Gilead Sciences, Inc. (Nasdaq: GILD) today announced the
presentation of 18 abstracts spanning the company’s HIV treatment
and prevention and COVID-19 clinical development programs during
the virtual IDWeek 2020 conference from October 21-25. The breadth
of data reflects Gilead’s commitment to advancing antiviral
innovation aiming to help end the HIV epidemic and to addressing
the treatment needs of patients with COVID-19.
“The global HIV epidemic and the COVID-19 pandemic are two of
the most complex public health challenges of our time,” explained
Diana Brainard, MD, Senior Vice President and Virology Therapeutic
Area Head, Gilead Sciences. “The data presented at IDWeek reflect
the latest progress in Gilead’s antiviral drug discovery and
development and underscore our commitment to supporting the global
health community to quickly and effectively respond to devastating
viral outbreaks worldwide.”
At IDWeek 2020, Gilead will present results from the ongoing
DISCOVER multi-center randomized clinical trial, evaluating the
safety and efficacy of Descovy (emtricitabine 200 mg/tenofovir
alafenamide 25 mg) for PrEP® and a new analysis leveraging a novel
statistical method to estimate the background HIV incidence rate in
DISCOVER. Separate data from DISCOVER will provide insight into the
impact of age and comorbidities on renal outcomes for study
participants. In addition to new data from the DISCOVER trial, the
key findings from an analysis examining real-world patterns of
persistence with Truvada (emtricitabine 200 mg/tenofovir disoproxil
fumarate 300 mg) for PrEP® in at-risk populations will be presented
in an oral presentation.
Gilead also will present new data on the efficacy and safety of
Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir
alafenamide 25 mg tablets, B/F/TAF) in certain populations of
people living with HIV that have historically been underrepresented
in HIV clinical research. The latest data from Gilead’s HIV
treatment research program to be presented include an oral
presentation on 48-week outcomes from the landmark community-based
and designed BRAAVE study evaluating the safety and efficacy of
switching to Biktarvy among Black American adults living with HIV
who are virally suppressed. Findings on the efficacy of Biktarvy in
people living with HIV who are virologically suppressed with
end-stage renal disease and requiring chronic hemodialysis will
also be presented.
Data on Gilead’s investigational antiviral Veklury® (remdesivir)
for injection (100 mg) administered by intravenous infusion for the
treatment of COVID-19 include two oral presentations examining the
safety and efficacy of Veklury in hospitalized patients with
moderate COVID-19 and global geographical disparities in clinical
outcomes of hospitalized patients with severe COVID-19 treated with
Veklury in Gilead’s open-label, Phase 3 SIMPLE studies.
Select accepted abstracts are as follows:
HIV prevention research
- Oral 103: Persistence on Emtricitabine/Tenofovir Disoproxil
Fumarate (F/TDF) for HIV Pre-Exposure Prophylaxis: Insights From
Real-World Evidence
- Poster 999: Using the Emtricitabine/Tenofovir Disoproxil
Fumarate (F/TDF) Adherence-Efficacy Relationship to Calculate
Background HIV Incidence: Results From the DISCOVER trial
- Poster 985: Impact of Age and Medical Comorbidities on Renal
Outcomes in the DISCOVER Trial
- Poster 995: Safety and Efficacy of Emtricitabine/Tenofovir
Alafenamide (F/TAF) and Emtricitabine/Tenofovir Disoproxil Fumarate
(F/TDF) for PrEP in DISCOVER Participants Taking F/TDF for PrEP at
Baseline
HIV treatment research
- Oral 109: Pre-Existing Resistance and Week 48 Virologic
Outcomes After Switching to Bictegravir/Emtricitabine/Tenofovir
Alafenamide (B/F/TAF) in African American Adults With HIV
- Late Breaker 7: Weight Change in Suppressed People With HIV
(PWH) Switched From Either Tenofovir Disoproxil Fumarate (TDF) or
Abacavir (ABC) to Tenofovir Alafenamide (TAF)
- Poster 1046: Week 48 Outcomes From the BRAAVE 2020 Study: A
Randomized Switch to Bictegravir/Emtricitabine/Tenofovir
Alafenamide (B/F/TAF) in African American Adults With HIV
- Poster 1002: A Daily Single Tablet Regimen (STR) of
Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in
Virologically Suppressed Adults Living With HIV and End Stage Renal
