– In Clinical Trials, Biktarvy Demonstrated
High Efficacy, Few Interactions With Other Drugs and a High Barrier
to Resistance Through 48 Weeks –
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the
U.S. Food and Drug Administration (FDA) has approved Biktarvy®
(bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg,
BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the
treatment of HIV-1 infection. Biktarvy combines the novel,
unboosted integrase strand transfer inhibitor (INSTI) bictegravir,
with the demonstrated safety and efficacy profile of the Descovy®
(FTC/TAF) dual nucleoside reverse transcriptase inhibitor (NRTI)
backbone, and is the smallest INSTI-based triple-therapy STR
available.
Biktarvy is indicated as a complete regimen for the treatment of
HIV-1 infection in adults who have no antiretroviral treatment
history or to replace the current antiretroviral regimen in those
who are virologically suppressed (HIV-1 RNA <50 c/mL) on a
stable antiretroviral regimen for at least three months with no
history of treatment failure and no known substitutions associated
with resistance to the individual components of Biktarvy. No dosage
adjustment of Biktarvy is required in patients with estimated
creatinine clearance greater than or equal to 30 mL per minute.
Biktarvy does not require testing for HLA-B*5701, has no food
intake requirements, and has no baseline viral load or CD4 count
restrictions. According to Biktarvy’s Prescribing Information,
prior to or when initiating treatment with Biktarvy, healthcare
providers should test for hepatitis B virus (HBV) infection and
renal function, and monitor renal function as clinically
appropriate during therapy.
Biktarvy has a Boxed Warning in its product label regarding the
risk of post treatment acute exacerbation of hepatitis B. See below
for Important Safety Information.
Photos and a multimedia gallery are available at
www.GileadHIVMedia.com.
“In clinical trials through 48 weeks, no patients taking the
regimen of bictegravir plus FTC/TAF developed treatment-emergent
resistance, results that were observed both in people new to
therapy and those who were virologically suppressed and chose to
switch regimens,” said Paul Sax, MD, Clinical Director of the
Division of Infectious Diseases at Brigham and Women’s Hospital,
Boston, Professor of Medicine at Harvard Medical School and a lead
clinical trial investigator. “In addition, the clinical data show
that the regimen’s antiviral efficacy, tolerability profile and
limited drug interactions offer an effective new treatment option
for a range of people living with HIV.”
The approval of Biktarvy is supported by data from four ongoing
Phase 3 studies: Studies 1489 and 1490 in treatment-naïve HIV-1
infected adults, and Studies 1844 and 1878 in virologically
suppressed adults. The trials are comprised of a diverse population
of 2,415 participants, including a wide range of adult age groups
and races/ethnicities. Biktarvy met its primary objective of
non-inferiority at 48 weeks across all four studies. Through 48
weeks, no participants in any of the four studies failed Biktarvy
with treatment-emergent virologic resistance, no patients
discontinued Biktarvy due to renal adverse events and there were no
cases of proximal renal tubulopathy or Fanconi syndrome. The most
common adverse reactions in patients taking Biktarvy were diarrhea,
nausea and headache.
In Study 1489, a total of 629 treatment-naïve adults with HIV
were randomized 1:1 to receive Biktarvy or
abacavir/dolutegravir/lamivudine (600/50/300mg) (ABC/DTG/3TC). At
Week 48, 92.4 percent (n=290/314) of patients taking Biktarvy and
93.0 percent (n=293/315) of patients taking ABC/DTG/3TC achieved
the primary endpoint of HIV-1 RNA <50 c/mL. In Study 1490, a
total of 645 treatment-naïve adults with HIV were randomized 1:1 to
receive Biktarvy or DTG+FTC/TAF. At Week 48, 89.4 percent
(n=286/320) of patients taking Biktarvy and 92.9 percent
(n=302/325) of patients taking DTG+FTC/TAF achieved the primary
endpoint of HIV-1 RNA <50 c/mL.
In Study 1878, a total of 577 virologically suppressed (HIV-1
RNA <50 c/mL) adults with HIV taking regimens of a boosted
protease inhibitor (bPI; atazanavir or darunavir) plus a dual-NRTI
backbone (ABC/3TC or FTC/tenofovir disoproxil fumarate) were
randomized 1:1 to continue their bPI regimen or to switch to
open-label coformulated Biktarvy once daily. At the primary
endpoint of Week 48, switching to Biktarvy was non-inferior to
continuing on a bPI regimen with 1.7 percent of patients in each
group having HIV-1 RNA ≥50 c/mL; the proportion of patients with
HIV-1 RNA <50 c/mL was 92.1 percent in the Biktarvy arm and 88.9
percent in the bPI arm, according to FDA snapshot algorithm.
Results from Study 1844 will be presented at a scientific
conference in 2018.
“Gilead is committed to improving care and simplifying therapy
for people living with HIV. We continue to invest in research in
next-generation treatments, including therapies that could
potentially cure HIV patients,” said John F. Milligan, PhD,
Gilead’s President and Chief Executive Officer. “We are pleased to
offer Biktarvy, our latest triple-therapy treatment, which brings
together the potency of an integrase inhibitor with the
most-prescribed dual-NRTI backbone in a once-daily single tablet
regimen.”
Additional clinical trials of Biktarvy are ongoing, including a
dedicated study in women, as well as a study in adolescents and
children living with HIV. Gilead plans to present data from these
studies at scientific conferences in 2018.
Biktarvy does not cure HIV infection or AIDS.
Patient Assistance
Programs
Gilead’s U.S. Advancing Access® program provides assistance
to appropriate patients in the United States who are
uninsured, underinsured or who need financial assistance to pay for
their medications, including Biktarvy.
The program offers information and assistance for patients,
including:
- Access to representatives who can
provide information related to coverage and insurance-related
questions.
- The Advancing Access Copay Coupon
Program, which provides co-pay assistance for eligible patients
with private insurance who need assistance paying for out-of-pocket
medication costs.
- The Advancing Access Patient Assistance
Program and Truvada for PrEP® Medication Assistance Program, which
will provide Gilead medications at no charge for eligible patients
with no other insurance options.
Additionally, Gilead is working closely with the ADAP
Crisis Task Force, as the company has done for each of its other
HIV medications, to provide discounts to state AIDS Drug Assistance
Programs (ADAPs) that will help ensure access to Biktarvy for
patients who receive medications through these programs.
Information about how to apply for any of these forms of
assistance can be found at www.GileadAdvancingAccess.com or by
calling 1-800-226-2056 Monday through Friday between 9:00 a.m. and
8:00 p.m. EST.
Important U.S. 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, also 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 were diarrhea (6%),
nausea (5%), 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: 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. 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.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers,
develops and commercializes innovative therapeutics in areas of
unmet medical need. The company’s mission is to advance the care of
patients suffering from life-threatening diseases. Gilead has
operations in more than 35 countries worldwide, with headquarters
in Foster City, California.
For nearly 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 10 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 risk that physicians may not see the benefits of
prescribing Biktarvy and the possibility of unfavorable results
from additional clinical trials involving Biktarvy. 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 10Q for the quarter
ended September 30, 2017, 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,
including BOXED WARNING, for Biktarvy is available
at www.gilead.com.
Biktarvy, Descovy, Advancing Access, Truvada,
Truvada for PrEP, 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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