Gilead Presents New Phase 2 Data on Bictegravir, an Investigational Integrase Strand Transfer Inhibitor for the Treatment of ...
February 13 2017 - 6:45PM
Business Wire
– Bictegravir in Combination with FTC/TAF
Showed 97 Percent Rates of Virologic Suppression in Phase 2 Study
–
– Phase 3 Studies Evaluating a Single Tablet
HIV Regimen of Bictegravir and FTC/TAF Now Fully Enrolled; Data
Expected Later This Year –
Gilead Sciences, Inc. (NASDAQ: GILD) today announced data from a
Phase 2 study evaluating the efficacy, safety and tolerability of a
combination of bictegravir (75 mg) (BIC) and
emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) versus
dolutegravir (50 mg) (DTG) and emtricitabine/tenofovir alafenamide
(200/25 mg) (FTC/TAF) in treatment naïve, HIV-1 infected adults.
Results found that the BIC+FTC/TAF and DTG+FTC/TAF regimens both
demonstrated high virologic response rates at Week 24 and Week 48.
Bictegravir is a novel investigational once-daily integrase strand
transfer inhibitor (INSTI) that is currently in Phase 3 trials as
part of a single tablet regimen in combination with FTC/TAF for the
treatment of HIV (bictegravir 50 mg/emtricitabine 200 mg/tenofovir
alafenamide 25 mg). The data are being presented in an oral session
(Session O-4) at the 2017 Conference on Retroviruses and
Opportunistic Infections (CROI) in Seattle.
“The high virologic response rates seen in this study show that
the pairing of bictegravir with FTC/TAF could potentially offer
patients and physicians a new HIV treatment option with
pre-clinical data supporting few drug interactions and a high
barrier to resistance,” said Paul Sax, MD, Clinical Director of
Infectious Diseases at Brigham and Women’s Hospital, Professor of
Medicine at Harvard Medical School and the lead study
investigator.
In the study, 98 treatment naïve, HIV-infected adults were
randomized 2:1 in a blinded fashion to receive either BIC+FTC/TAF
(n=65) or DTG+FTC/TAF (n=33). The once-daily treatments were
administered without regard for food for 48 weeks. At Week 24, 97
percent (n=63/65) of patients taking BIC+FTC/TAF and 94 percent
(n=31/33; 95 percent CI: -8.5 percent to 14.2 percent, p=0.50) of
patients taking DTG+FTC/TAF achieved HIV-1 RNA levels less than 50
copies/mL. At Week 48, 97 percent (n=63/65) of patients taking
BIC+FTC/TAF and 91 percent (n=30/33; 95 percent CI: -6.0 percent to
18.8 percent, p=0.17) of patients taking DTG+FTC/TAF achieved HIV-1
RNA levels less than 50 copies/mL. No viral resistance was detected
in the BIC+FTC/TAF arm. Mean CD4 count increases at Week 48 were
258 cells/µL in the BIC+FTC/TAF arm and 192 cells/µL in the
DTG+FTC/TAF arm. One subject in the BIC+FTC/TAF arm discontinued
due to an adverse event of urticaria following the Week 24 visit.
Median changes in estimated glomerular filtration by
Cockcroft-Gault (GFRCG) at Week 48 were -7.0 mL/min for BIC+FTC/TAF
and -11.3 mL/min for DTG+FTC/TAF, with no discontinuations due to
renal adverse events. There were no treatment-related serious
adverse events and no deaths in either arm, and the most commonly
reported adverse events were diarrhea and nausea.
“We are pleased with these positive Phase 2 data, which we
believe demonstrate that bictegravir in combination with the
FTC/TAF backbone potentially represents a potent new treatment
option and an important evolution in HIV therapy,” said Norbert
Bischofberger, PhD, Executive Vice President, Research and
Development and Chief Scientific Officer, Gilead Sciences. “Based
on the data observed in this study, we rapidly advanced the
combination of bictegravir and FTC/TAF into four Phase 3 clinical
trials. The studies are fully enrolled and we look forward to the
availability of these data later this year.”
Bictegravir, including 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 study 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.
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 Gilead may be unable to obtain data
from the bictegravir and FTC/TAF Phase 3 clinical trials in the
currently anticipated timelines. In addition, there is the
possibility of unfavorable results from these clinical trials. As a
result, bictegravir 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 September 30, 2016, 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.Sung Lee, 650-524-7792InvestorsorRyan
McKeel, 650-377-3548Media
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