– Latest Outcomes From HIV Prevention and
Treatment Clinical Research, Including Data From Pivotal Phase 3
PURPOSE 1 & 2 Trials –
– Real World Evidence in COVID-19 Reinforce
Veklury (remdesivir) as the Antiviral Standard of Care for the
Treatment of People Hospitalized for COVID-19 –
– Investigational Obeldesivir Safety and
Tolerability Data From BIRCH and OAKTREE Trials Support Continued
Evaluation as a Potential Treatment Option for RSV –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced the
upcoming presentation of new findings from its antiviral research
and development programs at IDWeek 2024, taking place from October
16-19. The data from 31 presentations across HIV treatment and
prevention, COVID-19 and viral hepatitis include one late breaker
abstract and six oral presentations, reflecting Gilead’s commitment
to helping address the evolving needs of a diverse range of people
and communities affected by some of the world’s most challenging
viruses.
“We look forward to sharing new research that highlights the
breadth of our antiviral portfolio and expanding pipeline as we
strive to treat, prevent, cure and help eradicate viral diseases
worldwide,” said Jared Baeten, MD, PhD, Senior Vice President,
Virology Therapeutic Area Head at Gilead Sciences. “The data
reflect our unwavering commitment to advance scientific innovations
in virology, aimed at addressing urgent global needs.”
HIV Research
Continuous scientific discovery in HIV is a pillar of Gilead’s
commitment to help end the HIV epidemic. Presented studies’ results
and analyses will include further evaluation of Biktarvy®
(bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg
tablets, B/F/TAF) as a long-term treatment option for a broad range
of people with HIV (PWH). Outcomes from pipeline research studies
will also provide insights into investigational treatment
candidates, including new data on GS-1720, a novel once-weekly
integrase strand transfer inhibitor (INSTI), and a late-breaker
oral presentation of Week 48 data from the Phase 2 study evaluating
an investigational once-weekly oral combination regimen of
islatravir and lenacapavir will also be presented.
Gilead will present an overview of results from its pivotal
Phase 3 PURPOSE 1 (NCT04994509) and PURPOSE 2 (NCT04925752) trials,
which studied the efficacy and safety of lenacapavir, the company’s
injectable HIV-1 capsid inhibitor, for the investigational use of
HIV prevention in a broad, diverse range of people globally. The
trials were unblinded in June and September, respectively.
Additionally, Gilead will present five-year outcomes in new
subgroup analyses from Studies 1489 (NCT02607930) and 1490
(NCT02607956), which assessed the safety and efficacy of Biktarvy
compared to Triumeq (ABC/DTG/3TC) and dolutegravir 50 mg (DTG) +
emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg,
DTG+F/TDF. The first analysis evaluated the safety and efficacy of
Biktarvy in treatment naïve PWH aged 50 or older, providing data to
inform treatment decisions in this increasing proportion of PWH
with a greater burden of age-related comorbidities. The second
analysis evaluated the safety and efficacy of Biktarvy in
treatment-naïve Black adults, a population that has historically
been underrepresented in clinical studies despite the
disproportionate impact of HIV on Black communities.
Gilead will also present three-year outcomes from the CAPELLA
study (NCT04150068), which evaluated twice-yearly subcutaneous
dosing of Sunlenca® (lenacapavir) in combination with an optimized
background regimen in people with multi-drug resistant HIV.
HIV prevention data will include an analysis of newly initiated
pre-exposure prophylaxis (PrEP) use in priority populations with
unmet needs for PrEP in the U.S.
Additional HIV research findings include a presentation of
survey data reporting current real-world trends for PWH with ART
resistance mutations and utilization of healthcare resources in
addition to the impact on efficacy, safety and clinical
outcomes.
COVID-19 Research
Across Gilead’s 14 presentations in COVID-19, key data will
highlight the dynamic nature of the SARS-CoV-2 virus and address
the needs of those most susceptible to severe outcomes from
COVID-19. A real-world evidence analysis will feature outcomes
following treatment with Veklury® (remdesivir, 100mg for
injection), for people hospitalized with COVID-19 who have
leukemia, lymphoma and multiple myeloma. Additionally, a
presentation of in vitro data will demonstrate the ongoing
antiviral activity of Veklury against recent Omicron
subvariants.
