FDA Gives Two New Hep C Medications Priority Review Status

Back in 2006, when I had my liver transplant, the heptologists at my transplant center told my husband and me that a new medication for treating Hepatitis C was in clinical trials and would be available the following year. We heard the same news in 2007, 2008, 2009 and 2010. Our skepticism is understandable, don't you agree?

Yet it appears that in 2011 our long wait will end. The FDA is giving Priority Review status to telaprevir, which was developed by Vertex Pharmaceuticals for people with genotype 1 chronic hepatitis C. In addition, Prioirity Review has been given to boceprevir, an oral hepatitis C virus (HCV) protease inhibitor developed by Merck.

The FDA gives Priority Review designation "...to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists... The goal for completing a Priority Review is six months." The target review date for telaprevir is May 23, 2011 (I could not find a review date for boceprevir).

Both medications show better cure rates and, for some people, reduce the treatment time. Furthermore, they will be the first drugs that directly target the Hepatitis C virus.

I don't know how quickly the drugs will reach the market after FDA approval but I hope it doesn't take long. My poor liver has taken enough abuse from this devastating virus.

Photo by Nina Briski