-- Biktarvy Now First and Only INSTI-Based
Single-Tablet Regimen That is FDA Approved and DHHS Guideline
Recommended for People Who are Virologically Suppressed with
M184V/I Resistance --
-- M184V/I One of the Most Common Forms of
Resistance Among People with HIV --
-- Biktarvy Is a Long-Term Treatment Option
with a High Barrier to Resistance for a Broad Range of Individuals
--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S.
Food and Drug Administration (FDA) approved a new, expanded
indication for Biktarvy® (bictegravir 50 mg/emtricitabine 200
mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to treat people
with HIV (PWH) who have suppressed viral loads with known or
suspected M184V/I resistance, a common form of treatment
resistance. HIV treatment resistance is permanent and irreversible,
which can jeopardize future treatment options for PWH. The M184V/I
resistance mutation has been found to be present in a range
(22-63%) of PWH with pre-existing resistance to nucleoside reverse
transcriptase inhibitors (NRTIs) across various HIV subtypes. This
label update is supported by Study 4030, which evaluated the
efficacy, safety, and tolerability profile of Biktarvy in a broad
range of people with HIV-1 with or without pre-existing NRTI
resistance, including those with the M184V/I resistance. Biktarvy
is now the first and only integrase strand transfer inhibitor
(INSTI)-based single-tablet regimen that is FDA approved and U.S.
Department of Health and Human Services (DHHS) guideline
recommended for PWH who are virally suppressed with M184V/I
resistance.
“Clinical data have established Biktarvy as a long-term HIV
treatment option for a broad range of PWH. With this label update,
healthcare providers have a better understanding of the efficacy of
Biktarvy in an underserved segment of PWH,” said Jared Baeten, MD,
PhD, Vice President, HIV Clinical Development, Gilead Sciences.
“Thanks to decades of therapeutic improvements, PWH may live
longer, healthier lives, but treatment needs remain. Treatment
resistance is one such area. We are committed to a person-centered
approach to HIV treatment research that not only advances
continuous scientific innovations to help address public health
needs, but also maximizes long-term outcomes for PWH.”
The expanded label is based on Week 48 data from Study 4030, a
Phase 3 randomized, double-blinded study of virologically
suppressed adults with HIV-1 on a baseline regimen of dolutegravir
(DTG) + either emtricitabine/tenofovir alafenamide (F/TAF) or
emtricitabine/tenofovir disoproxil fumarate (F/TDF). Participants
were randomized 1:1 to switch to Biktarvy (n=284) or DTG+F/TAF
(n=281). Study participants must have been stably suppressed (HIV-1
RNA < 50 copies/mL) with current baseline regimen for at least
six months if NRTI resistance was documented or suspected, or at
least three months if NRTI resistance was not documented or
suspected prior to trial entry. Of the participants receiving
Biktarvy, 47 had HIV-1 with pre-existing M184V/I resistance
substitutions. The primary endpoint was the proportion of
participants with HIV RNA ≥ 50 copies/mL at Week 48. Eighty-nine
percent (42/47) of participants with M184V/I remained suppressed
(HIV-1 RNA < 50 copies/mL) and 11% (5/47 participants) did not
have virologic data at the Week 48 timepoint. No participants with
M184V/I who received Biktarvy and had virologic data had HIV RNA ≥
50 copies/mL at Week 48. Additionally, at Week 48 the proportion of
subjects with HIV-1 RNA ≥ 50 copies/mL was 0.4% (1/284) in the
Biktarvy group and 1.1% (3/281) in the DTG+F/TAF group (difference
-0.7% [95% CI: -2.8%, 1.0%]). There were also zero cases of
treatment-emergent resistance to Biktarvy, regardless of known or
suspected pre-existing M184V/I resistance, in the final resistance
analysis population. Overall, the safety profile in virologically
suppressed adults in Study 4030 was similar to that in participants
in other studies of Biktarvy with no antiretroviral treatment
history.
Once someone with HIV has developed resistance to a treatment,
it will persist for the rest of their life. Reducing the risk of
drug resistance is a key goal in HIV therapy. HIV drug resistance
continues to receive clinical and public health attention because
it may hinder the ability of HIV medicines to suppress and block
replication of the virus over the course of an individual’s life.
Resistance may lead to treatment failure in individuals, while also
creating the potential for transmission of treatment-resistant HIV
within communities.
“Treatment failure in HIV must be avoided whenever possible, so
a high barrier to resistance should be standard of care to maximize
the chances of durable virologic suppression,” said Paul E. Sax,
MD, Clinical Director, Division of Infectious Diseases, Brigham and
Women’s Hospital, Professor of Medicine, Harvard Medical School.
“This label update builds on the established high resistance
barrier of Biktarvy by showing that it’s effective in PWH who may
have certain forms of pre-existing resistance or a history of past
treatment failure.”
Please see below for U.S. Indications and Important Safety
Information for Biktarvy, including Boxed Warning.
There is 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.
U.S. Indication for
Biktarvy
Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir
alafenamide 25 mg) is indicated as a complete regimen for the
treatment of HIV-1 infection in adults and pediatric patients
weighing at least 14 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 known or suspected substitutions
associated with resistance to bictegravir or tenofovir.
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.
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 and address unmet
needs in virology, oncology and inflammation. Gilead operates in
more than 35 countries worldwide, with headquarters in Foster City,
California.
For more than 35 years, Gilead has been a leading innovator in
the field of HIV, driving advances in treatment, prevention and
cure research. Gilead researchers have developed 12 HIV
medications, including the first single-tablet regimen to treat
HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP)
to help reduce new HIV infections, and the first long-acting
injectable HIV treatment medication administered twice-yearly. Our
advances in medical research have helped to transform HIV into a
treatable, 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 was recognized as the number one
philanthropic funder of HIV-related programs in a report released
by Funders Concerned About AIDS.
Learn more about Gilead’s unique collaborations worldwide and
the work to help end the HIV epidemic for everyone, everywhere.
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; the risk that physicians may not see the
benefits of prescribing Biktarvy to treat virologically suppressed
people with HIV; and any assumptions underlying any of the
foregoing. These and other risks, uncertainties and factors are
described in detail in Gilead’s Quarterly Report on Form 10-Q for
the quarter ended September 30, 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. Prescribing Information for Biktarvy,
including BOXED WARNING, is available at www.gilead.com
Biktarvy, 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) 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/20240226441430/en/
Jacquie Ross, Investors investor_relations@gilead.com
Meaghan Smith, Media public_affairs@gilead.com
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