Novel therapy combinations gain ground in treating...( overall tolerability of the CIFN regime...),Health

overall tolerability of the CIFN regimen was comparable to PEG IFN. Three patients experienced thrombocytopenias (reduced blood platelets), but there were no severe neutropenias (low white blood cell count) or thrombocytopenias. CIFN patients experienced a higher rate of injection site reactions and a slightly higher drop-out rate of 18 percent, compared to only 12 percent of the pegIFN group.

28 Days of the Hepatitis C Protease Inhibitor VX-950, In Combination with Peg-Interferon-Alfa-2a and Ribavirin, is Well-Tolerated and Demonstrates Robust Antiviral Effects [Abstract 686f]

Scientists are reviewing new compounds in combination with current standard hepatitis therapies to produce better patient outcomes. A new oral peptidomimetic protease inhibitor, VX-950, has previously shown substantial anti-viral effects in combination with the frequently used hepatitis therapy pegylated interferon (pegIFN). In this study, researchers evaluated the safety and antiviral response of VX-950 in combination with pegIFN and ribavirin (RBV).

The study included 12 hepatitis C patients who received 750 mg of VX-950 every eight hours, 180 g of pegIFN weekly, and either 1000 or 1200 mg of RBV daily. After 28 days, patients began standard therapy with pegIFN/RBV.

All patients responded to the study drug regimen and showed continual declines in hepatitis RNA throughout the treatment period. Two patients had levels of HCV RNA in their blood below the limits of detection of a highly sensitive assay after just eight days. All patients had undetectable HCV RNA by the end of 28 days. No patients experienced viral breakthrough at any time.

"These data confirm the rapid and dramatic antiviral effects of VX-950. All subjects achieving undetectable HCV RNA within 28 days of treatment is an unprecedented result with an investigational agent," said Eric Lawitz, M.D., of Alamo Medical Research, Texas, and lead author of the study. "We look
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Contact: Aimee Frank
newsroom@gastro.org
213-743-6219
American Gastroenterological Association
21-May-2006

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