Gilead Sciences, Inc. (Nasdaq:GILD) today announced that new
data from the company’s HIV research and development program will
be presented at the 23rd International AIDS Conference (AIDS 2020:
Virtual) from July 6-10. The breadth of data presented at the
meeting, along with Gilead-led symposia and workshops, reflect the
company’s commitment to advancing the scientific understanding of
HIV prevention, treatment and cure strategies.
“Continued scientific innovation is essential to better
understanding and addressing the evolving needs of people living
with or at risk for HIV,” said Diana Brainard, MD, Senior Vice
President and Virology Therapeutic Area Head, Gilead Sciences.
“Gilead is actively pursuing innovative cure and long-term viral
suppression strategies, while seeking to optimize antiretroviral
and prevention therapies for all individuals impacted by HIV.
Through the data presented at AIDS 2020: Virtual, we aim to advance
care in a transformative way and contribute to the shared goal of
ending the HIV/AIDS epidemic.”
Phase 1 trial results supporting further evaluation of a
six-month dosing interval for a sustained delivery formulation of
Gilead’s novel, investigational HIV-1 capsid inhibitor, lenacapavir
(GS-6207), will be presented. Lenacapavir is an investigational
agent that is being developed as a component of a long-acting
regimen in combination with other antiretroviral agents.
Lenacapavir disrupts HIV capsid, a multimeric shell that is
essential to viral replication, at multiple stages throughout the
viral life cycle. In May 2019, the FDA granted Breakthrough Therapy
Designation for the development of lenacapavir for the treatment of
HIV-1 infection in heavily treatment-experienced patients with
multi-drug resistance in combination with other antiretroviral
drugs.
HIV treatment data to be presented includes a pooled analysis of
four international trials evaluating the safety and efficacy of
Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir
alafenamide 25 mg; B/F/TAF) in adults aged 65 or older.
Additionally, data evaluating the safety and efficacy of an
investigational low-dose formulation of E/C/F/TAF (elvitegravir 90
mg/cobicistat 90 mg/emtricitabine 120 mg/tenofovir alafenamide 6
mg) in virologically suppressed children two years or older and
weighing 14 to less than 25 kg who are living with HIV will be
shared in a late-breaking presentation.
Prevention data around the impact of COVID-19 shelter-in-place
orders on pre-exposure prophylaxis (PrEP) access and usage and HIV
risk behavior in the United States will be shared in a
late-breaking presentation. Data from the ongoing DISCOVER
multi-year global Phase 3 registrational clinical trial evaluating
the safety and efficacy of once-daily Descovy (emtricitabine 200
mg/tenofovir alafenamide 25 mg; F/TAF) for PrEP® will also be
presented.
Insights from Gilead’s cure research program include an oral
presentation on vesatolimod, a toll-like receptor 7 (TLR7) agonist,
and dose-dependent immune responses induced in HIV controllers.
Select accepted abstracts are as follows:
Investigational Long-Acting HIV
Therapy
E-posters – Track B
PEB0265: Lenacapavir/GS-6207 Sustained
Delivery Formulation Supports 6-Month Dosing Interval
HIV Treatment Research
OAB04 – Antiretrovirals session 2
OAB0403: Pooled Analysis of 4
International Trials of Bictegravir/Emtricitabine/Tenofovir
Alafenamide (B/F/TAF) in Adults Aged >65 or Older Demonstrating
Safety and Efficacy: Week 48 Results
E-posters – Track B
PEB0257: Baseline NRTI Resistance in
Suppressed Participants Did Not Lead to Viral Blips on
Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) or
Dolutegravir (DTG)+F/TAF Through Week 48 in Study 380-4030
E-posters – Track B
PEB0254: Prevalence and Risk Factors of
Pre-Existing NNRTI Resistance Among Suppressed PLWH in B/F/TAF
Switch Studies
E-posters – Track B
PEB0229: The BICSTaR Prospective Cohort:
Real-World Effectiveness, Safety and Tolerability of
Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in
Routine Clinical Practice in People Living with HIV (PLWH)
Prime channel live sessions – Track D
late-breaker abstracts
OABLB01: Safety, PK, and Efficacy of
Low-dose E/C/F/TAF in Virologically Suppressed Children ≥2 Years
Old Living with HIV
HIV Prevention Research
Prime channel live sessions – Track D
late-breaker abstracts
OADLB01: Impact of COVID-19 Related
Shelter-in-Place Orders on PrEP Access, Usage and HIV Risk
Behaviors in the United States
E-posters – Track B
PEB0165: DISCOVER: Study for HIV
Pre-Exposure Prophylaxis (PrEP): No Evidence of Risk Compensation
in Participants Taking F/TDF or F/TAF for PrEP Through 96 Weeks
PDB04 – Resistance
PDB0404: Deep Sequencing with Unique
Molecular Identifiers for Evaluation of HIV-1 Drug Resistance in
the DISCOVER Pre-exposure Prophylaxis Trial
PDB03 – Opportunistic infections
PDB0303: Persistently High Rates of
Sexually Transmitted Infections in the DISCOVER HIV PrEP Trial
HIV Cure Research
OAB02 – ARV, cure and testing
strategies
OAB0205: Vesatolimod, a Toll-Like Receptor
7 (TLR7) Agonist, Induces Dose-Dependent Immune Responses in HIV
Controllers
Please see below for U.S. Indications and Important Safety
Information, including Boxed Warnings, for Biktarvy® and Descovy
for PrEP®.
Lenacapavir (GS-6207), vesatolimod, and the low-dose formulation
of E/C/F/TAF are investigational compounds and are not approved by
the U.S. Food and Drug Administration or any other regulatory
authority. Their safety and efficacy have not been established. In
May 2019, FDA granted Breakthrough Therapy Designation for the
development of lenacapavir (GS-6207) for the treatment of HIV-1
infection in heavily treatment-experienced patients with multi-drug
resistance.
Biktarvy and Descovy do not prevent other sexually transmitted
infections or cure HIV or AIDS.
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.
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.
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,
the low-dose formulation of E/C/F/TAF, lenacapavir and vesatolimod,
and the possibility that we are unable to complete one or more of
such trials on the currently anticipated timelines or at all. In
addition, it is possible that Gilead may make a strategic decision
to discontinue development of the low-dose formulation of
E/C/F/TAF, lenacapavir and vesatolimod, and as a result, the
low-dose formulation of E/C/F/TAF, lenacapavir and vesatolimod 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 March 31, 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,
and Descovy for PrEP, including BOXED WARNINGS, is available at
www.gilead.com
Biktarvy, Descovy, Descovy 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200701005549/en/
Douglas Maffei, PhD, Investors (650) 522-2739
Brian Plummer, Media (202) 309-5207
Gilead Sciences (NASDAQ:GILD)
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