– Additional Data in Pregnant Adults Who Are
Virologically Suppressed Reinforce Safety and Tolerability Profile
of Biktarvy in Broad Range of People With HIV –
– Perinatal Guidelines Recognize Biktarvy as
Alternative Regimen for Use During Pregnancy and for Those Trying
to Conceive –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S.
Food and Drug Administration (FDA) approved an updated label with
additional data reinforcing the safety and efficacy profile of
Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir
alafenamide 25 mg tablets, B/F/TAF) to treat pregnant people with
HIV-1 (PWH) with suppressed viral loads. These additional data stem
from Study 5310, which evaluated the pharmacokinetics, safety and
efficacy of Biktarvy in pregnant PWH who have suppressed viral
loads and no known resistance to any components of Biktarvy in
their second and third trimesters and through a median of 16 weeks
postpartum. This update makes Biktarvy the only second-generation
integrase strand transfer inhibitor (INSTI)-based single-tablet
regimen (STR) with in-label clinical trial data and FDA approval in
virologically suppressed adults who are pregnant. The U.S.
Department of Health and Human Services (DHHS) perinatal guidelines
recognize Biktarvy as having sufficient data to support being
recommended as an alternative complete regimen for use in pregnancy
and for people who are trying to conceive. Additionally, guidelines
recommend continuing Biktarvy for PWH already on treatment who are
virologically suppressed and tolerating treatment well who may
become pregnant.
“This label update marks an important milestone for Biktarvy,
reinforcing its efficacy profile for pregnant PWH, an often
understudied and most vulnerable community in clinical research,”
said Jared Baeten, MD, PhD, Vice President, HIV Clinical
Development, Gilead Sciences. “Not only is Biktarvy an alternative
regimen for use in pregnancy, but people of childbearing potential
can also remain on Biktarvy if they become pregnant. We continue to
keep people at the center of our tireless commitment to HIV
treatment research and development so that our medicines address
the needs of the broad range of communities that we serve.”
The updated label now includes additional data from Study 5310,
a Phase 1b, open-label, single-arm, multicenter clinical trial
evaluating the pharmacokinetics, safety and efficacy of Biktarvy in
pregnant PWH who were virologically suppressed (HIV-1 RNA < 50
copies/mL) and had no known resistance to the components of
Biktarvy. Participants were administered Biktarvy once daily from
the second or third trimester through postpartum. Lower plasma
exposures of Biktarvy were observed during pregnancy as compared to
postpartum; all 32 participants who completed the study maintained
viral suppression during pregnancy, at delivery and through week 18
postpartum. The median CD4+ cell count at baseline was 558
cells/μL, and the median change in CD4+ cell count from baseline to
week 12 postpartum was 159 cells/μL. All 29 newborn participants
had negative/nondetectable HIV-1 PCR results at birth and/or at
four to eight weeks post birth. Further, the study did not identify
any new safety or tolerability concerns for people who use Biktarvy
during pregnancy and postpartum as the overall incidence and types
of adverse events observed were consistent with those expected for
the population studied.
This label update marks a significant milestone in Gilead’s
efforts to address the individual needs of all people impacted by
HIV, as these data can help to provide assurance for people of
childbearing potential to remain on Biktarvy if they were to become
pregnant. The Biktarvy label was also updated in February 2024 to
align with Centers for Disease Control and Prevention (CDC)
guidance on breastfeeding, which encourages a dialogue between a
person and their healthcare provider regarding breastfeeding.
“As an OB-GYN and a longtime women’s health advocate, I’m
incredibly passionate about helping end health disparities among
women, and especially Black women who are disproportionately
impacted by HIV,” said Yolanda M. Lawson, MD, President, National
Medical Association. “I’m encouraged by the tremendous progress
made in personalizing HIV treatment over the years, including this
milestone that further supports the safety profile of Biktarvy use
during pregnancy. Together, we can help bring all PWH the care they
need, including those who are or may become pregnant, so they can
continue to live longer, healthier lives while on HIV
treatment.”
“These additional data can help to better inform treatment
decisions between pregnant PWH and their providers and mark an
incredible step forward in addressing the unique needs PWH have
when they are pregnant or planning to become pregnant,” said
William R. Short, MD, Associate Professor of Medicine, Perelman
School of Medicine at the University of Pennsylvania. “As experts
in perinatal care, we will continue to recommend ways pregnant PWH
can maintain undetectable viral loads so they can stay healthy and
prevent transmission to their baby.”
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: BIKTARVY is recommended in pregnant
individuals who are virologically suppressed on a stable ARV
regimen with no known substitutions associated with resistance to
any of the individual components of BIKTARVY. Lower plasma
exposures of BIKTARVY were observed during pregnancy; therefore,
viral load should be monitored closely during pregnancy.
- Lactation: Individuals infected with HIV-1 should be
informed of the potential risks of breastfeeding.
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, COVID-19, and cancer. Gilead operates in more than
35 countries worldwide, with headquarters in Foster City,
Calif.
For 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.
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 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 pregnant people with HIV
with suppressed viral loads; and any assumptions underlying any of
the foregoing. These and other risks, uncertainties and factors are
described in detail in Gilead’s Annual Report on Form 10-K for the
year ended December 31, 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.
Biktarvy, Descovy, Gilead and the Gilead logo
are trademarks of Gilead Sciences, Inc., or its related
companies.
U.S. Prescribing Information for Biktarvy,
including BOXED WARNING, is available at www.gilead.com.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on X/Twitter
(@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
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version on businesswire.com: https://www.businesswire.com/news/home/20240426676086/en/
Meaghan Smith, Media public_affairs@gilead.com
Jacquie Ross, Investors investor_relations@gilead.com
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