– Phase 3 Data from the BRAAVE 2020 Study in
Black or African American Virologically Suppressed Adults
Presented, Including Patients with a History of Treatment Failure
or Pre-Existing Resistance –
– Analysis of Separate Studies Shows
Biktarvy is Effective and Well-Tolerated in Treatment-Naïve Adults
50 and Older, with No Significant Differences in Bone Density,
Kidney Safety or Weight Over Three Years –
Gilead Sciences Inc. (Nasdaq: GILD) today
announced data from the BRAAVE 2020 study, a Phase 3 clinical trial
evaluating the safety and efficacy of switching to Biktarvy®
(bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg
tablets, BIC/FTC/TAF) in virologically suppressed adults living
with HIV who self-identified as Black or African American. The data
show that, at 24 weeks, switching to Biktarvy from a standard
regimen of two nucleoside reverse transcriptase inhibitors (NRTIs)
plus a third agent may potentially be an effective and
well-tolerated treatment regimen in patients with a history of
treatment failure or pre-existing resistance, and did not result in
treatment emergent resistance to study drugs with Biktarvy. The use
of Biktarvy in individuals with a history of treatment failure or
known resistance to the components of Biktarvy is
investigational.
“As an African American I have experienced the impact of HIV in
my community, family and friends. Importantly, as a front-line
doctor treating a high percentage of persons of color with HIV, I
am keenly aware of race-specific complications affecting Black
Americans with HIV. However, less is known of the impact that race
has on the efficacy and side effects of HIV medications,” said
Debbie P. Hagins, MD, Medical Director, CARE Centers of Coastal
Georgia, APCRF, Coastal Health District, Savannah, GA and principal
investigator for the BRAAVE 2020 study. “BRAAVE 2020 is a landmark
HIV treatment study, investigating the specific treatment responses
of Black and African Americans, who experience the highest rates of
HIV in the United States. These findings from the BRAAVE study
provide further evidence of Biktarvy’s role as an effective and
well-tolerated treatment option for Black Americans living with HIV
and supports further study in people living with HIV who have
certain pre-existing drug resistance.”
Biktarvy is indicated in the U.S. 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 treatment
history. While it is also indicated for treatment experienced
adults and pediatric patients weighing at least 25 kg who are
virologically suppressed and on a stable antiretroviral regimen,
these patients must have no history of treatment failure and no
known substitutions associated with resistance to the individual
components of Biktarvy.
On June 18, 2019, the U.S. Food and Drug Administration (FDA)
approved the supplemental indication for including pediatric
patients weighing at least 25 kg, an important milestone for
Biktarvy and Gilead’s HIV treatment portfolio.
Gilead also announced results of a pooled analysis from two
Phase 3 studies showing Biktarvy continued to be highly effective
and well-tolerated in treatment-naïve patients age 50 and older
over three years of treatment. Importantly, participants
experienced no clinically significant differences in key measures
such as bone density, renal laboratory markers or weight. These
data from the two 144-week studies in treatment-naïve adults living
with HIV will be presented at CROI 2020, in addition to results
from an investigational study evaluating the efficacy, safety and
pharmacokinetics of low-dose Biktarvy in pediatric patients.
“These data affirm once-daily Biktarvy as an effective choice
for appropriate people switching treatment regimens, and as a
well-tolerated first-line option that enables people over 50 living
with HIV to sustain an undetectable viral load over the long-term,”
said Diana Brainard, MD, Senior Vice President, HIV and Emerging
Viruses, Gilead Sciences. “The data presented at CROI 2020 are part
of our relentless pursuit to address unmet needs in HIV treatment.
The results underscore the ability of Biktarvy to meet the specific
treatment needs of diverse groups of people living with HIV today,
including men and women aging with HIV.”
Key abstracts for Biktarvy data presented at CROI 2020
include:
Oral 2979: Randomized Switch To B/F/TAF In African American
Adults with HIV
In the BRAAVE 2020 study, adults (495) who self-identified as
Black or African American and were virologically-suppressed on a
baseline regimen of two NRTIs plus a third agent, were randomized
2:1 to switch to open-label Biktarvy once-daily or to stay on their
baseline regimen. Study participants with prior treatment failure
and pre-existing NNRTI, PI and/or NRTI resistance were eligible to
enroll. People living with HIV with resistance to tenofovir
(K65R/E/N, ≥3 thymidine analogue mutations or T69-insertions),
primary INSTI-resistance, or a history of failure on an INSTI-based
regimen were excluded. 32 percent of evaluable patients were
cisgender women and 2 percent were transgender women. The primary
endpoint of the study was noninferior virologic response (HIV-1 RNA
≥ 50 c/mL) at Week 24. The secondary endpoint was a change from
baseline in CD4 count.
