Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the
second pivotal Phase 3 clinical trial (Study 103) 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 of non-inferiority at week 48
as compared to ritonavir-boosted atazanavir plus Truvada®
(emtricitabine/tenofovir disoproxil fumarate) based on the
proportion of subjects who achieved HIV RNA levels (viral load) of
less than 50 copies/mL.
The primary endpoint analysis indicated that 90 percent of
patients in the Quad arm compared to 87 percent in the
ritonavir-boosted atazanavir plus Truvada arm (95 percent CI for
the difference: -1.9 percent to 7.8 percent) achieved HIV RNA of
less than 50 copies/mL through week 48. The predefined criterion
for non-inferiority was a lower bound of a two sided 95 percent CI
of -12 percent. The discontinuation rate due to adverse events was
higher in the ritonavir-boosted atazanavir arm (5.1 percent) as
compared to the Quad (3.1 percent). This difference was driven
primarily by elevated bilirubin levels observed in the
ritonavir-boosted atazanavir arm. Other adverse events and
laboratory abnormalities were similar between the two arms. Gilead
plans to submit these data for presentation at a scientific
conference early next year.
“The 90 percent response rate observed on the Quad arm in this
study is an unprecedented result and speaks to the potency, safety
and convenience of an integrase-based single-tablet regimen,” said
Norbert Bischofberger, PhD, Executive Vice President, Research and
Development and Chief Scientific Officer, Gilead Sciences. “Based
on the availability of data from both pivotal Studies 102 and 103,
we are now working toward filing for U.S. regulatory approval of
the Quad by the end of the year.”
Conference Call
At 4:30 p.m. Eastern Time today, Gilead’s management will host a
conference call and a simultaneous webcast to discuss results from
this study. To access the webcast live via the internet, please
connect to the company’s website at www.gilead.com 15 minutes prior to the conference
call to ensure adequate time for any software download that may be
needed to hear the webcast. Alternatively, please call
1-866-730-5770 (U.S.) or 1-857-350-1594 (international) and dial
the participant passcode 86019231 to access the call.
A replay of the webcast will be archived on the company’s
website for one year, and a phone replay will be available
approximately two hours following the call through September 21,
2011. To access the phone replay, please call 1-888-286-8010 (U.S.)
or 1-617-801-6888 (international) and dial the participant passcode
88891133.
About Study 103
Study 103 is a randomized, double-blind clinical trial comparing
the efficacy, safety and tolerability of the Quad versus
ritonavir-boosted atazanavir plus Truvada over a 96-week period at
more than 200 study sites in North America, South America, Europe
and Asia Pacific. Eligible participants are 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=353) or ritonavir 100 mg and atazanavir 300 mg
plus Truvada (emtricitabine/tenofovir disoproxil fumarate)
(n=355).
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 the Quad
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. 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. Study 102, a
randomized, double-blind clinical trial comparing the efficacy,
safety and tolerability of the Quad versus Atripla® (efavirenz 600
mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) is
ongoing, and the company announced that the study met its primary
objective of non-inferiority at week 48 on August 15, 2011.
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 103 for presentation at a scientific
conference and for filing for regulatory approval of the Quad. In
addition, Gilead may obtain unfavorable results from 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 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 quarter 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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