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Hepatitis C Drug Rocks Virus in Early Test

Dramatic Impact in 2 Weeks; Long-Term Effect, Safety Unknown
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WebMD Health News

May 17, 2005 -- In early tests on humans, a new hepatitis C drug had the most powerful punch yet seen against this major cause of liver cancer.

The drug, from Vertex Pharmaceuticals, is code-named VX-950. Liver specialist Henk W. Reesink, MD, of academic Medical Center in Amsterdam, Netherlands, presented the findings at Digestive Disease Week 2005, the annual meeting of several major medical specialty societies.

"This is really a breakthrough in the treatment of hepatitis C virus," Reesink tells WebMD. "This first human study was very successful. In the first two or three days of treatment there is a very rapid [1,000-fold] decline in hepatitis C virus levels. Then, over two weeks, there are further declines -- in some dosage groups, about a 25,000-fold reduction in viral levels. That has never been shown with any other drug."

Reesink warns that VX-950 is in the very earliest stage of human studies. Nobody knows if it will prove safe over time. Nobody knows whether its effects will continue long enough to cure hepatitis C virus infection.

And while the drug appears exquisitely effective against genotype 1 -- the most difficult-to-treat strain of hepatitis C virus and the one most common in the U.S. and Europe -- it's not clear whether it will work against other strains.

Despite being highly preliminary, Reesink's report excited the assembly of specialists, says Eugene R. Schiff, MD, chief of hepatology and director of the Center for Liver Diseases at the University of Miami School of Medicine.

"I was impressed, and everybody in the audience was impressed," Schiff tells WebMD. "Yes, this is preliminary, but this is an important advance. It is the most important paper presented at this meeting. They showed -- with an oral agent -- that they could drop hepatitis C viral levels, some to undetectable levels, in a relatively short period of time."

Most of the patients in the Reesink study already had failed state-of-the-art treatment for hepatitis C. That treatment is a combination of a highly active form of interferon plus an antiviral drug called ribavirin. This treatment offers long-term viral suppression -- what many experts call a cure -- in about half of patients. But this treatment takes nearly a year, and the side effects often are very difficult to endure.

VX-950: Protease Inhibitor Targets Hepatitis C Virus

VX-950 is a designer drug discovered only after huge effort. It targets a key hepatitis C protein. That protein is called protease, an enzyme the virus needs to reproduce.

It's not the first time a hepatitis C protease inhibitor has been tested in humans. Recently, an experimental hepatitis C protease inhibitor called BILN 2061 showed promising results in short-term human trials. But that drug had to be put on hold when monkey studies suggested it was toxic to the heart.

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