– 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 –
FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct. 4, 2017--
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 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171004005686/en/
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.InvestorsSung Lee, 650-524-7792orMediaRyan
McKeel, 650-377-3548
