Biotech Values

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Gilead Amends Study Design for Ongoing Hepatitis C Clinical Trials That Include GS 9190, Pegylated Interferon and Ribavirin, and Another Direct-Acting Antiviral Agent




Change Does Not Affect Ongoing "All Oral" Clinical Trials Evaluating
Multiple Direct-Acting Antivirals in Combination



FOSTER CITY, Calif., Sep 04, 2011 (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.