Disease on Chronic Hemodialysis
- Poster 1028: Long-term Follow-up After a Switch to
Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) From
Dolutegravir/Abacavir/Lamivudine
- Poster 1448: Forgiveness of Bictegravir/Emtricitabine/Tenofovir
Alafenamide (B/F/TAF): In Vitro Simulations of Intermittent Poor
Adherence Find Limited HIV-1 Breakthrough and High Barrier to
Resistance
- Poster 633: Bictegravir/Emtricitabine/Tenofovir Alafenamide
(B/F/TAF) Efficacy in Participants With Pre-Existing Primary
Integrase Inhibitor Resistance Through 48 Weeks of Phase 3 Clinical
Trials
COVID-19 treatment research
- Oral 72: Remdesivir vs. Standard Care in Patients With Moderate
COVID -19
- Oral 73: Geographical Disparities in Clinical Outcomes of
Severe COVID-19 Patients Treated With Remdesivir
- Poster 561: Safety of Remdesivir vs. Standard Care in Patients
With Moderate COVID-19
- Poster 557: Impact of Concomitant Hydroxychloroquine Use on
Safety and Efficacy of Remdesivir in Moderate COVID-19
Patients
For more information, including a complete list of abstracts,
please visit: https://www.eventscribe.com/2020/IDWeek/index.asp
Please see below for U.S. Indications and Important Safety
Information, including Boxed Warnings, for Biktarvy®, Descovy for
PrEP® and Truvada for PrEP®.
There is no cure for HIV or AIDS.
Veklury has not been approved by the U.S. Food and Drug
Administration (FDA) for any use, and its safety and efficacy have
not been established. Gilead submitted a new drug application for
Veklury on August 7, 2020; the NDA is currently under FDA review.
Veklury is currently authorized for temporary use under an
Emergency Use Authorization (EUA) for the treatment of hospitalized
patients with COVID-19, including patients with moderate to severe
disease, regardless of the need for supplemental oxygen. This
authorization is temporary and may be revoked, and does not take
the place of the formal new drug application submission, review and
approval process. For information about the authorized use of
Veklury and mandatory requirements of the EUA in the U.S., please
review the Fact Sheets and FDA Letter of Authorization available at
www.gilead.com/remdesivir.
U.S. Important Safety Information and
Indication 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: Cases of acute
renal failure and Fanconi syndrome have been reported with the use
of tenofovir prodrugs. In clinical trials of BIKTARVY, there have
been no cases of Fanconi syndrome or proximal renal tubulopathy
(PRT). Do not initiate BIKTARVY in patients with estimated
creatinine clearance (CrCl) <30 mL/min. 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: Patients weighing ≥25 kg: 1 tablet taken once
daily with or without food.
- Renal impairment: 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
Biktarvy
Biktarvy is indicated as a complete regimen for the treatment of
HIV-1 infection in adults and pediatric patients weighing at least
25 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 history of treatment failure and no known resistance to any
component of Biktarvy.
U.S. Important Safety Information and
Indication for Descovy for PrEP
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF DESCOVY
FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT
ACUTE EXACERBATION OF HEPATITIS B
- Descovy for PrEP must be prescribed only to patients confirmed
to be HIV negative immediately prior to initiation and at least
every 3 months during use. Drug-resistant HIV-1 variants have been
identified with use of emtricitabine/tenofovir disoproxil fumarate
(FTC/TDF) for HIV-1 PrEP following undetected acute HIV-1
infection. Do not initiate if signs or symptoms of acute HIV-1
infection are present unless HIV-negative status is confirmed.
- Severe acute exacerbations of hepatitis B have been reported in
patients infected with hepatitis B virus (HBV) who discontinued
products containing FTC and/or TDF and may occur with
discontinuation of Descovy. Closely monitor hepatic function with
both clinical and laboratory follow-up for at least several months
in patients with HBV who discontinue Descovy. If appropriate,
anti-hepatitis B therapy may be warranted.
Contraindication:
- Descovy for PrEP is contraindicated in patients with unknown or
positive HIV status.
