- Key Findings from HIV Treatment Research
Studies Evaluating Biktarvy® and Investigational Long-Acting
Combination Regimens Affirm Commitment to Continuous Biomedical
Innovation –
– Latest Real-World Evidence Analyses
Evaluate Impact of Veklury® on Mortality and Long-COVID –
– New Data Evaluating the Safety and
Efficacy of Hepcludex® in People with HIV/HBV/HDV Coinfection to Be
Presented –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced the
upcoming presentation of new clinical data and real-world evidence
(RWE) from its antiviral research and development programs at the
31st Conference on Retroviruses and Opportunistic Infections (CROI
2024) taking place from March 3-6. The data from nearly eighty
studies across HIV, COVID-19 and viral hepatitis include
late-breaking data, four oral presentations, and reflect Gilead’s
commitment to address the evolving needs of a diverse range of
people and communities affected by some of the world’s most
challenging viruses.
“At CROI 2024, 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 Frank Duff, MD, Senior Vice
President, Virology Therapeutic Area Head, Gilead Sciences. “The
data selected for presentation at CROI is a reflection of our
unwavering commitment to advancing person-centered biomedical
innovation in virology, aimed at fulfilling urgent global
needs.”
HIV Treatment Research
Scientific discovery in HIV treatment is a pillar of Gilead’s
commitment to help end the epidemic. At CROI 2024, presented study
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 who may also have common comorbidities and other
specific health needs. Outcomes from pipeline research studies will
also provide insights into investigational treatment candidates,
including the novel combination regimen of lenacapavir plus
bictegravir. Additionally, key findings from a study evaluating the
investigational combination of lenacapavir with broadly
neutralizing antibodies (bNAbs) will be featured in a late-breaker
oral presentation. A late-breaker oral presentation of Week 24 data
from the ongoing Phase 2 study evaluating an investigational
once-weekly oral combination regimen of islatravir and lenacapavir
will also be presented.
Specifically, Biktarvy presentations will include a two-year
analysis of data from the Phase 3 ALLIANCE trial evaluating factors
associated with hepatitis B (HBV) treatment response in adults with
HIV-1/HBV co-infection initiating treatment. Additionally, a
late-breaker oral presentation of Week 24 data from the INSIGHT
trial evaluating Biktarvy in people with HIV and tuberculosis will
be presented.
Gilead will also present outcomes from the ARTISTRY-1 Phase 2/3
study investigating the efficacy and safety of switching from a
complex stable baseline regimen to an investigational once-daily
single-tablet regimen of lenacapavir and bictegravir. Additional
lenacapavir data presented at CROI 2024 will evaluate the efficacy
and safety of the novel antiviral agent in combination with broadly
neutralizing antibodies teropavimab (GS-5423) and zinlirvimab
(GS-2872) as a potential long-acting treatment regimen with
twice-yearly dosing.
Additional HIV treatment research pipeline findings include an
oral presentation of new proof-of-concept data on GS-1720, a novel
once-weekly integrase strand transfer inhibitor (INSTI) and
PRESTIGIO registry data evaluating sensitivity to broadly
neutralizing antibodies teropavimab (GS-5423) and zinlirvimab
(GS-2872) in people with multi-drug resistant HIV.
COVID-19 Research
Gilead remains committed to understanding the COVID-19 treatment
landscape and will present multiple RWE analyses, including on the
impact of Veklury® (remdesivir) in reducing mortality in
immunocompromised people hospitalized for COVID-19 during the
Omicron period (Dec’21 - April’23). Gilead will also present a
study on the disparities in COVID-19 treatment initiation by race
and ethnicity among hospitalized patients and one on the effect of
Veklury on long-COVID among people hospitalized with COVID-19.
Additional presentations will include RWE of Veklury in combination
with dexamethasone for the treatment of COVID-19, and study results
from kidney transplant patients hospitalized with COVID-19.
