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AASLD, In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

All STAT-C therapy still on track; looking forward to INFORM-2: Roche reported positive news from three final higher-dose cohorts of the INFORM-1 trial, a Phase I study of two direct-acting antiviral compounds administered orally to hepatitis C patients without standard-of-care interferon and ribavirin, at the American Association for the Study of Liver Disease meeting in Boston on Nov. 3. While it is early days, the effort is being followed closely for its potential to eliminate IFN/RBV and their side effects from the standard treatment regimen for HCV (1"The Pink Sheet," May 4, 2009). The investigational therapy combines InterMune's ritonavir-boosted protease inhibitor, ITMN-191/R7227, with the nucleoside polymerase inhibitor R7128, from Pharmasset. The Phase II INFORM-2 study will launch in the first quarter of 2010 to investigate twice-daily dosing of the STAT-C combination alone, in combination with interferon alfa-2a, with ribavirin, and with both. Longer term studies evaluating sustained virologic response - which is considered a cure in hep C - are planned for the first half of 2010

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