Vertex hep C drug helps tough to treat patients

Vertex hep C drug helps tough to treat patients

Wed Oct 28


* 57 pct prior null responders achieve SVR on telaprevir

* 90 pct prior relapsers achieve SVR on telaprevir

NEW YORK, Oct 28 (Reuters) - Vertex Pharmaceuticals Inc's (VRTX.O) closely watched hepatitis C drug telaprevir knocked out the virus in a significant number of patients who had failed to respond to standard treatments or relapsed after taking the standard drugs, according to a study.

Interim results from an ongoing study released on Wednesday showed that 57 percent of patients, who failed to respond to treatment wit h the standard treatments of pegylated-interferon and ribavirin and 90 percent of those who responded but later relapsed, achieved a sustained viral response when telaprevir was added to their regimen.

The percentage of patients in whom the virus is undetectable after completing treatment yields the critical measure known as sustained viral response, or SVR.

"Results that include SVR rates of 57 percent in the difficult-to-treat null responder population are important for prior treatment-failure patients who h ave limited options," Peter Mueller, Vertex's chief scientific offic er, said in a statement.

There was also a 55 percent SVR rate among patients on telaprevir who had appeared to be responding to prior standard treatment after 12 weeks, but still had detectable levels of the virus at week 24.

Telaprevir, an experimental treatment for the serious liver disease, is the most important drug in Vertex's developmental pipeline and is expected to become its first commercial product.

The company plans to file an application seeking U.S. approval of telaprevir in the second half of 2010.

Patients in this open label study had been in the control groups of previous telaprevir trials and were then given the Vertex drug.

Of 117 patients enrolled in the study, data from 94 was included in the interim analysis, Vertex said.

Eight patients in the study discontinued treatment due to adverse side effects, including rash and anemia. (Reporting by Bill Berkrot, editing by Leslie Gevirtz)