Vertex's Hepatitis C Drug Aces Review

Vertex Pharmaceuticals Inc.'s hepatitis C virus treatment results in a sustained virologic response in more patients and in less time than traditional treatment alone, according to a briefing document filed Tuesday by Food and Drug Administration staff members. Using FDA criteria, the regimen including Vertex's telaprevir had a 79 percent SVR for patients. The HCV protease inhibitor is up for review by an FDA advisory committee on Thursday.

The brief notes two side effects reported by Vertex: anemia and skin rashes in some patients taking the three-drug combination regimen -- telaprevir plus standard HCV drugs. The telaprevir-based drug cocktail proved more effective than the older drugs alone, which had a 46 percent SVR rate, the paper says.

The committee's daylong hearing on Thursday will center on whether to recommend approval of telaprevir, whose prospective brand name has not been disclosed. Founded in 1989, Vertex has been hiring hundreds of sales and marketing reps in anticipation of a launch.

Today the same FDA committee considers Merck & Co.'s HCV treatment boceprevir, which also inhibits the protease enzyme the virus needs for replication. Taken with other HCV drugs, boceprevir yielded an SVR for 66 percent of patients, according to an FDA briefing paper. Boceprevir also caused side effects in some patients, including anemia and blood disorders. If the drug is approved, Merck plans to market it as Victrelis.

For more information, visit www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm252750.htm.

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