Viral Hepatitis Research
Gilead will present new data evaluating the safety and efficacy
of Hepcludex® (bulevirtide) in people living with the coinfections
of HIV, hepatitis B (HBV) and hepatitis delta (HDV). The aim of
this 96-week analysis from the Phase 3 MYR301 study is to evaluate
the safety and efficacy of Hepcludex (2 mg or 10 mg) in patients
with HIV/HBV/HDV coinfection. A separate analysis of RWE will
examine liver-related events in people living with HIV/HBV
coinfection with and without HDV. Since limited data is available
to describe the natural history of triple infection with
HBV/HIV/HDV, this retrospective cohort study, conducted using
HealthVerity claims data from the US, evaluates baseline liver
health, HDV prevalence, and the risk of liver-related events in
individuals with HBV/HIV with or without HDV.
Select accepted abstracts are as follows:
HIV Treatment Research
(B/F/TAF)
Disposition
Factors associated with HBV response to
B/F/TAF vs. DTG + F/TDF at W96 in people with HIV-1 and HBV
Poster
Efficacy, safety and PK of BIC/FTC/TAF in
adults with HIV and Tuberculosis on rifampicin at Week 24
LB Oral
Inflammatory profile of B/F/TAF,
DTG/ABC/3TC, and DTG+F/TAF over 5-years and effects of viral
blips
Poster
Longitudinal analysis of preexisting
resistance-associated mutations prior to B/F/TAF switch
Poster
Safety of tenofovir alafenamide in
individuals with a history of proximal renal tubulopathy on TDF
Poster
Weight gain in people with HIV (PWH) vs
people without HIV (PWoH) over a 3-year period
Poster
A randomized trial switching adults ≥ 60
years old from first-line ART to B/F/TAF: week 48 results
Poster
Long-Acting HIV Treatment Research
(Lenacapavir)
Efficacy and safety of weekly islatravir
plus lenacapavir in PWH at 24 weeks: a Phase 2 study
LB Oral
Lenacapavir efficacy in CAPELLA patients
with no fully active agents in optimized background regimen
Poster
Lenacapavir plus bNAbs for people with HIV
and sensitivity to either teropavimab or zinlirvimab
Oral
HIV Pipeline Research
Phase 2 study of switch to daily BIC + LEN
in individuals on a multi-tablet HIV treatment regimen
Poster
Preclinical characterization of GS-5894, a
potent NNRTI with once-weekly oral dosing potential
Poster
Antiviral activity, safety, and
pharmacokinetics of GS-1720, a novel weekly oral INSTI
Oral
Teropavimab and zinlirvimab sensitivity in
people living with MDR HIV-1: PRESTIGIO registry data
Poster
Type I IFN signaling and regulation in
vesatolimod-treated virally suppressed adults with HIV-1
Poster
HIV Prevention Research
Sexual health outcomes among daily and
on-demand oral PrEP users in China
Oral
HIV Cure Research
Immune profile during ATI in AELIX-002 HTI
vaccine trial and its role in post-intervention control
Oral
COVID-19 Research
Remdesivir reduces mortality in
immunocompromised patients hospitalized for COVID-19 during
Omicron
LB Poster
Effect of remdesivir on post-COVID
conditions among individuals hospitalized with COVID-19 by age
LB Poster
Disparities in treatment initiation by
race and ethnicity among patients hospitalized for COVID-19
Poster
Remdesivir+dexamethasone vs. dexamethasone
for the treatment of COVID-19: real-world study in the US
LB Poster
Characteristics and outcomes of kidney
transplant patients hospitalized for COVID-19 in the United
States
Poster
Viral Hepatitis Research
Risk of liver-related events in
individuals with HBV/HIV coinfection with and without HDV
Poster
Efficacy and safety of BLV 2 or 10 mg for
96 weeks in CHD including two patients with HIV/HBV/HDV
Poster
For more information, including a complete list of abstracts and
their corresponding oral and poster sessions, please visit
https://www.croiconference.org.
Teropavimab, zinlirvimab, vesatolimod, GS-5894 and GS-1720 are
investigational compounds, and alone or in combination with
lenacapavir, are not approved by the U.S. Food and Drug
Administration or any other regulatory authority for any use. Their
safety and efficacy are unknown.
Lenacapavir, marketed as Sunlenca®, is 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 people with multi-drug resistant HIV in combination
with other antiretroviral(s).
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 people living with HIV
and people who would benefit from pre-exposure prophylaxis
(PrEP).
