NEJM study points to new era in hepatitis C...( NEW YORK (June 4 2009) -- For patie...),Health

NEW YORK (June 4, 2009) -- For patients with the most common form of hepatitis C, the addition of a hepatitis Cspecific protease inhibitor called telaprevir to the current standard therapy can significantly improve the chances of being cured, and it does it in half the time of standard therapy alone.

Results of the Phase IIb clinical trial -- led by Duke Clinical Research Institute (DCRI) and 36 other sites, including NewYork-Presbyterian Hospital/Weill Cornell Medical Center -- are published in the April 30th issue of the New England Journal of Medicine. The study was funded by Vertex Pharmaceuticals Incorporated, the maker of the drug telaprevir. The drug works by blocking an enzyme that the hepatitis C virus needs in order to replicate itself.

"These findings point the way to a new era in the treatment of hepatitis C," says Dr. Ira M. Jacobson, a co-author of the study and chief of the Division of Gastroenterology and Hepatology at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, and the Vincent Astor Distinguished Professor of Clinical Medicine at Weill Cornell Medical College. "Not only does adding telaprevir make standard hepatitis C treatment more effective, but it makes it work much more quickly. We showed that the duration of therapy can be reduced from 48 weeks to 24 weeks for most patients. This could help reduce the potentially severe side effects of longer regimens with standard therapy."

The randomized, double-blinded trial followed 250 patients with untreated hepatitis C genotype 1. Researchers measured rates of sustained viral response or viral cure -- an undetectable quantity of hepatitis C virus -- 24 weeks after the end of completion of therapy. They compared a 12-week regimen of telaprevir combined with two different durations of the standard therapy -- peginterferon alfa-2a and ribavirin -- to a control group taking 48 weeks of standard therapy alone. Results showed that 67 percent of patient
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