– Veklury Was Associated With a Lower Risk
of Developing Long-COVID in One Analysis –
– Veklury Was Associated With a Reduced Risk
of Mortality Among People Who Are Immunocompromised in a Separate
Analysis –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data
from three real-world retrospective studies being presented at the
31st Conference on Retroviruses and Opportunistic Infections
(CROI).
- One study showed Veklury® (remdesivir) was associated with a
reduced risk of certain long-COVID symptoms in people who were
hospitalized for COVID-19.
- In a separate study, Veklury use was associated with
significantly reduced mortality among people who were
immunocompromised and were hospitalized for COVID-19 during the
Omicron period (Dec’21 – April’23), irrespective of oxygen
requirements.
- A third analysis revealed that treatment with Veklury and
dexamethasone among patients hospitalized for COVID-19 was
associated with reduced mortality as compared to treatment with
only dexamethasone, irrespective of oxygen requirements.
“The real-world data presented at CROI continue to reinforce the
strong efficacy and safety profile of Veklury, as well as the
potential benefit of Veklury for people affected by COVID-19,” said
Frank Duff, MD, Senior Vice President, Virology Therapeutic Area
Head, Gilead Sciences. “As we enter the fourth year of COVID-19,
Veklury remains the antiviral standard of care for people
hospitalized for COVID-19. These latest data add to our scientific
understanding about Veklury’s potential role in reducing mortality,
including in immunocompromised people, and helping to reduce the
risk of getting long-COVID symptoms.”
To understand Veklury’s potential impact on the risk of
long-COVID, also known as post-COVID conditions (PCC), Gilead
analyzed HealthVerity data from 52,006 patients. Results from the
study demonstrate that Veklury use was associated with a 10% lower
risk of any PCC in both age groups analyzed: HR 0.90 (95%
confidence interval [CI]: 0.86–0.93) in those <65 years old and
HR 0.90 (95% CI: 0.86–0.95) in those ≥65 years old. Veklury use was
associated with lower risk for 6 of 16 individual
symptoms/diagnoses in the ≥65 age group (including cognitive
dysfunction, cerebrovascular disease, neuropsychiatric features,
diarrhea, chest pain, and dysautonomia) and for 8 of 16 individual
symptoms/diagnoses in the <65 age group (including the 6
symptoms in the ≥65 age group, as well as thromboembolic disease
and headache). Results from this analysis build on existing
evidence that support the importance of treating COVID-19 early in
the disease course with an antiviral.
In a separate analysis, data from the PINC AI Healthcare
database from the Omicron era (Dec’21 – Apr’23) showed an
association between Veklury use and reduced mortality among
immunocompromised people in the study who were hospitalized for
COVID-19. The study included 10,687 immunocompromised people who
received Veklury and 4,989 who were matched controls. Results at
Day 28 showed that people who were immunocompromised and treated
with Veklury had an overall 25% significantly lower mortality risk
compared to the non-Veklury group, irrespective of supplemental
oxygen requirements (HR: 0.75, 95% CI:0.68-0.83; p<0.0001). This
research builds on and further reinforces previous research
presented at CROI 2023.
Additional data from a real-world study showed improved outcomes
among patients with COVID-19 who received treatment with Veklury in
combination with dexamethasone compared to dexamethasone alone. The
study matched 33,037 patients who received both Veklury and
dexamethasone to 33,037 patients who received only dexamethasone.
Patients who received the dual therapy had a significantly lower
mortality risk compared to dexamethasone monotherapy across all
supplemental oxygen requirements at both 14 and 28 days. For
patients with no documented use of supplemental oxygen at baseline,
treatment with Veklury was associated with a 20% (p<0.001) lower
risk of mortality at Day 28. Patients on low-flow or high-flow
oxygen had a 26% (p<0.001) and 29% (p<0.001) lower risk of
mortality at Day 28, respectively. Patients on invasive mechanical
ventilation/ECMO at baseline had a 19% (p=0.0182) reduced risk for
mortality at Day 28.
About Veklury
Veklury (remdesivir) is a nucleotide analog prodrug 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 and is a
recommended treatment for reducing disease progression in
non-hospitalized patients at high risk of disease progression.
Veklury has an established safety profile and limited known drug
interactions in diverse populations. It plays an important role in
reducing disease progression across a spectrum of disease severity
and enabling patients to recover faster.
