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R&D In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Roche initiates PI/PI combo HCV trial early: Roche announces the first patients have been dosed in its INFORM-1 trial Nov. 10, almost a year early. The trial is the first dual-combination study with oral antivirals in hepatitis C in the absence of interferon, which, in combination with ribavirin, is the standard of care for HCV. Roche will dose patients with its protease inhibitor ITMN-191 (R7227), partnered with InterMune, and its polymerase inhibitor R7128, partnered with Pharmasset, over 14 days in treatment-naive patients infected with HCV genotype 1. Roche recently dropped its lead polymerase inhibitor candidate, R1626, for safety reasons, and shifted focus to R7128 (1"The Pink Sheet" DAILY, Oct. 21, 2008). Top-line data from the combination trial could come as early as the second quarter of 2009. The trial combines the two most promising mechanisms for HCV therapy. Panelists at the recent ICAAC conference predicted that the protease inhibitors should reach the market in 2011, followed by polymerase inhibitors in 2014. Initially protease inhibitors will be used in combination with interferon/ribavirin therapy, but there is potential that combination therapy with protease and polymerase inhibitors will eventually replace the older standard regimen

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