnancy: There are insufficient human data on the use of
Veklury during pregnancy. Pregnant women hospitalized with COVID-19
are at risk for serious morbidity and mortality. Veklury should be
used during pregnancy only if the potential benefit justifies the
potential risk for the mother and the fetus.
- Lactation: It is not known whether Veklury can pass into breast
milk. Breastfeeding individuals with COVID-19 should follow
practices according to clinical guidelines to avoid exposing the
infant to COVID-19.
About Gilead Sciences Gilead
Sciences, Inc. is a biopharmaceutical company that has pursued and
achieved breakthroughs in medicine for more than three decades,
with the goal of creating a healthier world for all people. The
company is committed to advancing innovative medicines to prevent
and treat life-threatening diseases, including HIV, viral hepatitis
and cancer. Gilead operates in more than 35 countries worldwide,
with headquarters in Foster City, California.
Forward-Looking Statements
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,
including the possibility of unfavorable results from ongoing or
additional clinical trials or studies involving Veklury; and the
possibility that Gilead may be unable to initiate, progress or
complete clinical trials or studies within currently anticipated
timelines or at all, including those involving Veklury. These and
other risks, uncertainties and factors are described in detail in
Gilead’s Quarterly Report on Form 10-Q for the quarter ended June
30, 2021, as filed with the U.S. Securities and Exchange
Commission. These risks, uncertainties and other factors could
cause actual results to differ materially from those referred to in
the forward-looking statements. All statements other than
statements of historical fact are statements that could be deemed
forward-looking statements. The reader is cautioned that any such
forward-looking statements are not guarantees of future performance
and is cautioned not to place undue reliance on these
forward-looking statements. All forward-looking statements are
based on information currently available to Gilead, and Gilead
assumes no obligation and disclaims any intent to update any such
forward-looking statements.
U.S. full Prescribing Information for Veklury
is available at www.gilead.com.
Veklury, Gilead and the Gilead logo are
registered 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
(@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5
or 1-650-574-3000.
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Jacquie Ross, Investors (408) 656-8793
Nicole Rodriguez, Media (949) 520-0057
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