An oral presentation will discuss how investigational
obeldesivir reduced SARS-CoV-2 infectious viral titers in people
with COVID-19. Gilead will also present full data results from the
obeldesivir BIRCH (NCT05603143) and OAKTREE (NCT05715528) clinical
trials. Previously, Gilead announced the early termination of the
BIRCH trial due to lower-than-expected COVID-19 incidence rates and
related hospitalizations or all-cause death by Day 29, which were
primary endpoints in the study. The decision did not reflect any
safety or efficacy concerns. Gilead also previously announced
top-line results from the OAKTREE trial which found that while the
study did not meet its primary endpoint in people without risk
factors, obeldesivir was found to have a generally well tolerated
safety profile. The detailed data add to the breadth of safety data
on obeldesivir.
Based on results from BIRCH and OAKTREE, as well as results from
preclinical studies in Respiratory Syncytial Virus (RSV), Gilead
has launched a Phase 2 trial to study obeldesivir as a potential
treatment for non-hospitalized adults with acute RSV. The study
will evaluate if obeldesivir can help participants' symptoms
improve faster.
Overview of Scientific
Presentations
HIV Treatment Research
Late Breaker
Week 48 Results of a Phase 2 Study
Evaluating Once-weekly Oral Islatravir Plus Lenacapavir
Oral Presentation
Abstract 155
Long-Acting Subcutaneous Lenacapavir in
People With Multi-Drug Resistant HIV-1: 3-Year Results of the
CAPELLA Study
Oral Presentation
Abstract 154
Pharmacokinetics and Safety of GS-1720
Following Multiple Ascending Doses in a Phase 1a Study in People
Without HIV-1
P-547
Efficacy and Safety of B/F/TAF in
Treatment-Naïve People With HIV Aged ≥ 50 Years: 5-Year Follow-Up
from Two Phase 3 Studies
P-550
Efficacy and Safety of B/F/TAF in Black
Adults With HIV who are Treatment Naïve: 5-Year Follow-Up from Two
Phase 3 Studies
P-474
Effects of Antiretroviral Resistance on
Outcomes and Healthcare Resource Use of People With HIV in the
United States and Europe – A Real-world Survey
P-590
Impact of Pharmacoenhancers on the
Pharmacokinetics and Safety of Lenacapavir in People With HIV
P-473
Health Care Resource Use Burden Among
People with HIV (PWH) and Concurrent Mental Health Disorders
(MHDs): Claims Analysis of Treatment-Naïve Medicaid Population
Initiating Multi-Tablet Regimens (MTRs) vs. Single-Table Regimens
(STRs)
P-529
Comparison of Renal Outcomes by Tenofovir
Alafenamide Fumarate (TAF) vs. Tenofovir Disoproxil Fumarate (TDF)
Containing Regimens for Prevention, and Treatment of HIV and/or HBV
Treatment: A Systematic Literature Review and Meta-Analysis
HIV Prevention Research
Oral Presentation Abstract 507
Trajectories of Newly Initiated
Pre-Exposure Prophylaxis (PrEP) Use Among Priority Populations With
Unmet Needs for PrEP in the USA
P-512
Changes in Renal Function After Switching
from Emtricitabine/Tenofovir Disoproxil Fumarate to
Emtricitabine/Tenofovir Alafenamide Fumarate for HIV Pre Exposure
Prophylaxis (PrEP): A Real-World Study
COVID-19 Research
Oral Presentation
Abstract 92
Obeldesivir Reduced SARS-CoV-2 Infectious
Titers in the BIRCH Phase 3 Clinical Trial (GS-US-611-6273)
P-2036
The OAKTREE Study: Obeldesivir for
Treatment of COVID-19 in Adults and Adolescents Without Risk
Factors for Progression to Severe Disease
P-2026
The BIRCH Study: Obeldesivir for the
Treatment of COVID-19 in People With Comorbid Risk Factors for
Progression to Severe Disease
P-2030
Remdesivir and Obeldesivir Retain Potent
Activity Against SARS-CoV-2 Omicron Variants
P-1925
Incidence of Long COVID Symptoms During
the Year Post Admission Among Patients Hospitalized for
COVID-19
P-1939
Health Status and Symptom Perceptions
Among Patients Diagnosed with Long COVID in the United States: An
Online Survey Study
P-1938
Impact of Race and Ethnicity on Patient
Perspectives of Health and Symptoms Following COVID-19
Diagnosis
P-2033
Patient Characteristics and Management of
COVID-19 Diagnosed in the Outpatient Setting
P-2020
Combination Therapy with Remdesivir and
Corticosteroids is Associated With Lower Mortality Risk vs.