Comprehensive management to reduce risks:
- Use Descovy for PrEP to reduce the risk of HIV-1 infection as
part of a comprehensive strategy that includes adherence to daily
dosing and safer sex practices, including condoms, to reduce the
risk of sexually transmitted infections (STIs).
- HIV-1 risk factors: Behavioral, biological, or
epidemiologic HIV-1 risk factors may include, but are not limited
to: condomless sex, past or current STIs, self-identified HIV risk,
having sexual partners of unknown HIV-1 viremic status, or sexual
activity in a high-prevalence area or network.
- Reduce STI risk: Counsel on the use of STI
prevention measures (e.g., consistent and correct condom use,
knowledge of partner's HIV-1 viremic status, regular testing for
STIs).
- Reduce potential for drug resistance: Only
prescribe Descovy for PrEP to patients confirmed to be HIV negative
immediately prior to initiation, at least every 3 months while
taking Descovy, and upon an STI diagnosis. HIV-1 resistance
substitutions may emerge in patients with undetected HIV-1
infection who are taking only Descovy because Descovy alone is not
a complete regimen for treating HIV-1.
- Some HIV tests may not detect acute HIV infection. Prior to
initiating Descovy for PrEP, ask patients about potential recent
exposure events. If recent (<1 month) exposures are reported or
suspected, or symptoms of acute HIV infection (e.g., fever,
fatigue, myalgia, skin rash) are present, confirm HIV-negative
status with a test approved by the FDA for use in the diagnosis of
acute HIV infection.
- If HIV-1 infection is suspected or if symptoms of acute
infection are present while taking Descovy for PrEP, convert the
Descovy for PrEP regimen to a complete HIV treatment regimen until
HIV-negative status is confirmed by a test approved by the FDA for
use in the diagnosis of acute HIV infection.
- Counsel on adherence: Counsel patients to
strictly adhere to daily dosing, as efficacy is strongly correlated
with adherence. Some patients, such as adolescents, may benefit
from more frequent visits and counseling.
Warnings and precautions:
- New onset or worsening renal impairment: Cases of
acute renal failure and Fanconi syndrome have been reported with
the use of tenofovir prodrugs. Do not initiate Descovy in patients
with estimated creatinine clearance (CrCl) <30 mL/min. Patients
with impaired renal function and/or taking nephrotoxic agents
(including NSAIDs) are at increased risk of renal-related adverse
reactions. Discontinue Descovy in patients who develop clinically
significant decreases in renal function or evidence of Fanconi
syndrome. Monitor renal function in all patients (see Dosage and
Administration section).
- Lactic acidosis and severe hepatomegaly with
steatosis: Fatal cases have been reported with the use
of nucleoside analogs, including FTC and TDF. Discontinue use 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 (≥2%) in the Descovy for PrEP
clinical trial were diarrhea, nausea, headache, fatigue, and
abdominal pain.
Drug interactions:
- Prescribing information: Consult the full
Prescribing Information for Descovy for more information, warnings,
and potentially significant drug interactions, including clinical
comments.
- Metabolism: Drugs that inhibit P-gp can increase
the concentrations of tenofovir alafenamide (TAF), a component of
Descovy. Drugs that induce P-gp can decrease the concentrations of
TAF, which may lead to loss of efficacy.
- Drugs affecting renal function: Coadministration
of Descovy 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: One tablet taken once daily with or
without food.
- HIV screening: Test for HIV-1 infection
immediately prior to initiating, at least every 3 months during
use, and upon diagnosis of an STI (see Warnings and Precautions
section).
- HBV screening: Test for HBV infection prior to or
when initiating Descovy.
- Renal impairment and monitoring: Not recommended
in patients with creatinine clearance (CrCl) <30 mL/min. Prior
to or when initiating Descovy, and during use on a clinically
appropriate schedule, assess serum creatinine, CrCl, urine glucose,
and urine protein in all patients. In patients with chronic kidney
disease, assess serum phosphorus.
U.S. Indication for Descovy for
PrEP
Descovy for PrEP is indicated in at-risk adults and adolescents
(≥35 kg) to reduce the risk of sexually acquired HIV-1 infection,
excluding individuals at risk from receptive vaginal sex.
