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Gilead hepatitis C drug may have heart issue-study
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Sun Nov 4, 2007 5:57pm EST
NEW YORK, Nov 4 (Reuters) - Gilead Sciences Inc (GILD.O: Quote, Profile, Research) said on Sunday an experimental hepatitis C treatment in very early stages of development showed encouraging antiviral activity, but a signal of a potential heart problem could put the drug on hold.
Gilead said it has initiated a specific study to look at the potential cardiac risk, which is expected to be concluded before the end of the year.
Preliminary interim results of the small, two-part phase 1 study of the drug, GS 9190, were presented at the American Association for the Study of Liver Diseases meeting in Boston.
Included in the study design was a standard test for cardiovascular safety. The company said in the second, multiple dose portion of the study, a possible but not confirmed QT elongation was observed. QT elongation is associated with an irregular heart rhythm and can be very dangerous.
The company's specific QT study involves healthy volunteers, Gilead said.
"Pending resolution of this safety concern, these encouraging preliminary Phase I trial data support further evaluation of GS 9190 in hepatitis C-infected patients," Gilead said.
Other than the potential QT elongation problem, there were no serious or treatment-limiting adverse events. All adverse events recorded were mild, with the exception of one moderate headache, researchers said.
The first part of the study involved 31 patients and involved escalating single doses from 40 milligrams to 480 mg of GS 9190 compared to placebo. Also tested was 120 mg and 240 mg with and without food.
All single doses of GS 9190 demonstrated antiviral activity with the drug showing the greatest effect 24 hours after administration, researchers said.
The second part of the study, with 23 patients, involved twice a day dosing at various strengths over a period of eight days.
Twice daily administration over eight days was generally well tolerated, researchers said. But it was during this part of the study that the potential heart problem cropped up.
"These Phase I data support continued evaluation of GS 9190 as a potential therapeutic option for hepatitis C virus," said Dr. Ira Jacobson, chief of the division of gastroenterology and hepatology at Weill Medical College of Cornell University, who presented the data. (Reporting by Bill Berkrot)
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