Corticosteroids Monotherapy in Patients Hospitalised for
COVID-19
P-1913
Characteristics, Clinical Management, and
Outcomes of Leukemia, Lymphoma and Multiple Myeloma Patients
Hospitalized With a Primary Diagnosis of COVID-19: Insights from
Hospitals Across the United States
P-1973
Characteristics, Clinical Management, and
Outcomes of Immunocompromised Patients Diagnosed with COVID-19 in
the Outpatient Setting in France
P-2021
How Have COVID-19 Treatment Guidelines and
the Scientific Evidence Evolved Throughout the Pandemic and Endemic
Era?
P-2031
Thorough QT/QTc Clinical Study to Evaluate
the Effect of Remdesivir on Cardiac Repolarization in Healthy Male
and Female Participants
P-2025
Resistance Analyses from the Remdesivir
Phase 2/3 Caravan Study in Pediatric and Neonatal Participants with
COVID-19
Viral Hepatitis Research
Oral Presentation Abstract 83
Predictors of Undetectable HDV RNA 48
Weeks After Completion of Finite Treatment With Bulevirtide and
Pegylated-Interferon Alpha 2a
P-2191
Efficacy and Safety of Bulevirtide
Monotherapy for Chronic Hepatitis D in Patients With and Without
Cirrhosis: Results from the Week 144 Interim Analysis of a Phase 3
Randomized Study
P-2185
Community Health Worker-led Intervention
to Increase Hepatitis Delta Virus Screening Among Immigrants in the
Metropolitan-DC Area
P-2180
Linkage to Care, Treatment Initiation, and
Outcomes in Individuals with Hepatitis B Virus Infection With and
Without Cirrhosis
P-2322
Screening Rates and Clinical Outcomes for
Hepatitis Delta in Individuals with HBV Coinfection
P-2188
Hepatitis C Screening: Before and After
Study of Hepatitis C Risk Score Alerts in CHORUS
For more information about Gilead at IDWeek 2024, including a
complete list of abstracts and their corresponding oral and poster
sessions, please visit https://idweek.org/program/.
GS-1720 is an investigational compound and not approved by the
U.S. Food and Drug Administration or any other regulatory authority
for any use. The use of the compound alone or in combination with
other antiretrovirals is investigational. Its safety and efficacy
are unknown.
Lenacapavir is presently marketed as Sunlenca and approved for
the treatment of adults with multi-drug resistant HIV in
combination with an optimized background regimen. Lenacapavir is
being studied in multiple ongoing early- and late-stage development
programs and has the potential to offer a diverse set of
person-centric options for treatment and prevention that could
uniquely fit into the lives of PWH and individuals who need or want
PrEP. The use of lenacapavir for HIV prevention is investigational
and the safety and efficacy of lenacapavir for this use have not
been established.
Please see below for U.S. Indication and Important Safety
Information, including Boxed Warning, for Biktarvy. Please
also see below for the U.S. Indication and Important Safety
Information for Sunlenca and Veklury.
There is currently no cure for HIV or AIDS.
All uses of obeldesivir are investigational and have not been
determined to be safe or efficacious and is not approved by the
FDA.
Bulevirtide 2 mg remains the only approved treatment for adults
with chronic HDV and compensated liver disease in the European
Economic Area (EEA), Great Britain and Switzerland and is not
approved in the U.S. Bulevirtide 10 mg is an investigational
product and is not approved anywhere.
About Biktarvy
Biktarvy is a complete HIV treatment that combines three
powerful medicines to form the smallest 3-drug, integrase strand
transfer inhibitor (INSTI)-based single-tablet regimen (STR)
available, offering simple once-daily dosing with or without food,
with a limited drug interaction potential and a high barrier to
resistance. Biktarvy combines the novel, unboosted INSTI
bictegravir, with the Descovy® (emtricitabine 200 mg/tenofovir
alafenamide 25 mg tablets, F/TAF) backbone. Biktarvy is a complete
STR and should not be taken with other HIV medicines.
