Gilead Announces Phase 3 Results for Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine & Tenofovir Alafena...
July 24 2017 - 5:06AM
Business Wire
– Bictegravir-Containing Regimen Found to be
Non-Inferior to Dolutegravir-Containing Regimens –
– Investigational Regimen Demonstrated No
Treatment-Emergent Resistance through 48 Weeks –
Gilead Sciences, Inc. (NASDAQ: GILD) today announced detailed
48-week results from two Phase 3 studies (Studies 1489 and 1490)
evaluating the efficacy and safety of a fixed-dose combination of
bictegravir (50 mg) (BIC), a novel investigational integrase strand
transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide
(200/25mg) (FTC/TAF), a dual-NRTI backbone, for the treatment of
HIV-1 infection in treatment-naïve adults. In the ongoing studies,
BIC/FTC/TAF was found to be statistically non-inferior to regimens
containing dolutegravir (50mg) (DTG) in combination with a
dual-NRTI backbone. The data were presented in two late-breaker
sessions [MOAB01 and TUPDB02] at the 9th IAS Conference on HIV
Science (IAS 2017) in Paris.
“Physicians continue to look for treatment regimens with simple,
convenient dosing that can sustain virologic suppression with a
safety profile that is appropriate for most HIV patients,” said
Joel Gallant, MD, MPH, Medical Director of Specialty Services at
Southwest CARE Center in Santa Fe, N.M. and lead author of Study
1489. “Combinations of an integrase inhibitor plus a dual-NRTI
backbone have become a standard of care for initial treatment of
HIV. In clinical trials, the investigational regimen of BIC/FTC/TAF
has been well tolerated with low rates of discontinuations due to
adverse events, a high barrier to resistance and few drug
interactions.”
“These data reinforce the safety and efficacy profile
consistently seen in other trials evaluating regimens based on the
FTC/TAF combination,” 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 lead
author of Study 1490. “These results suggest that the combination
of bictegravir with FTC/TAF has the potential to be appropriate for
a broad range of HIV patients, including those with mild to
moderate renal impairment.”
In Study 1489, a total of 629 treatment-naïve adults with HIV
were randomized 1:1 to receive BIC/FTC/TAF or
abacavir/dolutegravir/lamivudine (600/50/300mg) (ABC/DTG/3TC). At
Week 48, 92.4 percent (n=290/314) of patients taking BIC/FTC/TAF
and 93.0 percent (n=293/315) of patients taking ABC/DTG/3TC
achieved the primary endpoint of HIV-1 RNA levels less than 50
copies/mL (difference: -0.6 percent, 95 percent CI: -4.8 percent to
3.6 percent, p=0.78).
A separate analysis investigated the effect of the two regimens
on changes in bone mineral density (BMD) and measures of renal
function. Mean percentage changes in BMD from baseline to Week 48
were -0.83 percent for BIC/FTC/TAF vs. -0.60 percent for
ABC/DTG/3TC (p=0.39) in lumbar spine, and -0.78 percent for
BIC/FTC/TAF vs. -1.02 percent for ABC/DTG/3TC (p=0.23) in total
hip. No differences were noted between the treatments in changes
from baseline to Week 48 for estimated glomerular filtration rate
(eGFR) or proteinuria. Lipid changes were not significantly
different between the two arms. No patients randomized to either
arm developed treatment-emergent resistance and discontinuations
due to adverse events were low in both groups (0.0 percent (n=0)
for BIC/FTC/TAF vs. 1.3 percent (n=4) for ABC/DTG/3TC). The most
commonly reported adverse events (all grades) were nausea (10
percent for BIC/FTC/TAF vs. 23 percent for ABC/DTG/3TC), diarrhea
(13 percent vs. 13 percent) and headache (11 percent vs. 14
percent).
In Study 1490, a total of 645 treatment-naïve adults with HIV
were randomized 1:1 to receive BIC/FTC/TAF or DTG+FTC/TAF. At Week
48, 89.4 percent (n=286/320) of patients taking BIC/FTC/TAF and
92.9 percent (n=302/325) of patients taking DTG+FTC/TAF achieved
the primary endpoint of HIV-1 RNA levels less than 50 copies/mL
(difference: -3.5 percent, 95 percent CI: -7.9 percent to 1.0
percent, p=0.12). No patients in either treatment arm developed
resistance to any of the study drugs. Lipid changes were not
significantly different between the two arms, and there were no
renal discontinuations or cases of proximal renal tubulopathy.
Discontinuations due to adverse events were low in both treatment
arms (1.6 percent (n=5) for BIC/FTC/TAF vs. <1.0 percent (n=1)
for DTG+FTC/TAF). The most commonly reported adverse events (all
grades) were headache (13 percent for BIC/FTC/TAF vs. 12 percent
for DTG+FTC/TAF) and diarrhea (12 percent vs. 12 percent).
“The Phase 3 findings presented at IAS 2017 demonstrate that a
single-tablet combination of bictegravir with the FTC/TAF backbone
may deliver an important novel triple-therapy HIV treatment,” said
Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President,
Research and Development and Chief Scientific Officer. “These data
in treatment-naïve patients, and data from two additional Phase 3
studies in treatment-experienced patients, formed the basis of our
regulatory applications in the United States and the European
Union.”
In addition to Studies 1489 and 1490, 48-week data from two
other ongoing studies evaluating BIC/FTC/TAF among virologically
suppressed adult patients (Studies 1844 and 1878) are also part of
the regulatory submissions in the U.S. and EU.
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 and is not approved anywhere
globally.
Further information about the clinical trials 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 the possibility that regulatory authorities may not
approve BIC/FTC/TAF in the currently anticipated timelines, and
marketing approvals, if granted, may have significant limitations
on their use. As a result, BIC/FTC/TAF may never be successfully
commercialized. 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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Gilead Sciences, Inc.InvestorsSung Lee, 650-524-7792MediaRyan
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