– 99% of Participants Achieved and
Maintained an Undetectable Viral Load With Biktarvy in Pooled
Analysis of 192-Week Data From Open-Label Extension Period of Two
Phase 3 Trials in Treatment-Naïve Adults –
– 72-Week Data From the BRAAVE Study
Demonstrate 99% of Black Adults Who Are Virologically Suppressed
and Switched to Biktarvy From a Standard Regimen Achieved and
Maintained an Undetectable Viral Load –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced a pooled
analysis of a 48-week open-label extension of two Phase 3 studies
(Study 1489 and Study 1490) shows 99% of participants who initiated
treatment with Biktarvy® (bictegravir 50 mg/emtricitabine 200
mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) maintained an
undetectable viral load (HIV-1 RNA <50 copies/mL) through four
years of follow-up (Week 192, n=476/480, missing=excluded). In the
48-week open-label extension, there were zero cases of
treatment-emergent resistance to any components of Biktarvy in
participants treated with Biktarvy. These findings, along with
long-term data from Phase 3 studies in virologically suppressed
Black Americans and virologically suppressed people living with HIV
aged 65 and older, demonstrated Biktarvy sustains efficacy with a
high barrier to resistance across a range of people living with
HIV, inclusive of their treatment history, gender, race or age.
These data were presented at the 11th International AIDS Society
(IAS) Conference on HIV Science.
“Four decades after the virus was first reported, it is
imperative to commit to driving scientific innovation to meet the
needs of people living in today’s world. Globally, the number of
older adults with HIV is increasing and communities of color,
especially Black adults, continue to be disproportionately affected
by HIV while underrepresented in HIV clinical trials,” said
Professor Chloe Orkin, MBBCH, FRCP, Lead for HIV Research at Queen
Mary University of London. “To help end the global HIV epidemic,
effective treatment needs to be acceptable and accessible to
everyone. The long-term data reinforce the durability of Biktarvy
and highlight its potential role in helping to meet the treatment
needs of a diverse group of people living with HIV.”
Gilead presented additional Biktarvy data at IAS 2021, including
findings from the BRAAVE 2020 Study, a Phase 3 clinical trial
designed with community input to evaluate the specific treatment
responses of virologically suppressed adults living with HIV who
self-identified as Black or African American following a switch to
Biktarvy from a variety of regimens. A total of 495 study
participants were randomly allocated and treated in a 2:1 ratio to
either switch to open-label Biktarvy for up to 72 weeks (n=330) or
to stay on a standard regimen of two nucleoside reverse
transcriptase inhibitors (NRTIs) plus a third agent for 24 weeks
with a delayed switch to Biktarvy for up to 48 weeks (n=165).
At 72 weeks, 99% of participants (n=246/248, missing=excluded)
who switched to Biktarvy at the start of the study maintained an
undetectable viral load regardless of age or sex at birth. These
results provide further evidence that Biktarvy is an effective and
durable treatment option for Black adults who are virologically
suppressed, including those with a history of treatment failure or
pre-existing resistance.
Gilead also presented long-term data from a Phase 3b open-label
trial enrolling people living with HIV aged 65 and older who
switched to Biktarvy (n=86) from either Genvoya® (elvitegravir 150
mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10
mg, E/C/F/TAF) or a tenofovir disoproxil fumarate (TDF)-based
regimen. The analysis showed that 100% of participants (n=68/68,
missing=excluded) and 74% of participants (n=64/86) in the snapshot
analysis of the Intention to Treat-Exposed (ITT-E) population
having HIV-1 RNA <50 copies/mL maintained high rates of
virologic suppression at Week 96 with no virologic failures or
emergent resistance through 96 weeks. The COVID-19 pandemic
impacted in-person visits during the study, with 11 participants
unable to be assessed after 84 weeks due to restrictions. There
were two participants (2.3%) with Grade 3-4 study drug-related AEs,
11 participants (13%) with Grade 3-4 laboratory abnormalities and
three participants (3.5%) with drug-related adverse events (AEs)
leading to study drug discontinuation. These results reinforce
Biktarvy as an effective and generally well-tolerated treatment
option with a high barrier to resistance in the growing population
of older people living with HIV.
