Gilead Amends Study Design for Ongoing Hepatitis C Clinical Trials That Include GS 9190, Pegylated Interferon & Ribavirin, & ...
September 04 2011 - 11:00AM
Business Wire
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that, in
consultation with the U.S. Food and Drug Administration (FDA), the
company will amend the design of ongoing clinical trials to
discontinue dosing of GS 9190 in hepatitis C-infected patients who
are receiving that compound in combination with pegylated
interferon and ribavirin, and another direct-acting antiviral
agent.
This decision follows reports of two serious adverse events in
patients enrolled in two separate studies who were receiving a
four-drug regimen of GS 9190, an investigational HCV NS5B
polymerase inhibitor; pegylated interferon and ribavirin; and one
of two protease inhibitors (GS 9451 in one study and GS 9256 in the
second study). Patient safety is Gilead’s top priority, and the
company will therefore immediately halt the dosing of GS 9190 in
patients receiving this combination of medications.
Pegylated interferon in combination with ribavirin is currently
part of the standard of care treatment for patients with chronic
hepatitis C. Because of the side effects that can be associated
with interferon, Gilead is working to develop multiple oral
antivirals that, when used in combination, may be able to reduce or
eliminate the need for interferon.
Gilead does not anticipate any impact on the timelines for or
goals of its planned and ongoing clinical studies evaluating an
“all oral” regimen for the treatment of chronic hepatitis C.
Studies that include GS 9190 but do not include pegylated
interferon will continue as planned. Similarly, studies that
include the combination of GS 9451 (an investigational protease
inhibitor), GS 5885 (an investigational NS5A) and pegylated
interferon and ribavirin will continue.
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
that could cause actual results to differ materially from those
referred to in the forward-looking statements, including the
risk that further analysis of the laboratory abnormalities,
adverse events and other data obtained to date may not support the
continued development of GS 9190 and the risk that further clinical
testing of Gilead’s developmental compounds (including GS 9190, GS
9451, GS 5885 and GS 9256) and all oral regimens containing such
compounds result in laboratory abnormalities, adverse events and
other clinical data that may not support the continued development
of such compounds or regimens. 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.
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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