Gilead’s Boosting Agent, Cobicistat, Meets 48-Week Primary Objective in Pivotal Phase 3 Study
December 05 2011 - 8:30AM
Business Wire
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that a
Phase 3 clinical trial (Study 114) of its pharmacoenhancing or
“boosting” agent cobicistat, which increases blood levels of
certain HIV medicines to allow for one pill once-daily dosing, met
its 48-week primary objective of non-inferiority to ritonavir.
The Study 114 primary endpoint analysis indicated that after 48
weeks of treatment, 85 percent of patients taking a regimen of
cobicistat-boosted atazanavir (a protease inhibitor) plus Truvada®
(emtricitabine and tenofovir disoproxil fumarate) achieved HIV RNA
(viral load) of less than 50 copies/mL, compared to 87 percent of
patients taking ritonavir-boosted atazanavir plus Truvada (95
percent CI for the difference: -7.4 percent to 3.0 percent). The
predefined criterion for non-inferiority was a lower bound of a
two-sided 95 percent CI of -12 percent. Discontinuation rates due
to adverse events were 7.3 percent and 7.2 percent in the
cobicistat and ritonavir arms of the study, respectively. Gilead
plans to submit these data for presentation to a scientific
conference in 2012.
“The majority of today’s protease-based HIV treatment regimens
depend on a boosting agent for optimal efficacy,” said Norbert
Bischofberger, PhD, Executive Vice President, Research and
Development and Chief Scientific Officer, Gilead Sciences. “These
results demonstrate that cobicistat may provide patients taking
protease-based regimens with a much-needed alternative boosting
agent. We are now working toward a second quarter 2012 U.S.
regulatory filing for cobicistat.”
Small increases in serum creatinine (a value used to estimate
kidney function) with resulting decreases in estimated creatinine
clearance (by Cockroft-Gault) were observed in this study. At 48
weeks, the mean increase from baseline in serum creatinine was 0.14
mg/dL among cobicistat patients and 0.09 mg/dL among ritonavir
patients. The increase in serum creatinine with cobicistat occurs
within days of drug initiation and is reversible with values
returning to baseline within days after cessation of cobicistat.
Results from a separate Phase 1 renal study in healthy volunteers
indicate that cobicistat does not affect actual glomerular
filtration rates (GFR) as assessed by iohexol clearance (a true
measure of kidney function).
About the Cobicistat Phase 3
Study
Study 114 is a randomized, double-blind, Phase 3 clinical trial
comparing the efficacy and safety of cobicistat-boosted atazanavir
versus ritonavir-boosted atazanavir, each administered with
Truvada, over a 96-week period at more than 200 study sites in
North America, South America, Europe and Asia Pacific. 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 regimen of cobicistat 150 mg,
atazanavir 300 mg and Truvada (n=344) or ritonavir 100 mg,
atazanavir 300 mg and Truvada (n=348).
The primary endpoint of the study was the proportion of patients
achieving HIV RNA levels of less than 50 copies/mL at 48 weeks of
treatment, as determined by the FDA-defined snapshot analysis.
Secondary objectives will evaluate the efficacy, safety and
tolerability of the treatment regimens through 96 weeks of
treatment. Additional information about the study can be found at
www.clinicaltrials.gov.
About Cobicistat
Cobicistat is Gilead’s proprietary potent mechanism-based
inhibitor of cytochrome P450 3A (CYP3A), an enzyme that metabolizes
drugs in the body. Cobicistat is an investigational product and its
safety and efficacy have not yet been established.
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
cobicistat in the timelines currently anticipated and the
possibility of unfavorable results from further clinical studies of
cobicistat. Further, Gilead may fail to obtain approvals from
regulatory authorities and any marketing approval, if granted, may
have significant limitations on its use. As a result, cobicistat
may never be successfully commercialized. In addition, Gilead may
make a strategic decision to discontinue development of cobicistat
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 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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