-- New Findings on Biktarvy® to Include
Long-term Switch Studies as well as Real-World Data and Patient
Reported Outcomes from the BICSTaR Study --
-- Data Evaluating Drug Resistance in People
Receiving Lenacapavir, Gilead’s Investigational HIV-1 Capsid
Inhibitor, as Part of a Long-acting HIV Treatment Regimen to be
Presented --
Gilead Sciences, Inc. (Nasdaq: GILD) today announced its
upcoming contributions to the HIV Glasgow 2020 conference, taking
place virtually from October 5-8. Gilead will present 13 studies
from the company’s HIV research and development programs in
addition to supporting several other independent studies at the
conference, which, along with its community-focused programs,
reflect Gilead’s ongoing focus and commitment to advancing
scientific discovery and supporting the development and delivery of
practical solutions that can help improve care for all people
affected by HIV.
“As the needs of the HIV community evolve, we must also evolve
our efforts to end the HIV epidemic through our scientific
innovation and community support,” said Diana Brainard, MD, Senior
Vice President and Virology Therapeutic Area Head, Gilead Sciences.
“We constantly seek to understand the evolving unmet needs among
persons living with HIV, and we are pleased to present new switch
data for Biktarvy, as well as real-world findings and
patient-reported outcomes from a treatment perspective, and new
data on our first-in-class investigational long-acting injectable
lenacapavir, which may represent a novel approach to HIV
treatment.”
Key Gilead data to be presented:
Gilead will present new studies evaluating the safety, efficacy
and resistance profile of the once-daily single tablet regimen,
Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir
alafenamide 25 mg tablets, B/F/TAF) in people living with HIV,
including older adults and those with a history of resistance, who
have switched from other regimens. Twelve-month data and a
preliminary, descriptive analysis of patient-reported outcomes will
also be presented from the global BICSTaR study, a real-world,
observational study evaluating the effectiveness, safety, and
tolerability of Biktarvy in treatment-naïve and
treatment-experienced people living with HIV.
The results of this large-scale study are expected to underline
the importance of real-world evidence and patient-reported outcomes
in understanding the impact on mental health component scores,
health-related quality of life (HRQoL) and treatment satisfaction
of people living with HIV, which could inform treatment strategies
for these groups.
Additional treatment research presented at the meeting includes
findings from a Phase 1b proof-of-concept study evaluating Gilead’s
investigational, novel inhibitor of HIV-1 capsid function,
lenacapavir, which is being developed as a component of a
long-acting regimen in combination with other antiretroviral
agents. Data on the impact of the COVID-19 pandemic on HIV clinics
and services in Greece will also be presented.
Key Gilead activities during the conference:
Beyond presenting scientific data from the company’s HIV
research and development program, Gilead will address the impact of
COVID-19 on the HIV community in a satellite symposium that will
explore the shifting management strategies and treatment approaches
to deliver patient-centered care during and after the COVID-19
pandemic.
In an effort to better understand the barriers that can
influence engagement in HIV care at individual, systemic and
community levels, Gilead will also convene discussions with the HIV
community. These Gilead-supported sessions are part of the
company’s ongoing efforts to help change the future of the epidemic
through partnerships that help to support community goals of
getting to zero new infections and AIDS-related deaths.
Select Gilead HIV clinical development program data to be
presented at Glasgow 2020:
HIV treatment research
- Poster 036: Long-term follow-up after a switch to
bictegravir/emtricitabine/tenofovir alafenamide, from a boosted
protease inhibitor-based regimen
- Poster 123: Sustained viral suppression after switch to
bictegravir/emtricitabine/tenofovir alafenamide among clinical
trial participants with pre-existing M184V/I
- Poster 038: Switching to bictegravir/emtricitabine/tenofovir
alafenamide in adults aged >65 or older: week 72 results from an
international, Phase 3b, open-label trial
- Poster 046: Starting or switching to
bictegravir/emtricitabine/tenofovir alafenamide in clinical
practice: pooled 12-month results from the global BICSTaR
study
- Poster 053: Patient-reported outcomes after one year of routine
clinical practice with bictegravir/emtricitabine/tenofovir
alafenamide in people living with HIV: the BICSTaR cohort
- Poster 124: Bictegravir/emtricitabine/tenofovir alafenamide
shows high efficacy in clinical study participants infected with
HIV-1 subtype F
- Poster 029: Impact of adherence on viral suppression with
bictegravir and dolutegravir containing triple therapy in clinical
practice
- Poster 100: The clinical relevance of potential drug-drug
interactions with bictegravir/emtricitabine/tenofovir alafenamide –
real-world data from the German IQVIA prescription database
- Poster 032: Persistence of guideline-recommended antiretroviral
therapy regimens among veterans with HIV newly initiating treatment
in the U.S.
Investigational long-acting HIV therapy
- Oral 324: Lenacapavir resistance analysis in a Phase 1b
clinical proof-of-concept study
For more information, including a complete list of abstract
titles at the meeting, please visit:
http://www.hivglasgow.org/wp-content/uploads/2020/09/Poster-Listing_16-September.pdf
Please see below for U.S. Indication and Important Safety
Information, including Boxed Warning, for Biktarvy. In the U.S.,
the use of Biktarvy in individuals with a history of treatment
failure or known resistance to the components of Biktarvy is
investigational, and the safety and efficacy of Biktarvy for this
use have not been established.
Lenacapavir is an investigational compound and is not approved
by the U.S. Food and Drug Administration (FDA) or any other
regulatory authority and its safety and efficacy are not yet known.
In May 2019, the 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.
There is no cure for HIV or AIDS.
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 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.
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 and lenacapavir, and
the possibility that we are unable to complete one or more of such
trials in the currently anticipated timelines or at all. In
addition, it is possible that Gilead may make a strategic decision
to discontinue development of lenacapavir and as a result,
lenacapavir 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,
including BOXED WARNING, is available at www.gilead.com
Biktarvy, 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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Douglas Maffei, PhD, Investors +1 (650) 522-2739
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