Gilead Announces Two-Year Data From Pivotal Phase 3 Study of Elvitegravir, an Integrase Inhibitor for HIV
December 09 2011 - 8:30AM
Business Wire
Gilead Sciences, Inc. (Nasdaq:GILD) today announced topline
Phase 3 clinical trial results showing that elvitegravir, an
integrase inhibitor being evaluated for the treatment of HIV-1
infection, was non-inferior to the integrase inhibitor raltegravir
after two years (96 weeks) of therapy in treatment-experienced
patients. Gilead plans to file for U.S. regulatory approval of
elvitegravir in the second quarter of 2012.
“These positive two-year data indicate that elvitegravir has the
potential to be an important new once-daily treatment option for
people living with HIV who have developed resistance to other
therapies,” said Norbert Bischofberger, PhD, Executive Vice
President, Research and Development and Chief Scientific Officer,
Gilead Sciences. “In addition, we are very excited about
elvitegravir’s role as part of our new Quad single-tablet regimen,
which is currently in U.S. regulatory review.”
In the pivotal Phase 3 trial (Study 145), elvitegravir (150 mg
or 85 mg) dosed once daily was compared to raltegravir (400 mg)
dosed twice daily, each administered with a background regimen that
included a ritonavir-boosted protease inhibitor (PI) and a second
antiretroviral. After 96 weeks of treatment, 48 percent of patients
receiving ritonavir-boosted elvitegravir achieved and maintained
HIV RNA levels (viral load) less than 50 copies/mL, compared to 45
percent of patients receiving raltegravir, based on the Time to
Loss of Virologic Response algorithm (TLOVR) (95 percent CI for the
difference: -4.6 percent to 9.9 percent). Discontinuation rates due
to adverse events, and safety and resistance profiles were
comparable in both arms of the study. Gilead plans to submit these
data for presentation to a scientific conference in 2012.
About the Elvitegravir Phase 3
Study
Study 145 was a double-blind, multicenter, randomized (1:1),
active-controlled, 96-week clinical trial evaluating the
non-inferiority of elvitegravir (n=351) versus raltegravir (n=351),
administered with a ritonavir-boosted protease inhibitor and other
agents in HIV-infected treatment-experienced adults with HIV RNA
(viral load) greater than or equal to 1,000 copies/mL. Patients
enrolled in the trial were required to have documented viral
resistance and/or at least six months of treatment experience with
two or more different classes of antiretrovirals prior to
screening.
Trial participants received either once-daily elvitegravir (150
mg or 85 mg) or twice-daily raltegravir 400 mg. Patients’
background regimens were based on the results of resistance testing
and include a fully-active ritonavir-boosted protease inhibitor,
and a second agent that was permitted to be a nucleoside or
nucleotide reverse transcriptase inhibitor, etravirine, maraviroc
or enfuvirtide. Due to known pharmacokinetic interactions, patients
randomized to elvitegravir whose background protease inhibitor was
either atazanavir or lopinavir received an 85 mg dose of
elvitegravir.
In January 2011, Gilead announced that it would extend the
blinded, randomized period of Study 145 from the originally planned
48 weeks to 96 weeks in order to obtain longer-term safety and
efficacy data. Based on the achievement of the non-inferiority
endpoint at 48 weeks, patients continued to receive the regimen to
which they were randomized in a blinded fashion through 96 weeks.
Secondary endpoints include various additional measures of the
efficacy, safety and tolerability of the two treatment
regimens.
Additional information about the study can be found at
www.clinicaltrials.gov.
About Elvitegravir
Integrase inhibitors interfere with HIV replication by blocking
the ability of the virus to integrate into the genetic material of
human cells. Elvitegravir was licensed by Gilead from Japan Tobacco
Inc. (JT) in March 2005. Under the terms of Gilead's agreement with
JT, Gilead has exclusive rights to develop and commercialize
elvitegravir in all countries of the world, excluding Japan, where
JT retains rights.
About Quad
The Quad contains elvitegravir, cobicistat (a pharmacoenhancing
or “boosting” agent that enables elvitegravir once-daily dosing),
and Truvada® (emtricitabine/tenofovir disoproxil fumarate). In
October 2011, Gilead submitted a New Drug Application to the U.S.
Food and Drug Administration for the Quad for the treatment of
HIV.
Elvitegravir, cobicistat and the Quad are investigational
products and have not yet been determined safe or efficacious in
humans.
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 worldwide.
Headquartered in Foster City, California, Gilead has operations in
North America, Europe and Asia Pacific.
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 Gilead's plans to present the data at a
scientific conference and file for regulatory approval of
elvitegravir in the timelines currently anticipated and the
possibility of unfavorable results from further clinical studies of
elvitegravir. Further, Gilead may fail to obtain approvals for
elvitegravir or the Quad from regulatory authorities and any
marketing approval, if granted, may have significant limitations on
its use. As a result, elvitegravir and the Quad may never be
successfully commercialized. In addition, Gilead may make a
strategic decision to discontinue development of elvitegravir or
the Quad if, for example, it believes commercialization will be
difficult relative to other opportunities in its pipeline. 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, 2011, 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.
U.S. full prescribing information for Truvada
is available at www.Truvada.com.
Truvada is a trademark of Gilead Sciences,
Inc.
For more information on Gilead Sciences, please
visit the company's website at www.gilead.com or call Gilead Public
Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
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