Veklury directly inhibits viral replication inside of the cell
by targeting the SARS-CoV-2 viral RNA polymerase. Based on in vitro
analyses, Veklury retains antiviral activity against recent Omicron
subvariants of concern, including XBB, XBB.1.5 and CH.1.1. Veklury
continues to be evaluated against emerging variants of interest and
concern, including EG.5, EG.5.1 and BA.2.86.
Veklury is approved in more than 50 countries worldwide. To
date, Veklury and generic remdesivir have been made available to
more than 14 million patients around the world, including more than
8 million people in middle- and low-income countries through
Gilead’s voluntary licensing program.
U.S. Indication for
Veklury
Veklury (remdesivir 100 mg for injection) is indicated for the
treatment of COVID-19 in adults and pediatric patients (weighing
≥1.5 kg) who are:
- Hospitalized, or
- Not hospitalized and have mild-to-moderate COVID-19 and are at
high risk for progression to severe COVID-19, including
hospitalization or death.
For more information, please see the U.S. full Prescribing
Information available at www.gilead.com.
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; most occurred within one hour. Monitor
patients during infusion and observe for at least one hour after
infusion is complete for signs and symptoms of hypersensitivity as
clinically appropriate. Symptoms may include hypotension,
hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea,
wheezing, angioedema, rash, nausea, diaphoresis, and shivering.
Slower infusion rates (maximum infusion time up to 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
- Administration should take place under conditions where
management of severe hypersensitivity reactions, such as
anaphylaxis, is possible.
- Treatment duration:
- For patients who are hospitalized, Veklury should be initiated
as soon as possible after diagnosis of symptomatic COVID-19.
- For patients who are hospitalized and do not require invasive
mechanical ventilation and/or ECMO, the recommended treatment
duration is 5 days. If a patient does not demonstrate clinical
improvement, treatment may be extended up to 5 additional days, for
a total treatment duration of up to 10 days.
- For patients who are hospitalized and require invasive
mechanical ventilation and/or ECMO, the recommended total treatment
duration is 10 days.
- For patients who are not hospitalized, diagnosed with
mild-to-moderate COVID-19, and are at high risk for progression to
severe COVID-19, including hospitalization or death, the
recommended total treatment duration is 3 days. Veklury should be
initiated as soon as possible after diagnosis of symptomatic
COVID-19 and within 7 days of symptom onset for outpatient
use.
- Testing prior to and during treatment: Perform hepatic
laboratory, and prothrombin time testing prior to initiating
Veklury and during use as clinically appropriate.
- Renal impairment: No dose adjustment of Veklury is recommended
in patients with any degree of renal impairment, including patients
on dialysis. Veklury may be administered without regard to the
timing of dialysis.
Pregnancy and lactation
- Pregnancy: A pregnancy registry has been established for
Veklury. Available clinical trial data for Veklury in pregnant
women have not identified a drug-associated risk of major birth
defects, miscarriage, or adverse maternal or fetal outcomes
following second- and third-trimester exposure. There are
insufficient data to evaluate the risk of Veklury exposure during
the first trimester. Maternal and fetal risks are associated with
untreated COVID-19 in pregnancy.
- Lactation: Veklury can pass into breast milk. The developmental
and health benefits of breastfeeding should be considered along
with the mother’s clinical need for Veklury and any potential
adverse effects on the breastfed child from Veklury or from an
underlying maternal condition. 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, COVID-19, 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 Gilead’s ability to initiate, progress or complete
clinical trials within currently anticipated timelines or at all,
and the possibility of unfavorable results from ongoing or
additional clinical trials, including those involving Veklury;
uncertainties relating to regulatory applications and related
filing and approval timelines; the risk that any regulatory
approvals, if granted, may be subject to significant limitations on
use; and any assumptions underlying any of the foregoing. These and
other risks, uncertainties and factors are described in detail in
Gilead’s Annual Report on Form 10-K for the year ended December 31,
2023, 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 involve
risks and uncertainties 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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version on businesswire.com: https://www.businesswire.com/news/home/20240304530607/en/
Jacquie Ross, Investors investor_relations@gilead.com
Meaghan Smith, Media public_affairs@gilead.com
Gilead Sciences (NASDAQ:GILD)
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