About Sunlenca
Sunlenca (lenacapavir), 300 mg tablet and 463.5 mg/1.5 mL
injection, is a first-in-class, long-acting HIV capsid inhibitor
approved in Australia, Canada, the European Union, Israel, Japan,
Switzerland, the United Arab Emirates, the United Kingdom, and the
United States for the treatment of HIV-1 infection, in combination
with other antiretroviral(s), in adults with multi-drug resistant
HIV who are heavily treatment-experienced. Sunlenca is the only HIV
treatment option administered twice-yearly. Sunlenca tablets are
approved for oral loading during initiation of Sunlenca treatment,
prior to or at the time of the first long-acting lenacapavir
injection depending on initiation option.
The multi-stage mechanism of action of Sunlenca’s active
pharmaceutical agent, lenacapavir, is distinguishable from other
currently approved classes of antiviral agents. While most
antivirals act on just one stage of viral replication, Sunlenca is
designed to inhibit HIV at multiple stages of its lifecycle and has
no known cross resistance exhibited in vitro to other existing drug
classes.
Lenacapavir is being evaluated as a long-acting option in
multiple ongoing and planned early and late-stage clinical studies
in Gilead's HIV prevention and treatment research program.
Lenacapavir for HIV prevention is investigational, and its safety
and efficacy for this use have not been established. Lenacapavir is
being developed as a foundation for potential future HIV therapies
with the goal of offering both long-acting oral and injectable
options with several dosing frequencies, in combination or as a
mono agent, that help address individual needs and preferences of
people and communities affected by HIV.
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 is the only antiviral studied in hospitalized COVID-19
patients in clinical trials and large real-world analyses that has
demonstrated reduced time to recovery, as well as disease
progression, mortality and readmission.
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 XBF, XBB.1.16, FL.22, E.G.5.1 and
BA.2.86. Veklury continues to be evaluated against emerging
variants of interest and concern.
Veklury is approved in more than 50 countries worldwide. To
date, Veklury and generic remdesivir have been made available to
approximately 14.5 million patients around the world, including
more than 8.1 million people in middle- and low-income countries
through Gilead’s voluntary licensing program.
U.S. Indication for
Biktarvy
Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir
alafenamide 25 mg) is indicated as a complete regimen for the
treatment of HIV-1 infection in adults and pediatric patients
weighing at least 14 kg who have no antiretroviral (ARV) treatment
history or to replace the current ARV regimen in those who are
virologically-suppressed (HIV-1 RNA <50 copies per mL) on a
stable ARV regimen with no known or suspected substitutions
associated with resistance to bictegravir or tenofovir.
U.S. Important Safety Information for
Biktarvy
BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS
B
- Severe acute exacerbations of hepatitis B have been reported in
patients who are coinfected with HIV-1 and HBV and have
discontinued products containing emtricitabine (FTC) and/or
tenofovir disoproxil fumarate (TDF) and may occur with
discontinuation of BIKTARVY. Closely monitor hepatic function with
both clinical and laboratory follow-up for at least several months
in patients who are coinfected with HIV-1 and HBV and discontinue
BIKTARVY. If appropriate, anti-hepatitis B therapy may be
warranted.
Contraindications
- Coadministration: Do not use BIKTARVY with dofetilide or
rifampin.
Warnings and precautions
- Drug interactions: See Contraindications and Drug
Interactions sections. Consider the potential for drug interactions
prior to and during BIKTARVY therapy and monitor for adverse
reactions.
- Immune reconstitution syndrome, including the occurrence
of autoimmune disorders with variable time to onset, has been
reported.
- New onset or worsening renal impairment: Postmarketing
cases of renal impairment, including acute renal failure, proximal
renal tubulopathy (PRT), and Fanconi syndrome have been reported
with tenofovir alafenamide (TAF)–containing products. Do not
initiate BIKTARVY in patients with estimated creatinine clearance
(CrCl) <30 mL/min except in virologically suppressed adults
<15 mL/min who are receiving chronic hemodialysis. Patients with
impaired renal function and/or taking nephrotoxic agents (including
NSAIDs) are at increased risk of renal-related adverse reactions.
Discontinue BIKTARVY in patients who develop clinically significant
decreases in renal function or evidence of Fanconi syndrome. Renal
monitoring: Prior to or when initiating BIKTARVY and during
therapy, assess serum creatinine, CrCl, urine glucose, and urine
protein in all patients as clinically appropriate. In patients with
chronic kidney disease, assess serum phosphorus.
