Phase III Clinical Trial of Gilead’s Investigational Elvitegravir Meets 48-Week Primary Objective
March 23 2011 - 8:30AM
Business Wire
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the
Phase III clinical trial of its investigational antiretroviral
agent elvitegravir, a novel oral integrase inhibitor being
evaluated for the treatment of HIV-1 infection in
treatment-experienced patients, met its primary objective. The
primary endpoint of this study was non-inferiority at week 48 of
elvitegravir, dosed once daily, compared to raltegravir, dosed
twice daily, each administered with a background regimen that
includes a ritonavir-boosted protease inhibitor (PI) and a second
antiretroviral agent. Responses at 48 weeks of elvitegravir met the
statistical criteria of non-inferiority as compared to raltegravir
based on the proportion of subjects who achieved and maintained HIV
RNA levels (viral load) of less than 50 copies/mL. Discontinuation
rates due to adverse events were comparable in both arms of the
study. Gilead plans to submit these data for presentation at a
scientific conference later this year.
On January 10, 2011, Gilead announced an amendment to the design
of this clinical trial, extending the blinded, randomized period of
the study to up to 96 weeks to obtain longer term safety and
efficacy data than originally planned. Based on the achievement of
the non-inferiority endpoint, patients will continue to receive the
regimen to which they were randomized in a blinded fashion.
Elvitegravir is also being studied as part of Gilead’s
investigational fixed-dose, single-tablet "Quad" regimen. The Quad
contains four Gilead compounds in a fixed-dose, single-tablet:
elvitegravir; cobicistat, a pharmacoenhancing or "boosting" agent
that increases blood levels of certain HIV medicines; and Truvada®
(emtricitabine/tenofovir disoproxil fumarate). The Quad is
currently in Phase III testing. In addition, cobicistat is being
evaluated as a stand-alone boosting agent for other
antiretrovirals, in particular, protease inhibitors.
"We are very pleased to have achieved the primary endpoint in
this clinical trial, as data from this study will support
regulatory filings for elvitegravir as well as Gilead's
investigational Quad pill," said Norbert Bischofberger, PhD,
Executive Vice President, Research and Development and Chief
Scientific Officer, Gilead Sciences. "By analyzing these data now
we will be in a better position to advance filings as quickly as
possible once data from subsequent Phase III clinical trials in our
Quad development program become available later this year."
About the Elvitegravir Phase III
Study
Study 145 is a randomized, double-blind, 48-week clinical trial
evaluating the non-inferiority of elvitegravir (n=351) versus
raltegravir (n=351), each administered with a background regimen in
HIV-infected treatment-experienced adults with HIV RNA (viral load)
of greater than or equal to 1,000 copies/mL. Patients have
documented viral resistance, as defined by International AIDS
Society-USA guidelines, or at least six months of treatment
experience with two or more different classes of antiretroviral
agents prior to screening.
Trial participants receive either once-daily elvitegravir 150 mg
or twice-daily raltegravir 400 mg. Patients' background regimens
are based on the results of resistance testing and include a
fully-active ritonavir-boosted PI, and a second agent that may be a
nucleoside reverse transcriptase inhibitor (NRTI), etravirine,
maraviroc or enfuvirtide. Due to known pharmacokinetic
interactions, elvitegravir patients whose background PI is either
atazanavir or lopinavir receive an 85 mg dose of elvitegravir.
The primary endpoint analysis indicated that 59.0 percent of
patients in the elvitegravir arm compared to 57.8 percent in the
raltegravir arm (95% CI for the difference: -6.0% to +8.2%)
achieved and maintained a viral load of less than 50 copies/mL
through week 48. The predefined criterion for non-inferiority was a
lower bound of a two sided 95% CI of -10 percent. The nature and
frequency of Grade 3/4 adverse events and laboratory abnormalities
were similar between the two arms.
The study is ongoing in a blinded fashion. 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.
The Quad, elvitegravir and cobicistat are investigational
products and have not yet been determined safe or efficacious in
humans.
About Elvitegravir
Elvitegravir is an HIV integrase inhibitor. Unlike other classes
of antiretroviral agents, 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 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.
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 risks related to completing the Phase III clinical
studies of elvitegravir, cobicistat and the Quad in the currently
anticipated timelines. In addition, we may obtain unfavorable
results from these studies, may need to modify or delay our studies
or to perform additional trials and we may fail to obtain approvals
from the regulatory authorities. As a result, elvitegravir,
cobicistat or the Quad may never be successfully commercialized.
Further, Gilead may make a strategic decision to discontinue
development of elvitegravir, cobicistat or the Quad if, for
example, we believe commercialization will be difficult relative to
other opportunities in our 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 Annual Report
on Form 10-K for the year ended December 31, 2010, 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.
Truvada is a registered 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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