-- People Living With HIV Switching to
Biktarvy from Boosted PI-Based Regimens Achieved Sustained Viral
Suppression up to 156 Weeks --
-- Ongoing Switch Study in Population Aged
65 Years and Older Shows Biktarvy Sustains Viral Suppression
Through 72 weeks --
-- Clinical and Patient Reported Outcomes in
People Living With HIV on Biktarvy Treatment in the international
BICSTaR Study Demonstrated Consistent Therapeutic Effectiveness and
Long-term Safety Profile in Real-World Practice Settings --
Gilead Sciences, Inc. (Nasdaq: GLD) today announced long-term
study results, which showed that people living with HIV who
switched to the once-daily, single tablet regimen, Biktarvy®
(bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg
tablets, B/F/TAF) from a boosted protease inhibitor-based regimen
consisting of atazanavir (ATV) or darunavir (DRV) plus either
emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) or abacavir
(ABC)/lamivudine (3TC) maintained virologic suppression (defined as
HIV-1 RNA <50 copies/mL) with no emergent resistance, through a
maximum of 156 weeks. In the study (study 1878), Biktarvy was
generally well-tolerated with minimal changes to estimated
glomerular filtration rate (eGFR), lipids and weight through 96
weeks. The most common drug-related adverse event was headache (two
percent). The primary endpoint was at week 48; results of the
open-label extension period through week 156 were presented at HIV
Glasgow 2020.
Additional switch data presented included a pooled analysis of
six studies evaluating the efficacy of switching to Biktarvy among
virologically-suppressed people living with HIV who have the most
common treatment-emergent resistance mutations (M184V/I). In the
analysis, of the 2,034 people living with HIV who switched to
Biktarvy retrospective proviral DNA genotyping was performed on
baseline samples from 90 percent (1824/2034) of study participants
and preexisting M184V/I was detected in 10 percent (182/1824). In
those with preexisting resistance, 98 percent (n=179/182) of
participants with M184V/I maintained virologic suppression with
Biktarvy at the point of last study visit (24-156 weeks), with no
treatment resistance emerging. The results support the continued
evaluation of Biktarvy as an effective and durable option for
virologically-suppressed people living with HIV with known
resistance. The use of Biktarvy in individuals with known
resistance to the components of Biktarvy is investigational.
Gilead also presented new findings from a Phase 3b open-label
trial showing people aged 65 years and older who switched to
Biktarvy (n=86) from Genvoya® (elvitegravir 150 mg/cobicistat 150
mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg, E/C/F/TAF) or
a TDF-based complete treatment regimen maintained high rates of
virologic suppression, with no virologic failures or emergent
resistance through 72 weeks. The results reinforce Biktarvy as an
effective and generally well-tolerated treatment option with a high
barrier to resistance in the growing population of older people
living with HIV. Throughout the course of the study, there were two
(two percent) Grade 3-4 study-drug related adverse events reported;
no serious adverse events considered to be study-drug related were
reported.
“People living with HIV have diverse and evolving needs as they
age, requiring antiretroviral therapies that address these needs.
The data presented at HIV Glasgow confirm that Biktarvy is an
effective long-term treatment choice that can help achieve this,”
said Hal Martin, Executive Director, Clinical Research, Virology at
Gilead Sciences. “It’s a proud moment for Gilead to see that modern
triple therapy with the F/TAF backbone continues to demonstrate
durable efficacy with an established safety profile in a broad
range of people living with HIV.”
Gilead also presented data from an observational, real-world,
global BICSTaR study, which aims to evaluate the effectiveness,
safety and patient-reported outcomes of treatment with Biktarvy in
1,400 people living with HIV in Germany, Canada, France and the
Netherlands. Of the 513 participants enrolled who completed 12
months of treatment, results from the real-world clinical cohort
showed effectiveness (based on virological suppression defined as
HIV-1 RNA <50 copies/mL) in 100 percent (n=74) of
treatment-naïve and 96 percent (n=357) of treatment-experienced
participants with available follow up at 12 months in routine
clinical practice. Notably, over a third of participants had more
than three comorbidities at baseline. During the study, Biktarvy
was generally well-tolerated and no primary resistance mutations to
the components of Biktarvy emerged. The most common drug-related
adverse events were gastrointestinal (two percent) and
neuropsychiatric (four percent).
A preliminary, descriptive analysis of patient-reported outcomes
after 12 months of treatment with Biktarvy from the BICSTaR study
was also presented at the meeting, with the results underlining the
importance of collecting patient-reported outcomes in order to
understand the impact on mental health status, health-related
quality of life and treatment satisfaction of people living with
HIV, which could inform treatment strategies for these groups.
“Regardless of whether people living with HIV are new to
treatment or have switched their regimen, it is encouraging to see
the results of this analysis on the impact of treatment with
Biktarvy in the real-world settings,” said Fernando Bognar, Vice
President, Medical Affairs, HIV at Gilead Sciences.
“Patient-reported outcomes observed in the BICSTaR study are
particularly important as they provide a more holistic
understanding of the impact on quality of life that people living
with HIV experience.”
Biktarvy is indicated in the United States as a complete regimen
for the treatment of HIV-1 infection in patients who have no
antiretroviral treatment history or to replace the current
antiretroviral regimen in those who are virologically suppressed on
a stable antiretroviral regimen for at least three months with no
history of treatment failure and no known mutations associated with
resistance to the individual components of Biktarvy. Biktarvy
carries a Boxed Warning in its U.S. product label regarding the
risk of post-treatment acute exacerbation of hepatitis B. See below
for Important Safety Information.
There is no cure for HIV or AIDS.
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: 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.
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 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 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.
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