HIV-1–negative status must be confirmed immediately prior to
initiation.
Limitation of Use:
- Descovy for PrEP is not indicated in individuals at risk of
HIV-1 from receptive vaginal sex because effectiveness in this
population has not been evaluated.
Important U.S. Safety Information and
Indication for Truvada for PrEP
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA
FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT
ACUTE EXACERBATION OF HEPATITIS B
- TRUVADA FOR PrEP must be prescribed only to patients confirmed
to be HIV negative immediately prior to initiation and at least
every 3 months during use. Drug-resistant HIV-1 variants have been
identified with use of TRUVADA FOR PrEP following undetected acute
HIV-1 infection. Do not initiate if signs or symptoms of acute
HIV-1 infection are present unless HIV-negative status is
confirmed
- Severe acute exacerbations of hepatitis B virus (HBV) have been
reported in patients who have HBV infection and discontinued
TRUVADA. Hepatic function should be monitored closely with both
clinical and laboratory follow-up for at least several months in
patients with HBV after discontinuing TRUVADA. If appropriate,
initiation of anti-hepatitis B therapy may be warranted
Contraindication:
- TRUVADA FOR PrEP is contraindicated in patients with unknown or
positive HIV status
Warnings and precautions:
- Comprehensive management to reduce risks:
- Use TRUVADA FOR PrEP to reduce the risk of HIV-1 infection as
part of a comprehensive strategy that includes adherence to daily
dosing and safer sex practices, including condoms, to reduce the
risk of sexually transmitted infections (STIs)
- HIV-1 risk factors: Behavioral, biological, or
epidemiologic HIV-1 risk factors may include, but are not limited
to condomless sex, past or current STIs, self-identified HIV risk,
having sexual partners of unknown HIV-1 viremic status, or sexual
activity in a high-prevalence area or network
- Reduce STI risk: Counsel on the use of STI prevention
measures (e.g., consistent and correct condom use, knowledge of
partner’s HIV-1 status, including viremic status, regular testing
for STIs)
- Reduce potential for drug resistance: Only prescribe
TRUVADA FOR PrEP to patients confirmed to be HIV negative
immediately prior to initiation, at least every 3 months while
taking TRUVADA, and upon an STI diagnosis. HIV-1 resistance
substitutions may emerge in patients with undetected HIV-1
infection who are taking only TRUVADA because TRUVADA alone is not
a complete regimen for treating HIV-1
- Some HIV tests may not detect acute HIV infection. Prior to
initiating TRUVADA FOR PrEP, ask patients about potential recent
exposure events. If recent (<1 month) exposures are reported or
suspected, or symptoms of acute HIV infection (e.g., fever,
fatigue, myalgia, skin rash) are present, confirm HIV-negative
status with a test approved by the FDA for use in the diagnosis of
acute HIV infection
- If HIV-1 infection is suspected or if symptoms of acute
infection are present while taking TRUVADA FOR PrEP, convert the
TRUVADA FOR PrEP regimen to a complete HIV treatment regimen until
HIV-negative status is confirmed by a test approved by the FDA for
use in the diagnosis of acute HIV infection
- Counsel on adherence: Counsel patients to strictly
adhere to daily dosing, as efficacy is strongly correlated with
adherence. Some patients, such as adolescents, may benefit from
more frequent visits and counseling
Warnings and precautions:
- New onset or worsening renal impairment: Cases of acute
renal impairment and Fanconi syndrome have been reported with the
use of TDF. TRUVADA is not recommended in patients with estimated
creatinine clearance (CrCl) <60 mL/min. Avoid concurrent or
recent use with a nephrotoxic agent. Acute renal failure has been
reported after initiation of high-dose or multiple NSAIDs in
patients at risk for renal dysfunction; consider alternatives to
NSAIDs in these patients. Monitor renal function in all patients
(see Dosage and Administration section)
- Bone effects: Decreases in bone mineral density (BMD)
and mineralization defects, including osteomalacia associated with
proximal renal tubulopathy, have been reported with the use of TDF.
