Gilead’s Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine & Tenofovir Alafenamide for the Treatment of ...
May 30 2017 - 8:30AM
Business Wire
– U.S. NDA Submission Planned for Q2 2017;
EU MAA Filing Planned for Q3 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 <50 copies/mL at Week 48, and the lower bound of the
95 percent CI for non-inferiority is 12 percent. The studies remain
blinded through 144 weeks.
In study 1844, patients (n=520) who were virologically
suppressed (HIV-1 RNA levels <50 copies/mL) on a regimen of
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
<50 copies/mL (Studies 1489 and 1490) and HIV-1 RNA ≥50
copies/mL (Studies 1844 and 1878). In all studies BIC/FTC/TAF was
well tolerated and no patients discontinued study medication due to
renal events. No patients randomized to the bictegravir or
dolutegravir arms developed treatment-emergent resistance. One
patient randomized to the protease inhibitor arm in Study 1878
developed an abacavir resistance mutation (L74V).
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170530005438/en/
Gilead Sciences, Inc.Sung Lee, 650-524-7792 (Investors)Ryan
McKeel, 650-377-3548 (Media)
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