Gilead’s Investigational Antiretroviral Quad Regimen Meets 48-Week Primary Objective in Pivotal Phase 3 Clinical Study 102
August 15 2011 - 8:30AM
Business Wire
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that a Phase
3 clinical trial (Study 102) of its investigational fixed-dose,
single-tablet “Quad” regimen of elvitegravir, cobicistat,
emtricitabine and tenofovir disoproxil fumarate, being evaluated
for HIV-1 infection in treatment-naïve patients, met its primary
objective, which was non-inferiority at week 48 as compared to
Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir
disoproxil fumarate 300 mg). The primary endpoint analysis
indicated that 88 percent of patients in the Quad arm compared to
84 percent in the Atripla (95% CI for the difference: -1.6% to
8.8%) achieved HIV RNA (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 -12 percent.
The mean 48-week increase in CD4 cell count from baseline was
239 cells/mm3 in the Quad arm compared to 206 cells/mm3 in the
Atripla arm (p=0.009). The frequency of Grade 3-4 adverse events
and laboratory abnormalities was similar between the Quad-treated
and the Atripla-treated arms. 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 early
next year.
The Quad contains four Gilead compounds in a complete
once-daily, single-tablet regimen: elvitegravir, an investigational
integrase inhibitor; cobicistat, an investigational
pharmacoenhancing or "boosting" agent that increases blood levels
of certain HIV medicines; and Truvada® (emtricitabine/tenofovir
disoproxil fumarate). The Phase 3 clinical program for the Quad
includes two studies (Studies 102 and 103) which are evaluating the
Quad regimen versus a standard of care among HIV-1 infected
antiretroviral treatment-naïve adults. The second pivotal Quad
study (Study 103), a randomized, double-blind clinical trial
comparing the efficacy, safety and tolerability of the Quad versus
ritonavir-boosted atazanavir and Truvada, is ongoing, and results
are expected later this quarter.
“Achieving non-inferiority to the current standard of care in
HIV therapy is a major developmental milestone for our Quad
regimen,” said Norbert Bischofberger, PhD, Executive Vice
President, Research and Development and Chief Scientific Officer,
Gilead Sciences. “We are very pleased with these results, which are
in line with our expectations and allow us to begin preparations
for a U.S. regulatory filing in the first quarter of 2012.”
Cobicistat is also being evaluated as a stand-alone boosting
agent for other antiretrovirals, in particular, the protease
inhibitor atazanavir. Results from the Phase 3 clinical trial of
cobicistat are expected in the fourth quarter of this year.
Forty-eight week results from the Phase 3 trial of elvitegravir as
a stand-alone agent were presented last month at the 6th
International AIDS Society Conference on HIV Pathogenesis,
Treatment and Prevention (IAS 2011) in Rome, Italy.
About Study 102
Study 102 is a randomized, double-blind clinical trial comparing
the efficacy, safety and tolerability of the Quad versus Atripla
over a 96-week period at 130 study sites in the United States and
Puerto Rico. Eligible participants were HIV-infected
treatment-naïve adults with HIV RNA levels greater than or equal to
5,000 copies/mL. Trial participants were randomized (1:1) to
receive a once-daily tablet containing elvitegravir 150
mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil
fumarate 300 mg (n=348) or Atripla (efavirenz 600 mg/emtricitabine
200 mg/tenofovir disoproxil fumarate 300 mg) (n=352).
The primary endpoint of the study is the proportion of patients
achieving HIV RNA levels of less than 50 copies/mL at 48 weeks of
treatment. Secondary objectives will evaluate the efficacy, safety
and tolerability of the treatment regimens through 96 weeks of
treatment.
The study is ongoing in a blinded fashion. After week 96,
subjects will continue to take their blinded study drug until
treatment assignments have been unblinded, at which point all
subjects will be given the option to participate in an open-label
rollover extension and receive the Quad single-tablet regimen.
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 Cobicistat
Cobicistat is Gilead’s proprietary potent mechanism-based
inhibitor of cytochrome P450 3A (CYP3A), an enzyme that metabolizes
drugs in the body. In addition to studying the agent as part of an
integrase-based fixed-dose regimen, Gilead is also examining
cobicistat’s potential stand-alone role in boosting commercially
available HIV protease inhibitors, which are used in many HIV
treatment regimens.
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 Gilead’s anticipated timelines for
submitting data from Study 102 for presentation at a scientific
conference, obtaining results from Study 103, preparing for a U.S.
regulatory filing for the Quad and obtaining results from the Phase
3 clinical trial of cobicistat. In addition, Gilead may obtain
unfavorable results from its elvitegravir, cobicistat and Quad
studies, may need to modify or delay its studies or to perform
additional trials and may fail to obtain approvals from the U.S.
Food and Drug Administration and other 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, 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 year ended
June 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.
Truvada is a registered trademark of Gilead
Sciences, Inc.Atripla is a registered trademark of Bristol-Myers
Squibb & Gilead Sciences, LLC.
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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