The study showed noninferior antiviral efficacy for people
switching to Biktarvy from a variety of regimens, including in
patients with pre-existing NRTI resistance. At Week 24, 96.3
percent of study participants treated with Biktarvy and 94.5
percent of study participants who stayed on their baseline regimen
maintained viral suppression, with no treatment-emergent resistance
detected. The most common adverse events (AEs) in the study were
headache, diarrhea and insomnia. Most treatment-related AEs were
grade 1. AEs leading to study drug discontinuation occurred in 1.8
percent of patients receiving Biktarvy and 0 percent remaining on
their baseline regimen.
In the United States, the use of Biktarvy in patients with a
history of treatment failure or known resistance to any components
of Biktarvy is investigational and the safety and efficacy of this
use has not been determined.
Poster 2886: 144-Week Efficacy and Safety Of B/F/TAF
In Treatment-Naive Adults ≥50 Yrs
The double-blind Phase 3 studies 1489 and 1490 randomized 1274
treatment-naïve adults to assess the safety and efficacy of
Biktarvy. Study 1489 evaluated Biktarvy compared to dolutegravir,
abacavir, and lamivudine (DTG/ABC/3TC), and study 1490 compared
Biktarvy to DTG + F/TAF. Study 1489 also observed proteinuria and
bone mineral density (BMD). A pooled analysis of these studies
assessed efficacy, defined as the proportion of participants
maintaining viral suppression (HIV-1 RNA <50 c/mL), and adverse
events (AEs) at 144 weeks in participants age 50 and older and in
participants who were younger than 50 when they entered the study.
Across the studies, 196 participants (N=96, 41, and 59, in the
Biktarvy, DTG/ABC/3TC, and DTG+FTC/TAF groups, respectively) were
age 50 or older; 17 percent of these were women, 27 percent were
Black, and 15 percent were of Latino/Hispanic ethnicity.
At Week 144, Biktarvy was found to be highly effective and
well-tolerated in adults age 50 or older, with no clinically
significant differences in bone density or renal safety, fasting
lipids or weight gain from baseline. Across treatment groups, the
most common adverse events in patients age 50 and older were
nasopharyngitis, diarrhea and upper respiratory tract infection,
and most treatment-related AEs were grade 1. AEs leading to study
drug discontinuation for participants age 50 and older occurred in
2 percent of patients receiving Biktarvy, compared to 5 percent
receiving DTG/ABC/3TC and 7 percent receiving DTG + F/TAF. In Study
1489, mean percent changes in hip and spine bone mineral density
(BMD), proteinuria, and renal biomarkers were similar between the
Biktarvy and DTG/ABC/3TC treatment groups. Small changes from
baseline were observed in all treatment groups in fasting lipids.
Median weight increased from baseline at Week 144, with no
significant difference between treatment groups (4.3 kg, 4.7 kg,
and 3.4 kg, in the Biktarvy, DTG/ABC/3TC, and DTG+FTC/TAF groups,
respectively.
Study 1489 and Study 1490 are ongoing. Beyond Week 144, study
participants will have the option to receive Biktarvy in an
open-label extension for up to 96 weeks.
Gilead will also present additional Biktarvy clinical
development program data on March 10, including Poster 3929:
Safety, PK, and Efficacy of Low Dose B/F/TAF in Children ≥2 Years
Old Living With HIV. In the United States, Biktarvy (50/200/25
mg) is currently approved for pediatric patients who weigh at least
25 kg. The low dose of Biktarvy (30/120/15 mg) used in this study
and the use in patients who weigh less than 25 kg are
investigational and the safety and efficacy have not been
determined.
Biktarvy does not cure HIV infection or AIDS.
Important U.S. 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%),
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.
INDICATION
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.
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 Annual Report
on Form 10-K for the year ended December 31, 2019, 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. full 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 on Gilead Sciences, please
visit the company’s website at www.gilead.com, follow Gilead on
Twitter (@GileadSciences) 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/20200309005725/en/
Douglas Maffei, PhD, Investors (650) 522-2739
Brian Plummer, Media (650) 524-7708
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