- Lactic acidosis and severe hepatomegaly with steatosis:
Fatal cases have been reported with the use of nucleoside analogs,
including FTC and TDF. Discontinue BIKTARVY if clinical or
laboratory findings suggestive of lactic acidosis or pronounced
hepatotoxicity develop, including hepatomegaly and steatosis in the
absence of marked transaminase elevations.
Adverse reactions
- Most common adverse reactions (incidence ≥5%; all
grades) in clinical studies through week 144 were diarrhea (6%),
nausea (6%), and headache (5%).
Drug interactions
- Prescribing information: Consult the full prescribing
information for BIKTARVY for more information on Contraindications,
Warnings, and potentially significant drug interactions, including
clinical comments.
- Enzymes/transporters: Drugs that induce P-gp or induce
both CYP3A and UGT1A1 can substantially decrease the concentration
of components of BIKTARVY. Drugs that inhibit P-gp, BCRP, or
inhibit both CYP3A and UGT1A1 may significantly increase the
concentrations of components of BIKTARVY. BIKTARVY can increase the
concentration of drugs that are substrates of OCT2 or MATE1.
- Drugs affecting renal function: Coadministration of
BIKTARVY with drugs that reduce renal function or compete for
active tubular secretion may increase concentrations of FTC and
tenofovir and the risk of adverse reactions.
Dosage and administration
- Dosage: Adult and pediatric patients weighing ≥25 kg: 1
tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine
(FTC), and 25 mg tenofovir alafenamide (TAF) taken once daily with
or without food. Pediatric patients weighing ≥14 kg to <25 kg: 1
tablet containing 30 mg BIC, 120 mg FTC, and 15 mg TAF taken once
daily with or without food. For children unable to swallow a whole
tablet, the tablet can be split and each part taken separately as
long as all parts are ingested within approximately 10
minutes.
- Renal impairment: For patients weighing ≥25 kg, not
recommended in patients with CrCl 15 to <30 mL/min, or <15
mL/min who are not receiving chronic hemodialysis, or <15 mL/min
who are receiving chronic hemodialysis and have no antiretroviral
treatment history. For patients weighing ≥14 kg to <25 kg, not
recommended in patients with CrCl <30 mL/min.
- Hepatic impairment: Not recommended in patients with
severe hepatic impairment.
- Prior to or when initiating: Test patients for HBV
infection.
- Prior to or when initiating, and during treatment: As
clinically appropriate, assess serum creatinine, CrCl, urine
glucose, and urine protein in all patients. In patients with
chronic kidney disease, assess serum phosphorus.
Pregnancy and lactation
- Pregnancy: BIKTARVY is recommended in pregnant
individuals who are virologically suppressed on a stable ARV
regimen with no known substitutions associated with resistance to
any of the individual components of BIKTARVY. Lower plasma
exposures of BIKTARVY were observed during pregnancy; therefore,
viral load should be monitored closely during pregnancy. An
Antiretroviral Pregnancy Registry (APR) has been established.
Available data from the APR for BIC, FTC, or TAF show no difference
in the rates of birth defects compared with a US reference
population.
- Lactation: Individuals infected with HIV-1 should be
informed of the potential risks of breastfeeding.
U.S. Indication for
Sunlenca
Sunlenca, a human immunodeficiency virus type 1 (HIV-1) capsid
inhibitor, in combination with other antiretroviral(s), is
indicated for the treatment of HIV-1 infection in heavily
treatment-experienced adults with multidrug resistant HIV-1
infection failing their current antiretroviral regimen due to
resistance, intolerance, or safety considerations.
U.S. Important Safety Information for
Sunlenca
Contraindications
- Coadministration: Concomitant administration of Sunlenca
is contraindicated with strong CYP3A inducers.
Warnings and precautions
- Immune reconstitution syndrome, including the occurrence
of autoimmune disorders with variable time to onset, has been
reported in patients treated with combination antiretroviral (ARV)
therapy.
- Long-acting properties and potential associated risks with
Sunlenca: Residual concentrations of Sunlenca may remain in the
systemic circulation of patients for up to 12 months or longer.