Consider monitoring BMD in patients with a history of pathologic
fracture or risk factors for bone loss
- Lactic acidosis and severe hepatomegaly with steatosis:
Fatal cases have been reported with the use of nucleoside analogs,
including TRUVADA. Discontinue use if clinical or laboratory
findings suggestive of lactic acidosis or pronounced hepatotoxicity
develop, including hepatomegaly and steatosis in the absence of
marked transaminase elevations
- Drug interactions: See Drug Interactions section.
Consider the potential for drug interactions prior to and during
use of TRUVADA, and monitor for adverse reactions
Adverse reactions:
- Common adverse reactions (>2% and more frequently
than placebo) of TRUVADA FOR PrEP in clinical trials were headache,
abdominal pain, and weight loss
Drug interactions:
- Prescribing information: Consult the full Prescribing
Information for TRUVADA for more information, warnings, and
potentially significant drug interactions, including clinical
comments
- Hepatitis C antivirals: Coadministration with
ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or
sofosbuvir/velpatasvir/voxilaprevir increases TDF exposure; monitor
for adverse reactions
- Drugs affecting renal function: Coadministration of
TRUVADA with drugs that reduce renal function or compete for active
tubular secretion may increase concentrations of emtricitabine
and/or tenofovir
Pregnancy and lactation:
- Pregnancy: An Antiretroviral Pregnancy Registry (APR)
has been established. Available data from observational studies and
the APR show no significant difference in the rate of major birth
defects for TRUVADA compared with a US reference population.
Consider HIV prevention methods, including TRUVADA FOR PrEP in
women due to the potential increased risk of HIV-1 infection during
pregnancy and mother-to-child transmission during acute HIV-1
infection
- Lactation: Emtricitabine and tenofovir have been
detected in human milk. Evaluate the benefits and risks of TRUVADA
FOR PrEP in breastfeeding women, including the risk of HIV-1
acquisition due to nonadherence, and subsequent mother to child
transmission. Health benefits of breastfeeding should be considered
along with potential adverse effects of TRUVADA on the child, which
are unknown
Dosage and administration:
- Dosage: One tablet, once daily, with or without
food
- HIV screening: Test for HIV-1 infection prior to
initiating and at least every 3 months during treatment
- HBV screening: Test for HBV infection prior to or when
initiating treatment
- Renal impairment and monitoring: Not recommended in
patients with CrCl <60 mL/min. Prior to or when initiating
TRUVADA, and during use on a clinically appropriate schedule,
assess serum creatinine, CrCl, urine glucose, and urine protein in
all patients. In patients with chronic kidney disease, assess serum
phosphorus
U.S. Indication for Truvada for
PrEP
TRUVADA FOR PrEP (pre-exposure prophylaxis) is indicated to
reduce the risk of sexually acquired HIV-1 in adults and
adolescents (≥35 kg) who are at risk for HIV. HIV-1–negative status
must be confirmed immediately prior to initiation.
About Veklury
(remdesivir)
Veklury is an investigational nucleotide analog with
broad-spectrum antiviral activity both in vitro and in vivo in
animal models against multiple emerging viral pathogens. Multiple
ongoing international Phase 3 clinical trials are evaluating the
safety and efficacy of Veklury for the treatment of SARS-CoV-2
infection, the virus that causes COVID-19, in different patient
populations, formulations, and in combination with other
therapies.
Important Information about Veklury in
the United States
In the United States, Veklury (remdesivir) is authorized for use
under an Emergency Use Authorization (EUA) only for the treatment
of hospitalized adult and pediatric patients with suspected or
laboratory-confirmed COVID-19. Veklury must be administered via
intravenous (IV) infusion and is supplied two ways: Veklury
(remdesivir) for injection, 100 mg, lyophilized powder, or Veklury
(remdesivir) injection, 100 mg/20 mL (5 mg/mL), concentrated
solution.
Veklury is an investigational drug that has not been approved by
the FDA for any use, and the safety and efficacy of Veklury for the
treatment of COVID-19 have not been established. This authorization
is temporary and may be revoked, and does not take the place of the
formal new drug application submission, review and approval
process. For information about the authorized use of Veklury and
mandatory requirements of the EUA in the U.S., please review the
Fact Sheets and FDA Letter of Authorization available at
www.gilead.com/remdesivir.
