November 3, 2008

New Hepatitis C Drug Shows Incredible Promise

A meticulously watched hepatitis C drug, developed by Vertex Pharmaceuticals Inc, has a remarkable capability to stop the virus in patients in which other treatments were unsuccessful, and others not previously treated for the severe liver disease.

Like previous studies, the experimental Vertex drug, telaprevir, when united with typical liver treatments, indicated the promise of cutting in half the 48 weeks of treatment required with the present set of care and has superior effectiveness.

In a study labeled Prove 3, 453 of the patients who had previous treatment with pegylated-interferon and ribavirin that proved ineffective, 52 percent who took telaprevir saw the virus retreat to barely discernible levels and stayed there 12 weeks after finishing the treatment.

This is according to interim investigations of information to be presented at the American Association for the Study of Liver Diseases meeting in San Francisco, CA this week.

In the 52 percent result, the virus was imperceptible in 41 percent of patients who had not reacted to prior treatment and 73 percent of those who had reverted back after preceding treatment.

"Efficacy in non-responders is huge. No one should have any doubt about whether this drug works," said Jason Kolbert, an analyst with Susquehanna Financial Group.

"If Vertex can deliver anything north of 35 percent in HCV failure patients that's a huge leap. If they come close to 50 percent, then it's a home run," Kolbert said prior to release of the 52 percent findings.

The trial was created for telaprevir patients to obtain the triple combination for 12 weeks and the regular treatment for 12 weeks. Of patients who were collecting interferon and ribavirin for 48 weeks, 30 percent were at untraceable levels at week 36, interim data states.

The Prove 3 outcome "is noteworthy as patients who have failed therapy are very difficult to manage due to limited available treatment options and are at greater risk for developing progressive liver disease," said Dr. John McHutchinson, leading investigator of the Vertex-sponsored study.

Hepatitis C is a blood-borne liver disease that can show the way to chronic liver disease, liver cancer, cirrhosis and even death. The virus has an effect on about 3.2 million people in the United States and 170 million people universally.

Vertex also announced results from a previous experiment called Prove 2 relating 323 hepatitis C patients who had never gotten treatment for the virus before.

An increasing SVR rate is very probable in patient population and telaprevir delivered on that.

In the previous study, 69 percent of participants in the telaprevir combination group saw the virus fall to undetectable levels after 24 weeks of treatment, contrasting the 46 percent SVR rate following 48 weeks of regular treatment.

A third study tested if telaprevir could be as successful if given twice daily instead of three times it was given in clinical trials.

The most common unfavorable side effects were gastrointestinal issues, skin rash and anemia. Fourteen percent of telaprevir patients stopped treatment because of the adverse dealings in Prove 2 and 16 percent in Prove 3, Vertex said.

Vertex will start crucial late stage tests of telaprevir with partner Johnson & Johnson.

Many other companies are currently creating possible rival medicines, including boceprevir from Schering-Plow Corp, but telaprevir is anticipated to be the earliest in its class to go on the market.


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