– >98% of Treatment-Naïve Patients
Achieved and Maintained Undetectable Viral Load with Biktarvy
Through Four Years in the Open-Label Extension Phase of Two Phase 3
Studies –
– Treatment-Naïve Adults Reached and
Maintained Undetectable Viral Load with Biktarvy for Certain
Transmitted-Drug Resistance and with No Treatment-Emergent
Resistance Through 144 Weeks –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced new,
long-term data from open-label extensions (OLE) of two Phase 3
studies (Study 1489 and Study 1490) of Biktarvy® (bictegravir 50
mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets,
B/F/TAF), demonstrating the sustained efficacy and safety profile
and no treatment-emergent resistance with Biktarvy for the
treatment of HIV-1 in treatment-naïve adults. The data were
presented at the 28th Conference on Retroviruses and Opportunistic
Infections (virtual CROI 2021).
In both studies, >98% of participants who initiated treatment
with Biktarvy and remained in the study achieved and maintained an
undetectable viral load (HIV-1 RNA <50 copies/mL) through four
years of follow-up (n=235/237 for study 1489, n=241/243 for study
1490). The high efficacy and durable viral suppression were also
observed in participants who switched to Biktarvy from a
dolutegravir-containing triple therapy for the 48-week OLE periods
(n=212 for study 1489, n=225 for study 1490). No treatment-emergent
resistance to any components of Biktarvy occurred in participants
treated with Biktarvy.
“Gilead is committed to developing innovative HIV treatments,
like Biktarvy, that help to address the unmet needs of people
living with HIV today, including achieving and maintaining an
undetectable viral load over the long-term,” said Diana Brainard,
MD, Senior Vice President, Virology Therapeutic Area, Gilead
Sciences. “These data reinforce that Biktarvy provides durable
viral suppression, strong efficacy and a high barrier to resistance
in both adults that are new to HIV therapy and those replacing
their existing treatment.”
Gilead presented additional Biktarvy data at virtual CROI 2021,
including findings from a 144-week analysis of the same Phase 3
studies (Study 1489 and Study 1490), which demonstrated that people
living with HIV who received initial therapy with Biktarvy reached
and maintained an undetectable viral load with no
treatment-emergent resistance through 144 weeks (n=634). In a
subgroup analysis of participants with transmitted-drug resistance
(TDR, n=248) based on retrospective sequencing of baseline samples,
Biktarvy achieved comparably high levels of durable viral
suppression through 144 weeks among participants with and without
TDR (98% vs. 97%; as treated analysis).
“As a clinician, my goal is to initiate treatment immediately
after diagnosis with a therapy that achieves and maintains
virologic control over the long-term,” said Kimberly Workowski, MD,
Professor of Medicine, Emory University. “The data presented at
CROI highlight that Biktarvy can achieve long-term viral
suppression at four years among a range of people living with HIV
and supports further study for patients with certain transmitted
drug-resistant 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. 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, randomized, 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. 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 TAF-containing products; while most of these cases were
characterized by potential confounders that may have contributed to
the reported renal events, it is also possible these factors may
have predisposed patients to tenofovir-related adverse events. Do
not initiate BIKTARVY in patients with estimated creatinine
clearance (CrCl) <30 mL/min except in virologically-suppressed
adults <15mL/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
<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 /mL) on a stable ARV regimen
with no history of treatment failure and no known resistance to any
component of Biktarvy.
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. Gilead operates 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, and cure
research. Today, millions of people living with HIV globally
receive antiretroviral therapy provided by Gilead or one of the
company’s manufacturing partners.
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 the possibility
that we are unable to complete one or more of such trials in the
currently anticipated timelines or at all. 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 Annual Report
on Form 10-K for the year ended December 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. 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) or call Gilead Public Affairs at 1-800-GILEAD-5
or 1-650-574-3000.
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