– BRAAVE 2020 Study Demonstrates
Non-Inferiority of Biktarvy for the Treatment of HIV in Black
Americans Who Are Virologically Suppressed, Including Patients With
a History of Treatment Failure or Pre-Existing Resistance –
– Additional Analysis Shows Potential of
Biktarvy to Be an Important Treatment Option for People Living With
HIV Who are Virologically Suppressed and Have End Stage Renal
Disease Requiring Hemodialysis –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced 48-week
data from the BRAAVE 2020 study, a Phase 3 clinical trial
evaluating the safety and efficacy of switching to Biktarvy®
(bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg
tablets, B/F/TAF) in virologically suppressed adults living with
HIV who self-identified as Black or African American. These data
presented at IDWeek 2020 show that switching from a standard
regimen of two nucleoside reverse transcriptase inhibitors (NRTIs)
plus a third agent to Biktarvy is an effective treatment regimen in
Black Americans with HIV who are virologically suppressed,
including individuals with a history of treatment failure or
pre-existing resistance.
BRAAVE 2020 is a Phase 3 clinical trial evaluating 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 randomized 2:1 to switch to open-label Biktarvy
or to stay on a standard regimen of two NRTIs plus a third agent
for 24 weeks with a delayed switch to Biktarvy until week 48. The
study demonstrated that at 48 weeks, treatment with Biktarvy
maintained high rates of virologic suppression in study
participants and did not result in treatment-emergent resistance to
any component of Biktarvy. In the analysis of preexisting
resistance and virologic outcomes, similar virologic suppression
rates were achieved irrespective of the presence of preexisting
drug resistance substitutions. Through 48 weeks, 99% of study
participants in the Biktarvy group (324/327) and 100% of study
participants in the delayed switch group (162/162) maintained HIV-1
RNA <50 copies/mL. The use of Biktarvy in individuals with a
history of treatment failure or known resistance to the components
of Biktarvy is investigational.
“Black and African Americans in this country have the highest
rates of new HIV infections every year compared to other races.
Adding to that burden are other inequalities such as lack of health
insurance, difficulties navigating the healthcare system, and
poverty; all of which contribute to higher rates of drug
resistance,” explained Debbie P. Hagins, MD, FAPCR, Medical
Director, CARE Centers of Southeast Georgia, Coastal Health
District, Savannah, GA and Principal Investigator for the BRAAVE
2020 study. “As drug resistance builds, treatment options become
more limited, sometimes leading to less desirable, but often
necessary, complicated treatment regimens. Again, lending itself to
further adherence challenges. These data from BRAAVE 2020, a
landmark study, designed with community input to understand
specific treatment responses of Black and African Americans, show
Biktarvy is an effective regimen for Black Americans, including
those with a history of some drug resistance.”
Biktarvy is indicated in the United States as a complete regimen
for the treatment of HIV-1 infection in adults or pediatric
patients weighing at least 25 kg who have no antiretroviral (ARV)
treatment history. While it is also indicated for adults and
pediatric patients weighing at least 25 kg who are virologically
suppressed and on a stable ARV regimen, these people must have no
history of treatment failure and no known substitutions associated
with resistance to the individual components of Biktarvy. Please
see below for U.S. Important Safety Information for Biktarvy,
including a Boxed Warning on the risk of post-treatment acute
exacerbation of hepatitis B.
Gilead presented additional Biktarvy clinical development
program data at IDWeek 2020, including 48-week findings from a
Phase 3, open-label, 48-week extension study, which found that a
once-daily regimen of Biktarvy maintained virologic suppression in
people living with HIV on chronic hemodialysis. This shows the
potential of Biktarvy as an effective treatment option with
convenient single tablet regimen dosing that can lessen the burden
of complex dose-adjusted regimens that many people living with HIV
on hemodialysis require. In addition, Gilead will present findings
from an in vitro simulation examining Biktarvy’s effect on drug
resistance during short lapses in adherence.
“An HIV treatment clinical trial program that addresses the
specific needs of people living with HIV such as disproportionately
impacted and underrepresented populations, or those who have
specific comorbidities, is central to Gilead’s mission of helping
to end the HIV epidemic,” said Diana Brainard, MD, Senior Vice
President and Virology Therapeutic Area Head, Gilead Sciences. “The
data presented at IDWeek highlight Gilead’s commitment and
Biktarvy’s potential to meet the specific treatment needs of
diverse groups of people living with HIV today, from individuals
facing drug resistance from prior treatment regimens to men and
women aging with HIV who are managing other health conditions.”
Additional data from a late-breaking oral presentation provide
important insight on tenofovir alafenamide’s (TAF) impact on
weight, further supporting the hypothesis that a switch from
tenofovir disoproxil fumarate (TDF) to TAF may result in weight
gain because the TDF-induced weight suppression is no longer
present. The study evaluated weight change in virologically
suppressed people living with HIV on a standard regimen of two
NRTIs plus an integrase strand transfer inhibitor (INSTI). After
one year, those who switched from TDF to TAF (n=828) and those who
switched from abacavir (ABC) to TAF (n=142) experienced a mean
unadjusted weight gain of 1.4 kg and 0.2 kg, respectively
(p=0.039). In the TDF to TAF switch group, 40% experienced weight
gain ≥ 3% compared with 27% of those in the ABC to TAF switch group
(p=0.003).
The use of Biktarvy in individuals with a history of treatment
failure or 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 for
Biktarvy.
Biktarvy does not cure HIV or AIDS.
U.S. Important Safety Information and
Indication 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
percent), 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 per 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 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 the possibility
that we are unable to complete one or more of such trials on 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 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. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201021005445/en/
Douglas Maffei, PhD, Investors 650-522-2739
Brian Plummer, Media 202-309-5207
Gilead Sciences (NASDAQ:GILD)
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