Results from a Phase 3 study (Study 1844) demonstrated the
safety and non-inferior efficacy of switching to Biktarvy in those
replacing their existing treatment regimen. In Study 1844,
participants (n=563) who were virologically suppressed (HIV-1 RNA
<50 copies/mL) on a regimen containing abacavir, dolutegravir,
and lamivudine (600/50/300mg) (ABC/DTG/3TC) were randomly allocated
and treated in a 1:1 ratio to stay on their existing regimen of
ABC/DTG/3TC (n=281) or switch to Biktarvy (n=282) in a blinded
manner. The primary endpoint was the proportion of patients with
HIV RNA ≥50 copies/mL at Week 48. Study participants were randomly
allocated through 48 weeks, after which point participants electing
to continue in the study enter an open-label extension receiving
Biktarvy. At the point of the last study visit, 98% (n=535/545) of
those who switched to Biktarvy maintained virologic suppression for
a median duration of two years, including those with pre-existing
resistance or who experienced viral “blips.” In participants
treated with Biktarvy, there were no cases of treatment failure
with resistance to any component of Biktarvy.
“A clinical research program that aims to address the
differentiated unmet needs of people living with HIV can help
inform long-term treatment strategies and is central to Gilead’s
mission to help end the HIV epidemic,” said Frank Duff, Senior Vice
President, Virology Therapeutic Area Head, Gilead Sciences. “The
four-year data presented at IAS demonstrate the robust and durable
efficacy and safety profile of Biktarvy as a treatment option for a
diverse range of people living with HIV.”
The use of Biktarvy in individuals with known resistance to the
components of Biktarvy is investigational; this use is not approved
by the U.S. Food and Drug Administration (FDA), and the safety and
efficacy of Biktarvy for this use has not been established. Please
see below for the U.S. Indication and Important Safety Information
for Biktarvy.
Biktarvy does not cure HIV or AIDS.
About Studies 1489 and
1490
Study 1489 and Study 1490 are Phase 3, double-blind,
active-controlled studies. For 144 weeks, treatment-naïve
participants were blinded to receive either Biktarvy (n=634) or a
dolutegravir-containing triple therapy (n=640). Treatment outcomes
were assessed at Week 144 and showed participants in both groups
achieved an undetectable viral load with no treatment-emergent
resistance. Beyond Week 144, participants were able to receive
Biktarvy in an active OLE Phase for up to 96 weeks. Study 1489 and
Study 1490 are ongoing.
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 /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: 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: Patients weighing ≥25 kg: 1 tablet taken once
daily with or without food.
- Renal impairment: 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.
- 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 U.S. 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 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 and cancer.
For more than 30 years, Gilead has been a leading innovator in
the field of HIV, driving advances in treatment, prevention and
cure research. Gilead researchers have developed 11 HIV
medications, including the first single tablet regimen to treat HIV
and the first once-daily oral antiretroviral tablet for
pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV
infection. These advances in medical research have helped to
transform HIV into a preventable, chronic condition for millions of
people.
Gilead is committed to continued scientific innovation to
provide solutions for the evolving needs of people affected by HIV
around the world. Through partnerships and collaborations, the
company also aims to improve education, expand access and address
barriers to care, with the goal of ending the HIV epidemic for
everyone, everywhere.
Gilead operates in more than 35 countries worldwide, with
headquarters in Foster City, California.
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 the possibility of unfavorable results from ongoing and
additional clinical trials involving Biktarvy; and Gilead’s ability
to receive FDA and other regulatory approvals for additional
indications for Biktarvy, and the risk that any such approvals, if
granted, may have significant limitations on its use. These and
other risks, uncertainties and factors are described in detail in
Gilead’s Quarterly Report on Form 10-Q for the quarter ended March
31, 2021, 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 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. Prescribing Information for Biktarvy and
Genvoya, including BOXED WARNINGS, are available at
www.gilead.com.
Biktarvy, Genvoya, Gilead and the Gilead logo
are registered 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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