The use of lenacapavir for HIV prevention is investigational and
the safety and efficacy of lenacapavir for this use have not been
established. 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.
Islatravir, alone or in combination with lenacapavir, is
investigational and not approved anywhere globally. Their safety
and efficacy have not been established.
Bictegravir is an investigational compound and is not approved
by any regulatory authority for use as a single-agent; its safety
and efficacy are not established.
Bictegravir and lenacapavir in combination are investigational
and not approved anywhere globally. Their safety and efficacy have
not yet been established.
The use of Biktarvy in individuals with HIV-1/HBV co-infection
is investigational, and the safety and efficacy of Biktarvy for
this use have not been established.
Hepcludex (bulevirtide) has received full marketing
authorization from the European Commission for the treatment of
adults with chronic HDV and compensated liver disease. In the
United States and other areas outside of the European Union and
European Economic Area, bulevirtide is an investigational product
and its safety and efficacy have not been established.
Please see below for the U.S. Indication and Important Safety
Information for Veklury and Sunlenca®. Please also see below for
U.S. Indication and Important Safety Information, including Boxed
Warning, for Biktarvy. There is currently no cure for HIV or
AIDS.
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 (300 mg tablet and 463.5 mg/1.5 mL injection)
[(lenacapavir)] is a first-in-class, long-acting HIV capsid
inhibitor 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 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 is contraindicated
in patients with a history of clinically significant
hypersensitivity reactions to Veklury or any of its components.
Please see below for the U.S. Indication and Important Safety
Information for Veklury.
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
Biktarvy
Biktarvy is indicated as a complete regimen for the treatment of
human immunodeficiency virus type 1 (HIV-1) infection in adults and
pediatric patients weighing at least 14 kg who have no
antiretroviral treatment history or to replace the current
antiretroviral regimen in those who are virologically-suppressed
(HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral
regimen with no history of treatment failure and no known
substitutions associated with resistance to the individual
components of Biktarvy.
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: There is insufficient human data on the use
of BIKTARVY during pregnancy. Dolutegravir, another integrase
inhibitor, has been associated with neural tube defects. Discuss
the benefit-risk of using BIKTARVY during pregnancy and conception.
An Antiretroviral Pregnancy Registry (APR) has been established.
Available data from the APR for FTC shows no difference in the
rates of birth defects compared with a US reference
population.
- Lactation: Women infected with HIV-1 should be
instructed not to breastfeed, due to the potential for HIV-1
transmission.
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 be
instructed not to breastfeed, due to the potential for HIV-1
transmission.
U.S. Indication for
Veklury
Veklury (remdesivir 100 mg for injection) is indicated for the
treatment of COVID-19 in adults and pediatric patients (≥28 days
old and weighing ≥3 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 in
Virology
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.
Gilead has a long history in virology and has pioneered
inventions once thought impossible, including antiviral treatments
for people and communities affected by some of the most challenging
public health concerns including HIV, viral hepatitis and
COVID-19.
Gilead helps people and communities across the full continuum of
care in virology by developing bold advances that treat, prevent
and cure viral diseases and collaborating with community and
research partners around the world. Gilead is deploying decades of
antiviral expertise to provide solutions that help address the
unmet and evolving needs of those impacted by viral diseases.
Our work in virology has helped to transform the global health
landscape and we are committed to advancing person-centered science
and actionable education programs that make a difference for people
and communities affected by viral diseases.
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 or studies within currently anticipated timelines
or at all, and the possibility of unfavorable results from ongoing
and additional clinical trials or studies, including those
involving Biktarvy, Hepcludex, Veklury, lenacapavir, teropavimab,
vesatolimod, zinlirvimab, GS-1720 and GS-5894; 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 these programs
and, as a result, these programs may never be successfully
commercialized for the indications currently under evaluation; 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 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.
Biktarvy, Sunlenca, Veklury, Hepcludex, Gilead
and the Gilead logo are registered trademarks of Gilead Sciences,
Inc., or its related companies. All other trademarks are the
property of their respective owner(s).
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on Twitter (
@Gilead Sciences ) and LinkedIn, 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/20240223287683/en/
Jacquie Ross, Investors investor_relations@gilead.com
Meaghan Smith, Media public_affairs@gilead.com
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