– U.S. NDA Submission Planned for Q2 2017; EU MAA Filing Planned
for Q3 2017 –
FOSTER CITY, Calif.--(BUSINESS WIRE)--May 30, 2017--
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that four Phase 3
studies evaluating a fixed-dose combination of bictegravir (50mg) (BIC),
a novel investigational integrase strand transfer inhibitor (INSTI), and
emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF) for the
treatment of HIV-1 infection met their primary objectives of
non-inferiority. Three of the ongoing studies are designed to explore
the efficacy and safety of BIC/FTC/TAF compared to regimens containing
dolutegravir (50mg) (DTG) among treatment-naïve patients (Studies 1489
and 1490), and among virologically suppressed patients switching from an
existing antiretroviral regimen (Study 1844). A fourth ongoing study in
virologically suppressed patients compares switching to BIC/FTC/TAF
versus remaining on a suppressive regimen of two nucleoside/nucleotide
reverse transcriptase inhibitors and a boosted protease inhibitor (Study
1878).
"Since the approval of Viread 16 years ago, Gilead has continually
worked to develop and improve treatments for people living with HIV.
This investigational single tablet regimen brings together the potency
of an integrase inhibitor, bictegravir, with the demonstrated efficacy
and safety profile of the FTC/TAF backbone,” said Norbert Bischofberger,
PhD, Executive Vice President, Research and Development and Chief
Scientific Officer, Gilead Sciences. “Based on the results from these
Phase 3 studies, the combination of bictegravir and FTC/TAF could
represent an important advance in triple-therapy treatment for a broad
range of HIV patients, and we look forward to submitting regulatory
applications in the U.S. and EU this year.”
Studies 1489 and 1490 are double-blind studies in which treatment-naïve
patients (n=600 in each study) were randomized 1:1 to receive
BIC/FTC/TAF and abacavir/dolutegravir/lamivudine (600/50/300mg)
(ABC/DTG/3TC) (Study 1489) or DTG+FTC/TAF (Study 1490). The primary
endpoint is proportion of patients with HIV-1 RNA levels
In study 1844, patients (n=520) who were virologically suppressed (HIV-1
RNA levels ABC/DTG/3TC or DTG+ABC/3TC
were randomized 1:1 to stay on their existing regimen or switch to
BIC/FTC/TAF in a blinded manner. Study 1878 is an open-label study in
which patients (n=520) who were virologically suppressed on a boosted
protease inhibitor of darunavir (800mg) or atazanavir (300mg) plus a
nucleoside/nucleotide backbone of ABC/3TC or emtricitabine/tenofovir
disoproxil fumarate (200/300mg) were randomized 1:1 to either maintain
their current regimen or switch to BIC/FTC/TAF. The primary endpoint in
these studies is the proportion of patients with HIV RNA ≥50 copies/mL
at Week 48, and the lower bound of the 95 percent CI for non-inferiority
is 4 percent. Both studies were randomized through 48 weeks, after which
point patients continuing in the studies enter an open-label extension
receiving BIC/FTC/TAF.
BIC/FTC/TAF met the definition of non-inferiority in all four studies,
with comparable proportions of patients having HIV-1 RNA
Gilead plans to submit data from these Phase 3 studies for presentations
at scientific conferences in 2017.
Bictegravir in combination with FTC/TAF as a single tablet regimen is an
investigational treatment that has not been determined to be safe or
efficacious.
Further information about the clinical studies can be found at www.clinicaltrials.gov.
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 30
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 risks
related to its ability to submit regulatory applications for BIC/FTC/TAF
in the United States and European Union in the currently anticipated
timelines. In addition, there is the possibility that any regulatory
applications submitted may not get approved or may have significant
limitations on the product's use. 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 March 31, 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.
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170530005438/en/
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.Sung Lee, 650-524-7792 (Investors)Ryan
McKeel, 650-377-3548 (Media)