There are limited clinical data available for Veklury. Serious
and unexpected adverse events may occur that have not been
previously reported with Veklury use. Hypersensitivity reactions,
including infusion-related and anaphylactic reactions, have been
observed during and following administration of Veklury. The use of
Veklury is contraindicated in patients with known hypersensitivity
to Veklury. Transaminase elevations have been observed in healthy
volunteers and patients with COVID-19 in clinical trials who
received Veklury. Patients should have appropriate clinical and
laboratory monitoring to aid in early detection of any potential
adverse events. Monitor renal and hepatic function prior to
initiating and daily during therapy with Veklury; additionally,
monitor serum chemistries and hematology daily during therapy. Do
not initiate Veklury in patients with ALT ≥5x ULN or with an eGFR
<30 mL/min. The decision to continue or discontinue Veklury
therapy after development of an adverse event should be made based
on the clinical risk/benefit assessment for the individual
patient.
Due to a risk of reduced antiviral activity, coadministration of
Veklury and chloroquine phosphate or hydroxychloroquine sulfate is
not recommended.
Healthcare providers and/or their designee are responsible for
mandatory FDA MedWatch reporting of all medication errors and
serious adverse events or deaths occurring during Veklury treatment
and considered to be potentially attributable to Veklury. These
events must be reported within 7 calendar days from the onset of
the event. MedWatch adverse event reports can be submitted to FDA
online at www.fda.gov/medwatch or by calling 1-800-FDA-1088.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical
company that discovers, develops and commercializes innovative
medicines in areas of unmet medical need. The company strives to
transform and simplify care for people with life-threatening
illnesses around the world. Gilead has operations in more than 35
countries worldwide, with headquarters in Foster City,
California.
For more than 30 years, Gilead has been a leading innovator in
the field of HIV, driving advances in treatment, prevention,
testing and linkage to care, and cure research. Today, it’s
estimated that more than 12 million people living with HIV globally
receive antiretroviral therapy provided by Gilead or one of the
company’s manufacturing partners.
Gilead is committed to supporting the global health community to
quickly and effectively respond to serious and life-threatening
viral outbreaks worldwide. To that end, we are contributing our
antiviral expertise and resources to help investigate potential
treatments for patients with COVID-19. For more information on
Gilead’s response to the coronavirus outbreak please visit the
company’s dedicated page:
https://www.gilead.com/purpose/advancing-global-health/covid-19.
Forward-Looking
Statement
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including the possibility of unfavorable results from ongoing and
additional clinical trials involving Biktarvy, Descovy for PrEP,
Truvada for PrEP and Veklury (remdesivir), and the possibility that
we are unable to complete one or more of such trials in the
currently anticipated timelines or at all. Further, it is possible
that Gilead may make a strategic decision to discontinue
development of Veklury or that FDA and other regulatory agencies
may not approve Veklury, and any marketing approvals, if granted,
may have significant limitations on its use. As a result, Veklury
may never be successfully commercialized. All statements other than
statements of historical fact are statements that could be deemed
forward-looking statements. These risks, uncertainties and other
factors could cause actual results to differ materially from those
referred to in the forward-looking statements. The reader is
cautioned not to rely on these forward-looking statements. These
and other risks are described in detail in Gilead’s Quarterly
Report on Form 10-Q for the quarter ended June 30, 2020, as filed
with the U.S. Securities and Exchange Commission. All
forward-looking statements are based on information currently
available to Gilead, and Gilead assumes no obligation to update any
such forward-looking statements.
U.S. full Prescribing Information for Biktarvy,
Descovy and Truvada, including BOXED WARNINGS, is available at
www.gilead.com
For more information about the emergency use of
Veklury in the United States, please see the Emergency Use
Authorization Fact Sheets available at
www.gilead.com/remdesivir.
Biktarvy, Veklury, Descovy, Descovy for PrEP,
Truvada, Truvada for PrEP, Gilead and the Gilead logo are
trademarks of Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on Twitter
(@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5
or 1-650-574-3000.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201019005466/en/
Douglas Maffei, PhD, Investors 650-522-2739
Brian Plummer, Media 202-309-5207
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