Gilead
Begins First Phase 3 Clinical Trials of Boosted Elvitegravir Quad
Pill
By
Liz Highleyman
Below is an excerpt from a Gilead press release describing
the newly initiated Quad trials, as well as another Phase 3 study
of cobicistat as a stand-alone boosting agent.
Gilead
Initiates Phase III Clinical Program Evaluating
Single-Tablet, Once-Daily "Quad" Regimen for HIV
Foster
City, Calif. -- April 12, 2010 -- Gilead Sciences, Inc. (Nasdaq:GILD)
today announced that it has dosed the first patient in the Phase
III clinical program evaluating its investigational fixed-dose,
single-tablet "Quad" regimen of elvitegravir, cobicistat
(formerly GS 9350), emtricitabine and tenofovir disoproxil fumarate.
The Phase III clinical program for the Quad includes two studies
(Studies 102 and 103) that will evaluate the Quad regimen versus
a standard of care among HIV-1 infected antiretroviral treatment-naive
adults.
"We are pleased to announce that the Quad Phase III clinical
program is underway," said Norbert Bischofberger, PhD, Executive
Vice President, Research and Development and Chief Scientific
Officer, Gilead Sciences. "Efficacy and safety results from
the Phase II study suggest that the Quad may represent an important
new option for patients with HIV. We look forward to further defining
the clinical profile of the Quad in a larger number of patients
in the Phase III trials."
Gilead is also examining cobicistat as a stand-alone boosting
agent for other antiretrovirals, in particular protease inhibitors.
Later this quarter, Gilead plans to initiate a Phase III clinical
trial evaluating the efficacy, safety and tolerability of cobicistat-boosted
atazanavir compared to ritonavir-boosted atazanavir, each in combination
with Truvada (emtricitabine and tenofovir disoproxil fumarate).
Study Design
Study 102 is a randomized, double-blind clinical trial that will
compare the efficacy, safety and tolerability of the Quad versus
Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil
fumarate 300 mg) over a 96-week period at 130 study sites in the
United States and Puerto Rico. Eligible participants will be HIV-infected
treatment-naive adults with HIV RNA levels greater than or equal
to 5,000 copies/mL. Approximately 700 trial participants will
be 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=350) or Atripla (efavirenz 600 mg/emtricitabine
200 mg/tenofovir disoproxil fumarate 300 mg) (n=350).
Study 103 is a randomized, double-blind clinical trial that will
compare the efficacy, safety and tolerability of the Quad versus
ritonavir-boosted atazanavir and Truvada over a 96-week period
at more than 200 study sites in North America, South America,
Europe and Asia Pacific. Eligible participants will be HIV-infected
treatment-naive adults with HIV RNA levels greater than or equal
to 5,000 copies/mL. Approximately 700 trial participants will
be 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=350) or ritonavir 100 mg and atazanavir
300 mg and emtricitabine 200 mg/tenofovir disoproxil fumarate
300 mg (n=350).
The primary endpoint of both trials will be 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.
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.
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.
The fixed-dose single-tablet "Quad" regimen, elvitegravir
and cobicistat 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 Australia.
The complete press release, which includes Truvada and Atripla
safety information, is available online at http://www.gilead.com/pr_1411934.
For complete prescribing information for Truvada, visit www.Truvada.com.
For complete prescribing information for Atripla, visit www.Atripla.com.
For more information on Gilead Sciences, please visit the company's
website at www.gilead.com.
4/16/10
Source
Gilead
Sciences. Gilead Initiates Phase III Clinical Program Evaluating
Single-Tablet, Once-Daily "Quad" Regimen for HIV. Press
release. April 12, 2010.
