Gilead Presents Results From Phase 3 Study Evaluating Patients Who Switched to Investigational Fixed-Dose Combination of Bict...
October 04 2017 - 8:00AM
Business Wire
– Bictegravir-Containing Regimen Found to Be
Non-Inferior to Boosted Protease Inhibitor-based Regimens in
Virologically Suppressed Adult Patients with HIV–
– No Patients in Bictegravir Treatment Arm
Demonstrated Treatment-Emergent Resistance Through 48 Weeks
–
Gilead Sciences, Inc. (NASDAQ: GILD) today announced detailed
48-week results from a Phase 3 study (Study 1878) evaluating the
efficacy and safety of switching virologically suppressed HIV-1
infected adult patients from a multi-tablet regimen containing a
boosted protease inhibitor (bPI) to a fixed-dose combination of
bictegravir (50 mg) (BIC), a novel investigational integrase strand
transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide
(200/25 mg) (FTC/TAF), a dual-NRTI backbone. In the ongoing study,
BIC/FTC/TAF was found to be statistically non-inferior to regimens
containing bPIs and demonstrated no treatment-emergent resistance
at 48 weeks. The data are being presented at IDWeek 2017 in San
Diego (Session 228).
“These data demonstrate the potential of BIC/FTC/TAF to match
the efficacy of a boosted protease inhibitor regimen while also
offering a high barrier to resistance and fewer interactions with
other drugs,” said Eric Daar, MD, Chief of the Division of HIV
Medicine at Los Angeles Biomedical Research Institute at
Harbor-UCLA Medical Center and lead author of Study 1878. “The
findings, along with data from three other Phase 3 studies in both
treatment-experienced and treatment-naïve patients, suggest that
the investigational regimen of BIC/FTC/TAF may be appropriate for a
broad range of people living with HIV.”
In Study 1878, a total of 577 virologically suppressed adults
with HIV taking regimens of boosted atazanavir (ATV) or darunavir
(DRV) + abacavir/lamivudine (ABC/3TC) or FTC/tenofovir disoproxil
fumarate (TDF) were randomized 1:1 to continue their bPI regimen or
to switch to open-label coformulated BIC/FTC/TAF once daily. At the
primary endpoint of Week 48, switching to BIC/FTC/TAF 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 (difference: 0.0
percent, 95 percent CI: -2.5 percent to 2.5 percent, p=1.00); the
proportion of patients with HIV-1 RNA <50 c/mL was 92.1 percent
in the BIC/FTC/TAF arm and 88.9 percent in the bPI arm, according
to FDA snapshot algorithm.
No patients in the BIC/FTC/TAF arm developed treatment-emergent
resistance, and one participant on DRV/ritonavir + ABC/3TC
developed a treatment-emergent NRTI mutation associated with
abacavir. No renal adverse events leading to discontinuations or
cases of proximal renal tubulopathy occurred with BIC/FTC/TAF. The
incidence of grade 3 or 4 adverse events was 4 percent (n=13) for
the BIC/FTC/TAF arm versus 6 percent (n=18) for the bPI arm; the
incidence of grade 3 or 4 laboratory abnormalities was 16 percent
(n=45) for the BIC/FTC/TAF arm versus 29 percent (n=83) for the bPI
arm. The most commonly reported adverse events (all grades) in both
arms included headache, diarrhea, nasopharyngitis and upper
respiratory tract infection.
“The combination of the unboosted integrase inhibitor
bictegravir with the FTC/TAF backbone has the potential to further
evolve HIV triple therapy with convenient dosing in a single-tablet
regimen,” said Norbert W. Bischofberger, PhD, Gilead’s Executive
Vice President, Research and Development and Chief Scientific
Officer. “We look forward to the opportunity to offer patients this
next-generation therapy as part of our TAF-based portfolio of
treatments for HIV.”
Gilead filed a New Drug Application for BIC/FTC/TAF with a
Priority Review voucher on June 12, 2017, and the U.S. Food
and Drug Administration (FDA) set a target action date of February
12, 2018, under the Prescription Drug User Fee Act. A marketing
application for BIC/FTC/TAF is also under review in the European
Union and was validated by the European Medicines Agency (EMA) on
July 13.
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, including
the FDA and EMA, may not approve BIC/FTC/TAF in the currently
anticipated timelines or at all, and any 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 June 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.
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, 650-524-7792orMediaRyan
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