Sunlenca may increase exposure, and potential risk of adverse
reactions, to drugs primarily metabolized by CYP3A initiated within
9 months after last injection. Counsel patients regarding the
dosing schedule because nonadherence could lead to loss of
virologic response and development of resistance. If virologic
failure occurs, switch to an alternative regimen if possible. If
discontinuing Sunlenca, begin alternate suppressive ARV regimen
within 28 weeks from last injection.
- Injection site reactions may occur, and nodules and
indurations may be persistent.
Adverse reactions
- Most common adverse reactions (incidence ≥3%, all
grades) are injection site reactions (65%) and nausea (4%).
Drug interactions
- Prescribing information: Consult the full prescribing
information for Sunlenca for more information on Contraindications,
Warnings, and potentially significant drug interactions, including
clinical comments.
- Enzymes/transporters: Drugs that are strong or moderate
inducers of CYP3A may significantly decrease the concentration of
Sunlenca. Drugs that strongly inhibit CYP3A, P-gp, and UGT1A1
together may significantly increase the concentration of Sunlenca.
Sunlenca may increase the exposure of drugs primarily metabolized
by CYP3A, when initiated within 9 months after the last injection
of Sunlenca, which may increase the potential risk of adverse
reactions.
Dosage and administration
- Dosage: Initiation with 1 of 2 options, followed by
maintenance dosing once every 6 months. Tablets may be taken with
or without food.
- Initiation Option 1: Day 1: 927 mg by subcutaneous
injection and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg
orally (2 x 300-mg tablets).
- Initiation Option 2: Day 1: 600 mg orally (2 x 300-mg
tablets). Day 2: 600 mg orally (2 x 300-mg tablets). Day 8: 300 mg
orally (1 x 300-mg tablet). Day 15: 927 mg by subcutaneous
injection.
- Maintenance: 927 mg by subcutaneous injection every 26
weeks +/- 2 weeks from date of last injection.
- Missed Dose: During the maintenance period, if more than
28 weeks have elapsed since the last injection and if clinically
appropriate to continue Sunlenca treatment, restart the initiation
dosage regimen from Day 1, Option 1 or Option 2.
Pregnancy and lactation
- Pregnancy: There is insufficient human data on the use
of Sunlenca during pregnancy. An Antiretroviral Pregnancy Registry
(APR) has been established.
- Lactation: Individuals infected with HIV-1 should
informed of the potential risks of breastfeeding.
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, cancer and inflammation. Gilead operates
in more than 35 countries worldwide, with headquarters in Foster
City, Calif.
For 35 years, Gilead has been a leading innovator in the field
of HIV, driving advances in treatment, prevention and cure
research. Gilead researchers have developed 12 HIV medications,
including the first single-tablet regimen to treat HIV, the first
antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce
new HIV infections, and the first long-acting injectable HIV
treatment medication administered twice-yearly. Our advances in
medical research have helped to transform HIV into a treatable,
preventable, chronic condition for millions of people.
Gilead is committed to continued scientific innovation to
provide solutions for the evolving needs of people affected by HIV
around the world. Through partnerships, collaborations and
charitable giving, the company also aims to improve education,
expand access and address barriers to care, with the goal of ending
the HIV epidemic worldwide. Gilead is recognized as one of the
leading funders of HIV-related programs in a report released by
Funders Concerned About AIDS.
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 Biktarvy,
Sunlenca, Veklury, bulevirtide, lenacapavir, obeldesivir and
GS-1720 (such as the BIRCH, CAPELLA and OAKTREE trials and Studies
1489 and 1490); uncertainties relating to regulatory applications
and related filing and approval timelines, including potential
applications for indications currently under evaluation; the
possibility that Gilead may make a strategic decision to
discontinue development of programs for indications that are
currently under evaluation, including lenacapavir, obeldesivir and
GS-1720, and, as a result, these programs may never be successfully
commercialized for such indications; and any assumptions underlying
any of the foregoing. 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, 2024, 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.
Biktarvy, Sunlenca, Veklury, Gilead and the
Gilead logo are trademarks of Gilead Sciences, Inc., or its related
companies. All other trademarks are the property of their
respective owner(s).
U.S. full Prescribing Information for Biktarvy,
including BOXED WARNING, U.S. full Prescribing Information
for Sunlenca, and U.S. full Prescribing Information for Veklury are
available at www.gilead.com.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on X/Twitter
(@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241008521376/en/
Meaghan Smith, Media public_affairs@gilead.com
Jacquie Ross, Investors investor_relations@gilead.com
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